82 FR 22893 - 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 82, Issue 96 (May 19, 2017)
Federal Register Volume 82, Issue 96 (May 19, 2017)
| Page Range | 22893-22895 | |
| FR Document | 2017-10149 |
[Federal Register Volume 82, Number 96 (Friday, May 19, 2017)] [Rules and Regulations] [Pages 22893-22895] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-10149] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 10 RIN 0906-AA89 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation AGENCY: Health Resources and Services Administration, HHS. ACTION: Final rule; further delay of effective date. ----------------------------------------------------------------------- SUMMARY: The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' HRSA published a final rule on January 5, 2017, that set forth the calculation of the ceiling price and application of civil monetary penalties. The final rule applied to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. In accordance with a January 20, 2017, memorandum from the Assistant to the President and Chief of Staff, entitled ``Regulatory Freeze Pending Review,'' HRSA issued an interim final rule that delayed the effective date of the final rule published in the Federal Register (82 FR 1210, (January 5, 2017)) to May 22, 2017. HHS invited commenters to provide their views on whether a longer delay of the effective date to October 1, 2017, would be more appropriate. After consideration of the comments received on the interim final rule, HHS is delaying the effective date of the January 5, 2017 final rule, to October 1, 2017. DATES: As of May 19, 2017, the effective date of the final rule published in the Federal Register (82 FR 1210, (January 5, 2017)) is further delayed to October 1, 2017. FOR FURTHER INFORMATION CONTACT: CAPT Krista Pedley, Director, Office of Pharmacy Affairs, Healthcare Systems Bureau, HRSA, 5600 Fishers Lane, Mail Stop 08W05A, Rockville, MD 20857, or by telephone at 301- 594-4353. SUPPLEMENTARY INFORMATION: I. Background In September 2010, HHS published an advanced notice of proposed rulemaking (ANPRM) in the Federal Register, ``340B Drug Pricing Program Manufacturer Civil Monetary Penalties'' (75 FR 57230, (September 20, 2010)). HHS subsequently published a notice of proposed rulemaking (NPRM) in June 2015 to implement civil monetary penalties (CMPs) for manufacturers who knowingly and intentionally charge a covered entity more than the ceiling price for a covered outpatient drug; to provide clarity regarding the requirement that manufacturers calculate the 340B ceiling price on a quarterly basis; and to establish the requirement that a manufacturer charge a $.01 (penny pricing policy) for drugs when the ceiling price calculation equals zero (80 FR 34583, (June 17, 2015)). The public comment period closed August 17, 2015, and HRSA received 35 comments. After review of the initial comments, HHS reopened the comment period (81 FR 22960, (April 19, 2016)) to invite additional comments on the following areas of the NPRM: 340B ceiling price calculations that result in a ceiling price that equals zero (penny pricing); the methodology that manufacturers use when estimating the ceiling price for a new covered outpatient drug; and the definition of the ``knowing and intentional'' standard to be applied when assessing a CMP for manufacturers that overcharge a covered entity. The comment period closed May 19, 2016, and HHS received 72 comments. On January 5, 2017, HHS published a final rule in the Federal Register (82 FR 1210, (January 5, 2017)) and comments from both the NPRM and the reopening notice were considered in the development of the final rule. The provisions of that rule were to be effective March 6, 2017; however, HHS issued a subsequent final rule (82 FR 12508, (March 6, 2017)) delaying the effective date to March 21, 2017, in accordance with a January 20, 2017 memorandum from the Assistant to the President and Chief of Staff, entitled ``Regulatory Freeze Pending Review.'' \1\ In the January 5, 2017 final rule, HHS recognized that the effective date fell during the middle of a quarter and stakeholders needed time to adjust systems and update their policies and procedures. As such, HHS stated that it intended to enforce the requirements of the final rule at the start of the next quarter, which began April 1, 2017. --------------------------------------------------------------------------- \1\ See: https://www.whitehouse.gov/the-press-office/2017/01/20/memorandum-heads-executive-departments-and-agencies. --------------------------------------------------------------------------- After further consideration and to provide affected parties sufficient time to make needed changes to facilitate compliance, and because there were questions raised, HHS issued an interim final rule (82 FR 14332, (March 20, 2017)) to delay the effective date of the final rule to May 22, 2017, and solicited additional