80_FR_26045 80 FR 25958 - Medicare Program; Changes to the Requirements for Part D Prescribers

80 FR 25958 - Medicare Program; Changes to the Requirements for Part D Prescribers

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 80, Issue 87 (May 6, 2015)

Page Range25958-25966
FR Document2015-10545

This interim final rule with comment period revises requirements related to beneficiary access to covered Part D drugs. Under these revised requirements, pharmacy claims and beneficiary requests for reimbursement for Medicare Part D prescriptions, written by prescribers other than physicians and eligible professionals who are permitted by state or other applicable law to prescribe medications, will not be rejected at the point of sale or denied by the plan if all other requirements are met. In addition, a plan sponsor will not reject a claim or deny a beneficiary request for reimbursement for a drug when prescribed by a prescriber who does not meet the applicable enrollment or opt-out requirement without first providing provisional coverage of the drug and individualized written notice to the beneficiary. This interim final rule with comment period also revises certain terminology to be consistent with existing policy and to improve clarity.

Federal Register, Volume 80 Issue 87 (Wednesday, May 6, 2015)
[Federal Register Volume 80, Number 87 (Wednesday, May 6, 2015)]
[Rules and Regulations]
[Pages 25958-25966]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-10545]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 423

[CMS-6107-IFC]
RIN 0938-AS60


Medicare Program; Changes to the Requirements for Part D 
Prescribers

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Interim final rule with comment period.

-----------------------------------------------------------------------

SUMMARY: This interim final rule with comment period revises 
requirements related to beneficiary access to covered Part D drugs. 
Under these revised requirements, pharmacy claims and beneficiary 
requests for reimbursement for Medicare Part D prescriptions, written 
by prescribers other than physicians and eligible professionals who are 
permitted by state or other applicable law to prescribe medications, 
will not be rejected at the point of sale or denied by the plan if all 
other requirements are met. In addition, a plan sponsor will not reject 
a claim or deny a beneficiary request for reimbursement for a drug when 
prescribed by a prescriber who does not meet the applicable enrollment 
or opt-out requirement without first providing provisional coverage of 
the drug and individualized written notice to the beneficiary. This 
interim final rule with comment period also revises certain terminology 
to be consistent with existing policy and to improve clarity.

DATES: 
    Effective date: These regulations are effective on June 1, 2015.
    Applicability date: The provisions at Sec.  423.120(c)(6) are 
applicable January 1, 2016.
    Comment date: To be assured consideration, comments must be 
received at one of the addresses provided below, no later than 5 p.m. 
on July 6, 2015.

ADDRESSES: In commenting, please refer to file code CMS-6107-IFC. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of four ways (please choose only one 
of the ways listed)
    1. Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-6107-IFC, P.O. Box 8013, 
Baltimore, MD 21244-8013.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-6107-IFC, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    4. By hand or courier. Alternatively, you may deliver (by hand or 
courier) your written comments ONLY to the following addresses prior to 
the close of the comment period: a. For delivery in Washington, DC--
Centers for Medicare & Medicaid Services, Department of Health and 
Human Services, Room 445-G, Hubert H. Humphrey Building, 200 
Independence Avenue SW., Washington, DC 20201.
    (Because access to the interior of the Hubert H. Humphrey Building 
is not readily available to persons without Federal government 
identification, commenters are encouraged to leave their comments in 
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing 
by stamping in and retaining an extra copy of the comments being 
filed.)
    b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, 7500 Security 
Boulevard, Baltimore, MD 21244-1850.
    If you intend to deliver your comments to the Baltimore address, 
call telephone number (410) 786-9994 in advance to schedule your 
arrival with one of our staff members.
    Comments erroneously mailed to the addresses indicated as 
appropriate for hand or courier delivery may be delayed and received 
after the comment period.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Frank Whelan, (410) 786-1302 for 
enrollment issues.
    Lisa Thorpe, (410) 786-3048, for provisional coverage, notice, and 
all other issues.

SUPPLEMENTARY INFORMATION: 
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in

[[Page 25959]]

a comment. We post all comments received before the close of the 
comment period on the following Web site as soon as possible after they 
have been received: http://regulations.gov. Follow the search 
instructions on that Web site to view public comments.
    Comments received timely will be also available for public 
inspection as they are received, generally beginning approximately 3 
weeks after publication of a document, at the headquarters of the 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 
a.m. to 4 p.m. To schedule an appointment to view public comments, 
phone 1-800-743-3951.

I. Background

A. Purpose

    Under this interim final rule with comment period (IFC), pharmacy 
claims and beneficiary requests for reimbursement for Medicare Part D 
prescriptions, written by prescribers other than physicians and 
eligible professionals who are permitted by state or other applicable 
law to prescribe medications, will not be rejected at the point of sale 
or denied by the plan if all other requirements are met. In addition, a 
plan sponsor will not reject a claim or deny a beneficiary request for 
reimbursement for a drug on the grounds that the prescriber has not 
enrolled in or opted out of Medicare without first providing 
provisional coverage of the drug and individualized written notice to 
the beneficiary. These changes are necessary to help make certain that 
Medicare beneficiaries continue to have access to needed Part D 
medications. As explained in section III. of this IFC, we believe that 
we have good cause to make these changes in an IFC because the ordinary 
notice-and-comment process would be contrary to the public interest; 
furthermore, we believe that notice-and-comment rulemaking for the 
technical changes we are making in this IFC (as described in sections 
II.D., II.E., and II.F. of this IFC) is unnecessary because these 
changes are not substantive and do not alter current policy.

B. Legal Authority

    There are four principal statutory authorities for the provisions 
in this IFC.
    First, sections 1102 and 1871 of the Social Security Act (the Act) 
provide general authority for the Secretary to prescribe regulations 
for the efficient administration of the Medicare program.
    Second, section 1866(j) of the Act provides specific authority with 
respect to the Medicare enrollment process for providers and suppliers.
    Third, section 6405(c) of the Affordable Care Act gives the 
Secretary the authority to require that pharmacy claims and beneficiary 
reimbursement requests for covered Part D drugs prescribed by a 
physician (as defined in section 1861(r) of the Act) or eligible 
professional (as defined in section 1848(k)(3)(B) of the Act) are not 
payable unless the prescribing physician or eligible professional is 
enrolled in Medicare under section 1866(j) of the Act.
    Fourth, section 1860D-12(b)(3)(D) of the Act authorizes the 
Secretary to include in a contract with a Part D sponsor such other 
terms and conditions that are not inconsistent with Part D as the 
Secretary may find necessary and appropriate.

C. Provider Enrollment Process

    The Medicare CMS-855 enrollment application collects information 
from providers and suppliers to confirm that they meet all Medicare 
requirements. Such data includes, but are not limited to, the 
provider's or supplier's licensure, tax identification number, National 
Provider Identifier (NPI), practice locations, final adverse action 
history, and owning and managing individuals and organizations. Upon 
receiving a CMS-855 application from a physician or eligible 
professional, the CMS contractor validates the information and performs 
various screening activities, such as reviewing the System for Award 
Management (SAM) to confirm that the individual is not debarred from 
receiving payments under any federal health program. As explained in 
section II. of this IFC, we have taken measures to improve the provider 
enrollment process to determine whether enrolling physicians and 
eligible professionals meet all Medicare requirements.

D. Section 6405 of the Affordable Care Act and the May 23, 2014 Final 
Rule

    As noted previously, section 6405(c) of the Affordable Care Act 
gives the Secretary the authority to extend the requirements of 
sections 6405(a) and (b) of the Affordable Care Act to all other 
categories of items or services under title XVIII of the Act that are 
ordered, prescribed, or referred by a physician or eligible 
professional, including covered Part D drugs. Sections 6405(a) and (b) 
of the Affordable Care Act require physicians and eligible 
professionals who order or certify durable medical equipment, 
prosthetics, orthotics, supplies, or home health services to be 
enrolled in Medicare.
    In accordance with section 6405(c) of the Affordable Care Act, we 
established new Sec.  423.120(c)(6) as part of a May 23, 2014 final 
rule titled, ``Medicare Program; Contract Year 2015 Policy and 
Technical Changes to the Medicare Advantage and the Medicare 
Prescription Drug Benefit Programs'' (79 FR 29843). Our objective was 
to help confirm that Part D drugs are prescribed only by physicians and 
eligible professionals who are qualified to do so under state law and 
under the requirements of the Medicare program. Section 423.120(c)(6) 
currently contains the following provisions:
     A Part D sponsor must deny, or must require its 
pharmaceutical benefit manager (PBM) to deny, a pharmacy claim for a 
Part D drug if an active and valid physician or eligible professional 
National Provider Identifier (NPI) is not contained on the claim.
     A Part D sponsor must deny, or must require its PBM to 
deny, a pharmacy claim for a Part D drug if the physician or eligible 
professional--is not enrolled in the Medicare program in an approved 
status; and does not have a valid opt-out affidavit on file with a Part 
A/B Medicare Administrative Contractor (MAC).
     A Part D sponsor must deny, or must require its PBM to 
deny, a request for reimbursement from a Medicare beneficiary for a 
drug if the request is not for a Part D drug that was dispensed in 
accordance with a prescription written by a physician or eligible 
professional who is identified by his or her legal name in the request; 
and
    ++ Is enrolled in Medicare in an approved status; or
    ++ Has a valid opt-out affidavit on file with a Part A/B MAC.
     In order for a Part D sponsor to submit to CMS a 
prescription drug event record (PDE), the PDE must contain an active 
and valid individual prescriber NPI and must pertain to a claim for a 
Part D drug that was dispensed in accordance with a prescription 
written by a physician or eligible professional who--is enrolled in 
Medicare in an approved status; or has a valid opt-out affidavit on 
file with a Part A/B MAC.
    These requirements apply as of June 1, 2015. However, on December 
3, 2014, through the Health Plan Management System (HPMS), we announced 
an enforcement delay until December 1, 2015. We are now in this IFC 
making another change to make these requirements applicable on January 
1, 2016. Accordingly, and as explained in section II.C. of this IFC, we 
are making

[[Page 25960]]

conforming changes to the regulation text.

II. Provisions of the Interim Final Rule With Comment Period

A. Enrollment

    There are prescribers other than physicians and eligible 
professionals, such as pharmacists, who are legally authorized under 
state or other law to prescribe covered Part D drugs. For example, 
under a Pharmacist Collaborative Practice Agreement, pharmacists may be 
legally authorized to prescribe covered Part D under state or other 
law. However, pharmacists are not physicians under section 1861(r) of 
the Act or eligible professionals under section 1848(k)(3)(B) of the 
Act, and are therefore not eligible to enroll in or opt-out of 
Medicare. Under Sec.  423.120(c)(6), as described previously in section 
I.D. of this IFC, beneficiaries who have been receiving necessary 
prescriptions from prescribers who are not Medicare-enrolled or opted-
out physicians or eligible professionals will no longer be able to 
obtain Part D coverage for these prescriptions once the requirements of 
Sec.  423.120(c)(6) are enforced. Changes to previously finalized 
policies regarding Sec.  423.120(c)(6) are necessary to preserve 
beneficiaries' ability to obtain prescriptions for covered Part D drugs 
prescribed by certain practitioners ineligible to enroll in Medicare. 
We note that the definition of ``physician'' includes dentists, hence 
dentists are eligible to enroll in or opt-out of Medicare. Accordingly, 
this IFC revises Sec.  423.120(c)(6)(ii), (iii), and (iv) such that 
prescriptions provided by ``other authorized prescribers'' (as defined 
in Sec.  423.100) may be covered under Part D. In other words, Part D 
sponsors will not be required to reject pharmacy claims or deny 
beneficiary requests for reimbursement for prescriptions written by 
``other authorized prescribers'' on the basis that the prescriber is 
not enrolled in or opted-out of Medicare. Therefore, Part D sponsors 
will continue to be able to cover pharmacy claims at the point of sale 
(POS) for prescriptions written by ``other authorized prescribers,'' 
provided all other existing Part D coverage requirements are met. We 
note, for example, that under Sec.  423.120(c)(6)(i), an ``other 
authorized prescriber'' must have an active and valid NPI which is 
contained in the pharmacy claim. This change will help beneficiaries to 
continue to receive needed prescriptions.
    In Sec.  423.100, we are defining ``other authorized prescriber'' 
as a person other than a physician (as defined in section 1861(r) of 
the Act) or eligible professional (as defined in section 1848(k)(3)(B) 
of the Act) who is authorized under state or other applicable law to 
write prescriptions. This definition, which applies to Sec.  
423.120(c)(6) only, will sufficiently protect the Medicare program 
because ``other authorized prescribers'' must have prescribing 
authority under state or other applicable law.

B. Provisional Coverage and Notice

    We conclude that, in order to further minimize interruptions to 
Part D beneficiaries' access to needed medications, other changes are 
also needed to the May 23, 2014 final rule. This conclusion is based on 
our analysis of Medicare prescriber enrollment levels and trends since 
promulgation of the final rule and discussions with various 
stakeholders about their concerns regarding beneficiary access once the 
provisions of Sec.  423.120(c)(6) are enforced. Thus, we are modifying 
the provisions of Sec.  423.120(c)(6) to prohibit sponsors from 
rejecting claims or denying beneficiary requests for reimbursement for 
a drug on the basis of the prescriber's enrollment status, unless the 
sponsor has first covered a 3-month provisional supply of the drug and 
provided individualized written notice to the beneficiary that the drug 
is being covered on a provisional basis. Such provisional supply and 
notice will allow sufficient time for an eligible prescriber to enroll 
in Medicare (or submit an opt-out affidavit), so that a beneficiary can 
continue to receive Part D coverage for the drug if prescribed by the 
same prescriber, or for the beneficiary to find a prescriber who meets 
the Medicare requirements to write Part D prescriptions. Enrolling in 
Medicare to prescribe or filing an opt-out affidavit is a process that 
can typically be completed within 3 months. In presumably rare cases 
when the prescriber will not enroll in Medicare or submit an opt-out 
affidavit, we believe the beneficiary should have sufficient time to 
find a prescriber whose prescriptions are coverable by the Part D 
program, if the beneficiary wishes to continue to receive Part D 
coverage for the drug. Once the Part D sponsor has provided the written 
notice to the beneficiary that a drug is being covered on a provisional 
basis because of the prescriber's current Medicare status, and the 
sponsor has covered the required provisional supply of the drug, the 
sponsor will be required to reject future claims and deny future 
requests for reimbursement for the beneficiary for the same drug if the 
prescription is from the same prescriber (unless the prescriber has 
enrolled or opted out in the meantime). We will issue future guidance 
as necessary on how sponsors and their PBMs should operationalize the 
term ``drug'' in their adjudication systems in addition to other 
guidance, as needed.
    The following discussion provides the rationale for adopting a same 
drug/same prescriber policy. First, beneficiaries may not readily know 
which prescribers are enrolled in or opted-out of Medicare and which 
are not. Therefore, our policy means that beneficiaries will receive a 
provisional supply and written notice about each unenrolled prescriber 
they see. Second, beneficiaries may need to fill multiple prescriptions 
from the same unenrolled prescriber, and we are particularly concerned 
about instances when beneficiaries need to do so in a short time period 
before their prescriber has been able to enroll or they have been able 
to find an enrolled prescriber. Therefore, our policy allows 
beneficiaries to receive more than one provisional supply from the same 
unenrolled prescriber for a different drug.
    The pertinent regulation text in this IFC states that the Part D 
sponsor must do the following: ``provide the beneficiary with . . . a 
3-month provisional supply (as prescribed by the prescriber . . .).'' 
This means that the Part D sponsor will be required to cover a full 3-
month supply, if prescribed by the unenrolled practitioner, regardless 
of how the supply is dispensed. For example, a beneficiary may receive 
a provisional supply in accordance with a prescription written for a 
month's supply with two subsequent refills; a prescription written for 
a one-time 3-month's supply; or three prescriptions written for a 1-
month's supply each. Conversely, an unenrolled prescriber might not 
prescribe a full 3-month's supply, and in such a case, the sponsor 
would of course not be required to provide a 3-month's provisional 
supply.
    In addition, certain prescriptions cannot be refilled, such as 
Schedule II controlled substances, and continuing supplies of such 
drugs are dispensed only upon a new prescription. For this reason, the 
regulation text also states that the provisional supply must be 
``allowed by applicable law.''
    We believe that a sponsor tracking dispensed provisional drug 
supplies is easier than tracking a timeframe after a dispensing event. 
Otherwise, in order to ensure a beneficiary receives a provisional 
supply of each drug prescribed by an unenrolled prescriber, Part D 
sponsors would have to keep track of rolling timeframes associated with 
the first dispensing event of each drug.

