Agency Information Collection Activities: Submission for OMB Review; Comment Request, 57151-57154 [2021-22444]

Download as PDF lotter on DSK11XQN23PROD with NOTICES1 Federal Register / Vol. 86, No. 196 / Thursday, October 14, 2021 / Notices 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 (CEHRT). 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 created incentive programs for EPs and eligible hospitals, including CAHs, in the Medicare Feefor-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 could adopt, implement, or upgrade to certified EHR technology. It also allowed for negative payment adjustments in the Medicare FFS and MA programs starting in 2015 for EPs, eligible hospitals, and CAHs participating in Medicare that are not meaningful users of CEHRT. The Medicaid Promoting Interoperability Program did not authorize negative payment adjustments, but its participants were eligible for positive incentive payments. In CY 2017, we began collecting data from eligible hospitals and CAHs to determine the application of the Medicare payment adjustments. At this time, Medicare eligible professionals no longer reported to the EHR Incentive Program, as they began reporting under the Merit-based Incentive Payment System (MIPS). This information collected was also used to make incentive payments to eligible hospitals and critical access hospitals in Puerto Rico. In the FY 2019 IPPS/LTCH PPS Final Rule (83 FR 41634), we focused on reducing burden on eligible hospitals and CAHs. We finalized a new scoring methodology for eligible hospitals and CAHs, removing the requirement to report on and meet the threshold for all objectives and measures. This approach required an eligible hospital or CAH to meet the requirements on six measures, with scoring based on performance. This approach reduced burden by decreasing the amount of time needed to report on measures. Additionally, we finalized two new optional opioid measures and one new care coordination measure to help address the opioid epidemic and improve interoperability. In the FY 2020 IPPS/LTCH Final Rule (84 FR 42591), we established the EHR Reporting Period to be a minimum of VerDate Sep<11>2014 17:44 Oct 13, 2021 Jkt 256001 any continuous 90-day period in CY 2021 for new and returning participants (eligible hospitals and CAHs) in the Medicare Promoting Interoperability Program attesting to CMS, as well as finalizing the removal of the Electronic Prescribing Objective’s Verify Opioid Treatment Agreement measure beginning with the EHR reporting period in CY 2020. In the FY 2021 IPPS/LTCH PPS Final Rule (85 FR 58966), we are finalizing as proposed changes that we believe will continue to be a low reporting burden on eligible hospitals and CAHs in the Medicare Promoting Interoperability Program while incentivizing the advanced use of CEHRT to support health information exchange, interoperability, advanced quality measurement, and maximizing clinical effectiveness and efficiencies. These finalized changes include continuing an EHR reporting period of a minimum of any continuous 90-day period in CY 2022, and maintaining the Query of PDMP measure as optional and worth 5 bonus points in CY 2021. In the FY 2022 IPPS/LTCH PPS Proposed Rule (86 FR 25628), we proposed changes that we believe will continue to be a low reporting burden on eligible hospitals and CAHs in the Medicare Promoting Interoperability Program while incentivizing the advanced use of CEHRT to support health information exchange, interoperability, advance quality measurement, and maximize clinical effectiveness and efficiencies. The proposals include continuing an EHR reporting period of a minimum of any continuous 90-day period in CY 2023, maintaining the Query of PDMP measure as optional but worth 10 bonus points in CY 2022, the addition of a new Health Information Exchange BiDirectional Exchange measure beginning in CY 2022 as an optional alternative to the two existing measures, a requirement of reporting 4 specific Public Health and Clinical Data Exchange Objective measures, the inclusion of a new SAFER Guides measure attestation response, and to adopt two new eCQMs to the Medicare Promoting Interoperability Program’s eCQM measure set beginning with the reporting period in CY 2023 (in addition to removing three eCQMs from the measure set beginning with the reporting period in CY 2024, in alignment with the finalized changes to the Hospital IQR Program. In the FY 2022 IPPS/LTCH PPS Final Rule (86 FR 45460 through 45498), we finalized these proposals. We did not finalize a proposal to update the Provide Patients Electronic Access to their Health PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 57151 Information measure to include a data retention requirement; however, this proposal would not have affected our information collection burden estimate. We note the previously approved PRA package under OMB control number 0938–1278 reflecting updates to information collection burden estimates based on policies finalized in the FY 2021 IPPS/LTCH PPS Final Rule include information collection burden estimates for 2021, which is the last year for including Medicaid eligible providers, eligible hospitals, and CAHs in the burden estimate as the Medicaid Promoting Interoperability Program concludes December 31, 2021. Therefore, this PRA request for information collection burden in 2022 does not include any burden under the Medicaid Promoting Interoperability Program. Form Number: CMS–10552 (OMB control number: 0938–1278); Frequency: Annually; Affected Public: State, Local or Private Government; Business and for-profit and Not-forprofit; Number of Respondents: 3,300; Total Annual Responses: 3,300; Total Annual Hours: 21,450. For policy questions regarding this collection, contact Jessica Warren at 410–786– 7519.) Dated: October 8, 2021. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2021–22448 Filed 10–13–21; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–372(S), CMS– 10305, CMS–10148, CMS–10784, CMS– 10715, CMS–10768, CMS–R–43 and CMS– 10417] Agency Information Collection Activities: Submission for OMB Review; Comment Request Centers for Medicare & Medicaid Services, Health and Human Services (HHS). ACTION: Notice. AGENCY: 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 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of SUMMARY: E:\FR\FM\14OCN1.SGM 14OCN1 57152 Federal Register / Vol. 86, No. 196 / Thursday, October 14, 2021 / Notices information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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. Comments on the collection(s) of information must be received by the OMB desk officer by November 15, 2021. DATES: Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/ PRAMain. Find this particular information collection by selecting ‘‘Currently under 30-day Review—Open for Public Comments’’ or by using the search function. 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 website address at: https:// www.cms.gov/Regulations-andGuidance/Legislation/Paperwork ReductionActof1995/PRA-Listing.html. FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786–4669. SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 (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 (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-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 lotter on DSK11XQN23PROD with NOTICES1 ADDRESSES: VerDate Sep<11>2014 17:44 Oct 13, 2021 Jkt 256001 comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment: 1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Annual Report on Home and Community Based Services Waivers and Supporting Regulations; Use: We use this report to compare actual data to the approved waiver estimates. In conjunction with the waiver compliance review reports, the information provided will be compared to that in the Medicaid Statistical Information System (MSIS) (CMS–R–284; OMB control number: 0938–0345) report and FFP claimed on a state’s Quarterly Expenditure Report (CMS–64; OMB control number: 0938– 1265), to determine whether to continue the state’s home and community-based services waiver. States’ estimates of cost and utilization for renewal purposes are based upon the data compiled in the CMS–372(S) reports. Form Number: CMS–372(S) (OMB control number: 0938–0272); Frequency: Yearly; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 48; Total Annual Responses: 253; Total Annual Hours: 11,132. (For policy questions regarding this collection contact Ralph Lollar at 410–786–0777.) 2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Medicare Part C and Part D Data Validation (42 CFR 422.516(g) and 423.514(j)); Use: Sections 1857(e) and 1860D–12 of the Social Security Act (‘‘the Act’’) authorize CMS to establish information collection requirements with respect to MAOs and Part D sponsors. Section 1857(e)(1) of the Act requires MAOs to provide the Secretary of the Department of Health and Human Services (DHHS) with such information as the Secretary may find necessary and appropriate. Section 1857(e)(1) of the Act applies to Prescription Drug Plans (PDPs) as indicated in section1860D–12. Pursuant to statutory authority, CMS codified these information collection requirements in regulation at §§ 422.516(g) Validation of Part C Reporting Requirements, and 423.514(j) Validation of Part D Reporting Requirements respectively. Data collected via Medicare Part C and Part D reporting requirements are an integral resource for oversight, monitoring, compliance and auditing activities necessary to ensure quality provision of Medicare benefits to beneficiaries. CMS uses the findings collected through the data validation PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 process to substantiate the data reported via Medicare Part C and Part D reporting requirements. Data validation provides CMS with assurance that plan-reported data are credible and consistently collected and reported by Part C and D SOs. CMS uses validated data to respond to inquiries from Congress, oversight agencies, and the public about Part C and D SOs. The validated data also allows CMS to effectively monitor and compare the performance of SOs over time. Validated plan-reported data may be used for Star Ratings, Display measures and other performance measures. Additionally, SOs can take advantage of the DV process to effectively assess their own performance and make improvements to their internal operations and reporting processes. Form Number: CMS–10305 (OMB control number: 0938–1115); Frequency: Yearly; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 761; Total Annual Responses: 761; Total Annual Hours: 20,945. (For policy questions regarding this collection contact Chanelle Jones at 410–786–8008.) 3. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: HIPAA Administrative Simplification (NonPrivacy/Security) Complaint Form; Use: The Secretary of Health and Human Services (HHS), hereafter known as ‘‘The Secretary,’’ codified 45 CFR parts 160 and 164 Administrative Simplification provisions that apply to the enforcement of the Health Insurance Portability and Accountability Act of 1996 Public Law 104–191 (HIPAA). The provisions address rules relating to the investigation of non-compliance of the HIPAA Administrative Simplification code sets, unique identifiers, operating rules, and transactions. 45 CFR 160.306, Complaints to the Secretary, provides for investigations of covered entities by the Secretary. Further, it outlines the procedures and requirements for filing a complaint against a covered entity. Anyone can file a complaint if he or she suspects a potential violation. Persons believing that a covered entity is not utilizing the adopted Administrative Simplification provisions of HIPAA are voluntarily requested to file a complaint with CMS via the Administrative Simplification Enforcement and Testing Tool (ASETT) online system, by mail, or by sending an email to the HIPAA mailbox at hipaacomplaint@cms.hhs.gov. Information provided on the standard form will be used during the investigation process to validate non- E:\FR\FM\14OCN1.SGM 14OCN1 lotter on DSK11XQN23PROD with NOTICES1 Federal Register / Vol. 86, No. 196 / Thursday, October 14, 2021 / Notices compliance of HIPAA Administrative Simplification provisions. This standard form collects identifying and contact information of the complainant, as well as the identifying and contact information of the filed against entity (FAE). This information enables CMS to respond to the complainant and gather more information if necessary, and to contact the FAE to discuss the complaint and CMS’ findings. Form Number: CMS– 10148 (OMB control number: 0938– 0948); Frequency: Occasionally; Affected Public: Private sector, Business or Not-for-profit institutions, State, Local, or Tribal Governments, Federal Government, Not-for-profits institutions; Number of Respondents: 21; Total Annual Responses: 21; Total Annual Hours: 12. (For policy questions regarding this collection contact Cecily Austin at 410–786–0895.) 4. Type of Information Collection Request: New collection (Request for a new OMB control); Title of Information Collection: The Home Health Care CAHPS® Survey (HHCAHPS) Mode Experiment; Use: The reporting of quality data by HHAs is mandated by Section 1895(b)(3)(B)(v)(II) of the Social Security Act (‘‘the Act’’). This statute requires that ‘‘each home health agency shall submit to the Secretary such data that the Secretary determines are appropriate for the measurement of health care quality. Such data shall be submitted in a form and manner, and at a time, specified by the Secretary for purposes of this clause.’’ HHCAHPS data are mandated in the Medicare regulations at 42 CFR 484.250(a), which requires HHAs to submit HHCAHPS data to meet the quality reporting requirements of section 1895(b)(3)(B)(v) of the Act. This collection of information is necessary to be able to test updates to the HHCAHPS survey and administration protocols. CMS proposes to conduct a mode experiment with the main goal of testing the effects of a web-based mode on response rates and scores as an addition to the three currently approved modes (OMB Control Number: 0938–1370). The addition of a web mode will give HHAs an alternative or an addition to the use of mail and telephone modes. CMS is also interested in testing a revised, shorter version of the HHCAHPS survey, based on feedback from patients and stakeholders. The data collected from the HHCAHPS Survey mode experiment will be used for the following purposes: • Test the shortened survey instrument, including several new items; VerDate Sep<11>2014 17:44 Oct 13, 2021 Jkt 256001 • Compare survey responses across the four proposed modes to determine if adjustments are needed to ensure that data collection mode does not influence results; and • Determine if and by how much patient characteristics affect the patients’ rating of the care they receive and adjust results based on those factors. The mode experiment is designed to examine the effects of the shortened survey on response rates and scores and to provide precise adjustment estimates for survey items and composites on the shortened survey instrument. Information from this mode experiment will help CMS determine whether an additional mode of administration (i.e., Web data collection) should be included and a shortened survey instrument should be used in the current national implementation of the HHCAHPS Survey. Form Number: CMS–10784 (OMB control number: 0938-New); Frequency: Annually; Affected Public: Individuals or Households; Number of Respondents: 6,280; Total Annual Responses: 6,280; Total Annual Hours: 1,049. (For policy questions regarding this collection contact Lori E. Teichman at 410–786–6684.) 