comment on whether that date should be further delayed to October 1, 2017. HHS received a number of comments on the interim final rule both supporting and opposing the delay of the effective date to May 22, 2017, or alternatively to October 1, 2017. After careful consideration of the comments received, HHS has decided to delay the effective date of the January 5, 2017 final rule to October 1, 2017. As the effective date of the final rule has been changed to October 1, 2017, enforcement will be correspondingly delayed to October 1, 2017. HHS continues to believe that the delay of the effective date provides regulated entities sufficient time to implement the requirements of the rule. Section 553(d) of the Administrative Procedure Act (APA) (5 U.S.C. 551 et seq.) requires that Federal agencies provide at least 30 days after publication of a final rule in the Federal Register before making it effective, unless good cause can be found not to do so. HHS finds that there is good cause for making this final rule effective less than 30 days after publication in the Federal Register given that failure to do so would result in the final rule published on January 5, 2017, going into effect for several weeks, before having a delayed effective date of October 1, 2017. To preclude this uncertainty in the marketplace and to ease the burdens on all stakeholders, HHS believes that a clear effective date is an important goal and one that becomes particularly important when it is paired with potential civil monetary penalties. The additional time provided to the public before the rule takes effect constitutes an extra quarter and will assist stakeholders in preparing to comply with these new program requirements. II. Analysis and Responses to Public Comments In the interim final rule, we solicited comments regarding whether HHS should delay the January 5, 2017 final rule to May 22, 2017, or alternatively to October 1, 2017. We received a broad range of 51 comments from covered entities, manufacturers, and groups representing these stakeholders. In this final rule, we will only be responding to comments related to whether HHS should delay the January 5, 2017 final rule to May 22, 2017, or to October 1, 2017. Comments that raised issues beyond the narrow scope of the interim final rule, including comments related to withdrawal of the rule or comments related to policy matters, were not [[Page 22894]] considered and are not addressed in this rulemaking. We have summarized the relevant comments received and provided our responses below. Comment: Some commenters supported the May 22, 2017, effective date and opposed further delaying the final rule until October 1, 2017. The commenters explain that adequate enforcement of manufacturers' pricing obligations is key to the success of the 340B Program. These commenters also suggest that further delay of the final rule would result in a lack of oversight, regulation and basic enforcements for manufacturers, which would continue to hamper the 340B Program and lessen covered entities' ability to stretch scarce resources. Response: HHS decided to delay the effective date of the January 5, 2017 final rule to October 1, 2017, to provide affected parties sufficient time to make needed changes to facilitate compliance. Given the comments received from stakeholders on the interim final rule regarding the challenges with complying with the January 5, 2017 final rule, HHS determined that delaying the effective date to October 1, 2017, is necessary to provide adequate time for compliance and to mitigate implementation concerns. HHS disagrees that further delay of the final rule would result in a lack of oversight, regulation, and basic enforcements for manufacturers. Comment: Many commenters opposed further delaying the effective date to October 1, 2017, and suggested that the final rule be enforced immediately. These commenters noted that overcharges in the 340B Program were a widespread problem and that during 2003 and 2005, the HHS Office of the Inspector General (OIG) issued a report,\2\ which found that HRSA lacked the necessary oversight mechanisms to ensure that covered entities pay at or below the 340B ceiling price. The commenters further noted that because of these deficiencies, Congress amended the 340B statute to improve manufacturer compliance by directing HRSA to implement standards for calculating ceiling prices and establish civil monetary penalties for manufacturers that knowingly and intentionally overcharge 340B covered entities. Commenters said that these standards were to be implemented in 2010 and given the long delay in promulgating regulations, they do not support any further delay of the January 5, 2017 final rule. The commenters stated that civil monetary penalties are needed now because they are the only viable penalty that HRSA can impose on manufacturers that violate their 340B pricing obligations. --------------------------------------------------------------------------- \2\ See: OIG, Deficiencies in the Oversight of the 340B Drug Pricing Program (October 2005). --------------------------------------------------------------------------- Response: HHS does not agree that that the final rule should be enforced immediately. We are delaying the effective date of the January 5, 2017 final rule to October 1, 2017, to ensure that affected parties have sufficient time to make changes needed to facilitate compliance, which we believe will benefit all 340B stakeholders and enhance program integrity. Comment: Some commenters raised concerns that the interim final rule did not satisfy APA requirements for rulemaking. Specifically, they argued that HHS had not shown good cause for delaying the effective date of the January 5, 2017 final rule without prior notice or opportunity for public comment and making that change effective immediately upon publication in the Federal Register. Response: HHS disagrees that the good cause exemptions of the APA do not apply here. Our finding that good cause existed to waive the normal rulemaking requirements of the APA was based on our view that in this limited instance notice and public comment was impracticable, unnecessary, or contrary to the public interest. Because completion of a rulemaking with notice and comment procedures would not occur until after the previously announced effective date, we believe a delay in determining the effective date would create confusion that could disrupt orderly implementation of the January 5, 2017 final rule, and would be impracticable, unnecessary, and contrary to the public interest. In addition, we reiterate that we remain concerned that the original effective date for the January 5, 2017 final rule did not allow for sufficient time to consider the regulatory burdens that may be posed and did not provide stakeholders sufficient time to come into compliance with the new program requirements in the final rule. While there was good cause to amend the effective date of the January 5, 2017 final rule, without prior notice or opportunity for public comment and to make the action immediately effective, we note that we implemented the action on an interim basis only and provided notice and an opportunity for comment on the further delay of the effective date of the final rule to October 1, 2017. Based on the foregoing considerations as well as the comments received on our proposal in the interim final rule to further delay the effective date, we are delaying the effective date of the final rule to October 1, 2017. Comment: Many commenters supported further delaying the effective date to October 1, 2017, at a minimum, and agreed with HHS that more time was needed for stakeholders to come into compliance. Response: HHS agrees with the commenters and has decided to delay the effective date of the January 5, 2017 final rule to October 1, 2017. III. Regulatory Impact Analysis HHS examined the effects of this final 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 8, 2011), the Regulatory Flexibility Act (Pub. L. 96- 354, September 19, 1980), the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132 on Federalism (August 4, 1999). Executive Orders 12866 and 13563 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). Executive Order 13563 is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review as established in Executive Order 12866, emphasizing the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Section 3(f) of Executive Order 12866 defines a ``significant regulatory action'' as an action that is likely to result in a rule: (1) Having an annual effect on the economy of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal governments or communities (also referred to as ``economically significant''); (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. A regulatory impact analysis (RIA) must be prepared for major rules with [[Page 22895]] economically significant effects ($100 million or more in any 1 year), and a ``significant'' regulatory action is subject to review by the Office of Management and Budget (OMB). HHS does not believe the proposal to delay the effective date of the January 5, 2017 final rule will have an economic impact of $100 million or more, and is therefore not designated as an ``economically significant'' final rule under section 3(f)(1) of the Executive Order 12866. Therefore, the economic impact of having no rule in place related to the policies addressed in the final rule is believed to be minimal, as the policies would not yet be required or enforceable. The Regulatory Flexibility Act (RFA) The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) (RFA) and the Small Business Regulatory Enforcement and Fairness Act of 1996, which amended the RFA, require HHS to analyze options for regulatory relief of small businesses. If a rule has a significant economic effect on a substantial number of small