[[Page 25961]]

    We note that providing beneficiaries with a provisional supply of a 
drug is consistent with other CMS requirements and Part D policies 
designed to provide reasonable access to needed medications. Under the 
Part D transition policy, for example, sponsors are generally required 
to cover off-formulary drugs (including drugs that are on-formulary but 
require prior authorization or step therapy) when a beneficiary changes 
prescription drug benefit plans and in other circumstances, in order to 
give the beneficiary and his or her prescriber time to find a suitable 
on-formulary drug or pursue an exception to continue taking the same 
drug.
    The existing Part D transition policy is an example of an instance 
in which a beneficiary might not receive a full 3-months' supply under 
the provisions of this IFC, even when prescribed the full 3 months' 
supply, due to other existing Part D transition requirements which take 
precedence. If an unenrolled physician prescribes an off-formulary drug 
for a beneficiary that is subject to the transition requirements set 
forth in Sec.  423.120(b)(3), and thus the provisional supply and 
notice requirements are simultaneously triggered, the beneficiary would 
not be able to receive more than a 30-day supply of the drug from a 
retail pharmacy, unless a formulary exception is approved, consistent 
with existing transition requirements. Conversely, if a formulary 
exception is approved, the beneficiary could receive the remaining 
provisional supply. We will issue guidance as to how sponsors should 
provide written notices to the beneficiary when the sponsor is required 
to issue a both a transition notice under Sec.  423.120(b)(3)(iv) and a 
provisional supply notice under the revised requirements of Sec.  
423.120(c)(6).
    Other examples when a beneficiary might not receive a full 3-
month's provisional supply, or any provisional supply at all, is when 
the prescriber does not have an active and valid NPI. Under Sec.  
423.120(c)(6)(i), the Part D sponsor or its PBM must reject a pharmacy 
claim unless it contains an active and valid prescriber NPI. Thus, a 
sponsor or its PBM cannot cover a provisional supply when the 
applicable pharmacy claim does not contain an active and valid 
prescriber NPI. Without a prescriber NPI, the sponsor or PBM would not 
be able to determine whether a drug should be covered on a provisional 
or regular basis, because the sponsor cannot determine the prescriber's 
Medicare enrollment or opt out status. An additional example is when 
the drug prescribed is subject to approved prior authorization or step 
therapy requirements by the plan. Such utilization management edits 
will still apply to provisional supplies. For these reasons, the 
regulation text in this IFC states that the Part D sponsor or its PBM 
must provide the beneficiary with a provisional supply and written 
notice ``subject to all other Part D rules and plan coverage 
requirements.''
    In light of our previous discussion for provisional coverage, we 
have made the following changes to Sec.  423.120(c)(6):
     Revised paragraphs (c)(6)(ii)(A) and (c)(6)(iii) to add 
the clause ``Except as provided in paragraph (c)(6)(v) of this 
section.'' The revised paragraphs would otherwise require Part D 
sponsors and their PBMs to reject pharmacy claims and deny beneficiary 
requests for reimbursement based on the Medicare status of the 
prescriber.
     Added new paragraph (c)(6)(v) to require that a Part D 
sponsor or its PBM not reject a pharmacy claim for a Part D drug under 
paragraphs (c)(6)(ii) or (c)(6)(iii) of this section unless the sponsor 
has provided the provisional coverage of the drug and written notice to 
the beneficiary required by paragraph (c)(6)(v)(B).
     Added new paragraph (c)(6)(v)(B) to require that upon 
receipt of a pharmacy claim or beneficiary request for reimbursement 
for a Part D drug that a Part D sponsor would otherwise be required to 
reject or deny in accordance with paragraphs (c)(6)(ii) and (iii) of 
this section, a Part D sponsor or its PBM must provide the beneficiary 
with the following two things, subject to all other Part D rules and 
plan coverage requirements.
     Added new paragraph (c)(6)(v)(B)(1)(i) to require a Part D 
sponsor to provide a 3-month provisional supply of the drug (as 
prescribed by the prescriber and if allowed by applicable law).
     Added new paragraph (c)(6)(v)(B)(1)(ii) to require a Part 
D sponsor to provide written notice within 3 business days after 
adjudication of the claim or request in a form and manner specified by 
CMS.
     Added new paragraph (c)(6)(v)(B)(2) to require that a Part 
D sponsor or its PBM must ensure that reasonable efforts are made to 
notify the prescriber of a beneficiary who was sent a notice.

C. Revision to Dates in Sec.  423.120(c)(5) and (c)(6)

    The requirements of Sec.  423.120(c)(5), which address certain NPI 
submission and verification activities related to pharmacy claims for 
Part D drugs, apply before June 1, 2015. As mentioned in section I.C. 
of this IFC, the requirements of Sec.  423.120(c)(6) apply beginning 
June 1, 2015. On December 3, 2014, we announced an enforcement delay of 
Sec.  423.120(c)(6) until December 1, 2015. We are now in this IFC 
making another change to make these requirements applicable on January 
1, 2016. This is to help make certain that stakeholders, such as 
beneficiaries and plan sponsors, have sufficient time to prepare for 
the requirements of Sec.  423.120(c)(6).
    To prevent potential confusion over the applicability of Sec.  
423.120(c)(5) and (c)(6), we are revising the dates identified therein. 
The beginning of Sec.  423.120(c)(5) will be changed from ``Before June 
1, 2015, the following are applicable'' to ``Before January 1, 2016, 
the following are applicable''. The beginning of Sec.  423.120(c)(6) 
will be changed from ``Beginning June 1, 2015, the following are 
applicable'' to ``Beginning January 1, 2016, the following are 
applicable''. We believe these revisions are necessary so that 
stakeholders will understand precisely when the requirements of Sec.  
423.120(c)(5) and (c)(6) apply to them.

D. Rejection of Pharmacy Claims

    This IFC also makes a technical change to Sec.  423.120(c)(6)(i) 
and (ii) by replacing language that requires plan sponsors to ``deny'' 
pharmacy claims that do not meet the requirements of Sec.  
423.120(c)(6) with language requiring plan sponsors to ``reject'' such 
claims. POS claim transactions are not considered coverage 
determinations under Part D program rules unless the plan chooses to 
treat the presentation of the prescription as a request for a coverage 
determination. Therefore, a Part D plan sponsor is not subject to the 
requirements for coverage determinations in part 423, subpart M, such 
as the timeframe and notification rules, nor to the requirements to 
conduct clinical review or to provide notice of appeal rights when a 
prescription cannot be filled under the Part D benefit at the POS. With 
the requirements finalized in the May 23, 2014 final rule (79 FR 
29843), we did not intend to redefine the nature of POS transactions in 
the Part D program specifically for claims that are not paid at the POS 
because the prescriber does not meet the enrollment or opt-out 
requirements. We believe the word ``deny'' in the regulation text may 
incorrectly be interpreted to require plans to issue a standardized 
denial notice with appeal rights (OMB approval 0938-0976, ``Notice of 
Denial of Medicare Prescription Drug Coverage'', CMS-10146) for 
rejected claims at POS, rather than follow our existing requirements at

[[Page 25962]]

Sec. Sec.  423.128(b)(7)(iii) and 423.562(a)(3). These provisions 
require plans to arrange with their network pharmacies to distribute a 
copy of the standardized pharmacy notice (OMB approval 0938-0975, 
``Medicare Prescription Drug Coverage and Your Rights'', CMS-10147) to 
the enrollee. We believe that this technical change will make the 
requirements at Sec.  423.120(c)(6)(i) and (ii) consistent with our 
other requirements for POS claim transactions and existing National 
Council for Prescription Drug Programs guidance. We are retaining use 
of the term ``deny'' at Sec.  423.120(c)(6)(iii), because plan sponsors 
are required to treat an enrollee request for reimbursement as a 
coverage determination under subpart M.

E. Name on Beneficiary Reimbursement Requests

    We also made a technical change at Sec.  423.120(c)(6)(iii) by 
replacing ``legal name'' with ``name'' for beneficiary reimbursement 
requests. Requiring that beneficiary requests for coverage include the 
prescriber's legal name is inconsistent with the existing standard 
required for coverage determination requests at Sec.  423.568(a) and 
related subregulatory guidance and is overly burdensome for 
beneficiaries. Throughout Chapter 18 of the Medicare Prescription Drug 
Manual (particularly section 30.3), CMS guidance to plan sponsors 
includes an expectation that plan sponsors will make reasonable and 
diligent efforts to obtain any missing information required to process 
beneficiary requests when the request does not include all information 
needed to make a decision, such as the prescriber's legal name, if 
necessary to determine coverage under the prescriber enrollment 
requirements. Additionally, Chapter 5, section 90.2.2 contains language 
stating that plans can require beneficiary requests for reimbursement 
to include prescriber name (not ``legal name'') and address or phone 
number or pharmacy name and phone number to assist the plan in locating 
the prescriber NPI necessary to submit the PDE to CMS. We recognize 
that the ``legal name'' standard was included in Sec.  423.120(c)(6) 
because it was adopted for Part A/B ordering and referring claims at 
Sec.  424.507(a)(2). However, given the regulations and manual guidance 
previously discussed, we do not believe this standard is appropriate 
for Part D beneficiary reimbursement requests.

F. Other Technical Changes

    In addition to the previously described revisions, we are making 
the following minor technical changes to Sec.  423.120(a)(6)(i) through 
(iv). (These changes will not affect the requirements or substance of 
these paragraphs.)
     In paragraphs (c)(6)(i), (ii), and (iii), we replaced the 
word ``if'' with ``unless,'' and deleted the word ``not.'' The current 
versions of these paragraphs are written in the negative, which has 
caused confusion for some readers. We believe these changes will 
clarify these paragraphs.
     In paragraphs (c)(6)(i) and (iv), we replaced references 
to ``physicians'' and ``eligible professionals'' with the term 
``prescriber.'' The latter word is necessary to reflect that these 
paragraphs also apply to prescribing individuals other than physicians 
and eligible professionals.
     In paragraph (c)(6)(ii), the current opening paragraph is 
incorporated into revised paragraph (c)(6)(ii)(A). Current paragraphs 
(c)(6)(ii)(A) and (B) are redesignated as new paragraphs 
(c)(6)(ii)(A)(1) and (2). The requirements pertaining to other 
authorized prescribers are addressed in revised paragraph 
(c)(6)(ii)(B). These organizational revisions of (c)(6)(ii) are 
necessary in order to incorporate the substantive and technical changes 
discussed in this IFC.
     In the opening paragraph of (c)(6)(iii), we changed the 
language ``for a drug if the request is not for a Part D drug that was 
dispensed in accordance with a prescription written by'' to ``unless 
the request pertains to a Part D drug that was prescribed by''. This is 
to make the paragraph clearer and more readable. We also--
    ++ Changed paragraph (c)(6)(iii)(A) from ``Is identified by his or 
her legal name in the request'' to ``A physician or, when permitted by 
applicable State law, other eligible professional (as defined in 
section 1848(k)(3)(B) of the Act) who is identified by name in the 
request; and who''.
    ++ Redesignated current paragraphs (c)(6)(iii)(B)(1) and (2) as new 
paragraphs (A)(1) and (2). The requirements pertaining to other 
authorized prescribers are addressed in revised paragraph 
(c)(6)(iii)(B).
    These technical revisions to (c)(6)(iii) are needed to accommodate 
the substantive and technical revisions heretofore discussed in this 
IFC.
     In paragraph (c)(6)(iv) we are making the following 
changes:
    ++ The opening paragraph is changed from ``In order for a Part D 
sponsor to submit to CMS a prescription drug event record (PDE), the 
PDE must contain an active and valid individual prescriber NPI and must 
pertain to a claim for a Part D drug that was dispensed in accordance 
with a prescription written by a physician or, when permitted by 
applicable State law, an eligible professional (as defined in section 
1848(k)(3)(B) of the Act) who'' to''A Part D plan sponsor submitting a 
prescription drug event (PDE) to CMS must include on the PDE the active 
and valid individual NPI of the prescriber of the drug, who must''. We 
believe the new language is more concise and straightforward.
    ++ We have redesignated current paragraphs (c)(6)(iv)(A) and (B) as 
new paragraphs (c)(6)(iv)(A)(1) and (2). The requirements pertaining to 
other authorized prescribers are addressed in revised paragraph 
(c)(6)(iv)(B).
    These technical revisions to paragraph (c)(6)(iv) are needed to 
accommodate the substantive and technical revisions discussed in this 
IFC.