5. Type of Information Collection Request: New collection (Request for a new OMB control number); Title of Information Collection: Transparency in Coverage; Use: The final rules titled ‘‘Transparency in Coverage,’’ published November 12, 2020 (85 FR 72158), establish requirements for group health plans and health insurance issuers offering non-grandfathered coverage in the individual and group markets to disclose to a participant, beneficiary, or enrollee (or an authorized representative on behalf of such individual) the consumer-specific estimated costsharing liability for covered items or services from a particular provider, thereby allowing a participant, beneficiary, or enrollee to obtain an accurate estimate and understanding of their potential out-of-pocket expenses and to effectively shop for covered items and services. Plans and issuers are required to make such information available for covered items and services through an internet-based self-service tool, and, if requested, in paper form. The internet-based self-service tool must allow participants, beneficiaries, or enrollees to search for cost-sharing information for a covered item or service by inputting the name of a specific in-network provider in conjunction with a billing code or descriptive term, as well as other relevant factors such as location of service, facility name, or dosage. In PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 57153 addition, the final rules require that the tool allow the user to refine and reorder search results based on geographic proximity of in-network providers. For covered items and services provided by out-of-network providers, the tool must provide the out-of-network allowed amount, percentage of billed charges, or other rates that provide a reasonably accurate estimate of the amount a plan or issuer will pay by allowing consumers to input a billing code, descriptive code, or other relevant factor, such as location. The final rules also require plans and issuers to publicly disclose applicable rates with in-network providers, including negotiated rates; historical data outlining the different billed charges and allowed amounts a plan or issuer has paid for covered items or services, including prescription drugs, furnished by out-of-network providers; and negotiated rates and historical net prices for covered prescription drugs furnished by in-network providers through three machine-readable files (an In-network Rate File, Allowed Amount File, and Prescription Drug File). The machine-readable files must be posted publicly on an internet website and updated on a monthly basis. Form Number: CMS–10715 (OMB control number: 0938–1372); Frequency: Frequently; Affected Public: Public and Private sectors; Number of Respondents: 908; Total Annual Responses: 74,460; Total Annual Hours: 28,618,546. (For policy questions regarding this collection contact Russell Tipps at 301– 492–4371.) 6. Type of Information Collection Request: New collection (Request for a new OMB control number); Title of Information Collection: The ESRD Network Peer Mentoring Program; Use: The End Stage Renal Disease (ESRD) Network Peer Mentoring Program is a voluntary program designed to provide patient peer support to people with kidney disease. In part, the peer support is beneficial because patients can give each other something most practitioners do not have: Lived experience with kidney disease. The support and perspective of someone who has ‘‘been there’’ can help people better cope with their circumstances. The ESRD Network Peer Mentoring Program is a partnership between dialysis facilities, ESRD Networks, and patient peer mentors and mentees that wish to engage in the program. The peer mentoring program is organized and published with educational opportunities for peer mentors and mentees, provides resources, and includes a complementary toolkit for ESRD Networks and dialysis facilities to E:\FR\FM\14OCN1.SGM 14OCN1 lotter on DSK11XQN23PROD with NOTICES1 57154 Federal Register / Vol. 86, No. 196 / Thursday, October 14, 2021 / Notices promote and operationalize the program. Program applicants are people with ESRD who: (1) Are adults over the age of 18; have been receiving in-center or home dialysis or have been transplanted for at least six months; actively engage in the care plan; consistently demonstrate leadership qualities at facility Quality Assurance & Performance Improvement (QAPI) meetings, Lobby Days, and other facility activities; and wish to be a peer mentor; or (2) are over 18 years of age; are newly diagnosed patients but have been on incenter dialysis for at least six months; are looking for peer support to help them transition to their new reality; and are known as a peer mentee. To participate in the ESRD Network Peer Mentoring Program, peer mentors and mentees will complete an online application form stored in Confluence. The application serves to validate the peer mentor or peer mentee interest in the ESRD Network Peer Mentoring Program. Information collection is important to the process of pairing peer mentors and mentees with similarly lived experience and interests with their kidney disease. In addition, the application collects information about the peers’ interest in kidney disease, treatment modality, age range, preferred gender recognition, and attitudes toward their kidney disease diagnosis. It also supports aligning hobbies, and genders to support best matched peers with each other. Form Number: CMS–10768 (OMB control number: 0938–NEW); Frequency: Once; Affected Public: Individuals and Households; Number of Respondents: 75; Total Annual Responses: 75; Total Annual Hours: 19. (For policy questions regarding this collection, contact Lisa Rees at 816– 426–6353.) 