entities, the Secretary must specifically consider the economic effect of the rule on small entities and analyze regulatory options that could lessen the impact of the rule. HHS will use an RFA threshold of at least a 3 percent impact on at least 5 percent of small entities. For purposes of the RFA, HHS considers all health care providers to be small entities either by meeting the Small Business Administration (SBA) size standard for a small business, or for being a nonprofit organization that is not dominant in its market. The current SBA size standard for health care providers ranges from annual receipts of $7 million to $35.5 million. As of January 1, 2017, over 12,000 covered entities participate in the 340B Program, which represent safety-net health care providers across the country. HHS determined, and the Secretary certifies that this final rule will not have a significant impact on the operations of a substantial number of small manufacturers; therefore, we are not preparing an analysis of impact for this RFA. HHS estimates the economic impact on small entities and small manufacturers will be minimal. Unfunded Mandates Reform Act Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing ``any rule that includes any Federal mandate that may result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year.'' During 2013, that threshold level was approximately $141 million. HHS does not expect this final rule to exceed the threshold. Executive Order 13132--Federalism HHS reviewed this final rule in accordance with Executive Order 13132 regarding federalism, and has determined that it does not have ``federalism implications.'' This final rule would not ``have substantial direct effects on the States, or on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule would not adversely affect the following family elements: Family safety, family stability, marital commitment; parental rights in the education, nurture, and supervision of their children; family functioning, disposable income or poverty; or the behavior and personal responsibility of youth, as determined under Section 654(c) of the Treasury and General Government Appropriations Act of 1999. Paperwork Reduction Act The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires that OMB approve all collections of information by a federal agency from the public before they can be implemented. This final rule is projected to have no impact on current reporting and recordkeeping burden for manufacturers under the 340B Program. This final rule would result in no new reporting burdens. Dated: May 10, 2017. George Sigounas, Administrator, Health Resources and Services Administration. Approved: May 15, 2017. Thomas E. Price, Secretary, Department of Health and Human Services. [FR Doc. 2017-10149 Filed 5-18-17; 8:45 am] BILLING CODE 4165-15-P
![Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Rules and Regulations 22893
* * * * * Manufacturer Civil Monetary Penalties’’ final rule (82 FR 14332, (March 20,
[FR Doc. 2017–10245 Filed 5–18–17; 8:45 am] (75 FR 57230, (September 20, 2010)). 2017)) to delay the effective date of the
BILLING CODE 6560–50–P HHS subsequently published a notice of final rule to May 22, 2017, and solicited
proposed rulemaking (NPRM) in June additional comment on whether that
2015 to implement civil monetary date should be further delayed to
DEPARTMENT OF HEALTH AND penalties (CMPs) for manufacturers who October 1, 2017. HHS received a
HUMAN SERVICES knowingly and intentionally charge a number of comments on the interim
covered entity more than the ceiling final rule both supporting and opposing
42 CFR Part 10 price for a covered outpatient drug; to the delay of the effective date to May 22,
provide clarity regarding the 2017, or alternatively to October 1,
RIN 0906–AA89
requirement that manufacturers 2017. After careful consideration of the
340B Drug Pricing Program Ceiling calculate the 340B ceiling price on a comments received, HHS has decided to
Price and Manufacturer Civil Monetary quarterly basis; and to establish the delay the effective date of the January 5,
Penalties Regulation requirement that a manufacturer charge 2017 final rule to October 1, 2017. As
a $.01 (penny pricing policy) for drugs the effective date of the final rule has
AGENCY: Health Resources and Services when the ceiling price calculation been changed to October 1, 2017,
Administration, HHS. equals zero (80 FR 34583, (June 17, enforcement will be correspondingly
ACTION: Final rule; further delay of 2015)). The public comment period delayed to October 1, 2017. HHS
effective date. closed August 17, 2015, and HRSA continues to believe that the delay of the
received 35 comments. After review of effective date provides regulated entities
SUMMARY: The Health Resources and the initial comments, HHS reopened the sufficient time to implement the
Services Administration (HRSA) comment period (81 FR 22960, (April requirements of the rule.
