The Trump Administration has formally withdrawn a number of pending Department of Health and Human Services (HHS) proposals that never reached the final rule stage. This includes: a controversial Part Medicare B drug payment innovation model; a proposal to protect same sex marriages in certain Medicare and Medicaid facilities (predating a related Supreme Court decision); a proposal to impose more stringent Medicare requirements related to the provision of orthotics and prosthetics; and a proposed rule regarding certification of compliance for health plans. Each of the rules is withdrawn as of October 4, 2017. Specifically:
- The Centers for Medicare & Medicaid Services (CMS) has withdrawn its proposed Part B Drug Payment Model, published March 11, 2016, that would test whether alternative drug payment designs would lead to a reduction in Medicare expenditures while preserving/enhancing access and quality of care to Medicare beneficiaries. In Phase I of this model, CMS would have tested a change from the average sales price (ASP) plus 6% Part B payment methodology to ASP plus 2.5%, plus a flat fee of $16.80. Phase II of the model would have implemented value-based purchasing tools that used in many commercial plans. CMS withdrew this proposal due to the “complexity of the issues related to the proposed model design and the desire to increase stakeholder input.”
- CMS has withdrawn a December 12, 2014 proposed rule to revise selected conditions of participation (CoPs) for providers, conditions for coverage for suppliers, and requirements for long-term care (LTC) facilities to conform with the Supreme Court decision in United States v. Windsor, and ensure that same-sex spouses in legally-valid marriages are recognized and afforded equal rights in Medicare and Medicaid participating facilities. In withdrawing the proposed rule, CMS cites the Supreme Court decision in Obergefell v. Hodges (135 S. Ct. 2584 (2015)) that held that the Due Process and Equal Protection clauses of the Fourteenth Amendment requires a state to license a marriage between two people of the same sex, and to recognize same-sex marriages lawfully performed in other states. According to CMS, “the Obergefell decision has addressed many of the concerns raised in the December 2014 proposed rule,” prompting CMS to withdraw the rule. Note that a separate October 4, 2016 final rule reforming requirements of participation for LTC facilities mandates that such facilities recognize same-sex marriages if valid under state law.
- CMS also has withdrawn its January 12, 2017 proposed rule that laid out stringent qualifications for providers and suppliers that furnish, fabricate, or bill for prosthetics and custom-fabricated orthotics under the Medicare program. In withdrawing the rule, CMS cited “the cost and time burdens that the proposed rule would create for many providers and suppliers, particularly the cost and burden for those providers and suppliers that are small businesses, and the complexity of the issues raised” in public comments.
- HHS has withdrawn a January 2, 2014 proposed rule intended to promote more consistent testing processes for “controlling health plans” to enable these entities to better achieve and demonstrate compliance with HIPAA standards and operating rules. In the withdrawal notice, HHS states that it intends to “re-examine the issues and explore options and alternatives to comply with the statutory requirements.” HHS also points note that the withdrawal of this proposed rule does not remove the requirements for covered entities to comply HIPAA regulations codified at 45 CFR parts 160 and 162.