7. Type of Information Collection Request: Revision of a previously approved collection; Title of Information Collection: Conditions of Coverage for Portable X-ray Suppliers and Supporting Regulations; Use: The requirements contained in this information collection request are classified as conditions of participation or conditions for coverage. Portable Xrays are basic radiology studies (predominately chest and extremity Xrays) performed on patients in skilled nursing facilities, residents of long-term care facilities and homebound patients. The CoPs are based on criteria described in the law, and are designed to ensure that each portable X-ray supplier has properly trained staff and provides the appropriate type and level of care for patients. The information collection requirements described below are VerDate Sep<11>2014 17:44 Oct 13, 2021 Jkt 256001 necessary to certify portable X-ray suppliers wishing to participate in the Medicare program. There are currently 506 portable X-ray suppliers participating in the Medicare program. On September 30, 2019 (84 FR 51732), CMS updated the personnel requirements for portable X-ray technicians at 42 CFR 486.104(a), to focus on the qualifications of the individual performing services removing school accreditation requirements and simplifying the structure of the requirements. Additionally, CMS also revised the requirements for referral of service at 42 CFR 486.106(a) for portable X-ray requirements for orders. This change removed the requirement that physician or non-physician practitioner’s orders for portable X-ray services must be written and signed and replacing the specific requirements related to the content of each portable X-ray order with a cross-reference to the requirements at 42 CFR 410.32, which also apply to portable X-ray services. Form Number: CMS–R–43 (OMB Control number: 0938–0338); Frequency: Yearly; Affected Public: Business or other for-profit and Not-forprofit institutions; Number of Respondents: 506; Total Annual Responses: 1,012; Total Annual Hours: 324. (For policy questions regarding this collection contact James Cowher at 410– 786–1948.) 8. Title of Information Collection: Medicare Fee-for-Service Prepayment Review of Medical Records; Type of Information Collection Request: Revision of a currently approved collection; Use: The Medical Review program is designed to prevent improper payments in the Medicare FFS program. Whenever possible, Medicare Administrative Contractors (MACs) are encouraged to automate this process; however, it may require the evaluation of medical records and related documents to determine whether Medicare claims are billed in compliance with coverage, coding, payment, and billing policies. Addressing improper payments in the Medicare fee-for-service (FFS) program and promoting compliance with Medicare coverage and coding rules is a top priority for the CMS. Preventing Medicare improper payments requires the active involvement of every component of CMS and effective coordination with its partners including various Medicare contractors and providers. The information required under this collection is requested by Medicare contractors to determine proper payment, or if there is a suspicion of fraud. Medicare contractors PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 request the information from providers/ suppliers submitting claims for payment when data analysis indicates aberrant billing patterns or other information which may present a vulnerability to the Medicare program. Form Number: CMS–10417 (OMB control number: 0938–0969); Frequency: Occasionally; Affected Public: Private Sector, State, Business, and Not-for Profits; Number of Respondents: 485,632; Number of Responses: 485,632; Total Annual Hours: 242,816. (For questions regarding this collection, contact Christine Grose at (410–786–1362). Dated: October 8, 2021. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2021–22444 Filed 10–13–21; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–D–6841] Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of the draft guidance entitled ‘‘Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices; Draft Guidance for Industry and Food and Drug Administration Staff.’’ This draft guidance explains that there are certain class I devices for which FDA does not intend to enforce Global Unique Device Identification Database (GUDID) submission requirements and describes how a labeler of a class I device can determine if its device is one of these devices in the revised section III of this draft guidance. When this draft guidance is finalized, the updates in section III of this draft guidance would supersede the recommendations in section III of the guidance ‘‘Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking’’ SUMMARY: E:\FR\FM\14OCN1.SGM 14OCN1

