83 FR 13130 - Agency Information Collection Activities: Proposed Collection; Comment Request

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

Federal Register Volume 83, Issue 59 (March 27, 2018)

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

[Federal Register Volume 83, Number 59 (Tuesday, March 27, 2018)]
[Notices]
[Pages 13130-13132]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-06081]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10341, CMS-10538, CMS-R-153, CMS-10561 and 
CMS-10336]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services.

ACTION: Notice.

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SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is 
announcing an opportunity for the public to comment on CMS' intention 
to collect information from the public. Under the Paperwork Reduction 
Act of 1995 (the PRA), federal agencies are required to publish notice 
in the Federal Register concerning each proposed collection of 
information (including each proposed extension or reinstatement of an 
existing collection of information) and to allow 60 days for public 
comment on the proposed action. Interested persons are invited to send 
comments regarding our burden estimates or any other aspect of this 
collection of information, including the necessity and utility of the 
proposed information collection for the proper performance of the 
agency's functions, the accuracy of the estimated burden, ways to 
enhance the quality, utility, and clarity of the information to be 
collected, and the use of automated collection techniques or other 
forms of information technology to minimize the information collection 
burden.

DATES: Comments must be received by May 29, 2018.

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number. To be assured consideration, comments and 
recommendations must be submitted in any one of the following ways:
    1. Electronically. You may send your comments electronically to 
http://www.regulations.gov. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) that are accepting comments.
    2. By regular mail. You may mail written comments to the following 
address: CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development, Attention: Document Identifier/OMB 
Control Number __, Room C4-26-05, 7500 Security Boulevard, Baltimore, 
Maryland 21244-1850.
    To obtain copies of a supporting statement and any related forms 
for the proposed collection(s) summarized in this notice, you may make 
your request using one of following:
    1. Access CMS' website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
    2. Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to [email protected].
    3. Call the Reports Clearance Office at (410) 786-1326.

FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669.

SUPPLEMENTARY INFORMATION: 

Contents

    This notice sets out a summary of the use and burden associated 
with the following information collections. More detailed information 
can be found in each collection's supporting statement and associated 
materials (see ADDRESSES).
CMS-10341 Affordable Care Act Information and Collection Requirements 
for Section 1115 Demonstration Projects
CMS-10538 Hospice Information for Medicare Part D Plans
CMS-R-153 Medicaid Drug Use Review (DUR) Program
CMS-10561 Essential Community Provider Data Collection to Support QHP 
Certification for PYs 2021-2023
CMS-10336 Medicare and Medicaid Programs; Electronic Health Record 
Incentive Program

    Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain 
approval from the Office of Management and Budget (OMB) for each 
collection of information they conduct or sponsor. The term 
``collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA requires federal agencies 
to publish a 60-day notice in the Federal Register concerning each 
proposed collection of information, including each proposed extension 
or reinstatement of an existing collection of information, before 
submitting the collection to OMB for approval. To comply with this 
requirement, CMS is publishing this notice.

Information Collection

    1. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Section 1115 
Demonstration Projects Regulations at 42 CFR 431.408, 431.412, 431.420, 
431.424, and 431.428; Use: This collection is necessary to ensure that 
states comply with regulatory and statutory requirements related to the 
development, implementation and evaluation of demonstration projects. 
States seeking waiver authority under Section 1115 are required to meet 
certain requirements for public notice, the evaluation of demonstration 
projects, and reports to the Secretary on the implementation of 
approved demonstrations. Form Number: CMS-10341 (OMB control number 
0938-1162); Frequency: Yearly and quarterly; Affected Public: State, 
Local, or Tribal Governments; Number of Respondents: 37; Total Annual 
Responses: 300; Total Annual Hours: 24,092. (For policy questions 
regarding this collection contact Tonya Moore at 410-786-0019.)
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Hospice 
Information for Medicare Part D Plans; Use: The form would be completed 
by the prescriber or the beneficiary's hospice, or if the prescriber or 
hospice provides the information verbally to the Part D sponsor, the 
form would be completed by the sponsor. Information provided on the 
form would be used by the Part D sponsor to establish coverage of the 
drug under Medicare Part D. Per statute, drugs that are necessary for 
the palliation and management of the terminal illness and related 
conditions are not eligible for payment under Part D. The standard form 
provides a vehicle for the hospice provider, prescriber or sponsor to 
document that the drug prescribed is ``unrelated'' to the

