Health Reform WK-EDGE Regulatory agenda focuses on payment updates, medical devices, drugs
Thursday, August 31, 2017

Regulatory agenda focuses on payment updates, medical devices, drugs

By Anthony H. Nguyen, J.D.

HHS issued its Semiannual Regulatory Agenda, publishing abstracts of departmental rulemakings that are in process and that will continue in 2017. The abstracts describe agency actions in the Proposed rule stage, Final rule stage, Long-term actions, and Completed actions. Actions include CMS calendar year (CY) 2017 home health, hospital outpatient, ambulatory surgical center, and physician payment rate updates, as well as FDA amendments to the current good manufacturing practice regulations for finished pharmaceuticals; CMS proposals for CY 2018 for hospital outpatient and physician payment rates; FDA long-term actions focused on drug and biologic postmarket safety reporting (Notice, 82 FR 40278, August 24, 2017).

CMS. There are three Proposed rules and a Final rule under development, besides one long-term action, on CMS’ regulatory action calendar. The agency listed five completed actions in the first half of 2017.

Long-term action includes a Final rule (82 FR 39447, June 16, 2016) that would update the requirements that hospitals and critical access hospitals (CAHs) must meet to participate in the Medicare and Medicaid programs. The requirements should conform to current standards of practice and support improvements in quality of care, reduce barriers to care, and reduce issues that may create workforce shortage concerns.

Payment updates for inpatient hospitals and long-term care hospital for fiscal year (FY) 2018 were proposed in the first half of the year (Proposed rule, 82 FR 19796, April 28, 2017; see IPPS spending projected to increase $3B, LTCH PPS to decrease $173M, April 17, 2017). Completed actions in late 2016 included a Final rule that implemented provisions of the Medicare Access and CHIP Reauthorization Act (MACRA), including significant changes from the Proposed rule based on nearly 4,000 public comments the agency received on the Quality Payment Program (QPP), which updates the Physician Fee Schedule (PFS) to reward high-quality patient care through the Merit-based Incentive Payment System (MIPS) and Advanced Alternative Payment Models (APMs). Changes from the Proposed rule (81 FR 28162, May 9, 2016) included more support for small practices and adopting a flexible, pick-your-own-pace approach to the initial years of the program (Final rule, 81 FR 77008, November 11, 2016; see MACRA final regulations reflect input from ‘months-long listening tour,’ November 4, 2016).

Proposed rules related to hospital outpatient and physician payment rates for CY 2018 are expected.

FDA. There are three Final rules under development, in addition to seven long-term actions, on the FDA’s regulatory action calendar. The agency listed eight completed actions in the first half of 2017.

A Final rule is expected that will update the FDA’s requirements for accepting clinical data used to bring new medical devices to market. To help ensure the quality and integrity of clinical trial data and the protection of study participants, the FDA proposed regulations to reduce burden on industry by avoiding the need for onsite inspections (Proposed Rule, 78 FR 12664, February 25, 2013; see FDA proposes the use of good clinical practice for all medical device studies conducted outside the United States, February 25, 2013).

A long-term action of significance is the FDA’s focus on amending the regulations regarding new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license application (BLAs) to revise and clarify procedures for changes to labeling an approved drug to reflect certain types of newly acquired information before FDA’s review of such change. This action would allow generic drug companies to update their labels with new safety information similar to their reference product counterparts (Proposed rule, 78 FR 67985, November 13, 2013; see FDA proposal would speed release of safety information on generic drugs, November 13, 2013).

The department’s complete regulatory agenda is accessible online at

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