Agencies

[Federal Register Volume 86, Number 196 (Thursday, October 14, 2021)]
[Notices]
[Pages 57151-57154]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-22444]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-372(S), CMS-10305, CMS-10148, CMS-10784, CMS-
10715, CMS-10768, CMS-R-43 and CMS-10417]


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

AGENCY: Centers for Medicare & Medicaid Services, Health and Human 
Services (HHS).

ACTION: Notice.

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

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 (PRA), federal agencies are required to publish notice in 
the Federal Register concerning each proposed collection of

[[Page 57152]]

information, including each proposed extension or reinstatement of an 
existing collection of information, and to allow a second opportunity 
for public comment on the notice. Interested persons are invited to 
send comments regarding the burden estimate 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 on the collection(s) of information must be received by 
the OMB desk officer by November 15, 2021.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
    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 website address at: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.

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

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(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 (44 U.S.C. 3506(c)(2)(A)) requires 
federal agencies to publish a 30-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 that 
summarizes the following proposed collection(s) of information for 
public comment:
    1. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Annual Report on 
Home and Community Based Services Waivers and Supporting Regulations; 
Use: We use this report to compare actual data to the approved waiver 
estimates. In conjunction with the waiver compliance review reports, 
the information provided will be compared to that in the Medicaid 
Statistical Information System (MSIS) (CMS-R-284; OMB control number: 
0938-0345) report and FFP claimed on a state's Quarterly Expenditure 
Report (CMS-64; OMB control number: 0938-1265), to determine whether to 
continue the state's home and community-based services waiver. States' 
estimates of cost and utilization for renewal purposes are based upon 
the data compiled in the CMS-372(S) reports. Form Number: CMS-372(S) 
(OMB control number: 0938-0272); Frequency: Yearly; Affected Public: 
State, Local, or Tribal Governments; Number of Respondents: 48; Total 
Annual Responses: 253; Total Annual Hours: 11,132. (For policy 
questions regarding this collection contact Ralph Lollar at 410-786-
0777.)
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicare Part C 
and Part D Data Validation (42 CFR 422.516(g) and 423.514(j)); Use: 
Sections 1857(e) and 1860D-12 of the Social Security Act (``the Act'') 
authorize CMS to establish information collection requirements with 
respect to MAOs and Part D sponsors. Section 1857(e)(1) of the Act 
requires MAOs to provide the Secretary of the Department of Health and 
Human Services (DHHS) with such information as the Secretary may find 
necessary and appropriate. Section 1857(e)(1) of the Act applies to 
Prescription Drug Plans (PDPs) as indicated in section1860D-12. 
Pursuant to statutory authority, CMS codified these information 
collection requirements in regulation at Sec. Sec.  422.516(g) 
Validation of Part C Reporting Requirements, and 423.514(j) Validation 
of Part D Reporting Requirements respectively.
    Data collected via Medicare Part C and Part D reporting 
requirements are an integral resource for oversight, monitoring, 
compliance and auditing activities necessary to ensure quality 
provision of Medicare benefits to beneficiaries. CMS uses the findings 
collected through the data validation process to substantiate the data 
reported via Medicare Part C and Part D reporting requirements. Data 
validation provides CMS with assurance that plan-reported data are 
credible and consistently collected and reported by Part C and D SOs. 
CMS uses validated data to respond to inquiries from Congress, 
oversight agencies, and the public about Part C and D SOs. The 
validated data also allows CMS to effectively monitor and compare the 
performance of SOs over time. Validated plan-reported data may be used 
for Star Ratings, Display measures and other performance measures. 
Additionally, SOs can take advantage of the DV process to effectively 
assess their own performance and make improvements to their internal 
operations and reporting processes. Form Number: CMS-10305 (OMB control 
number: 0938-1115); Frequency: Yearly; Affected Public: State, Local, 
or Tribal Governments; Number of Respondents: 761; Total Annual 
Responses: 761; Total Annual Hours: 20,945. (For policy questions 
regarding this collection contact Chanelle Jones at 410-786-8008.)
    3. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: HIPAA 
Administrative Simplification (Non-Privacy/Security) Complaint Form; 
Use: The Secretary of Health and Human Services (HHS), hereafter known 
as ``The Secretary,'' codified 45 CFR parts 160 and 164 Administrative 
Simplification provisions that apply to the enforcement of the Health 
Insurance Portability and Accountability Act of 1996 Public Law 104-191 
(HIPAA). The provisions address rules relating to the investigation of 
non-compliance of the HIPAA Administrative Simplification code sets, 
unique identifiers, operating rules, and transactions. 45 CFR 160.306, 
Complaints to the Secretary, provides for investigations of covered 
entities by the Secretary. Further, it outlines the procedures and 
requirements for filing a complaint against a covered entity.
    Anyone can file a complaint if he or she suspects a potential 
violation. Persons believing that a covered entity is not utilizing the 
adopted Administrative Simplification provisions of HIPAA are 
voluntarily requested to file a complaint with CMS via the 
Administrative Simplification Enforcement and Testing Tool (ASETT) 
online system, by mail, or by sending an email to the HIPAA mailbox at 
[email protected]. Information provided on the standard form 
will be used during the investigation process to validate non-