III. Waiver of Proposed Rulemaking

    We ordinarily publish a notice of proposed rulemaking in the 
Federal Register and invite public comment on the proposed rule. The 
notice of proposed rulemaking includes a reference to the legal 
authority under which the rule is proposed and the terms and substance 
of the proposed rule or a description of the subjects and issues 
involved. However, this procedure can be waived if an agency finds good 
cause that a notice-and-comment procedure is impracticable, 
unnecessary, or contrary to the public interest and incorporates a 
statement of the finding and its reasons in the rule issued.
    We believe we have good cause to make our previously discussed 
changes in this IFC. Concerning the substantive changes, we believe 
that notice-and-comment rulemaking is contrary to the public interest 
for the reasons that follow.
    Several months after publication of the May 23, 2014 final rule 
that imposed the enrollment or opt-out requirement as of June 1, 2015, 
it was brought to our attention during implementation that there are 
prescribers who can and do prescribe Part D medications but who are 
also unable to enroll in Medicare to prescribe because they do not 
technically meet even the broad definition of ``eligible health 
professional.'' The May 23, 2014 final rule was not only complex and 
controversial, but with respect to the prescriber enrollment provisions 
themselves, we were focused on the fact that dentists can enroll and 
represent the largest group of unenrolled current Part D prescribers. 
Additionally, we did

[[Page 25963]]

not receive any explicit comments on the pharmacist issue.
    Once we became aware of the issue, we promptly considered 
alternatives to address it, such as directing pharmacists to opt-out, 
but concluded that this is not permissible under the applicable 
statutory language. Ultimately, we came to the conclusion that the May 
23, 2014 rule must be updated. The existing rule could cause an 
unintended disruption in beneficiaries' access to Part D drugs because 
under the current regulations, as of June 1, 2015, pharmacists' (and 
potentially certain other prescribers') prescriptions could not be 
filled.
    Additionally, we concluded that changes to the May 23, 2014 rule 
needed to include a provisional supply to prevent disruptions to 
beneficiaries' access to Part D drugs. This is based on our monitoring 
of prescriber enrollment levels and trends and meetings with 
stakeholders during implementation. Prescriber enrollment is a 
voluntary act, and while we remain confident that the Part D 
prescribers who need to enroll or opt-out will ultimately do so in 
large numbers, it will take some time. The non-dentist and non-
pharmacist prescribers who need to enroll are ones who did not enroll 
to be able to order and certify under Sec.  424.507. In addition, 
dentists are a group of providers that has not yet had a robust direct 
relationship with Medicare due to the fact that dentists generally do 
not bill Medicare for their services. Since it is in the public's 
interest that we make certain that beneficiary access to needed drugs 
will not be impaired when these important program integrity protections 
become applicable, we have also added the provisional supply provisions 
in this IFC. Without such swift action, we would be forced to either 
enforce the rule as written, which could cause beneficiary harm by 
disrupting access, or further delay enforcement, which also could cause 
beneficiary harm by continuing to permit unqualified individuals to 
prescribe Part D drugs. Both outcomes are contrary to the public 
interest. In addition, the provisional supply provisions include a 
written notice to the beneficiary. We believe that the written notices 
will result in beneficiaries' discussing the enrollment status issue 
with their prescribers, which will assist in our prescriber enrollment 
efforts. In addition, to resolve these problems, it is necessary to 
implement the provisions of this IFC prior to the Medicare Part D bid 
deadline for the 2016 contract year, which begins on January 1, 2016. 
The statutory bid deadline this year is June 1, 2015. Any changes to 
Part D requirements for contract year 2016 must be implemented prior to 
the bid deadline so that Part D sponsors may account for them in their 
bids; we cannot impose costly new requirements on the plans for a 
contract year that are not accounted for in their bids for that 
contract year under section 1860D-12(f)(2) of the Act. Thus, an IFC is 
the only means for ensuring that our requirements do not cause 
unintended disruption to beneficiary access to Part D drugs, while 
ensuring that the changes that will minimize such disruptions are 
incorporated into Part D sponsors' 2016 bids; the length of time 
involved with notice-and rulemaking would prevent us from accomplishing 
these objectives without further delaying enforcement of the existing 
regulations, which for the reasons discussed later in this section, 
could cause beneficiary harm. Moreover, a prompt publication is 
necessary to give Part D plan sponsors time to implement the 
operational changes needed for them to be prepared for these 
requirements in the 2016 contract year.
    If Part D sponsors were unable to account for these new 
requirements in their 2016 bids, we would have to delay the 
applicability date of the enrollment/opt-out requirements to no sooner 
than January 1, 2017. We believe that such an outcome similarly is 
contrary to the public interest because it would unduly delay the 
extremely important program integrity and basic quality assurance 
protection for Medicare beneficiaries that we implemented in our May 
23, 2014 final rule, and beneficiaries could be harmed as a result. As 
we explained in the May 23, 2014 final rule, we have been concerned 
about instances where unqualified individuals are prescribing Part D 
drugs. In fact, in a June 2013 report the OIG found that the Part D 
program inappropriately paid for drugs ordered by individuals who did 
not appear to have the authority to prescribe. (See ``Medicare 
Inappropriately Paid for Drugs Ordered by Individuals Without 
Prescribing Authority'' (OEI-02-09-00608).) There have also been 
reports that the prescriptions of physicians with suspended licenses 
have been covered by the Part D program.
    The Centers for Disease Control and Prevention (CDC) has 
characterized prescription drug abuse as an epidemic, and found that an 
increase in painkiller prescribing is the key driver of the increase in 
prescription overdoses.\1\ The CDC reports that the drug overdose death 
rate has more than doubled from 1999 through 2013, and more than half 
of those deaths were related to pharmaceuticals.\2\ The Department of 
Health and Human Services has several initiatives to address 
prescription drug abuse; for instance, the National Institute on Drug 
Abuse, the National Institutes of Health, and the Substance Abuse and 
Mental Health Services Administration are working with public and 
private stakeholders to reduce opioid overdoses. CMS has also adopted 
an approach to reduce opioid overutilization in Medicare Part D.
---------------------------------------------------------------------------

    \1\ http://www.cdc.gov/vitalsigns/pdf/2014-07-vitalsigns.pdf.
    \2\ http://www.cdc.gov/homeandrecreationalsafety/overdose/facts.html.
---------------------------------------------------------------------------

    The new enrollment requirements addressed in the May 23, 2014 final 
rule represent an important component of this effort and are a crucial 
program integrity and basic quality assurance protection for Medicare 
beneficiaries, for the requirements help us to confirm that prescribers 
are qualified to prescribe Part D drugs. It is important that these 
protections are in place as soon as possible. We have identified 68,000 
prescribers that have been removed from Medicare for reasons such as 
licensure issues, operational status, or exclusion by the OIG, and we 
have a responsibility to enforce these protections to beneficiaries as 
soon as possible without compromising continuity of care or beneficiary 
access to needed medications. The CDC has recommended swift regulatory 
action against health care providers acting outside the limits of 
accepted medical practice to decrease provider behaviors that 
contribute to prescription painkiller abuse, diversion, and 
overdose.\3\
---------------------------------------------------------------------------

    \3\ http://www.cdc.gov/drugoverdose/pdf/policyimpact-prescriptionpainkillerod-a.pdf.
---------------------------------------------------------------------------

    Thus, for all of these reasons, we find good cause to waive prior 
notice and comment with respect to the substantive changes being made 
in this IFC.
    With respect to the technical changes being made in this IFC, we 
believe notice-and-comment rulemaking is unnecessary because these 
changes are not substantive and do not alter current policy.

IV. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995, we are required to 
provide 60-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
the Office of Management and Budget (OMB) for review and approval. In 
order to fairly evaluate whether an information collection should be 
approved by OMB, section 3506(c)(2)(A) of the Paperwork

[[Page 25964]]

Reduction Act of 1995 requires that we solicit comment on the following 
issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our estimate of the information collection 
burden.
     The quality, utility, and clarity of the information to be 
collected.
     Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    We are soliciting public comment on the following section of this 
document that contains information collection requirements (ICRs).
    We believe the principal information collection requirement 
associated with this IFC is that some Part D sponsors and PBMs will 
need to collect information about which NPIs are for ``other authorized 
prescribers'' in order to properly adjudicate pharmacy claims 
containing such prescriber NPIs in light of the revised provisions of 
Sec.  423.120(c)(6) in this IFC. However, we estimate that half of the 
30 Part D sponsors and PBMs with Part D adjudications systems already 
collect information about the prescriptive authority of prescriber NPIs 
in order to mitigate current potential audit risks associated with 
submitting PDEs to CMS for Part D drugs that were not dispensed upon a 
valid prescription.
    In a CMS analysis of PDE data, there were just over 1.3 million 
prescribers writing Part D prescriptions in 2013. Approximately 17,000 
of these prescribers have NPIs a taxonomy in the National Provider & 
Plan Enumeration System (NPPES) that would fall under the definition of 
``other authorized prescribers'' (largely pharmacist taxonomies).
    NPIs and the addresses and taxonomy codes that pertain to them are 
publicly available information through the CMS Web site for NPPES. We 
estimated that collecting information about which NPIs are for ``other 
authorized prescribers'' would take an average of 30 minutes (0.5 
hours) per NPI associated with a pharmacist or 8,500 hours, and the 
estimated total burden for 15 sponsors/PBMs to be 17,500 hours for 
2016. The estimated total annual cost for this burden is $3,343,050. 
This is based upon the national median hourly rate of $26.22 for 
insurance claim and policy processing clerk multiplied by the number of 
burden hours in 2016. We did not estimate any burden in 2017 and 2018 
for the collection of information about ``other authorized prescriber'' 
NPIs, as the number of new pharmacist NPIs and existing pharmacist NPIs 
becoming inactive will be negligible in light of the fact that there 
are only approximately 17,000 total ``other authorized prescribers'' 
writing Part D prescriptions in 2013.
    We note that since NPPES is not a provider credentialing system, 
but rather an enumeration system that contains self-reported 
credentials, Part D sponsors might not rely upon a taxonomy in NPPES as 
documentation that an NPI in fact belongs to a pharmacist with an 
active license who is permitted to prescribe. We have used data from 
NPPES to provide an estimate as to how many ``other authorized 
prescribers'' NPIs about which Part D sponsors and PBMs will need to 
collect information.
    In the alternative, we understand that Part D sponsors/PBMs may 
purchase prescriber ID validation services from a private company that 
can provide them with a list of ``other authorized providers.'' 
However, we do not provide a collection estimate for all options that 
sponsors/PBMs may have in implementing the provisions of this IFC.
    We also revised the provisions of Sec.  423.120(c)(6) to require 
Part D sponsors to cover a provisional supply of a drug before they 
reject a claim based on a prescriber's Medicare status. These 
modifications will also require Part D sponsors to provide written 
notice to the beneficiary and take reasonable efforts to provide 
written notice to the prescriber. The burden associated with these 
modifications is the time and effort necessary for Part D adjudications 
systems to be programmed, model notices to be created, and such notices 
to be generated and disseminated to perform these tasks. We estimated 
that this will take 30 sponsors and PBMs with Part D adjudications 
systems 156,000 hours for software developers and programmers to 
program their systems in 2016 to comply with the modifications to Sec.  
423.120(c)(6) in this IFC. In 2017 and 2018, we estimated the total 
burden to be 83,000 hours for each year.
    We estimated the total hours by estimating a 6-month preparation 
and testing period. Six months includes approximately 1,040 full-time 
working hours. We estimated 5 full time staff (or 10 staff working half 
their hours on this project). Five staff x 1,040 hours x 30 sponsors/
PBMs = 156,000 total hours. We estimated an hourly rate of $64.32 for 
such developers and programmers, which is $10,033,920 in total burden 
cost.
    We also estimated 212 parent organizations will create two template 
notices to notify beneficiaries and prescribers under the modifications 
of Sec.  423.120(c)(6). We estimated this will take 3 hours per entity 
for a total of 636 hours. We estimated an hourly rate of $45.54 for a 
business operation specialist to create such notices. Thus, the total 
estimated burden cost for parent organizations to create two model 
notices is $28,963.44.
    Once the templates have been developed, we estimated that these 
notices would take an average of 5 minutes (0.083 hours) to prepare. 
Thus, we estimated the annual burden hours for 2016 to be 1,743,000 
hours. This is based upon the national median hourly rate of $26.22 for 
an insurance claim and policy processing clerk multiplied by the number 
of burden hours. The estimated annual burden cost for 2016 is 
$45,701,460.
    Therefore, we estimated the total regulatory impact for these 
provisions in 2016 to be $55,764,343.44 ($10,033,920 + $28,963.44 + 
$45,701,460).
    Approximately 2 million beneficiaries enter the Part D program 
every year. If we assume that 25 percent of these new beneficiaries 
will see 1 prescriber who is not enrolled or opted out, and that 
prescriber prescribes 2 drugs, we anticipate that parent organizations 
will have to send 1 million notices in 2017 and 2018 each (250,000 
beneficiaries x 2 prescriptions x 2 notices each = 1,000,000). We 
estimate these notices would take an average of 5 minutes (0.083 hours) 
to prepare. Thus, we estimate the total burden to be 83,000 hours for 
each year, and the annual cost to be $2,176,260. This is based upon the 
national median hourly rate of $26.22 for insurance claim and policy 
processing clerk multiplied by the number of burden hours.
    Table 1 outlines the projected costs of this IFC commencing 2016 
through 2018:

                                         Table 1--Projected Burden Costs
----------------------------------------------------------------------------------------------------------------
                                         Programming       Create notices      Send notices      Annual impact
----------------------------------------------------------------------------------------------------------------
2016................................        $10,033,920         $28,963.44        $45,701,460     $55,764,343.44
2017................................                N/A                N/A          2,176,260          2,176,260

[[Page 25965]]

 
2018................................                N/A                N/A          2,176,260          2,176,260
----------------------------------------------------------------------------------------------------------------

    If you comment on these information collection and recordkeeping 
requirements, please do either of the following:
    1. Submit your comments electronically as specified in the 
ADDRESSES section of this interim final rule with comment period; or
    2. Submit your comments to the Office of Information and Regulatory 
Affairs, Office of Management and Budget, Attention: CMS Desk Officer, 
[CMS-6107-IFC]; Fax: (202) 395-6974; or Email: 
[email protected].

V. Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this preamble, 
and, when we proceed with a subsequent document, we will respond to the 
comments in the preamble to that document.

VI. Regulatory Impact Statement

    We have examined the impacts of this rule as required by Executive 
Order 12866 on Regulatory Planning and Review (September 30, 1993), 
Executive Order 13563 on Improving Regulation and Regulatory Review 
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 
1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, 
section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 
1995; Pub. L. 104-4) and Executive Order 13132 on Federalism (August 4, 
1999).
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). A 
regulatory impact analysis (RIA) must be prepared for major rules with 
economically significant effects ($100 million or more in any 1 year). 
The impact of this IFC is directly associated with the information 
collection requirements discussed in section IV. of this IFC and will 
not exceed $100 million in any one year. Therefore, this is IFC is not 
a major rule.
    The average Part D beneficiary takes 9 drugs prescribed by three 
prescribers annually. Based on 2013 PDE data, approximately 380,000 (28 
percent) Part D prescribers were not found in the Provider Enrollment, 
Chain, and Ownership System (PECOS) and are associated with just under 
8,000,000 unique beneficiaries. Generally, PECOS is the CMS record 
database of all physicians and eligible professionals who are or were 
enrolled in or opted out of Medicare. Thus, these prescribers write 
prescriptions on average for 21 beneficiaries (8,000,000/380,000 = 21). 
For purposes of this analysis, we assumed that on January 1, 2016, 
250,000 prescribers will still need to enroll in or opt-out of Medicare 
to prescribe coverable Part D drugs. We also assume that these 250,000 
prescribers will write prescriptions for 5.25 million beneficiaries 
(250,000 x 21). We further assume that no beneficiaries will switch 
prescribers until they receive a notice that a drug is being covered on 
a provisional basis. Additionally, we assumed that these prescribers 
will write on average two prescriptions for each of these 
beneficiaries. We assumed that Part D parent organizations will be able 
to send each prescriber a notice. Finally, we did not offset our 
estimation in light of our expectation that, in some cases, transition 
and provisional supply notices will be combined into one notice. We 
estimated that parent organizations will send 21 million beneficiary 
and prescriber notices in accordance with the modifications to Sec.  
423.120(c)(6) in 2016 (5,250,000 beneficiaries x 2 prescriptions x 2 
notices each = 21,000,000), which we expect to occur as a downward 
trend that we do not reflect in this analysis.
    Prescribers are expected to enroll on a steady basis throughout 
2016 as a result of the prescriber enrollment requirements. By 2017, we 
expect that the majority of Part D prescribers will have enrolled in or 
opted out of Medicare in order for their prescriptions to be coverable 
by the Part D program. When a prescriber does not enroll or opt out, 
the beneficiary will either change to a prescriber who is enrolled or 
opted out, or the beneficiary will pay out of pocket for the 
prescriptions written by that prescriber. Nevertheless, parent 
organizations will have to send notices on an ongoing basis to 
beneficiaries who are new to the Part D program and receive a 
prescription from a prescriber who is not enrolled in or opted out of 
Medicare.
    The RFA requires agencies to analyze options for regulatory relief 
of small businesses. For purposes of the RFA, small entities include 
small businesses, nonprofit organizations, and small governmental 
jurisdictions. Most entities and most other providers and suppliers are 
small entities, either by nonprofit status or by having revenues 
between $7.5 million and $38.5 million in any 1 year. Individuals and 
states are not included in the definition of a small entity. We do not 
believe that this IFC would have a significant economic impact on a 
substantial number of small businesses, as Part D sponsors and parent 
organizations do not generally meet the definition of a small business.
    Section 1102(b) of the Act requires us to prepare a regulatory 
impact analysis if a rule may have a significant impact on the 
operations of a substantial number of small rural hospitals. This 
analysis must conform to the provisions of section 604 of the RFA. For 
purposes of section 1102(b) of the Act, we define a small rural 
hospital that is located outside of a Metropolitan Statistical Area for 
Medicare payment regulations and has fewer than 100 beds. We are not 
preparing an analysis for section 1102(b) of the Act because we have 
determined and the Secretary certified that this IFC would not have a 
significant impact on the operations of a substantial number of small 
rural hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule whose mandates require spending in any 1 year of $100 
million in 1995 dollars, updated annually for inflation. In 2015, this 
is approximately $144 million. We believe that this IFC will have no 
consequential effect on state, local or tribal governments or on the 
private sector.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed rule (and subsequent 
final rule) that imposes substantial direct requirements or costs on 
state and local governments, preempts state law, or

[[Page 25966]]

otherwise has federalism implications. Since this regulation does not 
impose any costs on state or local governments, the requirements of 
Executive Order 13132 are not applicable. In accordance with the 
provisions of Executive Order 12866, this IFC was reviewed by the 
Office of Management and Budget.

