Roster of Pending Health-related Federal Regulations – as of 10/14/2015


Bid Pricing Tool for Medicare Advantage and Prescription Drug Plans



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Bid Pricing Tool for Medicare Advantage and Prescription Drug Plans

CMS-10142

AGENCY: CMS
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-09-24/pdf/2015-24263.pdf



Released: 9/24/2015
Due date: 11/23/2015

2. Type of Information Collection Request: Revision of a currently approved collection; Title: Bid Pricing Tool (BPT) for Medicare Advantage (MA) Plans and Prescription Drug Plans (PDP); Use: CMS requires that Medicare Advantage organizations and Prescription Drug Plans complete the Bid Pricing Tool (BPT) as part of the annual bidding process. During this process, organizations prepare their proposed actuarial bid pricing for the upcoming contract year and submit them to CMS for review and approval. The BPT collects the actuarial pricing information for each plan. The BPT calculates the bid, enrollee premiums, and payment rates of the plan. CMS publishes beneficiary premium information using a variety of formats (www.medicare.gov, the Medicare & You handbook, Summary of Benefits marketing information) for the purpose of beneficiary education and enrollment.

9/15/2015: Paperwork Reduction Act Notice. No comments recommended.















PQRS and eRx Program Data Assessment

CMS-10519

AGENCY: CMS
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-09-25/pdf/2015-24474.pdf


Released: 9/25/2015
Due date: 11/24/2015

1. Type of Information Collection Request: Revision of a currently approved collection; Title: Physician Quality Reporting System (PQRS) and the Electronic Prescribing Incentive (eRx) Program Data Assessment, Accuracy, and Improper Payments Identification Support; Use: The incentive and reporting programs have data integrity issues, such as rejected and improper payments. This four year project will evaluate incentive payment information for accuracy and identify improper payments, with the goal of recovering these payments. Additionally, based on the results of the project, CMS will develop recommendations to avoid future data integrity issues.
CMS will analyze data submission, processing, and reporting for potential errors, inconsistencies, and gaps related to data handling, program requirements, and clinical quality measure specifications of PQRS and the eRx program. CMS will conduct surveys of Group Practices, Registries, and Data Submission Vendors (DSVs) to evaluate PQRS and the eRx program. Follow-up interviews will occur with a small number of respondents.

9/15/2015: Paperwork Reduction Act Notice. No comments recommended.















Data Collection for Medicare Beneficiaries Receiving Beta Amyloid PET for Dementia

CMS-10583

AGENCY: CMS
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-09-25/pdf/2015-24474.pdf


Released: 9/25/2015
Due date: 11/24/2015

2. Type of Information Collection Request: New collection; Title: Data Collection for Medicare Beneficiaries Receiving Beta Amyloid Positron Emission Tomography (PET) for Dementia and Neurodegenerative Disease; Use: In the Decision Memorandum #CAG-00431N issued on September 27, 2013, CMS determined sufficient evidence exists to support the use of beta amyloid PET in 2 scenarios: (1) to exclude Alzheimer’s disease (AD) in narrowly defined and clinically difficult differential diagnoses; and (2) to enrich clinical trials seeking better treatments or prevention strategies for AD. CMS will cover one beta amyloid PET scan per patient through Coverage with Evidence Development under section 1862(a)(1)(E) of the Social Security Act (Act) in clinical studies that meet specific criteria established by CMS. Clinical studies must have CMS approval, involve subjects from appropriate populations, and use comparative and longitudinal methods. Radiopharmaceuticals used in the scan must have FDA approval. Approved studies must address defined research questions established by CMS. Clinical studies in this National Coverage Determination (NCD) must adhere to the designated timeframe and meet standards established by CMS in the NCD. Consistent with section 1142 of the Act, AHRQ supports clinical research studies that CMS determines to meet specifically identified requirements and research questions.
To qualify for payment, providers must prescribe beta amyloid PET for beneficiaries with a set of clinical criteria specific to each cancer. Providers must transmit data elements to CMS for evaluation of the short and long-term benefits of beta amyloid PET to beneficiaries and for use in future clinical decision making.

9/15/2015: Paperwork Reduction Act Notice. No comments recommended.















Medicare Clinical Diagnostic Laboratory Tests Payment System

CMS-1621-P

AGENCY: CMS
Medicare Program; Medicare Clinical Diagnostic Laboratory Tests Payment System

http://www.gpo.gov/fdsys/pkg/FR-2015-10-01/pdf/2015-24770.pdf



Released: 10/1/2015
Due date: 11/24/2015

This proposed rule would significantly revise the Medicare payment system for clinical diagnostic laboratory tests and would implement other changes required by section 216 of the Protecting Access to Medicare Act of 2014.

10/2/2015: A thorough review of the proposed payment changes is recommended to determine the potential impact on Tribal health programs.















Fiscal Soundness Reporting Requirements

CMS-906

AGENCY: CMS
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-10-02/pdf/2015-25108.pdf

Released: 10/2/2015
Due date: 12/1/2015

Type of Information Collection Request: Extension of a currently approved collection; Title: The Fiscal Soundness Reporting Requirements; Use: CMS has responsibility for overseeing the ongoing financial performance of all Medicare Advantage organizations (MAOs), prescription drug plan (PDP) sponsors, and PACE organizations. Specifically, CMS needs the requested collection of information to establish that contracting entities within those programs maintain fiscally sound organizations and thereby remain a going concern. All contracting organizations must submit annual independently audited financial statements one time per year. MAOs with a negative net worth and/or a net loss greater than one-half of their total net worth must file three quarterly financial statements. Currently, approximately 71 MAOs file quarterly financial statements. Part D organizations also must file 3 quarterly financial statements. PACE organizations must file 4 quarterly financial statements for the first three years in the program, as well as those with a negative net worth and/or a net loss greater than one-half of their total net worth.

10/2/2015: Paperwork Reduction Act notice. No comments recommended.















Hospital Wage Index Occupational Mix Survey

CMS-10079

AGENCY: CMS
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-10-09/pdf/2015-25809.pdf


Released: 10/9/2015
Due date: 12/8/2015

Type of Information Collection Request: Extension of a currently approved collection; Title: Hospital Wage Index Occupational Mix Survey and Supporting Regulations in 42 CFR, Section 412.64; Use: Section 304(c) of Public Law 106-554 amended section 1886(d) (3) (E) of the Social Security Act to require CMS to collect data every three years on the occupational mix of employees for each short-term, acute care hospital participating in the Medicare program to construct an occupational mix adjustment to the wage index, for application beginning October 1, 2004 (the FY 2005 wage index). The occupational mix adjustment serves to control for the effect of hospital employment choices on the wage index. For example, hospitals might choose to employ different combinations of registered nurses, licensed practical nurses, nursing aides, and medical assistants for the purpose of providing nursing care to their patients. The varying labor costs associated with these choices reflect hospital management decisions rather than geographic differences in the costs of labor. The FY 2016 survey will provide for the collection of hospital-specific wages and hours data for calendar year 2016 (i.e., payroll periods ending between January 1, 2016, and December 31, 2016). The 2016 Medicare occupational mix survey will apply beginning with the FY 2019 wage index.

10/9/2015: Paperwork Reduction Act notice. No comments recommended.















Sharing What Works--Best Practice, Promising Practice, and Local Effort Form

IHS (OMB 0917-0034)

AGENCY: IHS
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-10-09/pdf/2015-25733.pdf



Released: 10/9/2015
Due date: 12/8/2015

Type of Information Collection Request: Extension without change of a currently approved collection; Title: IHS Sharing What Works--Best Practice, Promising Practice, and Local Effort (BPPPLE) Form; Use: IHS seeks to raise the health status of the AI/AN population to the highest possible level by providing comprehensive health care and preventive health services. To support the IHS mission and encourage the creation and utilization of performance driven products/services by IHS, tribal, and urban Indian health (I/T/U) programs, Office of Preventive and Clinical Services program divisions (i.e., behavioral health, health promotion/disease prevention, nursing, and dental) have developed a centralized program database of best practices, promising practices, and local efforts (BPPPLE) and resources. This collection serves to further the development of a database of BPPPLE, resources, and policies available to the public on the IHS Web site. This database will serve as a resource for program evaluation and for modeling examples of various health care projects occurring in AI/AN communities.


10/9/2015: See detailed notes for this entry under the Priority Roster items shown above.















EHR Incentive Program--Stage 3 and Modifications to Meaningful Use

CMS-3310-FC and CMS-3311-FC

AGENCY: CMS
Medicare and Medicaid Programs; Electronic Health Record Incentive Program--Stage 3 and Modifications to Meaningful Use in 2015 through 2017
https://s3.amazonaws.com/public-inspection.federalregister.gov/2015-25595.pdf


Released: 10/6/2015
Due Date: 12/15/2015
Published: 10/16/2015 (expected)



This final rule with comment period specifies the requirements that eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) must meet to qualify for Medicare and Medicaid electronic health record (EHR) incentive payments and avoid downward payment adjustments under the Medicare EHR Incentive Program. In addition, it changes the Medicare and Medicaid EHR Incentive Programs reporting period in 2015 to a 90-day period aligned with the calendar year. This final rule with comment period also removes reporting requirements on measures that have become redundant, duplicative, or topped out from the Medicare and Medicaid EHR Incentive Programs. In addition, this final rule with comment period establishes the requirements for Stage 3 of the program as optional in 2017 and required for all participants beginning in 2018. This final rule with comment period continues to encourage the electronic submission of clinical quality measure (CQM) data, establishes requirements to transition the program to a single stage, and aligns reporting for providers in the Medicare and Medicaid EHR Incentive Programs.
CMS seeks comments on sections II.B.1.b.(3).(iii), II.B.1.b.(4).(a), II.B.2.b, II.D.1.e, and II.G.2 of preamble to this final rule with comment period ; paragraphs (1)(ii)(C)(3), (1)(iii), (2)(ii)(C)(3) and 2(iii) of the definition of an EHR reporting period at §495.4; and paragraphs (2)(ii)(C)(2) and (2)(iii) of the definition of an EHR reporting period for a payment adjustment year at §495.4.
NIHB and TTAG submitted comments on the proposed version of this rule (CMS-3310-P) on May 29, 2015. A summary of the recommendations from tribal organizations, as well as the responses from CMS, is detailed in the entry under Priority Roster items.

10/7/2015: See analysis and detailed notes in the entry above under Priority Roster.















Revisions to the Table for Calculating the Premium Tax Credit, et al.

Rev. Proc. 2014-37

Rev. Proc. 2014-62

AGENCY: IRS
Revisions to the Table for Calculating the Health Insurance Premium Tax Credit, Updates to the Percentage for Determining Qualification for Minimum Essential Coverage, and Cross-Reference to the Percentage for Determining Qualification for Shared Responsibility Payment Exemption
http://www.irs.gov/pub/irs-drop/rp-14-37.pdf
http://www.irs.gov/pub/irs-drop/rp-14-62.pdf


Released: 7/24/2014, 12/8/2014
Due date: None

Rev. Proc. 2014-37 provides indexing adjustments for certain provisions under sections 36B and 5000A of the Internal Revenue Code (Code). In particular, it updates the Applicable Percentage Table in § 36B(b)(3)(A)(i). This table is used to calculate the premium tax credit for an individual for taxable years beginning after calendar year (CY) 2014. This revenue procedure also updates the required contribution percentage in § 36B(c)(2)(C)(i)(II), which is used to determine whether an individual qualifies for affordable employer-sponsored minimum essential coverage under § 36B for plan years beginning after CY 2014. In addition, this revenue procedure cross-references the required contribution percentage (affordability percentage) under § 5000A(e)(1)(A) for plan years beginning after calendar year 2014, as determined under guidance issued by HHS. This percentage is used to determine whether an individual qualifies for an exemption from the individual shared responsibility payment because of a lack of affordable minimum essential coverage.
Rev. Proc. 2014-62 uses the methodology described in Rev. Proc. 2014-37 to update the Applicable Percentage Table and required contribution percentage for CY 2016. In addition, this revenue procedure cross-references the required contribution percentage (affordability percentage) for CY 2016, as determined under guidance issued by HHS.
Analysis: Refer to TSGAC Briefing Memo linked in the right column.

7/30/2014: No comments requested.


Associated with IRS REG-104579-113 and TD-9863.
8/1: See analysis to the left.
9/30/2015: TSGAC briefing memo on topic prepared.















Key Dates in 2015: QHP Certification in the FFM, et al.

CCIIO (no reference number)

AGENCY: CCIIO
Key Dates in 2015: QHP Certification in the Federally-Facilitated Marketplaces; Rate Review; Risk Adjustment, Reinsurance, and Risk Corridors
http://www.cms.gov/CCIIO/Resources/Regulations-and-Guidance/Downloads/2015-Key-Dates-QHP-Certification-in-the-FFM-Rate-Review-and-3Rs-final.pdf


Released: 4/14/2015
Due date: None


This guidance provides key dates in 2015 related to qualified health plan (QHP) certification in the Federally-Facilitated Marketplace (FFM); rate review for single risk pool compliant plans; and risk adjustment, reinsurance, and risk corridors for PY 2014.
Some key dates regarding QHP certification appear below.
QHP Agreement/Final Certification

--Certification Notices and QHP Agreements Sent to Issuers: 9/17/2015-9/18/2015

--Agreements Signed by Issuers and Returned to CMS with Final Plan List: 9/21/2015-9/25/2015

--Validation Notice Confirming Final Plan List and Countersigned Agreements Sent to Issuers: 10/8/2015-10/9/2015

--Open Enrollment: 11/1/2015-1/31/2016

4/15/2015: No comments sought by CMS/CCIIO.















Summary of Benefits and Coverage and Uniform Glossary

TD 9724

DoL (RIN 1210-AB69)

CMS-9938-F

AGENCY: IRS/DoL/CMS
Summary of Benefits and Coverage and Uniform Glossary
http://www.gpo.gov/fdsys/pkg/FR-2015-06-16/pdf/2015-14559.pdf

Released: 6/16/2015
Due date: None


This document contains final regulations regarding the summary of benefits and coverage (SBC) and the uniform glossary for group health plans and health insurance coverage in the group and individual markets under ACA. It finalizes changes to the regulations that implement the disclosure requirements under section 2715 of the Public Health Service Act to help plans and individuals better understand their health coverage, as well as gain a better understanding of other coverage options for comparison.
A CMS fact sheet on this final rule is available at http://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/Fact-Sheet_SBCFinalRule-6-11-15-MM-508.pdf.
Analysis:

TTAG submitted comments on the proposed version of this rule on February 28, 2015. A summary of the recommendations from TTAG appears below. The agencies did not specifically address any of the tribal recommendations regarding the two Indian-specific cost-sharing variations in this final rule.




  1. Review of the SBC template: The SBC template might require some modifications as qualified health plan (QHP) issuers work to incorporate the required plan information for the two Indian-specific cost-sharing variations; CMS should review the SBC template to determine any need for modifications to accommodate the information necessary for the “limited” and “zero” cost-sharing variations and engage with tribal representatives on this review.

  2. Review of SBCs for Accuracy: In the past, tribal representatives have found inaccuracies in some of the SBCs voluntarily prepared by some QHP issuers to describe the Indian-specific cost-sharing variations; CMS should review SBCs to assess the accuracy of the application of the “limited” and “zero” cost-sharing variations.

  3. Sample Language: To address confusion on the part of some QHP issuers, CMS should provide sample language, for use by issuers in the preparation of SBCs, to describe how the “zero” and “limited” cost-sharing variations impact deductibles, co-insurance, etc. for in-network and out-of-network providers.

10/2/2015: SBCs are to be released by each WHP issuer for each QHP variation prior to November 1, 2015.















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