administers section 340B of the Public 19, 2016)) to invite additional comments Section 553(d) of the Administrative
Health Service Act (PHSA), referred to on the following areas of the NPRM: Procedure Act (APA) (5 U.S.C. 551 et
as the ‘‘340B Drug Pricing Program’’ or 340B ceiling price calculations that seq.) requires that Federal agencies
the ‘‘340B Program.’’ HRSA published a result in a ceiling price that equals zero provide at least 30 days after
final rule on January 5, 2017, that set (penny pricing); the methodology that publication of a final rule in the Federal
forth the calculation of the ceiling price manufacturers use when estimating the Register before making it effective,
and application of civil monetary ceiling price for a new covered unless good cause can be found not to
penalties. The final rule applied to all outpatient drug; and the definition of do so. HHS finds that there is good
drug manufacturers that are required to the ‘‘knowing and intentional’’ standard cause for making this final rule effective
make their drugs available to covered to be applied when assessing a CMP for less than 30 days after publication in the
entities under the 340B Program. In manufacturers that overcharge a covered Federal Register given that failure to do
accordance with a January 20, 2017, entity. The comment period closed May so would result in the final rule
memorandum from the Assistant to the 19, 2016, and HHS received 72 published on January 5, 2017, going into
President and Chief of Staff, entitled comments. effect for several weeks, before having a
‘‘Regulatory Freeze Pending Review,’’ On January 5, 2017, HHS published a delayed effective date of October 1,
HRSA issued an interim final rule that final rule in the Federal Register (82 FR 2017. To preclude this uncertainty in
delayed the effective date of the final 1210, (January 5, 2017)) and comments the marketplace and to ease the burdens
rule published in the Federal Register from both the NPRM and the reopening on all stakeholders, HHS believes that a
(82 FR 1210, (January 5, 2017)) to May notice were considered in the clear effective date is an important goal
22, 2017. HHS invited commenters to development of the final rule. The and one that becomes particularly
provide their views on whether a longer provisions of that rule were to be important when it is paired with
delay of the effective date to October 1, effective March 6, 2017; however, HHS potential civil monetary penalties. The
2017, would be more appropriate. After issued a subsequent final rule (82 FR additional time provided to the public
consideration of the comments received 12508, (March 6, 2017)) delaying the before the rule takes effect constitutes
on the interim final rule, HHS is effective date to March 21, 2017, in an extra quarter and will assist
delaying the effective date of the accordance with a January 20, 2017 stakeholders in preparing to comply
January 5, 2017 final rule, to October 1, memorandum from the Assistant to the with these new program requirements.
2017. President and Chief of Staff, entitled II. Analysis and Responses to Public
DATES: As of May 19, 2017, the effective ‘‘Regulatory Freeze Pending Review.’’ 1 Comments
date of the final rule published in the In the January 5, 2017 final rule, HHS
In the interim final rule, we solicited
Federal Register (82 FR 1210, (January recognized that the effective date fell
comments regarding whether HHS
5, 2017)) is further delayed to October during the middle of a quarter and
should delay the January 5, 2017 final
1, 2017. stakeholders needed time to adjust
rule to May 22, 2017, or alternatively to
FOR FURTHER INFORMATION CONTACT: systems and update their policies and
October 1, 2017. We received a broad
CAPT Krista Pedley, Director, Office of procedures. As such, HHS stated that it
range of 51 comments from covered
Pharmacy Affairs, Healthcare Systems intended to enforce the requirements of
entities, manufacturers, and groups
Bureau, HRSA, 5600 Fishers Lane, Mail the final rule at the start of the next
representing these stakeholders. In this
Stop 08W05A, Rockville, MD 20857, or quarter, which began April 1, 2017.