List of Subjects in 42 CFR Part 423

    Administrative practice and procedure, Emergency medical services, 
Health facilities, Health maintenance organizations (HMO), Health 
professionals, Medicare, Penalties, Privacy, Reporting and 
recordkeeping requirements.

    For the reasons stated in the preamble of this interim final rule 
with comment period, the Centers for Medicare & Medicaid Services 
amends 42 CFR part 423 as follows:

PART 423--VOLUNTARY MEDICARE PRESCRIPTION DRUG PROGRAM

0
1. The authority citation for part 423 continues to read as follows:

    Authority:  Secs. 1102, 1106, 1860D-1 through 1860D-42, and 1871 
of the Social Security Act (42 U.S.C. 1302, 1306, 1395w-101 through 
1395w-152, and 1395hh).


0
2. Amend Sec.  423.100 by adding a definition of ``Other authorized 
prescriber'' in alphabetical order to read as follows:


Sec.  423.100  Definitions.

* * * * *
    Other authorized prescriber means, for purposes of Sec.  
423.120(c)(6) only, an individual other than a physician (as defined in 
section 1861(r) of the Act) or eligible professional (as defined in 
section 1848(k)(3)(B) of the Act) who is authorized under State or 
other applicable law to write prescriptions.
* * * * *

0
3. Amend Sec.  423.120 by revising paragraphs (c)(5) introductory text 
and (c)(6) to read as follows:


Sec.  423.120  Access to covered Part D drugs.

* * * * *
    (c) * * *
* * * * *
    (5) Before January 1, 2016, the following are applicable:
* * * * *
    (6) Beginning January 1, 2016, the following are applicable:
    (i) A Part D plan sponsor must reject, or must require its 
pharmaceutical benefit manager (PBM) to reject, a pharmacy claim for a 
Part D drug unless the claim contains the active and valid National 
Provider Identifier (NPI) of the prescriber who prescribed the drug.
    (ii)(A) Except as provided in paragraph (c)(6)(v) of this section, 
a Part D plan sponsor must reject, or must require its PBM to reject, a 
pharmacy claim for a Part D drug unless the physician or, when 
permitted by applicable State law, the eligible professional (as 
defined in section 1848(k)(3)(B) of the Act) who prescribed the drug--
    (1) Is enrolled in the Medicare program in an approved status; or
    (2) Has a valid opt-out affidavit on file with a Part A/B Medicare 
Administrative Contractor (MAC).
    (B) Pharmacy claims for Part D drugs prescribed by an other 
authorized prescriber (as defined in Sec.  423.100) are not subject to 
the requirements specified in paragraph (c)(6)(ii)(A) of this section.
    (iii) Except as provided in paragraph (c)(6)(v) of this section, a 
Part D plan sponsor must deny, or must require its PBM to deny, a 
request for reimbursement from a Medicare beneficiary unless the 
request pertains to a Part D drug that was prescribed by--
    (A) A physician or, when permitted by applicable State law, other 
eligible professional (as defined in section 1848(k)(3)(B) of the Act) 
who is identified by name in the request and who--
    (1) Is enrolled in Medicare in an approved status; or
    (2) Has a valid opt-out affidavit on file with a Part A/B MAC; or
    (B) An other authorized prescriber (as defined in Sec.  423.100) 
who is identified by name in the request.
    (iv) A Part D plan sponsor submitting a prescription drug event 
(PDE) to CMS must include on the PDE the active and valid individual 
NPI of the prescriber of the drug, who must--
    (A)(1) Be enrolled in Medicare in an approved status, or
    (2) Have a valid opt out affidavit on file with a Part A/B MAC; or
    (B) Be an other authorized prescriber (as defined in Sec.  
423.100).
    (v)(A) A Part D sponsor or its PBM must not reject a pharmacy claim 
for a Part D drug under paragraph (c)(6)(ii) of the section or deny a 
request for reimbursement under paragraph (c)(6)(iii) of this section 
unless the sponsor has provided the provisional coverage of the drug 
and written notice to the beneficiary required by paragraph 
(c)(6)(v)(B) of this section.
    (B) Upon receipt of a pharmacy claim or beneficiary request for 
reimbursement for a Part D drug that a Part D sponsor would otherwise 
be required to reject or deny in accordance with paragraphs (c)(6)(ii) 
or (iii) of this section, a Part D sponsor or its PBM must do the 
following:
    (1) Provide the beneficiary with the following, subject to all 
other Part D rules and plan coverage requirements:
    (i) A 3-month provisional supply of the drug (as prescribed by the 
prescriber and if allowed by applicable law).
    (ii) Written notice within 3 business days after adjudication of 
the claim or request in a form and manner specified by CMS.
    (2) Ensure that reasonable efforts are made to notify the 
prescriber of a beneficiary who was sent a notice under paragraph 
(c)(6)(v)(B)(1)(ii) of this section.
* * * * *

    Dated: April 17, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
    Dated: April 29, 2015.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2015-10545 Filed 5-1-15; 4:15 pm]
 BILLING CODE 4120-01-P



                                            25958              Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations

                                            12(d) of the National Technology                        DEPARTMENT OF HEALTH AND                              address ONLY: Centers for Medicare &
                                            Transfer and Advancement Act                            HUMAN SERVICES                                        Medicaid Services, Department of
                                            (NTTAA) (15 U.S.C. 272 note).                                                                                 Health and Human Services, Attention:
                                                                                                    Centers for Medicare & Medicaid                       CMS–6107–IFC, P.O. Box 8013,
                                            VII. Congressional Review Act                           Services                                              Baltimore, MD 21244–8013.
                                              Pursuant to the Congressional Review                                                                           Please allow sufficient time for mailed
                                            Act (5 U.S.C. 801 et seq.), EPA will                    42 CFR Part 423                                       comments to be received before the
                                            submit a report containing this rule and                [CMS–6107–IFC]                                        close of the comment period.
                                            other required information to the U.S.                                                                           3. By express or overnight mail. You
                                                                                                    RIN 0938–AS60                                         may send written comments to the
                                            Senate, the U.S. House of
                                            Representatives, and the Comptroller                                                                          following address ONLY: Centers for
                                                                                                    Medicare Program; Changes to the
                                            General of the United States prior to                                                                         Medicare & Medicaid Services,
                                                                                                    Requirements for Part D Prescribers
                                            publication of the rule in the Federal                                                                        Department of Health and Human
                                            Register. This action is not a ‘‘major                  AGENCY:  Centers for Medicare &                       Services, Attention: CMS–6107–IFC,
                                            rule’’ as defined by 5 U.S.C. 804(2).                   Medicaid Services (CMS), HHS.                         Mail Stop C4–26–05, 7500 Security
                                                                                                    ACTION: Interim final rule with comment               Boulevard, Baltimore, MD 21244–1850.
                                            List of Subjects in 40 CFR Part 180                     period.                                                  4. By hand or courier. Alternatively,
                                                                                                                                                          you may deliver (by hand or courier)
                                              Environmental protection,                             SUMMARY:        This interim final rule with          your written comments ONLY to the
                                            Administrative practice and procedure,                      comment period revises requirements               following addresses prior to the close of
                                            Agricultural commodities, Pesticides                        related to beneficiary access to covered          the comment period: a. For delivery in
                                            and pests, Reporting and recordkeeping                      Part D drugs. Under these revised                 Washington, DC—Centers for Medicare
                                            requirements.                                               requirements, pharmacy claims and                 & Medicaid Services, Department of
                                               Dated: April 27, 2015.                                   beneficiary requests for reimbursement            Health and Human Services, Room 445–
                                            Susan Lewis,                                                for Medicare Part D prescriptions,                G, Hubert H. Humphrey Building, 200
                                                                                                        written by prescribers other than                 Independence Avenue SW.,
                                            Director, Registration Division, Office of
                                                                                                        physicians and eligible professionals             Washington, DC 20201.
                                            Pesticide Programs.
                                                                                                        who are permitted by state or other                  (Because access to the interior of the
                                               Therefore, 40 CFR chapter I is                           applicable law to prescribe medications,          Hubert H. Humphrey Building is not
                                            amended as follows:                                         will not be rejected at the point of sale         readily available to persons without
                                                                                                        or denied by the plan if all other                Federal government identification,
                                            PART 180—[AMENDED]                                          requirements are met. In addition, a              commenters are encouraged to leave
                                                                                                        plan sponsor will not reject a claim or           their comments in the CMS drop slots
                                            ■ 1. The authority citation for part 180                    deny a beneficiary request for                    located in the main lobby of the
                                            continues to read as follows:                               reimbursement for a drug when                     building. A stamp-in clock is available
                                               Authority: 21 U.S.C. 321(q), 346a and 371.               prescribed by a prescriber who does not           for persons wishing to retain a proof of
                                                                                                        meet the applicable enrollment or opt-            filing by stamping in and retaining an
                                            ■ 2. In § 180.632, the section heading                      out requirement without first providing           extra copy of the comments being filed.)
                                            and paragraph (a) are revised to read as                    provisional coverage of the drug and                 b. For delivery in Baltimore, MD—
                                            follows:                                                    individualized written notice to the              Centers for Medicare & Medicaid
                                                                                                        beneficiary. This interim final rule with         Services, Department of Health and
                                            § 180.632 Fenazaquin; Tolerances for                        comment period also revises certain
                                            residues.                                                                                                     Human Services, 7500 Security
                                                                                                        terminology to be consistent with                 Boulevard, Baltimore, MD 21244–1850.
                                               (a) General. Tolerances are                              existing policy and to improve clarity.              If you intend to deliver your
                                            established for residues of the                             DATES:                                            comments to the Baltimore address, call
                                            insecticide fenazaquin, including its                          Effective date: These regulations are          telephone number (410) 786–9994 in
                                            metabolites and degradates, in or on the effective on June 1, 2015.                                           advance to schedule your arrival with
                                            commodities in the table below.                                Applicability date: The provisions at          one of our staff members.
                                            Compliance with the tolerance levels                        § 423.120(c)(6) are applicable January 1,            Comments erroneously mailed to the
                                            specified below is to be determined by                      2016.                                             addresses indicated as appropriate for
                                            measuring only fenazaquin, or 4-[2-[4-                         Comment date: To be assured
                                                                                                                                                          hand or courier delivery may be delayed
                                            (1,1-dimethylethyl)phenyl]                                  consideration, comments must be
                                                                                                                                                          and received after the comment period.
                                            ethoxy]quinazoline.                                         received at one of the addresses
                                                                                                                                                             For information on viewing public
                                                                                                        provided below, no later than 5 p.m. on
                                                                                                                                                          comments, see the beginning of the
                                                                                            Parts  per  July 6, 2015.
                                                        Commodity                                                                                         SUPPLEMENTARY INFORMATION section.
                                                                                             million    ADDRESSES: In commenting, please refer
                                                                                                                                                          FOR FURTHER INFORMATION CONTACT:
                                                                                                        to file code CMS–6107–IFC. Because of
                                            Almond ......................................          0.02 staff and resource limitations, we cannot         Frank Whelan, (410) 786–1302 for
                                            Almond, hulls ............................             4.0  accept comments by facsimile (FAX)                enrollment issues.
                                            Apple .........................................        0.2  transmission.                                        Lisa Thorpe, (410) 786–3048, for
                                            Cherry .......................................         2.0     You may submit comments in one of              provisional coverage, notice, and all
                                            Citrus Oil ...................................        10    four ways (please choose only one of the          other issues.
                                            Fruit, Citrus, Group 10 except                                                                                SUPPLEMENTARY INFORMATION:
                                                                                                        ways listed)
tkelley on DSK3SPTVN1PROD with RULES




                                               Grape fruit .............................           0.5                                                       Inspection of Public Comments: All
                                                                                                           1. Electronically. You may submit
                                            Pear ..........................................        0.2                                                    comments received before the close of
                                                                                                        electronic comments on this regulation
                                                                                                        to http://www.regulations.gov. Follow             the comment period are available for
                                            *      *        *         *         *                                                                         viewing by the public, including any
                                                                                                        the ‘‘Submit a comment’’ instructions.
                                            [FR Doc. 2015–10375 Filed 5–5–15; 8:45 am]                     2. By regular mail. You may mail               personally identifiable or confidential
                                            BILLING CODE 6560–50–P                                      written comments to the following                 business information that is included in


                                       VerDate Sep<11>2014   18:11 May 05, 2015   Jkt 235001   PO 00000   Frm 00062   Fmt 4700   Sfmt 4700   E:\FR\FM\06MYR1.SGM   06MYR1


                                                               Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations                                         25959

