2017-15726. Agency Information Collection Activities: Submission for OMB Review; Comment Request

AGENCY:

Centers for Medicare & Medicaid 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 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 August 25, 2017.

ADDRESSES:

When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: [phone] OR, Email: [e-mail].

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' Web site address at Web site 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 [e-mail].

3. Call the Reports Clearance Office at [phone].

FOR FURTHER INFORMATION CONTACT:

William Parham at [phone].

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. No comments were received in response to the 60-day comment period. 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: Reinstatement of a previously approved collection; Title of Information Collection: Hospice Facility Cost Report; Use: Providers of services participating in the Medicare program are required under §§ 1815(a), 1833(e), and 1861(v)(1)(A) of the Social Security Act (42 U.S.C. 1395g) to submit annual information to determine costs for health care services rendered to Medicare beneficiaries. In addition, regulations at 42 CFR 413.20, 413.24 and 418.310 require adequate cost data and cost reports from providers on an annual basis. The Form CMS-1984-14 cost report is needed to determine a provider's reasonable costs incurred in furnishing medical services to Medicare beneficiaries. The data is used by CMS to calculate: Market basket weight and the labor related shares, Rate setting and payment refinement, and Medicare and total facility margins for Medicare-covered services by type of service. Form Number: CMS-1984-14 (OMB control number: 0938-0758); Frequency: Annually; Affected Public: Private sector—Business or other for-profit and Not-for-profit institutions; Number of Respondents: 3,545; Total Annual Responses: 3,545; Total Annual Hours: 666,460. (For policy questions regarding this collection contact Yaakov Feinstein at 410-786-3137.)

2. Type of Information Collection Request: Reinstatement without change of a previously approved collection; Title of Information Collection: Electronic Submission of Medicare Graduate Medical Education (GME) Affiliation Agreements; Use: Sections 1886(h)(4)(F) and 1886(d)(5)(B)(v) of the Act establish limits on the number of allopathic and osteopathic FTE residents that hospitals may count for purposes of calculating direct GME payments and the indirect medical education (IME) adjustment. In addition, under the authority granted by section 1886(h)(4)(H)(ii) of the Act, the Secretary issued regulations on May 12, 1998 (63 FR 26358) to allow institutions that are members of the same Medicare GME affiliated group to elect to apply their direct GME and IME FTE resident caps based on the aggregate cap of all hospitals that are part of a Medicare GME affiliation group. Under those regulations, specified at § 413.79(f) for direct GME and at § 412.105(f)(1)(vi) for IME, hospitals that are part of the same Medicare GME affiliated group are permitted to adjust each hospital's caps to reflect the rotation of residents among affiliated hospitals during an academic year. Under § 413.75(b), a Medicare GME affiliated group may be formed by two or more hospitals if: (1) The hospitals are located in the same urban or rural area or in a contiguous area and have a shared rotational arrangement as specified at § 413.79(f)(2); (2) the hospitals are not located in the same or in a contiguous area, but have a shared rotational arrangement and they are jointly listed as the sponsor, primary clinical site, or major participating institution for one or more programs as these terms are used in the most recent publication of the Graduate Medical Education Directory, or as the sponsor or is listed under “affiliations and outside rotations” for one or more programs in Opportunities, Directory of Osteopathic Post-Doctoral Education Programs; or (3) effective beginning July 1, 2003, two or more hospitals are under common ownership and have a shared rotational arrangement under § 413.79(f)(2). Form Number: CMS-10326 (OMB control number: 0938-1111); Frequency: Annually; Affected Public: Business or other For-profit and Not-for-profit institutions; Number of Respondents: 125; Total Annual Responses: 125; Total Annual Hours: 166. (For policy questions regarding this collection contact Renate Dombrowski at 410-786-4645.)

3. Type of Information Collection Request: Reinstatement with change of a previously approved collection; Title of Information Collection: Community Mental Health Center Cost Report; Use: Providers of services participating in the Medicare program are required under sections 1815(a) and 1861(v)(1)(A) of the Social Security Act (42 U.S.C. 1395g) to submit annual information to achieve settlement of costs for health care services rendered to Medicare beneficiaries. In addition, regulations at 42 CFR 413.20 and 413.24 require adequate cost data and cost reports from providers on an annual basis. The Form CMS-2088-17 cost report is needed to determine a provider's reasonable costs incurred in furnishing medical services to Medicare beneficiaries and reimbursement due to or due from a provider. The primary function of the cost report is to collect data that is used by CMS to support program operations, payment refinement activities and to make Medicare Trust Fund projections. Form Number: CMS-2088-17 (OMB control number: 0938-0037); Frequency: Yearly; Affected Public: Private Sector (Business or other for-profits, Not-for-Profit Institutions); Number of Respondents: 219; Total Annual Responses: 219; Total Annual Hours: 19,710. (For policy questions regarding this collection contact Jill Keplinger at 410-786-4550.)

4. Type of Information Collection Request: Reinstatement without change of a previously approved collection; Title of Information Collection: CMS Enterprise Identity Management; Use: HIPAA regulations require covered entities to verify the identity of the person requesting Personal Health Information (PHI) and the person's authority to have access to that information. Per the HIPAA Security Rule, covered entities, regardless of their size, are required under Section164.312(a)(2)(i) to “assign a unique name and/or number for identifying and tracking user identity.” A `user' is defined in Section 164.304 as a “person or entity with authorized access”. Accordingly, the Security Rule requires covered entities to assign a unique name and/or number to each employee or workforce member who uses a system that receives, maintains or transmits electronic PHI, so that system access and activity can be identified and tracked by user. This pertains to workforce members within health plans, group health plans, small or large provider offices, clearinghouses and beneficiaries. Federal law requires that CMS take precautions to minimize the security risk to the Federal information system. FIPS PUB 201—1 Para 1.2: “Homeland Security Presidential Directive 12 (HSPD 12), signed by the President on August 27, 2004, established the requirements for a common identification standard for the identification of credentials issued by Federal Departments and agencies to Federal employees and contractors (including contractor employees) for gaining physical access to Federally controlled facilities and logical access to Federally controlled information systems. HSPD 12 directs the department of Commerce to develop a Federal Information Processing Standards (FIPS) publication to define such a common identification credential.” Form Number: CMS-10452 (OMB control number: 0938-1236); Frequency: Annually; Affected Public: Individuals and Households; Number of Respondents: 750,000; Total Annual Responses: 750,000; Total Annual Hours: 300,000. (For policy questions regarding this collection contact Robert Burger at 410-786-2125.)