final rule, we will only be responding to
After further consideration and to
by telephone at 301–594–4353. comments related to whether HHS
provide affected parties sufficient time
should delay the January 5, 2017 final
nlaroche on DSK30NT082PROD with RULES
SUPPLEMENTARY INFORMATION: to make needed changes to facilitate
rule to May 22, 2017, or to October 1,
I. Background compliance, and because there were
2017. Comments that raised issues
questions raised, HHS issued an interim
In September 2010, HHS published an beyond the narrow scope of the interim
advanced notice of proposed 1 See: https://www.whitehouse.gov/the-press- final rule, including comments related
rulemaking (ANPRM) in the Federal office/2017/01/20/memorandum-heads-executive- to withdrawal of the rule or comments
Register, ‘‘340B Drug Pricing Program departments-and-agencies. related to policy matters, were not
VerDate Sep<11>2014 14:45 May 18, 2017 Jkt 241001 PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 E:\FR\FM\19MYR1.SGM 19MYR1](https://thefederalregister.org/doc/82_FR_22989/page/1.svg)
![Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Rules and Regulations 22895
economically significant effects ($100 and Tribal governments, in the DEPARTMENT OF HEALTH AND
million or more in any 1 year), and a aggregate, or by the private sector, of HUMAN SERVICES
‘‘significant’’ regulatory action is subject $100 million or more (adjusted annually
to review by the Office of Management for inflation) in any one year.’’ During Centers for Medicare & Medicaid
and Budget (OMB). 2013, that threshold level was Services
HHS does not believe the proposal to approximately $141 million. HHS does
delay the effective date of the January 5, not expect this final rule to exceed the 42 CFR Parts 510 and 512
2017 final rule will have an economic threshold.
impact of $100 million or more, and is [CMS–5519–F3]
therefore not designated as an Executive Order 13132—Federalism RIN 0938–AS90
‘‘economically significant’’ final rule
under section 3(f)(1) of the Executive HHS reviewed this final rule in Medicare Program; Advancing Care
Order 12866. Therefore, the economic accordance with Executive Order 13132 Coordination Through Episode
impact of having no rule in place related regarding federalism, and has Payment Models (EPMs); Cardiac
to the policies addressed in the final determined that it does not have Rehabilitation Incentive Payment
rule is believed to be minimal, as the ‘‘federalism implications.’’ This final Model; and Changes to the
policies would not yet be required or rule would not ‘‘have substantial direct Comprehensive Care for Joint
enforceable. effects on the States, or on the Replacement Model (CJR); Delay of
The Regulatory Flexibility Act (RFA) relationship between the national Effective Date
government and the States, or on the
The Regulatory Flexibility Act (5 AGENCY: Centers for Medicare &
distribution of power and
U.S.C. 601 et seq.) (RFA) and the Small Medicaid Services (CMS), HHS.
responsibilities among the various
Business Regulatory Enforcement and ACTION: Final rule; delay of effective
levels of government.’’ This final rule
Fairness Act of 1996, which amended date.
would not adversely affect the following
the RFA, require HHS to analyze
options for regulatory relief of small family elements: Family safety, family SUMMARY: This final rule finalizes May
businesses. If a rule has a significant stability, marital commitment; parental 20, 2017 as the effective date of the final
economic effect on a substantial number rights in the education, nurture, and rule titled ‘‘Advancing Care
of small entities, the Secretary must supervision of their children; family Coordination Through Episode Payment
specifically consider the economic functioning, disposable income or Models (EPMs); Cardiac Rehabilitation
effect of the rule on small entities and poverty; or the behavior and personal Incentive Payment Model; and Changes
analyze regulatory options that could responsibility of youth, as determined to the Comprehensive Care for Joint
lessen the impact of the rule. HHS will under Section 654(c) of the Treasury Replacement Model (CJR)’’ originally
use an RFA threshold of at least a 3 and General Government published in the January 3, 2017
percent impact on at least 5 percent of Appropriations Act of 1999. Federal Register. This final rule also
small entities. finalizes a delay of the applicability date
For purposes of the RFA, HHS Paperwork Reduction Act of the regulations at 42 CFR part 512
considers all health care providers to be The Paperwork Reduction Act of 1995 from July 1, 2017 to January 1, 2018 and
small entities either by meeting the (44 U.S.C. 3507(d)) requires that OMB delays the effective date of the specific
Small Business Administration (SBA) approve all collections of information CJR regulations listed in the DATES
size standard for a small business, or for section from July 1, 2017 to January 1,
by a federal agency from the public
being a nonprofit organization that is 2018.