                                            a comment. We post all comments                            Second, section 1866(j) of the Act                 supplies, or home health services to be
                                            received before the close of the                        provides specific authority with respect              enrolled in Medicare.
                                            comment period on the following Web                     to the Medicare enrollment process for                   In accordance with section 6405(c) of
                                            site as soon as possible after they have                providers and suppliers.                              the Affordable Care Act, we established
                                            been received: http://regulations.gov.                     Third, section 6405(c) of the                      new § 423.120(c)(6) as part of a May 23,
                                            Follow the search instructions on that                  Affordable Care Act gives the Secretary               2014 final rule titled, ‘‘Medicare
                                            Web site to view public comments.                       the authority to require that pharmacy                Program; Contract Year 2015 Policy and
                                               Comments received timely will be                     claims and beneficiary reimbursement                  Technical Changes to the Medicare
                                            also available for public inspection as                 requests for covered Part D drugs                     Advantage and the Medicare
                                            they are received, generally beginning                  prescribed by a physician (as defined in              Prescription Drug Benefit Programs’’ (79
                                            approximately 3 weeks after publication                 section 1861(r) of the Act) or eligible               FR 29843). Our objective was to help
                                            of a document, at the headquarters of                   professional (as defined in section                   confirm that Part D drugs are prescribed
                                            the Centers for Medicare & Medicaid                     1848(k)(3)(B) of the Act) are not payable             only by physicians and eligible
                                            Services, 7500 Security Boulevard,                      unless the prescribing physician or                   professionals who are qualified to do so
                                            Baltimore, Maryland 21244, Monday                       eligible professional is enrolled in                  under state law and under the
                                            through Friday of each week from 8:30                   Medicare under section 1866(j) of the                 requirements of the Medicare program.
                                            a.m. to 4 p.m. To schedule an                           Act.                                                  Section 423.120(c)(6) currently contains
                                            appointment to view public comments,                       Fourth, section 1860D–12(b)(3)(D) of               the following provisions:
                                            phone 1–800–743–3951.                                   the Act authorizes the Secretary to                      • A Part D sponsor must deny, or
                                                                                                    include in a contract with a Part D                   must require its pharmaceutical benefit
                                            I. Background                                                                                                 manager (PBM) to deny, a pharmacy
                                                                                                    sponsor such other terms and
                                            A. Purpose                                              conditions that are not inconsistent with             claim for a Part D drug if an active and
                                                                                                    Part D as the Secretary may find                      valid physician or eligible professional
                                               Under this interim final rule with                   necessary and appropriate.                            National Provider Identifier (NPI) is not
                                            comment period (IFC), pharmacy claims                                                                         contained on the claim.
                                            and beneficiary requests for                            C. Provider Enrollment Process                           • A Part D sponsor must deny, or
                                            reimbursement for Medicare Part D                          The Medicare CMS–855 enrollment                    must require its PBM to deny, a
                                            prescriptions, written by prescribers                   application collects information from                 pharmacy claim for a Part D drug if the
                                            other than physicians and eligible                      providers and suppliers to confirm that               physician or eligible professional—is
                                            professionals who are permitted by state                they meet all Medicare requirements.                  not enrolled in the Medicare program in
                                            or other applicable law to prescribe                    Such data includes, but are not limited               an approved status; and does not have
                                            medications, will not be rejected at the                to, the provider’s or supplier’s licensure,           a valid opt-out affidavit on file with a
                                            point of sale or denied by the plan if all              tax identification number, National                   Part A/B Medicare Administrative
                                            other requirements are met. In addition,                Provider Identifier (NPI), practice                   Contractor (MAC).
                                            a plan sponsor will not reject a claim or               locations, final adverse action history,                 • A Part D sponsor must deny, or
                                            deny a beneficiary request for                          and owning and managing individuals                   must require its PBM to deny, a request
                                            reimbursement for a drug on the                         and organizations. Upon receiving a                   for reimbursement from a Medicare
                                            grounds that the prescriber has not                     CMS–855 application from a physician                  beneficiary for a drug if the request is
                                            enrolled in or opted out of Medicare                    or eligible professional, the CMS                     not for a Part D drug that was dispensed
                                            without first providing provisional                     contractor validates the information and              in accordance with a prescription
                                            coverage of the drug and individualized                 performs various screening activities,                written by a physician or eligible
                                            written notice to the beneficiary. These                such as reviewing the System for Award                professional who is identified by his or
                                            changes are necessary to help make                      Management (SAM) to confirm that the                  her legal name in the request; and
                                            certain that Medicare beneficiaries                     individual is not debarred from                          ++ Is enrolled in Medicare in an
                                            continue to have access to needed Part                  receiving payments under any federal                  approved status; or
                                            D medications. As explained in section                  health program. As explained in section                  ++ Has a valid opt-out affidavit on
                                            III. of this IFC, we believe that we have               II. of this IFC, we have taken measures               file with a Part A/B MAC.
                                            good cause to make these changes in an                  to improve the provider enrollment                       • In order for a Part D sponsor to
                                            IFC because the ordinary notice-and-                    process to determine whether enrolling                submit to CMS a prescription drug event
                                            comment process would be contrary to                    physicians and eligible professionals                 record (PDE), the PDE must contain an
                                            the public interest; furthermore, we                    meet all Medicare requirements.                       active and valid individual prescriber
                                            believe that notice-and-comment                                                                               NPI and must pertain to a claim for a
                                            rulemaking for the technical changes we                 D. Section 6405 of the Affordable Care
                                                                                                                                                          Part D drug that was dispensed in
                                            are making in this IFC (as described in                 Act and the May 23, 2014 Final Rule
                                                                                                                                                          accordance with a prescription written
                                            sections II.D., II.E., and II.F. of this IFC)              As noted previously, section 6405(c)               by a physician or eligible professional
                                            is unnecessary because these changes                    of the Affordable Care Act gives the                  who—is enrolled in Medicare in an
                                            are not substantive and do not alter                    Secretary the authority to extend the                 approved status; or has a valid opt-out
                                            current policy.                                         requirements of sections 6405(a) and (b)              affidavit on file with a Part A/B MAC.
                                            B. Legal Authority                                      of the Affordable Care Act to all other                  These requirements apply as of June
                                                                                                    categories of items or services under                 1, 2015. However, on December 3, 2014,
                                              There are four principal statutory                    title XVIII of the Act that are ordered,              through the Health Plan Management
                                            authorities for the provisions in this                  prescribed, or referred by a physician or             System (HPMS), we announced an
tkelley on DSK3SPTVN1PROD with RULES




                                            IFC.                                                    eligible professional, including covered              enforcement delay until December 1,
                                              First, sections 1102 and 1871 of the                  Part D drugs. Sections 6405(a) and (b) of             2015. We are now in this IFC making
                                            Social Security Act (the Act) provide                   the Affordable Care Act require                       another change to make these
                                            general authority for the Secretary to                  physicians and eligible professionals                 requirements applicable on January 1,
                                            prescribe regulations for the efficient                 who order or certify durable medical                  2016. Accordingly, and as explained in
                                            administration of the Medicare program.                 equipment, prosthetics, orthotics,                    section II.C. of this IFC, we are making


                                       VerDate Sep<11>2014   18:11 May 05, 2015   Jkt 235001   PO 00000   Frm 00063   Fmt 4700   Sfmt 4700   E:\FR\FM\06MYR1.SGM   06MYR1


                                            25960              Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations

                                            conforming changes to the regulation                    professional (as defined in section                   the meantime). We will issue future
                                            text.                                                   1848(k)(3)(B) of the Act) who is                      guidance as necessary on how sponsors
                                                                                                    authorized under state or other                       and their PBMs should operationalize
                                            II. Provisions of the Interim Final Rule
                                                                                                    applicable law to write prescriptions.                the term ‘‘drug’’ in their adjudication
                                            With Comment Period
                                                                                                    This definition, which applies to                     systems in addition to other guidance,
                                            A. Enrollment                                           § 423.120(c)(6) only, will sufficiently               as needed.
                                               There are prescribers other than                     protect the Medicare program because                     The following discussion provides the
                                            physicians and eligible professionals,                  ‘‘other authorized prescribers’’ must                 rationale for adopting a same drug/same
                                            such as pharmacists, who are legally                    have prescribing authority under state                prescriber policy. First, beneficiaries
                                            authorized under state or other law to                  or other applicable law.                              may not readily know which prescribers
                                                                                                                                                          are enrolled in or opted-out of Medicare
                                            prescribe covered Part D drugs. For                     B. Provisional Coverage and Notice                    and which are not. Therefore, our policy
                                            example, under a Pharmacist                                We conclude that, in order to further              means that beneficiaries will receive a
                                            Collaborative Practice Agreement,                       minimize interruptions to Part D                      provisional supply and written notice
                                            pharmacists may be legally authorized                   beneficiaries’ access to needed                       about each unenrolled prescriber they
                                            to prescribe covered Part D under state                 medications, other changes are also                   see. Second, beneficiaries may need to
                                            or other law. However, pharmacists are                  needed to the May 23, 2014 final rule.                fill multiple prescriptions from the same
                                            not physicians under section 1861(r) of                 This conclusion is based on our analysis              unenrolled prescriber, and we are
                                            the Act or eligible professionals under                 of Medicare prescriber enrollment levels              particularly concerned about instances
                                            section 1848(k)(3)(B) of the Act, and are               and trends since promulgation of the                  when beneficiaries need to do so in a
                                            therefore not eligible to enroll in or opt-             final rule and discussions with various               short time period before their prescriber
                                            out of Medicare. Under § 423.120(c)(6),                 stakeholders about their concerns                     has been able to enroll or they have
                                            as described previously in section I.D. of              regarding beneficiary access once the                 been able to find an enrolled prescriber.
                                            this IFC, beneficiaries who have been                   provisions of § 423.120(c)(6) are                     Therefore, our policy allows
                                            receiving necessary prescriptions from                  enforced. Thus, we are modifying the                  beneficiaries to receive more than one
                                            prescribers who are not Medicare-                       provisions of § 423.120(c)(6) to prohibit             provisional supply from the same
                                            enrolled or opted-out physicians or                     sponsors from rejecting claims or                     unenrolled prescriber for a different
                                            eligible professionals will no longer be                denying beneficiary requests for                      drug.
                                            able to obtain Part D coverage for these                reimbursement for a drug on the basis                    The pertinent regulation text in this
                                            prescriptions once the requirements of                  of the prescriber’s enrollment status,                IFC states that the Part D sponsor must
                                            § 423.120(c)(6) are enforced. Changes to                unless the sponsor has first covered a 3-             do the following: ‘‘provide the
                                            previously finalized policies regarding                 month provisional supply of the drug                  beneficiary with . . . a 3-month
                                            § 423.120(c)(6) are necessary to preserve               and provided individualized written                   provisional supply (as prescribed by the
                                            beneficiaries’ ability to obtain                        notice to the beneficiary that the drug is            prescriber . . .).’’ This means that the
                                            prescriptions for covered Part D drugs                  being covered on a provisional basis.                 Part D sponsor will be required to cover
                                            prescribed by certain practitioners                     Such provisional supply and notice will               a full 3-month supply, if prescribed by
                                            ineligible to enroll in Medicare. We note               allow sufficient time for an eligible                 the unenrolled practitioner, regardless
                                            that the definition of ‘‘physician’’                    prescriber to enroll in Medicare (or                  of how the supply is dispensed. For
                                            includes dentists, hence dentists are                   submit an opt-out affidavit), so that a               example, a beneficiary may receive a
                                            eligible to enroll in or opt-out of                     beneficiary can continue to receive Part              provisional supply in accordance with a
                                            Medicare. Accordingly, this IFC revises                 D coverage for the drug if prescribed by              prescription written for a month’s
                                            § 423.120(c)(6)(ii), (iii), and (iv) such               the same prescriber, or for the                       supply with two subsequent refills; a
                                            that prescriptions provided by ‘‘other                  beneficiary to find a prescriber who                  prescription written for a one-time 3-
                                            authorized prescribers’’ (as defined in                 meets the Medicare requirements to                    month’s supply; or three prescriptions
                                            § 423.100) may be covered under Part D.                 write Part D prescriptions. Enrolling in              written for a 1-month’s supply each.
                                            In other words, Part D sponsors will not                Medicare to prescribe or filing an opt-               Conversely, an unenrolled prescriber
                                            be required to reject pharmacy claims or                out affidavit is a process that can                   might not prescribe a full 3-month’s
                                            deny beneficiary requests for                           typically be completed within 3 months.               supply, and in such a case, the sponsor
                                            reimbursement for prescriptions written                 In presumably rare cases when the                     would of course not be required to
                                            by ‘‘other authorized prescribers’’ on the              prescriber will not enroll in Medicare or             provide a 3-month’s provisional supply.
                                            basis that the prescriber is not enrolled               submit an opt-out affidavit, we believe                  In addition, certain prescriptions
                                            in or opted-out of Medicare. Therefore,                 the beneficiary should have sufficient                cannot be refilled, such as Schedule II
                                            Part D sponsors will continue to be able                time to find a prescriber whose                       controlled substances, and continuing
                                            to cover pharmacy claims at the point of                prescriptions are coverable by the Part               supplies of such drugs are dispensed
                                            sale (POS) for prescriptions written by                 D program, if the beneficiary wishes to               only upon a new prescription. For this
                                            ‘‘other authorized prescribers,’’                       continue to receive Part D coverage for               reason, the regulation text also states
                                            provided all other existing Part D                      the drug. Once the Part D sponsor has                 that the provisional supply must be
                                            coverage requirements are met. We note,                 provided the written notice to the                    ‘‘allowed by applicable law.’’
                                            for example, that under                                 beneficiary that a drug is being covered                 We believe that a sponsor tracking
                                            § 423.120(c)(6)(i), an ‘‘other authorized               on a provisional basis because of the                 dispensed provisional drug supplies is
                                            prescriber’’ must have an active and                    prescriber’s current Medicare status,                 easier than tracking a timeframe after a
                                            valid NPI which is contained in the                     and the sponsor has covered the                       dispensing event. Otherwise, in order to
                                            pharmacy claim. This change will help                   required provisional supply of the drug,              ensure a beneficiary receives a
tkelley on DSK3SPTVN1PROD with RULES




                                            beneficiaries to continue to receive                    the sponsor will be required to reject                provisional supply of each drug
                                            needed prescriptions.                                   future claims and deny future requests                prescribed by an unenrolled prescriber,
                                               In § 423.100, we are defining ‘‘other                for reimbursement for the beneficiary                 Part D sponsors would have to keep
                                            authorized prescriber’’ as a person other               for the same drug if the prescription is              track of rolling timeframes associated
                                            than a physician (as defined in section                 from the same prescriber (unless the                  with the first dispensing event of each
                                            1861(r) of the Act) or eligible                         prescriber has enrolled or opted out in               drug.


