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

The growth in prescription drug coverage has led to increased complexity in the delivery and reimbursement of medications. PBMs are organizations which address this complexity by impacting most aspects of the pharmaceutical supply chain. Continue Reading Pharmacy Benefit Managers 101: Who They Are and What They Do

This is the second article in our series on Association Health Plans (AHP). This week’s discussion focuses on the potential impact of the Department of Labor’s (DOL) decision to relax some AHP requirements.

The U.S. Department of Labor (DOL) recently expanded the ability of small groups and the self-employed to obtain health coverage through AHPs. A final rule published June 21 eases certain AHP requirements and restrictions. Continue Reading DOL Rule Relaxes Some AHP Requirements, Points to Other Protections

A new federal rule gives small employers and the self-employed an additional avenue for obtaining group health coverage.

The final rule, released by the U.S. Department of Labor (DOL) June 19 and published June 21, broadens the definition of “employer” for purposes of determining who can establish multiple employer group health plans under section 3(5) of the Employee Retirement Income Security Act of 1974 (ERISA). Continue Reading New Labor Department Rule Expands Group Health Coverage Option

The National Association of Specialty Pharmacy (NASP) recently issued its comments in response to the Department of Health and Human Services’ (HHS) request for information related to HHS’s Drug Pricing Blueprint.[1]  The Blueprint is part of the Trump Administration’s initiative to lower prescription drug prices.  Center for Medicare and Medicaid Services (CMS) Administrator Seema Verma has said that “[l]owering drug prices is a top priority for the President and CMS, and the agency is committed to finding innovative ways to increase competition and lower out-of-pocket costs for consumers.”[2]  Continue Reading NASP Comments on the HHS Drug Pricing Blueprint

On June 7, 2018 the United States Patent and Trademark Office (USPTO) issued a new Memorandum that clarifies its view of Subject Matter Eligibility, under 35 U.S.C. § 101, regarding the patentability of Personalized Medicine discoveries.

The Memorandum was prompted by the Federal Circuit’s recent Vanda decision, where the Court provided its own insights as to the Subject Matter Eligibility of Personalized Medicine patent claims. [1] The claims in Vanda recited a method of treating a patient suffering from schizophrenia with the drug, iloperidone, and included specific steps, such as administering iloperidone to the patient in an amount guided by the genotype of the patient, which can predict the rate of drug metabolism. The Court summarized Vanda by stating: “The inventors recognized the relationships between iloperidone, CYP2D6 metabolism, and QTc prolongation, but that is not what they claimed. They claimed an application of that relationship.” Continue Reading Patent Office Guidance Improves Personalized Medicine’s Long-Term Prognosis