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.

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.  

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.

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).

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.”

With the global telehealth market projected to more than quadruple in value over the next five years, even slow-moving government payors have responded to the pressure to expand reimbursement options for telemedicine services. But reimbursement woes continue to top the list of concerns voiced by providers, and the U.S. Department of Health and Human Services, Office of Inspector General (“OIG”) is keeping a watchful eye on reimbursement-related growing pains. On April 30, 2018, OIG released a report that identifies the impact of some of these growing pains on Medicare claims payments.

The National Labor Relations Board (the “Board”) recently held that a California hospital illegally maintained a dress code policy that effectively prohibited employees from wearing pins and badge reels with union insignia.  The hospital’s policy at issue required that “[o]nly [employer] approved pins, badges, and professional certifications may be worn.” In addition, employees were only permitted to wear identification badge reels with “approved logos or text.”

For those of you who may have lost hope regarding the patentability of personalized medicine discoveries, here’s some encouragement.  Recently the Federal Circuit affirmed the validity of a patent directed to a method of treating schizophrenia, which is based on genetic testing of the patient. Vanda Pharms. Inc. v. West-Ward Pharms. Int’l Ltd., Nos. 2016-2707, 2016-2708, 2018 WL 1770273, —F.3d — (Fed. Cir. Apr. 13, 2018).  The Court found that the claims of U.S. Patent No. 8,586,610 were patent eligible and not drawn to a law of nature under 35 U.S.C. § 101.  Claim 1 is representative and is shown below: