By Rebecca Mayo, J.D.
HHS issued its semiannual regulatory agenda which is an inventory of rulemaking actions under development throughout the department. The agenda provides abstracts of Proposed rules, Final rules, and long-term actions agencies are undertaking. This agenda included changes in standards for over-the-counter (OTC) drug products, tobacco and nicotine products, and sunlamps. Proposed rules were also presented to revise CMS payment systems, HIPAA policies and discrimination policies (Notice, 83 FR 27126, June 11, 2018).
HIPAA and policy updates. One notable Proposed rule would change the requirement that health care providers make a good faith effort to obtain from individuals a written acknowledgement of receipt of the provider’s notice of privacy practices, and, if not obtained, to document its good faith efforts and reason the acknowledgement was not obtained.
Another proposed rule would implement Section 1557 of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148), which prohibits discrimination on the basis of race, color, national origin, sex, age, or disability under any health program or activity receiving Federal financial assistance, under HHS or established by the ACA.
OTC Drugs. One Proposed rule would add the common cold indication to certain OTC antihistamine active ingredients. A number of long-term actions relating to OTC drugs would address things such as external analgesic products, acetaminophen safety, products marketed for children under 2 years old, labeling for laxative drug products, weight control products, pediatric dosing for cough/cold products. Another rule would require electronic package inserts for humans drug and biological prescription products in lieu of paper to ensure that the information is the most up-to-date information.
Tobacco and nicotine products. A product standard is proposed to require testing standards for batteries used in electronic nicotine delivery systems (ENDS) and require design protections through a battery management system for ENDS using batteries. A proposed regulation would allow FDA to administratively detain tobacco products encountered during inspections that are believed to be adulterated or misbranded.
Sunlamps. The FDA is updating the performance standard for sun lamp products to improve safety, reflect new scientific information, and work towards harmonization with international standards. Another long-term action would apply device restrictions to sunlamp products including ultraviolet (UV) lamps and UV tanning beds and booths.
CMS. Proposed rules relating to CMS include reforming Medicare regulations that are unnecessary, obsolete, or excessively burdensome. Annual proposed rules include revising Medicare hospital inpatient and long-term care hospital prospective payment systems for operating and capital-related costs, updating the payment rates and requirements under the prospective payment system, and revising payment policies under the Medicare physician fee schedule.
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