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terminal illness and related conditions. It also gives a hospice 
organization the option to communicate a beneficiary's change in 
hospice status and care plan to Part D sponsors. Form Number: CMS-10538 
(OMB control number 0938-1269); Frequency: Occasionally; Affected 
Public: Private sector (business or other for-profits); Number of 
Respondents: 424; Total Annual Responses: 376,487; Total Annual Hours: 
31,374. (For policy questions regarding this collection contact Shelly 
Winston at 410-786-3694.)
    3. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicaid Drug Use 
Review (DUR) Program; Use: States must provide for a review of drug 
therapy before each prescription is filled or delivered to a Medicaid 
patient. This review includes screening for potential drug therapy 
problems due to therapeutic duplication, drug-disease 
contraindications, drug-drug interactions, incorrect drug dosage or 
duration of drug treatment, drug-allergy interactions, and clinical 
abuse/misuse. Pharmacists must make a reasonable effort to obtain, 
record, and maintain Medicaid patient profiles. These profiles must 
reflect at least the patient's name, address, telephone number, date of 
birth/age, gender, history, e.g., allergies, drug reactions, list of 
medications, and pharmacist's comments relevant to the individual's 
drug therapy.
    The State must conduct RetroDUR which provides for the ongoing 
periodic examination of claims data and other records in order to 
identify patterns of fraud, abuse, inappropriate or medically 
unnecessary care. Patterns or trends of drug therapy problems are 
identified and reviewed to determine the need for intervention activity 
with pharmacists and/or physicians. States may conduct interventions 
via telephone, correspondence, or face-to-face contact.
    Annual reports are submitted to CMS for the purposes of monitoring 
compliance and evaluating the progress of States' DUR programs. The 
information submitted by States is reviewed and results are compiled by 
CMS in a format intended to provide information, comparisons and trends 
related to States' experiences with DUR. The States benefit from the 
information and may enhance their programs each year based on State 
reported innovative practices that are compiled by CMS from the DUR 
annual reports. Form Number: CMS-R-153 (OMB control number: 0938-0659); 
Frequency: Yearly, quarterly, and occasionally; Affected Public: State, 
Local, or Tribal Governments; Number of Respondents: 51; Total Annual 
Responses: 663; Total Annual Hours: 41,004. (For policy questions 
regarding this collection contact Emeka Egwim at 410-786-1092.)
    4. Type of Information Collection Request: Extension of a currently 
approved information collection; Title of Information Collection: 
Essential Community Provider Data Collection to Support QHP 
Certification for PYs 2021-2023; Use: For plan years beginning on or 
after January 1, 2021, Health and Human Services (HHS) intends to 
continue collecting more complete provider data for inclusion on the 
HHS Essential Community Provider (ECP) list to ensure a more accurate 
reflection of the universe of qualified available ECPs in a given 
service area that can be counted toward an issuer's satisfaction of the 
ECP standard. HHS intends to continue collecting these data on 
qualified and available ECPs directly from providers through the online 
ECP petition. Providers will submit an ECP petition to be added to the 
HHS ECP list or update required data fields to remain on the list. Form 
Number: CMS-10561 (OMB Control Number: 0938-1295); Frequency: Annually; 
Affected Public: Private sector (Business or other for-profits and Not-
for-profit Institutions); Number of Respondents: 14,260; Total Annual 
Responses: 14,260; Total Annual Hours: 7,468. (For policy questions 
regarding this collection contact Deborah Hunter at (202) 309-1098).
    5. Type of Information Collection Request: Extension of a currently 
approved information collection; Title of Information Collection: 
Medicare and Medicaid Programs; Electronic Health Record Incentive 
