Health Law Daily Wrap Up, WORTH NOTING—PROPOSED RULES: Obama-era proposed rules withdrawn by CMS, HHS, (Oct. 4, 2017)
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Wednesday, October 4, 2017

Health Law Daily Wrap Up, WORTH NOTING—PROPOSED RULES: Obama-era proposed rules withdrawn by CMS, HHS, (Oct. 4, 2017)

Four proposed regulations from the Obama Administration that were never finalized were withdrawn by CMS and HHS. The proposed regulations were withdrawn for a variety of reasons, and covered Medicare, Medicaid, and requirements under the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

Same-sex spouses. A 2014 Proposed rule (79 FR 73873) designed to ensure recognition of legally married same-sex spouses in facilities that participate in Medicare and Medicaid following the Supreme Court’s decision in U.S. v. Windsor (see CMS to update regulations to comport with same-sex spouse eligibility, December 12, 2014) was withdrawn by CMS. The agency explained that a 2015 Supreme Court decision, Obergefell v. Hodges, which required all states to recognize and perform same-sex marriages, mooted the Proposed rule (Withdrawal of proposed rule, 82 FR 46181, October 4, 2017).

Qualifications for fabricating prosthetics and orthotics. A Proposed rule (82 FR 3678, January 12, 2017) specifying the qualifications needed for qualified practitioners to furnish and fabricate and qualified suppliers to fabricate prosthetics and custom-fabricated orthotics (see Suggested requirements for qualified practitioners and suppliers of prosthetics and custom-fabricated orthotics, January 12, 2017) was withdrawn in light of public comments received by CMS on the cost and time burdens that the Proposed rule would have created (Withdrawal of proposed rule, 82 FR 46181, October 4, 2017).

Part B drug payments. A controversial Proposed rule that would have tested changes to Medicare Part B payments for prescription drugs was officially withdrawn. The Proposed rule (81 FR 13230, March 11, 2016) would have created a two-phase demonstration project (see Will alternative drug payment models reduce Part B expenditures?, March 9, 2017). The project would have run through the CMS Innovation Center as established by section 3021 of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148), and tested alternative payment models for drugs furnished incident to a physician’s services, drugs administered via a covered item of durable medical equipment, and other drugs specified by statute (Withdrawal of proposed rule, 82 FR 46182, October 4, 2017).

In December 2016, the Obama Administration announced that due to significant opposition and the looming administrative transition, it would not seek to finalize the Proposed rule before President Trump’s inauguration (see CMS withdraws controversial proposed Part B drug price reduction demonstration, December 16, 2016), though it was not formally withdrawn at the time. In the withdrawal, CMS noted that it will continue to pursue similar projects, but due to the complexity of the issues the agency wanted a clean slate.

CHP certification. HHS withdrew a 2014 Proposed rule (79 FR 298) that would have required a controlling health plan (CHP) to submit information and documentation demonstrating compliance with HIPAA standards and rules for certain electronic transactions (see HHS to require certification of compliance for health care plans, January 3, 2014). The Proposed rule was withdrawn, but does not remove any requirements for covered entities to comply with HIPAA regulations (Withdrawal of proposed rule, 82 FR 46182, October 4, 2017).

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