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compliance of HIPAA Administrative Simplification provisions.
    This standard form collects identifying and contact information of 
the complainant, as well as the identifying and contact information of 
the filed against entity (FAE). This information enables CMS to respond 
to the complainant and gather more information if necessary, and to 
contact the FAE to discuss the complaint and CMS' findings. Form 
Number: CMS-10148 (OMB control number: 0938-0948); Frequency: 
Occasionally; Affected Public: Private sector, Business or Not-for-
profit institutions, State, Local, or Tribal Governments, Federal 
Government, Not-for-profits institutions; Number of Respondents: 21; 
Total Annual Responses: 21; Total Annual Hours: 12. (For policy 
questions regarding this collection contact Cecily Austin at 410-786-
0895.)
    4. Type of Information Collection Request: New collection (Request 
for a new OMB control); Title of Information Collection: The Home 
Health Care CAHPS[supreg] Survey (HHCAHPS) Mode Experiment; Use: The 
reporting of quality data by HHAs is mandated by Section 
1895(b)(3)(B)(v)(II) of the Social Security Act (``the Act''). This 
statute requires that ``each home health agency shall submit to the 
Secretary such data that the Secretary determines are appropriate for 
the measurement of health care quality. Such data shall be submitted in 
a form and manner, and at a time, specified by the Secretary for 
purposes of this clause.'' HHCAHPS data are mandated in the Medicare 
regulations at 42 CFR 484.250(a), which requires HHAs to submit HHCAHPS 
data to meet the quality reporting requirements of section 
1895(b)(3)(B)(v) of the Act. This collection of information is 
necessary to be able to test updates to the HHCAHPS survey and 
administration protocols.
    CMS proposes to conduct a mode experiment with the main goal of 
testing the effects of a web-based mode on response rates and scores as 
an addition to the three currently approved modes (OMB Control Number: 
0938-1370). The addition of a web mode will give HHAs an alternative or 
an addition to the use of mail and telephone modes. CMS is also 
interested in testing a revised, shorter version of the HHCAHPS survey, 
based on feedback from patients and stakeholders.
    The data collected from the HHCAHPS Survey mode experiment will be 
used for the following purposes:
     Test the shortened survey instrument, including several 
new items;
     Compare survey responses across the four proposed modes to 
determine if adjustments are needed to ensure that data collection mode 
does not influence results; and
     Determine if and by how much patient characteristics 
affect the patients' rating of the care they receive and adjust results 
based on those factors.
    The mode experiment is designed to examine the effects of the 
shortened survey on response rates and scores and to provide precise 
adjustment estimates for survey items and composites on the shortened 
survey instrument. Information from this mode experiment will help CMS 
determine whether an additional mode of administration (i.e., Web data 
collection) should be included and a shortened survey instrument should 
be used in the current national implementation of the HHCAHPS Survey. 
Form Number: CMS-10784 (OMB control number: 0938-New); Frequency: 
Annually; Affected Public: Individuals or Households; Number of 
Respondents: 6,280; Total Annual Responses: 6,280; Total Annual Hours: 
1,049. (For policy questions regarding this collection contact Lori E. 
Teichman at 410-786-6684.)
    5. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: 
Transparency in Coverage; Use: The final rules titled ``Transparency in 
Coverage,'' published November 12, 2020 (85 FR 72158), establish 
requirements for group health plans and health insurance issuers 
offering non-grandfathered coverage in the individual and group markets 
to disclose to a participant, beneficiary, or enrollee (or an 
authorized representative on behalf of such individual) the consumer-
specific estimated cost-sharing liability for covered items or services 
from a particular provider, thereby allowing a participant, 
beneficiary, or enrollee to obtain an accurate estimate and 
understanding of their potential out-of-pocket expenses and to 
effectively shop for covered items and services. Plans and issuers are 
required to make such information available for covered items and 
services through an internet-based self-service tool, and, if 
requested, in paper form. The internet-based self-service tool must 
allow participants, beneficiaries, or enrollees to search for cost-
sharing information for a covered item or service by inputting the name 
of a specific in-network provider in conjunction with a billing code or 
descriptive term, as well as other relevant factors such as location of 
service, facility name, or dosage. In addition, the final rules require 
that the tool allow the user to refine and reorder search results based 
on geographic proximity of in-network providers. For covered items and 
services provided by out-of-network providers, the tool must provide 
the out-of-network allowed amount, percentage of billed charges, or 
other rates that provide a reasonably accurate estimate of the amount a 
plan or issuer will pay by allowing consumers to input a billing code, 
descriptive code, or other relevant factor, such as location.
    The final rules also require plans and issuers to publicly disclose 
applicable rates with in-network providers, including negotiated rates; 
historical data outlining the different billed charges and allowed 
amounts a plan or issuer has paid for covered items or services, 
including prescription drugs, furnished by out-of-network providers; 
and negotiated rates and historical net prices for covered prescription 
drugs furnished by in-network providers through three machine-readable 
files (an In-network Rate File, Allowed Amount File, and Prescription 
Drug File). The machine-readable files must be posted publicly on an 
internet website and updated on a monthly basis. Form Number: CMS-10715 
(OMB control number: 0938-1372); Frequency: Frequently; Affected 
Public: Public and Private sectors; Number of Respondents: 908; Total 
Annual Responses: 74,460; Total Annual Hours: 28,618,546. (For policy 
questions regarding this collection contact Russell Tipps at 301-492-
4371.)
    6. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: The 
ESRD Network Peer Mentoring Program; Use: The End Stage Renal Disease 
(ESRD) Network Peer Mentoring Program is a voluntary program designed 
to provide patient peer support to people with kidney disease. In part, 
the peer support is beneficial because patients can give each other 
something most practitioners do not have: Lived experience with kidney 
disease. The support and perspective of someone who has ``been there'' 
can help people better cope with their circumstances.
    The ESRD Network Peer Mentoring Program is a partnership between 
dialysis facilities, ESRD Networks, and patient peer mentors and 
mentees that wish to engage in the program. The peer mentoring program 
is organized and published with educational opportunities for peer 
mentors and mentees, provides resources, and includes a complementary 
toolkit for ESRD Networks and dialysis facilities to