                                       VerDate Sep<11>2014   18:11 May 05, 2015   Jkt 235001   PO 00000   Frm 00064   Fmt 4700   Sfmt 4700   E:\FR\FM\06MYR1.SGM   06MYR1


                                                               Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations                                          25961

                                               We note that providing beneficiaries                 approved prior authorization or step                  of § 423.120(c)(6) apply beginning June
                                            with a provisional supply of a drug is                  therapy requirements by the plan. Such                1, 2015. On December 3, 2014, we
                                            consistent with other CMS requirements                  utilization management edits will still               announced an enforcement delay of
                                            and Part D policies designed to provide                 apply to provisional supplies. For these              § 423.120(c)(6) until December 1, 2015.
                                            reasonable access to needed                             reasons, the regulation text in this IFC              We are now in this IFC making another
                                            medications. Under the Part D transition                states that the Part D sponsor or its PBM             change to make these requirements
                                            policy, for example, sponsors are                       must provide the beneficiary with a                   applicable on January 1, 2016. This is to
                                            generally required to cover off-                        provisional supply and written notice                 help make certain that stakeholders,
                                            formulary drugs (including drugs that                   ‘‘subject to all other Part D rules and               such as beneficiaries and plan sponsors,
                                            are on-formulary but require prior                      plan coverage requirements.’’                         have sufficient time to prepare for the
                                            authorization or step therapy) when a                      In light of our previous discussion for            requirements of § 423.120(c)(6).
                                            beneficiary changes prescription drug                   provisional coverage, we have made the                   To prevent potential confusion over
                                            benefit plans and in other                              following changes to § 423.120(c)(6):                 the applicability of § 423.120(c)(5) and
                                            circumstances, in order to give the                        • Revised paragraphs (c)(6)(ii)(A) and             (c)(6), we are revising the dates
                                            beneficiary and his or her prescriber                   (c)(6)(iii) to add the clause ‘‘Except as             identified therein. The beginning of
                                            time to find a suitable on-formulary                    provided in paragraph (c)(6)(v) of this               § 423.120(c)(5) will be changed from
                                            drug or pursue an exception to continue                 section.’’ The revised paragraphs would               ‘‘Before June 1, 2015, the following are
                                            taking the same drug.                                   otherwise require Part D sponsors and                 applicable’’ to ‘‘Before January 1, 2016,
                                               The existing Part D transition policy                their PBMs to reject pharmacy claims                  the following are applicable’’. The
                                            is an example of an instance in which                   and deny beneficiary requests for                     beginning of § 423.120(c)(6) will be
                                            a beneficiary might not receive a full 3-               reimbursement based on the Medicare                   changed from ‘‘Beginning June 1, 2015,
                                            months’ supply under the provisions of                  status of the prescriber.                             the following are applicable’’ to
                                            this IFC, even when prescribed the full                    • Added new paragraph (c)(6)(v) to                 ‘‘Beginning January 1, 2016, the
                                            3 months’ supply, due to other existing                 require that a Part D sponsor or its PBM              following are applicable’’. We believe
                                            Part D transition requirements which                    not reject a pharmacy claim for a Part                these revisions are necessary so that
                                            take precedence. If an unenrolled                       D drug under paragraphs (c)(6)(ii) or                 stakeholders will understand precisely
                                            physician prescribes an off-formulary                   (c)(6)(iii) of this section unless the                when the requirements of
                                            drug for a beneficiary that is subject to               sponsor has provided the provisional                  § 423.120(c)(5) and (c)(6) apply to them.
                                            the transition requirements set forth in                coverage of the drug and written notice               D. Rejection of Pharmacy Claims
                                            § 423.120(b)(3), and thus the provisional               to the beneficiary required by paragraph
                                            supply and notice requirements are                      (c)(6)(v)(B).                                            This IFC also makes a technical
                                            simultaneously triggered, the                              • Added new paragraph (c)(6)(v)(B) to              change to § 423.120(c)(6)(i) and (ii) by
                                            beneficiary would not be able to receive                require that upon receipt of a pharmacy               replacing language that requires plan
                                            more than a 30-day supply of the drug                   claim or beneficiary request for                      sponsors to ‘‘deny’’ pharmacy claims
                                            from a retail pharmacy, unless a                        reimbursement for a Part D drug that a                that do not meet the requirements of
                                            formulary exception is approved,                        Part D sponsor would otherwise be                     § 423.120(c)(6) with language requiring
                                            consistent with existing transition                     required to reject or deny in accordance              plan sponsors to ‘‘reject’’ such claims.
                                            requirements. Conversely, if a formulary                with paragraphs (c)(6)(ii) and (iii) of this          POS claim transactions are not
                                            exception is approved, the beneficiary                  section, a Part D sponsor or its PBM                  considered coverage determinations
                                            could receive the remaining provisional                 must provide the beneficiary with the                 under Part D program rules unless the
                                            supply. We will issue guidance as to                    following two things, subject to all other            plan chooses to treat the presentation of
                                            how sponsors should provide written                     Part D rules and plan coverage                        the prescription as a request for a
                                            notices to the beneficiary when the                     requirements.                                         coverage determination. Therefore, a
                                            sponsor is required to issue a both a                      • Added new paragraph                              Part D plan sponsor is not subject to the
                                            transition notice under                                 (c)(6)(v)(B)(1)(i) to require a Part D                requirements for coverage
                                            § 423.120(b)(3)(iv) and a provisional                   sponsor to provide a 3-month                          determinations in part 423, subpart M,
                                            supply notice under the revised                         provisional supply of the drug (as                    such as the timeframe and notification
                                            requirements of § 423.120(c)(6).                        prescribed by the prescriber and if                   rules, nor to the requirements to
                                               Other examples when a beneficiary                    allowed by applicable law).                           conduct clinical review or to provide
                                            might not receive a full 3-month’s                         • Added new paragraph                              notice of appeal rights when a
                                            provisional supply, or any provisional                  (c)(6)(v)(B)(1)(ii) to require a Part D               prescription cannot be filled under the
                                            supply at all, is when the prescriber                   sponsor to provide written notice within              Part D benefit at the POS. With the
                                            does not have an active and valid NPI.                  3 business days after adjudication of the             requirements finalized in the May 23,
                                            Under § 423.120(c)(6)(i), the Part D                    claim or request in a form and manner                 2014 final rule (79 FR 29843), we did
                                            sponsor or its PBM must reject a                        specified by CMS.                                     not intend to redefine the nature of POS
                                            pharmacy claim unless it contains an                       • Added new paragraph (c)(6)(v)(B)(2)              transactions in the Part D program
                                            active and valid prescriber NPI. Thus, a                to require that a Part D sponsor or its               specifically for claims that are not paid
                                            sponsor or its PBM cannot cover a                       PBM must ensure that reasonable efforts               at the POS because the prescriber does
                                            provisional supply when the applicable                  are made to notify the prescriber of a                not meet the enrollment or opt-out
                                            pharmacy claim does not contain an                      beneficiary who was sent a notice.                    requirements. We believe the word
                                            active and valid prescriber NPI. Without                                                                      ‘‘deny’’ in the regulation text may
                                            a prescriber NPI, the sponsor or PBM                    C. Revision to Dates in § 423.120(c)(5)               incorrectly be interpreted to require
                                            would not be able to determine whether                  and (c)(6)                                            plans to issue a standardized denial
tkelley on DSK3SPTVN1PROD with RULES




                                            a drug should be covered on a                             The requirements of § 423.120(c)(5),                notice with appeal rights (OMB
                                            provisional or regular basis, because the               which address certain NPI submission                  approval 0938–0976, ‘‘Notice of Denial
                                            sponsor cannot determine the                            and verification activities related to                of Medicare Prescription Drug
                                            prescriber’s Medicare enrollment or opt                 pharmacy claims for Part D drugs, apply               Coverage’’, CMS–10146) for rejected
                                            out status. An additional example is                    before June 1, 2015. As mentioned in                  claims at POS, rather than follow our
                                            when the drug prescribed is subject to                  section I.C. of this IFC, the requirements            existing requirements at


                                       VerDate Sep<11>2014   18:11 May 05, 2015   Jkt 235001   PO 00000   Frm 00065   Fmt 4700   Sfmt 4700   E:\FR\FM\06MYR1.SGM   06MYR1


                                            25962              Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations

                                            §§ 423.128(b)(7)(iii) and 423.562(a)(3).                following minor technical changes to                  accordance with a prescription written
                                            These provisions require plans to                       § 423.120(a)(6)(i) through (iv). (These               by a physician or, when permitted by
                                            arrange with their network pharmacies                   changes will not affect the requirements              applicable State law, an eligible
                                            to distribute a copy of the standardized                or substance of these paragraphs.)                    professional (as defined in section
                                            pharmacy notice (OMB approval 0938–                        • In paragraphs (c)(6)(i), (ii), and (iii),        1848(k)(3)(B) of the Act) who’’ to’’A Part
                                            0975, ‘‘Medicare Prescription Drug                      we replaced the word ‘‘if’’ with                      D plan sponsor submitting a
                                            Coverage and Your Rights’’, CMS–                        ‘‘unless,’’ and deleted the word ‘‘not.’’             prescription drug event (PDE) to CMS
                                            10147) to the enrollee. We believe that                 The current versions of these paragraphs              must include on the PDE the active and
                                            this technical change will make the                     are written in the negative, which has                valid individual NPI of the prescriber of
                                            requirements at § 423.120(c)(6)(i) and                  caused confusion for some readers. We                 the drug, who must’’. We believe the
                                            (ii) consistent with our other                          believe these changes will clarify these              new language is more concise and
                                            requirements for POS claim transactions                 paragraphs.                                           straightforward.
                                            and existing National Council for                          • In paragraphs (c)(6)(i) and (iv), we                ++ We have redesignated current
                                            Prescription Drug Programs guidance.                    replaced references to ‘‘physicians’’ and             paragraphs (c)(6)(iv)(A) and (B) as new
                                            We are retaining use of the term ‘‘deny’’               ‘‘eligible professionals’’ with the term              paragraphs (c)(6)(iv)(A)(1) and (2). The
                                            at § 423.120(c)(6)(iii), because plan                   ‘‘prescriber.’’ The latter word is                    requirements pertaining to other
                                            sponsors are required to treat an                       necessary to reflect that these                       authorized prescribers are addressed in
                                            enrollee request for reimbursement as a                 paragraphs also apply to prescribing                  revised paragraph (c)(6)(iv)(B).
                                            coverage determination under subpart                    individuals other than physicians and                    These technical revisions to
                                            M.                                                      eligible professionals.                               paragraph (c)(6)(iv) are needed to
                                                                                                       • In paragraph (c)(6)(ii), the current             accommodate the substantive and
                                            E. Name on Beneficiary Reimbursement                    opening paragraph is incorporated into
                                            Requests                                                                                                      technical revisions discussed in this
                                                                                                    revised paragraph (c)(6)(ii)(A). Current              IFC.
                                              We also made a technical change at                    paragraphs (c)(6)(ii)(A) and (B) are
                                            § 423.120(c)(6)(iii) by replacing ‘‘legal               redesignated as new paragraphs                        III. Waiver of Proposed Rulemaking
                                            name’’ with ‘‘name’’ for beneficiary                    (c)(6)(ii)(A)(1) and (2). The requirements               We ordinarily publish a notice of
                                            reimbursement requests. Requiring that                  pertaining to other authorized                        proposed rulemaking in the Federal
                                            beneficiary requests for coverage                       prescribers are addressed in revised                  Register and invite public comment on
                                            include the prescriber’s legal name is                  paragraph (c)(6)(ii)(B). These                        the proposed rule. The notice of
                                            inconsistent with the existing standard                 organizational revisions of (c)(6)(ii) are            proposed rulemaking includes a
                                            required for coverage determination                     necessary in order to incorporate the                 reference to the legal authority under
                                            requests at § 423.568(a) and related                    substantive and technical changes
                                            subregulatory guidance and is overly                                                                          which the rule is proposed and the
                                                                                                    discussed in this IFC.                                terms and substance of the proposed
                                            burdensome for beneficiaries.                              • In the opening paragraph of
                                            Throughout Chapter 18 of the Medicare                                                                         rule or a description of the subjects and
                                                                                                    (c)(6)(iii), we changed the language ‘‘for
                                            Prescription Drug Manual (particularly                                                                        issues involved. However, this
                                                                                                    a drug if the request is not for a Part D
                                            section 30.3), CMS guidance to plan                                                                           procedure can be waived if an agency
                                                                                                    drug that was dispensed in accordance
                                            sponsors includes an expectation that                                                                         finds good cause that a notice-and-
                                                                                                    with a prescription written by’’ to
                                            plan sponsors will make reasonable and                                                                        comment procedure is impracticable,
                                                                                                    ‘‘unless the request pertains to a Part D
                                            diligent efforts to obtain any missing                                                                        unnecessary, or contrary to the public
                                                                                                    drug that was prescribed by’’. This is to
                                            information required to process                                                                               interest and incorporates a statement of
                                                                                                    make the paragraph clearer and more
                                            beneficiary requests when the request                                                                         the finding and its reasons in the rule
                                                                                                    readable. We also—
                                            does not include all information needed                    ++ Changed paragraph (c)(6)(iii)(A)                issued.
                                            to make a decision, such as the                         from ‘‘Is identified by his or her legal                 We believe we have good cause to
                                            prescriber’s legal name, if necessary to                name in the request’’ to ‘‘A physician or,            make our previously discussed changes
                                            determine coverage under the prescriber                 when permitted by applicable State law,               in this IFC. Concerning the substantive
                                            enrollment requirements. Additionally,                  other eligible professional (as defined in            changes, we believe that notice-and-
                                            Chapter 5, section 90.2.2 contains                      section 1848(k)(3)(B) of the Act) who is              comment rulemaking is contrary to the
                                            language stating that plans can require                 identified by name in the request; and                public interest for the reasons that
                                            beneficiary requests for reimbursement                  who’’.                                                follow.
                                            to include prescriber name (not ‘‘legal                    ++ Redesignated current paragraphs                    Several months after publication of
                                            name’’) and address or phone number or                  (c)(6)(iii)(B)(1) and (2) as new                      the May 23, 2014 final rule that imposed
                                            pharmacy name and phone number to                       paragraphs (A)(1) and (2). The                        the enrollment or opt-out requirement
                                            assist the plan in locating the prescriber              requirements pertaining to other                      as of June 1, 2015, it was brought to our
                                            NPI necessary to submit the PDE to                      authorized prescribers are addressed in               attention during implementation that
                                            CMS. We recognize that the ‘‘legal                      revised paragraph (c)(6)(iii)(B).                     there are prescribers who can and do
                                            name’’ standard was included in                            These technical revisions to (c)(6)(iii)           prescribe Part D medications but who
                                            § 423.120(c)(6) because it was adopted                  are needed to accommodate the                         are also unable to enroll in Medicare to
                                            for Part A/B ordering and referring                     substantive and technical revisions                   prescribe because they do not
                                            claims at § 424.507(a)(2). However,                     heretofore discussed in this IFC.                     technically meet even the broad
                                            given the regulations and manual                           • In paragraph (c)(6)(iv) we are                   definition of ‘‘eligible health
                                            guidance previously discussed, we do                    making the following changes:                         professional.’’ The May 23, 2014 final
                                            not believe this standard is appropriate                   ++ The opening paragraph is changed                rule was not only complex and
tkelley on DSK3SPTVN1PROD with RULES




                                            for Part D beneficiary reimbursement                    from ‘‘In order for a Part D sponsor to               controversial, but with respect to the
                                            requests.                                               submit to CMS a prescription drug event               prescriber enrollment provisions
                                                                                                    record (PDE), the PDE must contain an                 themselves, we were focused on the fact
                                            F. Other Technical Changes                              active and valid individual prescriber                that dentists can enroll and represent
                                              In addition to the previously                         NPI and must pertain to a claim for a                 the largest group of unenrolled current
                                            described revisions, we are making the                  Part D drug that was dispensed in                     Part D prescribers. Additionally, we did


                                       VerDate Sep<11>2014   18:11 May 05, 2015   Jkt 235001   PO 00000   Frm 00066   Fmt 4700   Sfmt 4700   E:\FR\FM\06MYR1.SGM   06MYR1


                                                               Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations                                                25963