before they can be implemented. This
not dominant in its market. The current DATES: Effective date: The final rule
SBA size standard for health care final rule is projected to have no impact
on current reporting and recordkeeping published in the January 3, 2017
providers ranges from annual receipts of Federal Register (82 FR 180)) is
$7 million to $35.5 million. As of burden for manufacturers under the
effective May 20, 2017, except for the
January 1, 2017, over 12,000 covered 340B Program. This final rule would
provisions of the final rule contained in
entities participate in the 340B Program, result in no new reporting burdens.
the following amendatory instructions,
which represent safety-net health care Dated: May 10, 2017. which are effective January 1, 2018:
providers across the country. HHS George Sigounas, Number 3 amending 42 CFR 510.2;
determined, and the Secretary certifies number 4 adding 42 CFR 510.110;
Administrator, Health Resources and Services
that this final rule will not have a Administration. number 6 amending 42 CFR 510.120;
significant impact on the operations of number 14 amending 42 CFR 510.405;
Approved: May 15, 2017.
a substantial number of small number 15 amending 42 CFR 510.410;
manufacturers; therefore, we are not Thomas E. Price,
number 16 revising 42 CFR 510.500;
preparing an analysis of impact for this Secretary, Department of Health and Human number 17 revising 42 CFR 510.505;
RFA. HHS estimates the economic Services. number 18 adding 42 CFR 510.506; and
impact on small entities and small [FR Doc. 2017–10149 Filed 5–18–17; 8:45 am] number 19 amending 42 CFR 510.515.
manufacturers will be minimal. BILLING CODE 4165–15–P Applicability date: The applicability
Unfunded Mandates Reform Act date of the regulations at 42 CFR part
512 is January 1, 2018.
Section 202(a) of the Unfunded
FOR FURTHER INFORMATION CONTACT:
Mandates Reform Act of 1995 requires
nlaroche on DSK30NT082PROD with RULES
that agencies prepare a written Sean Harris (410) 786–0812. For
statement, which includes an questions related to the EPMs:
assessment of anticipated costs and EPMRULE@cms.hhs.gov. For questions
benefits, before proposing ‘‘any rule that related to the CJR model: CJR@
includes any Federal mandate that may cms.hhs.gov.
result in the expenditure by State, local, SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014 14:45 May 18, 2017 Jkt 241001 PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 E:\FR\FM\19MYR1.SGM 19MYR1](https://thefederalregister.org/doc/82_FR_22989/page/3.svg)
Document Created: 2018-11-08 08:48:27
Document Modified: 2018-11-08 08:48:27
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule; further delay of effective date. | |
| Dates | As of May 19, 2017, the effective date of the final rule published in the Federal Register (82 FR 1210, (January 5, 2017)) is further delayed to October 1, 2017. | |
| Contact | CAPT Krista Pedley, Director, Office of Pharmacy Affairs, Healthcare Systems Bureau, HRSA, 5600 Fishers Lane, Mail Stop 08W05A, Rockville, MD 20857, or by telephone at 301- 594-4353. | |
| FR Citation | 82 FR 22893 | |
| RIN Number | 0906-AA89 |
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