2019-14719. 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 9, 2019.

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' 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 [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. 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: Revision with change of a currently approved collection; Title of Information Collection: Notice of Denial of Medical Coverage (or Payment) (NDMCP); Use: Section 1852(g)(1)(B) of the Social Security Act (the Act) requires Medicare health plans to provide enrollees with a written notice in understandable language of the reasons for the denial and a description of the applicable appeals processes. Medicare health plans, including Medicare Advantage plans, cost plans, and Health Care Prepayment Plans (HCPPs), are required to issue the Notice of Denial of Medical Coverage (or Payment) (NDMCP) when a request for either a medical service or payment is denied, in whole or in part. Additionally, the notices inform Medicare enrollees of their right to file an appeal, outlining the steps and timeframes for filing. All Medicare health plans are required to use these standardized notices. In 2013, Medicaid appeal rights were integrated into form CMS-10003 for beneficiaries who are eligible for Medicare and full Medicaid benefits under a State Medicaid plan. These appeal rights are provided in instances where a Medicare health plan enrollee receives full benefits under a State Medical Assistance (Medicaid) program being managed by the plan and the plan denies a service or item that is also subject to Medicaid appeal rights.

Changes to the collection from the 60-day package to the 30-day package include:

• Removal of language related to State Fair Hearings to comply with the change in Medicaid managed care rules at 42 CFR 438.402(c)(1)(i), effective 2017, that all Medicaid managed care denials must now first have a plan-level review before a State Fair Hearing can be requested.
• Updates to comply with the Medicare Advantage final rule, published May 23, 2019, Federal Register, 84 FR 23832, effective January 1, 2020, regarding the change in timeframes for Medicare Advantage appeals related to Part B drugs.
• Removing the option to delete sections related to expedited payment requests (if applicable); plans are to leave all language regarding fast appeals. Text has been added to the notice informing enrollees they do not have a right to request an expedited appeal if they are asking to be paid back for an item or service already received (42 CFR 422.570(a)).
• The addition of language in the instructions that “applicable integrated plans” should follow notification requirements under final rule published April 16, 2019, Federal Register, 84 FR 15680, and amended May 23, 2019, Federal Register, 84 FR 23832, effective January 1, 2021.
• The addition of instructions for MA-PDs to enter text in the free text field “why did we deny your request?” when they have determined that the requested drug being denied is covered under Part D.

Form Number: CMS-10003 (OMB control number: 0938-0829); Frequency: Yearly; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 694; Total Annual Responses: 9,373,200; Total Annual Hours: 1,561,575. (For policy questions regarding this collection contact Staci Paige at 410-786-1943.)

Dated: July 5, 2019.

William N. Parham, III,

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