                                            not receive any explicit comments on                    must be implemented prior to the bid                  of those deaths were related to
                                            the pharmacist issue.                                   deadline so that Part D sponsors may                  pharmaceuticals.2 The Department of
                                               Once we became aware of the issue,                   account for them in their bids; we                    Health and Human Services has several
                                            we promptly considered alternatives to                  cannot impose costly new requirements                 initiatives to address prescription drug
                                            address it, such as directing pharmacists               on the plans for a contract year that are             abuse; for instance, the National
                                            to opt-out, but concluded that this is not              not accounted for in their bids for that              Institute on Drug Abuse, the National
                                            permissible under the applicable                        contract year under section 1860D–                    Institutes of Health, and the Substance
                                            statutory language. Ultimately, we came                 12(f)(2) of the Act. Thus, an IFC is the              Abuse and Mental Health Services
                                            to the conclusion that the May 23, 2014                 only means for ensuring that our                      Administration are working with public
                                            rule must be updated. The existing rule                 requirements do not cause unintended                  and private stakeholders to reduce
                                            could cause an unintended disruption                    disruption to beneficiary access to Part              opioid overdoses. CMS has also adopted
                                            in beneficiaries’ access to Part D drugs                D drugs, while ensuring that the                      an approach to reduce opioid
                                            because under the current regulations,                  changes that will minimize such                       overutilization in Medicare Part D.
                                            as of June 1, 2015, pharmacists’ (and                   disruptions are incorporated into Part D                The new enrollment requirements
                                            potentially certain other prescribers’)                 sponsors’ 2016 bids; the length of time               addressed in the May 23, 2014 final rule
                                            prescriptions could not be filled.                      involved with notice-and rulemaking                   represent an important component of
                                               Additionally, we concluded that                      would prevent us from accomplishing                   this effort and are a crucial program
                                            changes to the May 23, 2014 rule                        these objectives without further                      integrity and basic quality assurance
                                            needed to include a provisional supply                  delaying enforcement of the existing                  protection for Medicare beneficiaries,
                                            to prevent disruptions to beneficiaries’                regulations, which for the reasons                    for the requirements help us to confirm
                                            access to Part D drugs. This is based on                discussed later in this section, could                that prescribers are qualified to
                                            our monitoring of prescriber enrollment                 cause beneficiary harm. Moreover, a                   prescribe Part D drugs. It is important
                                            levels and trends and meetings with                     prompt publication is necessary to give               that these protections are in place as
                                            stakeholders during implementation.                     Part D plan sponsors time to implement
                                            Prescriber enrollment is a voluntary act,                                                                     soon as possible. We have identified
                                                                                                    the operational changes needed for them               68,000 prescribers that have been
                                            and while we remain confident that the                  to be prepared for these requirements in
                                            Part D prescribers who need to enroll or                                                                      removed from Medicare for reasons
                                                                                                    the 2016 contract year.                               such as licensure issues, operational
                                            opt-out will ultimately do so in large                    If Part D sponsors were unable to
                                            numbers, it will take some time. The                                                                          status, or exclusion by the OIG, and we
                                                                                                    account for these new requirements in
                                            non-dentist and non-pharmacist                                                                                have a responsibility to enforce these
                                                                                                    their 2016 bids, we would have to delay
                                            prescribers who need to enroll are ones                                                                       protections to beneficiaries as soon as
                                                                                                    the applicability date of the enrollment/
                                            who did not enroll to be able to order                  opt-out requirements to no sooner than                possible without compromising
                                            and certify under § 424.507. In addition,               January 1, 2017. We believe that such an              continuity of care or beneficiary access
                                            dentists are a group of providers that                  outcome similarly is contrary to the                  to needed medications. The CDC has
                                            has not yet had a robust direct                         public interest because it would unduly               recommended swift regulatory action
                                            relationship with Medicare due to the                   delay the extremely important program                 against health care providers acting
                                            fact that dentists generally do not bill                integrity and basic quality assurance                 outside the limits of accepted medical
                                            Medicare for their services. Since it is in             protection for Medicare beneficiaries                 practice to decrease provider behaviors
                                            the public’s interest that we make                      that we implemented in our May 23,                    that contribute to prescription painkiller
                                            certain that beneficiary access to needed               2014 final rule, and beneficiaries could              abuse, diversion, and overdose.3
                                            drugs will not be impaired when these                   be harmed as a result. As we explained                  Thus, for all of these reasons, we find
                                            important program integrity protections                 in the May 23, 2014 final rule, we have               good cause to waive prior notice and
                                            become applicable, we have also added                   been concerned about instances where                  comment with respect to the substantive
                                            the provisional supply provisions in                    unqualified individuals are prescribing               changes being made in this IFC.
                                            this IFC. Without such swift action, we                 Part D drugs. In fact, in a June 2013                   With respect to the technical changes
                                            would be forced to either enforce the                   report the OIG found that the Part D                  being made in this IFC, we believe
                                            rule as written, which could cause                      program inappropriately paid for drugs                notice-and-comment rulemaking is
                                            beneficiary harm by disrupting access,                  ordered by individuals who did not                    unnecessary because these changes are
                                            or further delay enforcement, which                     appear to have the authority to                       not substantive and do not alter current
                                            also could cause beneficiary harm by                    prescribe. (See ‘‘Medicare                            policy.
                                            continuing to permit unqualified                        Inappropriately Paid for Drugs Ordered
                                            individuals to prescribe Part D drugs.                                                                        IV. Collection of Information
                                                                                                    by Individuals Without Prescribing
                                            Both outcomes are contrary to the                                                                             Requirements
                                                                                                    Authority’’ (OEI–02–09–00608).) There
                                            public interest. In addition, the                       have also been reports that the                         Under the Paperwork Reduction Act
                                            provisional supply provisions include a                 prescriptions of physicians with                      of 1995, we are required to provide 60-
                                            written notice to the beneficiary. We                   suspended licenses have been covered                  day notice in the Federal Register and
                                            believe that the written notices will                   by the Part D program.                                solicit public comment before a
                                            result in beneficiaries’ discussing the                   The Centers for Disease Control and                 collection of information requirement is
                                            enrollment status issue with their                      Prevention (CDC) has characterized                    submitted to the Office of Management
                                            prescribers, which will assist in our                   prescription drug abuse as an epidemic,               and Budget (OMB) for review and
                                            prescriber enrollment efforts. In                       and found that an increase in painkiller              approval. In order to fairly evaluate
                                            addition, to resolve these problems, it is              prescribing is the key driver of the                  whether an information collection
                                            necessary to implement the provisions                   increase in prescription overdoses.1 The
tkelley on DSK3SPTVN1PROD with RULES




                                                                                                                                                          should be approved by OMB, section
                                            of this IFC prior to the Medicare Part D                CDC reports that the drug overdose                    3506(c)(2)(A) of the Paperwork
                                            bid deadline for the 2016 contract year,                death rate has more than doubled from
                                            which begins on January 1, 2016. The                    1999 through 2013, and more than half                   2 http://www.cdc.gov/homeandrecreationalsafety/
                                            statutory bid deadline this year is June                                                                      overdose/facts.html.
                                            1, 2015. Any changes to Part D                            1 http://www.cdc.gov/vitalsigns/pdf/2014-07-          3 http://www.cdc.gov/drugoverdose/pdf/

                                            requirements for contract year 2016                     vitalsigns.pdf.                                       policyimpact-prescriptionpainkillerod-a.pdf.



                                       VerDate Sep<11>2014   18:11 May 05, 2015   Jkt 235001   PO 00000   Frm 00067   Fmt 4700   Sfmt 4700   E:\FR\FM\06MYR1.SGM   06MYR1


                                            25964                     Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations

                                            Reduction Act of 1995 requires that we                                     number of burden hours in 2016. We                        approximately 1,040 full-time working
                                            solicit comment on the following issues:                                   did not estimate any burden in 2017 and                   hours. We estimated 5 full time staff (or
                                               • The need for the information                                          2018 for the collection of information                    10 staff working half their hours on this
                                            collection and its usefulness in carrying                                  about ‘‘other authorized prescriber’’                     project). Five staff × 1,040 hours × 30
                                            out the proper functions of our agency.                                    NPIs, as the number of new pharmacist                     sponsors/PBMs = 156,000 total hours.
                                               • The accuracy of our estimate of the                                   NPIs and existing pharmacist NPIs                         We estimated an hourly rate of $64.32
                                            information collection burden.                                             becoming inactive will be negligible in                   for such developers and programmers,
                                               • The quality, utility, and clarity of                                  light of the fact that there are only                     which is $10,033,920 in total burden
                                            the information to be collected.                                           approximately 17,000 total ‘‘other                        cost.
                                               • Recommendations to minimize the                                       authorized prescribers’’ writing Part D
                                            information collection burden on the                                                                                                    We also estimated 212 parent
                                                                                                                       prescriptions in 2013.                                    organizations will create two template
                                            affected public, including automated                                          We note that since NPPES is not a
                                            collection techniques.                                                                                                               notices to notify beneficiaries and
                                                                                                                       provider credentialing system, but
                                               We are soliciting public comment on                                                                                               prescribers under the modifications of
                                                                                                                       rather an enumeration system that
                                            the following section of this document                                                                                               § 423.120(c)(6). We estimated this will
                                                                                                                       contains self-reported credentials, Part
                                            that contains information collection                                                                                                 take 3 hours per entity for a total of 636
                                                                                                                       D sponsors might not rely upon a
                                            requirements (ICRs).                                                                                                                 hours. We estimated an hourly rate of
                                                                                                                       taxonomy in NPPES as documentation
                                               We believe the principal information                                                                                              $45.54 for a business operation
                                                                                                                       that an NPI in fact belongs to a
                                            collection requirement associated with                                                                                               specialist to create such notices. Thus,
                                                                                                                       pharmacist with an active license who
                                            this IFC is that some Part D sponsors                                                                                                the total estimated burden cost for
                                                                                                                       is permitted to prescribe. We have used
                                            and PBMs will need to collect                                                                                                        parent organizations to create two
                                                                                                                       data from NPPES to provide an estimate
                                            information about which NPIs are for                                                                                                 model notices is $28,963.44.
                                                                                                                       as to how many ‘‘other authorized
                                            ‘‘other authorized prescribers’’ in order                                  prescribers’’ NPIs about which Part D                        Once the templates have been
                                            to properly adjudicate pharmacy claims                                     sponsors and PBMs will need to collect                    developed, we estimated that these
                                            containing such prescriber NPIs in light                                   information.                                              notices would take an average of 5
                                            of the revised provisions of                                                  In the alternative, we understand that                 minutes (0.083 hours) to prepare. Thus,
                                            § 423.120(c)(6) in this IFC. However, we                                   Part D sponsors/PBMs may purchase                         we estimated the annual burden hours
                                            estimate that half of the 30 Part D                                        prescriber ID validation services from a                  for 2016 to be 1,743,000 hours. This is
                                            sponsors and PBMs with Part D                                              private company that can provide them                     based upon the national median hourly
                                            adjudications systems already collect                                      with a list of ‘‘other authorized                         rate of $26.22 for an insurance claim
                                            information about the prescriptive                                         providers.’’ However, we do not provide                   and policy processing clerk multiplied
                                            authority of prescriber NPIs in order to                                   a collection estimate for all options that                by the number of burden hours. The
                                            mitigate current potential audit risks                                     sponsors/PBMs may have in                                 estimated annual burden cost for 2016
                                            associated with submitting PDEs to CMS                                     implementing the provisions of this IFC.                  is $45,701,460.
                                            for Part D drugs that were not dispensed                                      We also revised the provisions of                         Therefore, we estimated the total
                                            upon a valid prescription.                                                 § 423.120(c)(6) to require Part D                         regulatory impact for these provisions in
                                               In a CMS analysis of PDE data, there                                    sponsors to cover a provisional supply                    2016 to be $55,764,343.44 ($10,033,920
                                            were just over 1.3 million prescribers                                     of a drug before they reject a claim                      + $28,963.44 + $45,701,460).
                                            writing Part D prescriptions in 2013.                                      based on a prescriber’s Medicare status.
                                            Approximately 17,000 of these                                              These modifications will also require                        Approximately 2 million beneficiaries
                                            prescribers have NPIs a taxonomy in the                                    Part D sponsors to provide written                        enter the Part D program every year. If
                                            National Provider & Plan Enumeration                                       notice to the beneficiary and take                        we assume that 25 percent of these new
                                            System (NPPES) that would fall under                                       reasonable efforts to provide written                     beneficiaries will see 1 prescriber who
                                            the definition of ‘‘other authorized                                       notice to the prescriber. The burden                      is not enrolled or opted out, and that
                                            prescribers’’ (largely pharmacist                                          associated with these modifications is                    prescriber prescribes 2 drugs, we
                                            taxonomies).                                                               the time and effort necessary for Part D                  anticipate that parent organizations will
                                               NPIs and the addresses and taxonomy                                     adjudications systems to be                               have to send 1 million notices in 2017
                                            codes that pertain to them are publicly                                    programmed, model notices to be                           and 2018 each (250,000 beneficiaries ×
                                            available information through the CMS                                      created, and such notices to be                           2 prescriptions × 2 notices each =
                                            Web site for NPPES. We estimated that                                      generated and disseminated to perform                     1,000,000). We estimate these notices
                                            collecting information about which NPIs                                    these tasks. We estimated that this will                  would take an average of 5 minutes
                                            are for ‘‘other authorized prescribers’’                                   take 30 sponsors and PBMs with Part D                     (0.083 hours) to prepare. Thus, we
                                            would take an average of 30 minutes                                        adjudications systems 156,000 hours for                   estimate the total burden to be 83,000
                                            (0.5 hours) per NPI associated with a                                      software developers and programmers to                    hours for each year, and the annual cost
                                            pharmacist or 8,500 hours, and the                                         program their systems in 2016 to                          to be $2,176,260. This is based upon the
                                            estimated total burden for 15 sponsors/                                    comply with the modifications to                          national median hourly rate of $26.22
                                            PBMs to be 17,500 hours for 2016. The                                      § 423.120(c)(6) in this IFC. In 2017 and                  for insurance claim and policy
                                            estimated total annual cost for this                                       2018, we estimated the total burden to                    processing clerk multiplied by the
                                            burden is $3,343,050. This is based                                        be 83,000 hours for each year.                            number of burden hours.
                                            upon the national median hourly rate of                                       We estimated the total hours by                           Table 1 outlines the projected costs of
                                            $26.22 for insurance claim and policy                                      estimating a 6-month preparation and                      this IFC commencing 2016 through
                                            processing clerk multiplied by the                                         testing period. Six months includes                       2018:
tkelley on DSK3SPTVN1PROD with RULES




                                                                                                                        TABLE 1—PROJECTED BURDEN COSTS
                                                                                                                                              Programming            Create notices        Send notices     Annual impact

                                            2016 .........................................................................................        $10,033,920              $28,963.44         $45,701,460    $55,764,343.44
                                            2017 .........................................................................................                N/A                    N/A            2,176,260         2,176,260



                                       VerDate Sep<11>2014         18:11 May 05, 2015          Jkt 235001      PO 00000        Frm 00068     Fmt 4700   Sfmt 4700   E:\FR\FM\06MYR1.SGM   06MYR1


                                                                      Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations                                                             25965

                                                                                                            TABLE 1—PROJECTED BURDEN COSTS—Continued
                                                                                                                                              Programming            Create notices        Send notices        Annual impact

                                            2018 .........................................................................................                  N/A                   N/A              2,176,260        2,176,260