Program; Use: The American Recovery and Reinvestment Act of 2009 
(Recovery Act) (Pub. L. 111-5) was enacted on February 17, 2009. The 
Recovery Act includes many measures to modernize our nation's 
infrastructure, and improve affordable health care. Expanded use of 
health information technology (HIT) and certified electronic health 
record (EHR) technology will improve the quality and value of America's 
health care. Title IV of Division B of the Recovery Act amends Titles 
XVIII and XIX of the Social Security Act (the Act) by establishing 
incentive payments to eligible professionals (EPs), eligible hospitals 
and critical access hospitals (CAHs), and Medicare Advantage (MA) 
organizations participating in the Medicare and Medicaid programs that 
adopt and successfully demonstrate meaningful use of certified EHR 
technology. These Recovery Act provisions, together with Title XIII of 
Division A of the Recovery Act, may be cited as the ``Health 
Information Technology for Economic and Clinical Health Act'' or the 
``HITECH Act.''
    The HITECH Act creates incentive programs for EPs and eligible 
hospitals, including CAHs, in the Medicare Fee-for-Service (FFS), MA, 
and Medicaid programs that successfully demonstrate meaningful use of 
certified EHR technology. In their first payment year, Medicaid EPs and 
eligible hospitals may adopt, implement or upgrade to certified EHR 
technology. It also, provides for payment adjustments in the Medicare 
FFS and MA programs starting in FY 2015 for EPs and eligible hospitals 
participating in Medicare that are not meaningful users of certified 
EHR technology. These payment adjustments do not pertain to Medicaid 
providers.
    The first final rule for the Medicare and Medicaid EHR Incentive 
Program, which was published in the Federal Register on July 28, 2010 
(CMS-0033-F), specified the initial criteria EPs, eligible hospitals 
and CAHs, and MA organizations must meet in order to qualify for 
incentive payments; calculation of incentive payment amounts; payment 
adjustments under Medicare for covered professional services and 
inpatient hospital services provided by EPs, eligible hospitals and 
CAHs failing to demonstrate meaningful use of certified EHR technology 
beginning in 2015; and other program participation requirements. On the 
same date, the Office of the National Coordinator of Health Information 
Technology (ONC) issued a closely related final rule (45 CFR part 170, 
RIN 0991-AB58) that specified the initial set of standards, 
implementation specifications, and certification criteria for certified 
EHR technology. ONC has also issued a separate final rule on the 
establishment of certification programs for health information 
technology (HIT) (45 CFR part 170, RIN 0991-AB59). The functionality of 
certified EHR technology should facilitate the implementation of 
meaningful use. Subsequently, final rules have been issued by CMS (77 
FR 53968) and ONC (77 FR 72985) to create a Stage 2 of meaningful use 
criteria and other changes to the CMS EHR Incentive Programs and the 
2014 Edition Certification Criteria for EHR technology.
    The information collection requirements contained in this 
information collection request are needed to implement the HITECH Act. 
In order to avoid duplicate payments, all EPs are enumerated through 
their National Provider Identifier (NPI), while all eligible hospitals 
and CAHs are

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enumerated through their CMS Certification Number (CCN). State Medicaid 
agencies and CMS use the provider's tax identification number and NPI 
or CCN combination in order to make payment, validate payment 
eligibility and detect and prevent duplicate payments for EPs, eligible 
hospitals and CAHs. Form Number: CMS-10336 (OMB Control Number: 0938-
1158); Frequency: Occasionally; Affected Public: Private sector; Number 
of Respondents: 214,694; Total Annual Responses: 214,694; Total Annual 
Hours: 2,034,740. (For policy questions regarding this collection 
contact Steven Johnson at (410) 786-3332).

    Dated: March 22, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2018-06081 Filed 3-26-18; 8:45 am]
 BILLING CODE 4120-01-P