On Wednesday, the Department of Health and Human Services (“HHS”) reversed course in its delay of implementing fines against drug manufacturers that intentionally overcharge 340B providers. In a notice of proposed rulemaking, HHS intends to advance the effective date of its final rule on the 340B drug price ceiling and civil monetary penalties to January 1, 2019, rather than July 1, 2019, as previously proposed. Continue Reading HHS proposes moving up the enforcement of 340B penalties to January 1, 2019

Anticipating open enrollment season for coverage in 2019, the Centers for Medicare and Medicaid Services (CMS) released coverage and premium information that will factor into consumer decisions about Medicare and individual commercial plans offered through exchanges. Enrollment and premium trends also inform regulatory and broader policy decisions at both federal and state levels. Continue Reading Open Enrollment Update: CMS Releases Benefit and Market Data

On September 10, 2018, the federal Food & Drug Administration (”FDA”) released its revised draft standard Memorandum of Understanding (“MOU”) between states and the FDA addressing the interstate distribution of compounded drug products.  See 83 Fed. Reg. 175, 45631 et seq. (Sept. 10, 2018). The draft is the latest in the FDA’s decades-long effort to clarify state and federal roles in investigating and responding to complaints related to compounded drug products shipped between states. Continue Reading FDA publishes revised draft MOU addressing state and federal oversight of 503A compounding pharmacies

There were several recent court decisions that have addressed the right of medical providers, acting under assignments of ERISA plan benefits from patients, to seek plan documents and summary plan descriptions, and to sue plan fiduciaries.

In one case, the district court dismissed the action, holding that the patients had not assigned their rights to sue the plan for statutory penalties. The provider attempted to obtain a retroactive assignment, but the Eleventh Circuit court of appeals held that the provider was not a participant nor a beneficiary in the plan and thus had no standing to bring a claim. Continue Reading Recent Case Law Regarding Health Plan Assignment of Benefits

A federal court decision to vacate regulations concerning “overpayments” to Medicare Advantage plans has left open questions about the way the government pays the insurers and pending cases brought by the U.S. Department of Justice. Continue Reading Court Decision on Overpayment Rule Leaves Uncertain Future for Medicare Payment Methodology and Pending Justice Department Lawsuits

This is the second article in our series on the new “Pathways” rules for Accountable Care Organizations. Our first article in the series can be found here.

The Centers for Medicare and Medicaid Services (CMS) released a report on August 27, 2018, showing Next Generation accountable care organizations (ACOs) produced net savings of $62 million in 2016 while maintaining quality of care.  CMS Administrator Seema Verma pointed to the savings as evidence that ACOs taking two-sided risk succeed, according to a CMS press release.  Continue Reading Performance Report: “Pathways” Rules Help CMS Advance Two-Sided Risk Sharing

By now, everyone operating a skilled nursing facility knows about CMS’ 2016 overhaul of the Requirements for Participation for Long-Term Care Facilities (“RoPs”).  The final rule amending the RoPs was published on October 4, 2016.  See 81 Fed. Reg. 68688 (Oct. 4, 2016).  Many of the changes made by CMS do not impose new requirements on facilities, but instead clarify existing requirements.  While CMS has been implementing the various changes in three phases over a three-year period, facilities should by now have implemented or taken steps to implement all of the new requirements.

We have reviewed the new RoPs and guidance documents issued by CMS to determine how the changes impact nursing facility admission agreements.  There were changes or clarifications to a number of subjects that impact such agreements, including: resident discharge requirements, resident representative requirements, selection of attending physicians and other health care providers, room transfer and roommate requirements, visitation rights, facility liability for resident property, bed hold policies, etcetera. Continue Reading Nursing Facilities Need To Update Their Admission Agreements

This is the third article in our series on Association Health Plans (AHP). This week’s discussion focuses on the mixed reaction to the recent Department of Labor (DOL) AHP.

In the health benefits market, some state-based associations, such as Wisconsin’s largest business association, have announced their intent to create an AHP. On the other hand, the National Federation of Independent Business (NFIB), a long-time advocate of AHPs, is declining to establish an AHP because the rule falls short of what the NFIB felt was needed to establish an AHP, according to reports.   Continue Reading Association Health Plans Are Drawing A Lot of Attention, Including Some Pushback