5. Type of Information Collection Request: Extension of a currently approved information collection; Title of Information Collection: Health Care Reform Insurance Web Portal Requirements 45 CFR part 159; Use: In accordance with the provisions of the ACA referenced above, the U.S. Department of Health and Human Services created a Web site called healthcare.gov to meet these and other provisions of the law, and data collection was conducted for six months based upon an emergency information collection request. The interim final rule published on May 5, 2010 served as the emergency Federal Register notice for the prior information collection request. The Office of Management and Budget (OMB) reviewed the request under emergency processing and approved it on April 30, 2010.

CMS updated the web portal system where state Departments of Insurance and issuers log in using a custom user ID and password validation. The states are asked to provide information on issuers in their state and various Web sites maintained for consumers. The issuers are also tasked with providing information on their major medical insurance products and plans. They are ultimately given the choice to download a basic information template to enter data then upload into the web portal; to manually enter data within the web portal itself; or to submit .xml files containing their information. Once the states and issuers submit their data, they will receive an email notifying them of any errors, and that their submission was received.

CMS mandates that issuers verify and update their information on a quarterly basis and requests that States verify State-submitted information on an annual basis. In the event that an issuer enhances its existing plans, proposes new plans, or deactivates plans, the organization would be required to update the information in the web portal. Changes occurring during the three month quarterly periods will be allowed utilizing effective dates for both the plans and rates associated with the plans. Form Number: CMS-10320 (OMB control number: 0938-1086); Frequency: Annually, Quarterly; Affected Public: State, Local, and Tribal Governments; Number of Respondents: 305; Total Annual Responses: 5,500; Total Annual Hours: 89,725. (For policy questions regarding this collection contact Kim Heckstall at 410-786-1647).

6. Type of Information Collection Request: Revision of currently approved collection; Title of Information Collection: Annual MLR and Rebate Calculation Report and MLR Rebate Notices; Use: Under Section 2718 of the Affordable Care Act and implementing regulation at 45 CFR part 158, a health insurance issuer (issuer) offering group or individual health insurance coverage must submit a report to the Secretary concerning the amount the issuer spends each year on claims, quality improvement expenses, non-claims costs, Federal and State taxes and licensing and regulatory fees, the amount of earned premium, and beginning with the 2014 reporting year, the amounts related to the reinsurance, risk corridors, and risk adjustment programs established under sections 1341, 1342, and 1343, respectively, of the Affordable Care Act. An issuer must provide an annual rebate if the amount it spends on certain costs compared to its premium revenue (excluding Federal and States taxes and licensing and regulatory fees) does not meet a certain ratio, referred to as the medical loss ratio (MLR). Each issuer is required to submit annually MLR data, including information about any rebates it must provide, on a form prescribed by CMS, for each State in which the issuer conducts business. Each issuer is also required to provide a rebate notice to each policyholder that is owed a rebate and each subscriber of policyholders that are owed a rebate for any given MLR reporting year. Additionally, each issuer is required to maintain for a period of seven years all documents, records and other evidence that support the data included in each issuer's annual report to the Secretary.

Under Section 1342 of the Patient Protection and Affordable Care Act and implementing regulation at 45 CFR part 153, issuers of qualified health plans (QHPs) must participate in a risk corridors program. A QHP issuer will pay risk corridors charges or be eligible to receive payments based on the ratio of the issuer's allowable costs to the target amount. Each QHP issuer is required to submit an annual report to CMS concerning the issuer's allowable costs, allowable administrative costs, premium, and proportion of market premium in QHPs. Risk corridors premium information that is specific to an issuer's QHPs is collected through a separate plan-level data form, which is included in this information collection. Additionally, each QHP issuer is required to maintain for a period of ten years all documents, records and other evidence sufficient to enable the evaluation of the issuer's compliance with applicable risk corridors standards.

On May 2, 2017, CMS published a 60-day notice in the Federal Register (82 FR 20481) for the public to submit written comments on this information collection; the public comment period closed on July 3, 2017. As part of the 60-day notice, CMS updated its annual burden hour estimates to reflect the actual numbers of submissions, rebates and rebate notices.

CMS received a total of six comments on a number of specific issues regarding the notice of the revised MLR PRA package. CMS has taken into consideration all of the comments and has modified the information collection instruments and instructions (the 2016 MLR Annual Reporting Form and Instructions; no comments were submitted on the 2016 Risk Corridors Plan-Level Data Form and Instructions) in order to correct errors and to provide additional clarifications. These modifications do not affect the previously estimated burden hours or costs. Form Number: CMS-10418 (OMB Control Number: 0938-1164); Frequency: Annually; Affected Public: Private Sector, Business or other for-profits and not-for-profit institutions; Number of Respondents: 545; Number of Responses: 2,532; Total Annual Hours: 200,597. (For policy questions regarding this collection, contact Christina Whitefield at [phone].)

Dated: July 21, 2017.

William N. Parham, III,

Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.