                                              If you comment on these information                                      exceed $100 million in any one year.                      that prescriber. Nevertheless, parent
                                            collection and recordkeeping                                               Therefore, this is IFC is not a major rule.               organizations will have to send notices
                                            requirements, please do either of the                                         The average Part D beneficiary takes                   on an ongoing basis to beneficiaries who
                                            following:                                                                 9 drugs prescribed by three prescribers                   are new to the Part D program and
                                              1. Submit your comments                                                  annually. Based on 2013 PDE data,                         receive a prescription from a prescriber
                                            electronically as specified in the                                         approximately 380,000 (28 percent) Part                   who is not enrolled in or opted out of
                                            ADDRESSES section of this interim final                                    D prescribers were not found in the                       Medicare.
                                            rule with comment period; or                                               Provider Enrollment, Chain, and                              The RFA requires agencies to analyze
                                              2. Submit your comments to the                                           Ownership System (PECOS) and are                          options for regulatory relief of small
                                            Office of Information and Regulatory                                       associated with just under 8,000,000                      businesses. For purposes of the RFA,
                                            Affairs, Office of Management and                                          unique beneficiaries. Generally, PECOS                    small entities include small businesses,
                                            Budget, Attention: CMS Desk Officer,                                       is the CMS record database of all                         nonprofit organizations, and small
                                            [CMS–6107–IFC]; Fax: (202) 395–6974;                                       physicians and eligible professionals                     governmental jurisdictions. Most
                                            or Email: OIRA_submission@                                                 who are or were enrolled in or opted out                  entities and most other providers and
                                            omb.eop.gov.                                                               of Medicare. Thus, these prescribers                      suppliers are small entities, either by
                                                                                                                       write prescriptions on average for 21                     nonprofit status or by having revenues
                                            V. Response to Comments                                                    beneficiaries (8,000,000/380,000 = 21).                   between $7.5 million and $38.5 million
                                              Because of the large number of public                                    For purposes of this analysis, we                         in any 1 year. Individuals and states are
                                            comments we normally receive on                                            assumed that on January 1, 2016,                          not included in the definition of a small
                                            Federal Register documents, we are not                                     250,000 prescribers will still need to                    entity. We do not believe that this IFC
                                            able to acknowledge or respond to them                                     enroll in or opt-out of Medicare to                       would have a significant economic
                                            individually. We will consider all                                         prescribe coverable Part D drugs. We                      impact on a substantial number of small
                                            comments we receive by the date and                                        also assume that these 250,000                            businesses, as Part D sponsors and
                                            time specified in the DATES section of                                     prescribers will write prescriptions for                  parent organizations do not generally
                                                                                                                       5.25 million beneficiaries (250,000 ×                     meet the definition of a small business.
                                            this preamble, and, when we proceed
                                                                                                                                                                                    Section 1102(b) of the Act requires us
                                            with a subsequent document, we will                                        21). We further assume that no
                                                                                                                                                                                 to prepare a regulatory impact analysis
                                            respond to the comments in the                                             beneficiaries will switch prescribers
                                                                                                                                                                                 if a rule may have a significant impact
                                            preamble to that document.                                                 until they receive a notice that a drug
                                                                                                                                                                                 on the operations of a substantial
                                                                                                                       is being covered on a provisional basis.
                                            VI. Regulatory Impact Statement                                                                                                      number of small rural hospitals. This
                                                                                                                       Additionally, we assumed that these
                                                                                                                                                                                 analysis must conform to the provisions
                                               We have examined the impacts of this                                    prescribers will write on average two
                                                                                                                                                                                 of section 604 of the RFA. For purposes
                                            rule as required by Executive Order                                        prescriptions for each of these                           of section 1102(b) of the Act, we define
                                            12866 on Regulatory Planning and                                           beneficiaries. We assumed that Part D                     a small rural hospital that is located
                                            Review (September 30, 1993), Executive                                     parent organizations will be able to send                 outside of a Metropolitan Statistical
                                            Order 13563 on Improving Regulation                                        each prescriber a notice. Finally, we did                 Area for Medicare payment regulations
                                            and Regulatory Review (January 18,                                         not offset our estimation in light of our                 and has fewer than 100 beds. We are not
                                            2011), the Regulatory Flexibility Act                                      expectation that, in some cases,                          preparing an analysis for section 1102(b)
                                            (RFA) (September 19, 1980, Pub. L. 96–                                     transition and provisional supply                         of the Act because we have determined
                                            354), section 1102(b) of the Social                                        notices will be combined into one                         and the Secretary certified that this IFC
                                            Security Act, section 202 of the                                           notice. We estimated that parent                          would not have a significant impact on
                                            Unfunded Mandates Reform Act of 1995                                       organizations will send 21 million                        the operations of a substantial number
                                            (March 22, 1995; Pub. L. 104–4) and                                        beneficiary and prescriber notices in                     of small rural hospitals.
                                            Executive Order 13132 on Federalism                                        accordance with the modifications to                         Section 202 of the Unfunded
                                            (August 4, 1999).                                                          § 423.120(c)(6) in 2016 (5,250,000                        Mandates Reform Act of 1995 (UMRA)
                                               Executive Orders 12866 and 13563                                        beneficiaries × 2 prescriptions × 2                       also requires that agencies assess
                                            direct agencies to assess all costs and                                    notices each = 21,000,000), which we                      anticipated costs and benefits before
                                            benefits of available regulatory                                           expect to occur as a downward trend                       issuing any rule whose mandates
                                            alternatives and, if regulation is                                         that we do not reflect in this analysis.                  require spending in any 1 year of $100
                                            necessary, to select regulatory                                               Prescribers are expected to enroll on                  million in 1995 dollars, updated
                                            approaches that maximize net benefits                                      a steady basis throughout 2016 as a                       annually for inflation. In 2015, this is
                                            (including potential economic,                                             result of the prescriber enrollment                       approximately $144 million. We believe
                                            environmental, public health and safety                                    requirements. By 2017, we expect that                     that this IFC will have no consequential
                                            effects, distributive impacts, and                                         the majority of Part D prescribers will                   effect on state, local or tribal
                                            equity). A regulatory impact analysis                                      have enrolled in or opted out of                          governments or on the private sector.
                                            (RIA) must be prepared for major rules                                     Medicare in order for their prescriptions                    Executive Order 13132 establishes
tkelley on DSK3SPTVN1PROD with RULES




                                            with economically significant effects                                      to be coverable by the Part D program.                    certain requirements that an agency
                                            ($100 million or more in any 1 year).                                      When a prescriber does not enroll or opt                  must meet when it promulgates a
                                            The impact of this IFC is directly                                         out, the beneficiary will either change to                proposed rule (and subsequent final
                                            associated with the information                                            a prescriber who is enrolled or opted                     rule) that imposes substantial direct
                                            collection requirements discussed in                                       out, or the beneficiary will pay out of                   requirements or costs on state and local
                                            section IV. of this IFC and will not                                       pocket for the prescriptions written by                   governments, preempts state law, or


                                       VerDate Sep<11>2014         18:11 May 05, 2015          Jkt 235001      PO 00000        Frm 00069     Fmt 4700   Sfmt 4700   E:\FR\FM\06MYR1.SGM   06MYR1


                                            25966              Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations

                                            otherwise has federalism implications.                     (ii)(A) Except as provided in                      section, a Part D sponsor or its PBM
                                            Since this regulation does not impose                   paragraph (c)(6)(v) of this section, a Part           must do the following:
                                            any costs on state or local governments,                D plan sponsor must reject, or must                     (1) Provide the beneficiary with the
                                            the requirements of Executive Order                     require its PBM to reject, a pharmacy                 following, subject to all other Part D
                                            13132 are not applicable. In accordance                 claim for a Part D drug unless the                    rules and plan coverage requirements:
                                            with the provisions of Executive Order                  physician or, when permitted by                         (i) A 3-month provisional supply of
                                            12866, this IFC was reviewed by the                     applicable State law, the eligible                    the drug (as prescribed by the prescriber
                                            Office of Management and Budget.                        professional (as defined in section                   and if allowed by applicable law).
                                                                                                    1848(k)(3)(B) of the Act) who prescribed                (ii) Written notice within 3 business
                                            List of Subjects in 42 CFR Part 423                                                                           days after adjudication of the claim or
                                                                                                    the drug—
                                              Administrative practice and                              (1) Is enrolled in the Medicare                    request in a form and manner specified
                                            procedure, Emergency medical services,                  program in an approved status; or                     by CMS.
                                            Health facilities, Health maintenance                      (2) Has a valid opt-out affidavit on file            (2) Ensure that reasonable efforts are
                                            organizations (HMO), Health                                                                                   made to notify the prescriber of a
                                                                                                    with a Part A/B Medicare
                                            professionals, Medicare, Penalties,                                                                           beneficiary who was sent a notice under
                                                                                                    Administrative Contractor (MAC).
                                            Privacy, Reporting and recordkeeping                                                                          paragraph (c)(6)(v)(B)(1)(ii) of this
                                                                                                       (B) Pharmacy claims for Part D drugs
                                            requirements.                                                                                                 section.
                                                                                                    prescribed by an other authorized
                                              For the reasons stated in the preamble                prescriber (as defined in § 423.100) are              *      *    *     *    *
                                            of this interim final rule with comment                 not subject to the requirements specified               Dated: April 17, 2015.
                                            period, the Centers for Medicare &                      in paragraph (c)(6)(ii)(A) of this section.           Andrew M. Slavitt,
                                            Medicaid Services amends 42 CFR part                       (iii) Except as provided in paragraph              Acting Administrator, Centers for Medicare
                                            423 as follows:                                         (c)(6)(v) of this section, a Part D plan              & Medicaid Services.
                                                                                                    sponsor must deny, or must require its                  Dated: April 29, 2015.
                                            PART 423—VOLUNTARY MEDICARE                             PBM to deny, a request for                            Sylvia M. Burwell,
                                            PRESCRIPTION DRUG PROGRAM                               reimbursement from a Medicare                         Secretary, Department of Health and Human
                                                                                                    beneficiary unless the request pertains               Services.
                                            ■ 1. The authority citation for part 423                to a Part D drug that was prescribed                  [FR Doc. 2015–10545 Filed 5–1–15; 4:15 pm]
                                            continues to read as follows:                           by—                                                   BILLING CODE 4120–01–P
                                              Authority: Secs. 1102, 1106, 1860D–1                     (A) A physician or, when permitted
                                            through 1860D–42, and 1871 of the Social                by applicable State law, other eligible
                                            Security Act (42 U.S.C. 1302, 1306, 1395w–              professional (as defined in section
                                            101 through 1395w–152, and 1395hh).                                                                           DEPARTMENT OF COMMERCE
                                                                                                    1848(k)(3)(B) of the Act) who is
                                            ■ 2. Amend § 423.100 by adding a                        identified by name in the request and                 National Oceanic and Atmospheric
                                            definition of ‘‘Other authorized                        who—                                                  Administration
                                            prescriber’’ in alphabetical order to read                 (1) Is enrolled in Medicare in an
                                            as follows:                                             approved status; or                                   50 CFR Part 622
                                                                                                       (2) Has a valid opt-out affidavit on file
                                            § 423.100   Definitions.                                                                                      [Docket No. 120815345–3525–02]
                                                                                                    with a Part A/B MAC; or
                                            *      *     *     *    *                                  (B) An other authorized prescriber (as             RIN 0648–XD901
                                               Other authorized prescriber means,                   defined in § 423.100) who is identified
                                            for purposes of § 423.120(c)(6) only, an                by name in the request.                               Fisheries of the Caribbean, Gulf of
                                            individual other than a physician (as                      (iv) A Part D plan sponsor submitting              Mexico, and South Atlantic; 2015
                                            defined in section 1861(r) of the Act) or               a prescription drug event (PDE) to CMS                Commercial Accountability Measure
                                            eligible professional (as defined in                    must include on the PDE the active and                and Closure for South Atlantic Gray
                                            section 1848(k)(3)(B) of the Act) who is                valid individual NPI of the prescriber of             Triggerfish
                                            authorized under State or other                         the drug, who must—                                   AGENCY:  National Marine Fisheries
                                            applicable law to write prescriptions.                     (A)(1) Be enrolled in Medicare in an               Service (NMFS), National Oceanic and
                                            *      *     *     *    *                               approved status, or                                   Atmospheric Administration (NOAA),
                                            ■ 3. Amend § 423.120 by revising                           (2) Have a valid opt out affidavit on              Commerce.
                                            paragraphs (c)(5) introductory text and                 file with a Part A/B MAC; or                          ACTION: Temporary rule; closure.
                                            (c)(6) to read as follows:                                 (B) Be an other authorized prescriber
                                                                                                    (as defined in § 423.100).                            SUMMARY:   NMFS implements
                                            § 423.120   Access to covered Part D drugs.                                                                   accountability measures for commercial
                                                                                                       (v)(A) A Part D sponsor or its PBM
                                            *     *     *    *     *                                must not reject a pharmacy claim for a                gray triggerfish in the exclusive
                                              (c) * * *                                             Part D drug under paragraph (c)(6)(ii) of             economic zone (EEZ) of the South
                                            *     *     *    *     *                                the section or deny a request for                     Atlantic. NMFS projects commercial
                                              (5) Before January 1, 2016, the                       reimbursement under paragraph                         landings for gray triggerfish, will reach
                                            following are applicable:                               (c)(6)(iii) of this section unless the                the commercial annual catch limit
                                            *     *     *    *     *                                sponsor has provided the provisional                  (ACL) on May 8, 2015. Therefore, NMFS
                                              (6) Beginning January 1, 2016, the                    coverage of the drug and written notice               is closing the commercial sector for gray
                                            following are applicable:                               to the beneficiary required by paragraph              triggerfish in the South Atlantic EEZ on
                                              (i) A Part D plan sponsor must reject,                (c)(6)(v)(B) of this section.                         May 8, 2015, and it will remain closed
tkelley on DSK3SPTVN1PROD with RULES




                                            or must require its pharmaceutical                         (B) Upon receipt of a pharmacy claim               until NMFS announces the start of the
                                            benefit manager (PBM) to reject, a                      or beneficiary request for                            next fishing season. This closure is
                                            pharmacy claim for a Part D drug unless                 reimbursement for a Part D drug that a                necessary to protect the gray triggerfish
                                            the claim contains the active and valid                 Part D sponsor would otherwise be                     resource.
                                            National Provider Identifier (NPI) of the               required to reject or deny in accordance              DATES: This rule is effective 12:01 a.m.,
                                            prescriber who prescribed the drug.                     with paragraphs (c)(6)(ii) or (iii) of this           local time, May 8, 2015, until NMFS


                                       VerDate Sep<11>2014   18:11 May 05, 2015   Jkt 235001   PO 00000   Frm 00070   Fmt 4700   Sfmt 4700   E:\FR\FM\06MYR1.SGM   06MYR1



Document Created: 2015-12-16 07:41:33
Document Modified: 2015-12-16 07:41:33
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionInterim final rule with comment period.
ContactFrank Whelan, (410) 786-1302 for enrollment issues.
FR Citation80 FR 25958 
RIN Number0938-AS60
CFR AssociatedAdministrative Practice and Procedure; Emergency Medical Services; Health Facilities; Health Maintenance Organizations (hmo); Health Professionals; Medicare; Penalties; Privacy and Reporting and Recordkeeping Requirements

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR