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From Health Law Daily, June 9, 2016

Regulatory agenda sees CMS eye innovation, FDA blink on drug label rule

By Anthony H. Nguyen, J.D.

HHS issued its Semiannual Regulatory Agenda, publishing abstracts of departmental rulemakings that are currently in process and that will continue in 2016. The abstracts describe agency actions in the Proposed rule stage, Final rule stage, Long-term actions, and Completed actions. Actions include a continued notice of an Office for Civil Rights (OCR) action regarding nondiscrimination under the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148); an Office of the National Coordinator (ONC) for Health Information Technology proposal to enhance oversight and accountability of its certification program; FDA proposals describing requirements for investigational new drug application (IND) annual reports and updating the standards for pet food labels; and CMS proposals for hospital and critical access hospital innovations and improvement in patient care, as well as inpatient hospital, home health, and physician payment rate updates (Notice, 81 FR 37294, June 9, 2016).

OCR. The OCR action, expected shortly, implements prohibitions against discrimination on the basis of race, color, national origin, sex, age, and disability as provided in Section 1557 of the ACA. Section 1557 provides protection from discrimination in health programs and activities of covered entities. It also identifies additional forms of federal financial assistance to which the section applies. The Notice of Proposed Rulemaking published on September 8, 2015 (80 FR 54172) (see HHS moves towards health care equity, proposes to leave sex discrimination behind, September 9, 2015).

ONC. The ONC proposed a rule regarding enhanced oversight and accountability of its certification program (Proposed rule, 81 FR 11056, March 2, 2016). The ONC would establish processes for direct review of health information technology under the program and allow for correction of non-conformities. Corrections would include suspension and termination of certifications.

FDA. Overall, the FDA has eight actions under development in the Proposed rule stage and 12 in the Final rule stage, as well as four long-term actions (laser products, tobacco ingredients, radiology devices, and drug compounding), on the FDA’s regulatory action calendar. Three actions were completed in the first half of 2016.

Proposed actions include updated standards for the labeling of pet food that include nutritional and ingredient information, as well as style and formatting standards, and a proposal to revise the requirements concerning annual reports submitted to INDs by replacing the current annual reporting requirement with a requirement that is generally consistent with the format, content, and timing of submission of the development safety update report for international harmonization. Other proposed actions include additions of indications for certain over-the-counter medications and requirements that govern the methods used in, and the facilities and controls used for, the pre-production design validation, manufacture, packing, and storage of tobacco products.

Some actions in the final stage include two-decade-in-the-making rules: foreign and domestic drug facility registration (Proposed rule, 71 FR 51276, August 29, 2006) and postmarket drug safety reports (Proposed rule, 68 FR 36527, June 18, 2003). The FDA also issued a revision of nutrition and supplement facts labels (Final rule, 81 FR 33742, May 27, 2016; see Nutrition Facts label gets ready for summer; reshapes serving sizes, trims fat info, May 20, 2016) and established minimum standards for the safe production and harvesting of fruits and vegetables (see FDA establishes farming standards to prevent contamination of produce, November 27, 2015).

In a date change with major industry ramifications, the FDA pushed to 2017 an expected date for a Final rule that 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).

CMS. There are six Proposed rules and two Final rules under development, in addition to three long-term actions, on CMS’ regulatory action calendar. The agency listed four completed actions in the first half of 2016.

Actions included a Proposed rule that would implement provisions of the Medicare Access and CHIP Reauthorization Act (MACRA) related to the Merit-based Incentive Payment System (MIPS) and Advance Alternative Payment Models (APM), including fewer reporting measures and removal of redundant reporting requirements (Proposed rule, 81 FR 28162, May 9, 2016; see Physician reporting streamlined, less burdensome under flexible Quality Payment Program, April 28, 2016). Payment updates for inpatient hospitals and long-term care facilities were proposed in the first half of the year (Proposed rule, 81 FR 24946, April 27, 2016; see CMS pulls plug on two-midnight payment cuts in IPPS/LTCH Proposed rule, April 27, 2016). Home health, outpatient hospitals and ambulatory surgical centers, and physician fee schedules are expected later in 2016.

The agency completed actions on covered outpatient drugs that will allow for larger Medicaid drug rebates (Final rule, 81 FR 5170, February 1, 2016; see CMS paves the way for bigger, better Medicaid drug rebates, February 1, 2016), as well as calendar year 2016 revisions for physician fee schedules and outpatient hospital payments.

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

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