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From Health Law Daily, January 12, 2018

Regulatory agenda focuses on cost-sharing, over-the-counter 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, 83 FR 1860, January 12, 2018).

CMS. There are six Proposed rules and one Final rule under development, in addition to one long-term action, on CMS’ regulatory agenda calendar. The agency listed three completed actions in the second half of 2017.

A Proposed rule would establish payment parameters and provisions related to the risk adjustment and risk adjustment data validation programs; cost-sharing parameters and cost-sharing reductions; and user fees for federally-facilitated exchanges and state-based exchanges on the federal platform.

Completed actions included revisions to the Medicare hospital inpatient prospective payment systems (IPPS) (see FY 2018 IPPS payment rates increase, LTCH PPS rates decrease, August 3, 2017; Final rule, 82 FR 37990, August 14, 2017); payment polices under the Medicare physician fee schedule (see CMS finalizes physician fee schedule payment rates for 2018, off-campus PBD cuts concerning to AHA, November 15, 2017; Final rule, 82 FR 52976, November 15, 2017); and the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 (see CMS cut to 340B spending overshadows OPPS update; associations threaten suit, November 2, 2017; Final rule, 82 FR 52356, November 13, 2017).

FDA. There are five Final rules and four Proposed rules under development, in addition to 10 long-term actions, on the FDA’s regulatory agenda calendar. The agency listed four completed actions in second half of 2017.

Notable Final rules intended for 2018 include: (1) amending the postmarket safety reporting regulations for human drugs and biological products to align with international harmonization requirements and updating reporting requirements in light of current pharmacovigilance practice and safety information sources (Proposed rule, 68 FR 12406, March 14, 2003); (2) requiring owners or consignees to label imported food that is refused entry into the United States (Proposed rule, 73 FR 54106, September 18, 2008); and (3) reviewing whether FDA considers certain active ingredients in over the counter (OTC) healthcare antiseptic hand wash and healthcare antiseptic products to be generally recognized as safe and effective (see FDA proposes getting the bugs out of its over-the-counter antiseptic standards, May 1, 2015; Proposed rule, 80 FR 25166, May 1, 2015).

The department’s complete regulatory agenda is accessible online at https://reginfo.gov/public/.

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