[[Page 57154]]

promote and operationalize the program.
    Program applicants are people with ESRD who: (1) Are adults over 
the age of 18; have been receiving in-center or home dialysis or have 
been transplanted for at least six months; actively engage in the care 
plan; consistently demonstrate leadership qualities at facility Quality 
Assurance & Performance Improvement (QAPI) meetings, Lobby Days, and 
other facility activities; and wish to be a peer mentor; or (2) are 
over 18 years of age; are newly diagnosed patients but have been on in-
center dialysis for at least six months; are looking for peer support 
to help them transition to their new reality; and are known as a peer 
mentee.
    To participate in the ESRD Network Peer Mentoring Program, peer 
mentors and mentees will complete an online application form stored in 
Confluence. The application serves to validate the peer mentor or peer 
mentee interest in the ESRD Network Peer Mentoring Program. Information 
collection is important to the process of pairing peer mentors and 
mentees with similarly lived experience and interests with their kidney 
disease. In addition, the application collects information about the 
peers' interest in kidney disease, treatment modality, age range, 
preferred gender recognition, and attitudes toward their kidney disease 
diagnosis. It also supports aligning hobbies, and genders to support 
best matched peers with each other. Form Number: CMS-10768 (OMB control 
number: 0938-NEW); Frequency: Once; Affected Public: Individuals and 
Households; Number of Respondents: 75; Total Annual Responses: 75; 
Total Annual Hours: 19. (For policy questions regarding this 
collection, contact Lisa Rees at 816-426-6353.)
    7. Type of Information Collection Request: Revision of a previously 
approved collection; Title of Information Collection: Conditions of 
Coverage for Portable X-ray Suppliers and Supporting Regulations; Use: 
The requirements contained in this information collection request are 
classified as conditions of participation or conditions for coverage. 
Portable X-rays are basic radiology studies (predominately chest and 
extremity X-rays) performed on patients in skilled nursing facilities, 
residents of long-term care facilities and homebound patients. The CoPs 
are based on criteria described in the law, and are designed to ensure 
that each portable X-ray supplier has properly trained staff and 
provides the appropriate type and level of care for patients. The 
information collection requirements described below are necessary to 
certify portable X-ray suppliers wishing to participate in the Medicare 
program. There are currently 506 portable X-ray suppliers participating 
in the Medicare program.
    On September 30, 2019 (84 FR 51732), CMS updated the personnel 
requirements for portable X-ray technicians at 42 CFR 486.104(a), to 
focus on the qualifications of the individual performing services 
removing school accreditation requirements and simplifying the 
structure of the requirements. Additionally, CMS also revised the 
requirements for referral of service at 42 CFR 486.106(a) for portable 
X-ray requirements for orders. This change removed the requirement that 
physician or non-physician practitioner's orders for portable X-ray 
services must be written and signed and replacing the specific 
requirements related to the content of each portable X-ray order with a 
cross-reference to the requirements at 42 CFR 410.32, which also apply 
to portable X-ray services. Form Number: CMS-R-43 (OMB Control number: 
0938-0338); Frequency: Yearly; Affected Public: Business or other for-
profit and Not-for-profit institutions; Number of Respondents: 506; 
Total Annual Responses: 1,012; Total Annual Hours: 324. (For policy 
questions regarding this collection contact James Cowher at 410-786-
1948.)
    8. Title of Information Collection: Medicare Fee-for-Service 
Prepayment Review of Medical Records; Type of Information Collection 
Request: Revision of a currently approved collection; Use: The Medical 
Review program is designed to prevent improper payments in the Medicare 
FFS program. Whenever possible, Medicare Administrative Contractors 
(MACs) are encouraged to automate this process; however, it may require 
the evaluation of medical records and related documents to determine 
whether Medicare claims are billed in compliance with coverage, coding, 
payment, and billing policies. Addressing improper payments in the 
Medicare fee-for-service (FFS) program and promoting compliance with 
Medicare coverage and coding rules is a top priority for the CMS. 
Preventing Medicare improper payments requires the active involvement 
of every component of CMS and effective coordination with its partners 
including various Medicare contractors and providers. The information 
required under this collection is requested by Medicare contractors to 
determine proper payment, or if there is a suspicion of fraud. Medicare 
contractors request the information from providers/suppliers submitting 
claims for payment when data analysis indicates aberrant billing 
patterns or other information which may present a vulnerability to the 
Medicare program. Form Number: CMS-10417 (OMB control number: 0938-
0969); Frequency: Occasionally; Affected Public: Private Sector, State, 
Business, and Not-for Profits; Number of Respondents: 485,632; Number 
of Responses: 485,632; Total Annual Hours: 242,816. (For questions 
regarding this collection, contact Christine Grose at (410-786-1362).

    Dated: October 8, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2021-22444 Filed 10-13-21; 8:45 am]
BILLING CODE 4120-01-P