Federal Regulatory Update: New Quarantine and Medicare Advantage Regulations

85 FR 7874 – Interim Final Rule - The CDC issued this interim final rule to amend its Foreign Quarantine regulations, to enable CDC to require airlines to collect, and provide to CDC, certain data regarding passengers and crew arriving from foreign countries for the purposes of health education, treatment, prophylaxis, or other appropriate public health interventions, including travel restrictions. Although the rule was not published until February 12, 2020, it became effective on February 7, 2020. 

Federal Regulatory Update, Including Acupuncture Approval to Fight Addiction

On January 30, 2020, CMS issued a new initiative to allow states to carry out demonstrations under Section 1115 waivers converting some of their federal Medicaid funding to block grants.  Under the initiative, states that apply can provide Medicaid coverage using flexible benefit designs under either an aggregate or per-capita cap financing model for certain populations without being required to comply with a list of Medicaid provisions, CMS said.

New OIG Advisory Opinion On Travel Expenses, Changes to Medicare Advantage, and Final Rule On How Pharmacist Input in the NCPDP

OIG Advisory Opinion No. 20-02

In a January 15, 2020 Advisory Opinion, the Office of Inspector General (OIG) weighed in on whether financial assistance for travel, lodging, and other expenses provided by a pharmaceutical manufacturer to certain patients prescribed the manufacturer’s drug, constitutes grounds for imposition of sanctions under the civil monetary penalty provision prohibiting inducements to beneficiaries, § 1128A(a)(5) of the Social Security Act (the “Act”), or under the exclusion authority at § 1128(b)(7) of the Act, or the civil monetary penalty provision at §1128A(a)(7) of the Act, as those sections relate to the commission of acts described in § 1128B(b) of the Act, the federal anti-kickback statute.

Will the Feds Do Anything About Vertical Mergers in Health Care? Read the Latest Guidelines on Vertical Mergers as Well as Other Regulatory and Litigation Updates

Federal Guidelines On Vertical Mergers

In January 2020, the DOJ’s Antitrust Division and the FTC published draft guidelines regarding vertical mergers.   The DOJ has not drafted merger guidelines in approximately 36 years, perhaps indicating that vertical mergers will receive heightened scrutiny in the near future.  Vertical mergers combine two or more companies that operate at different levels in the same supply chain. 

Ten New Jersey Bills That Became Law, a Proposal to Expand New Jersey’s Cannabis Program to Telemedicine, and MedPac’s Recommendation to Congress About Physician and Facility Payments

New Jersey Statutes

This past month, the New Jersey Legislature approved ten additional statutes impacting health care. These bills have already been approved and become law. The statutes are as follows:

A1277 – Approved – This bill requires general acute care hospitals and emergency shelters for the homeless to provide information about special services and resources to certain individuals receiving services from the hospital or shelter. Such hospitals will be required to inquire, as part of the intake process, whether the individual seeking services is homeless or is a military veteran. 

Extension for Licensure of One Room Centers

The New Jersey Assembly recently proposed Bill No.1989 extending the effective date for one room centers to become licensed to July 1, 2020, citing staffing and resource limitations.  We will keep track of this bill along the legislative process, and inform you if and when the bill passes both houses and is approved by the Governor.

New Jersey and Federal Legislative Update

New Jersey Statutes:

A3717 – Approved – We previously reported on this statute, which initially passed both houses, but was then vetoed by the Governor.  After some modifications, the statute passed both houses again and became law after excluding self-insured plans, the State Health Benefits Plan, and the School Employees Health Benefits Plan.  The statute prohibits a pharmacy benefits manager from retroactively reducing payments on a properly filed claim for payment by a pharmacy.

Legislative and Litigation Update

New Jersey State Regulatory Issues

51 N.J.R. 1806(a) – Notice of Action on Petition for Rulemaking

The Department of Health received a petition to make amendments to N.J.A.C. 8:43G, the Hospital Licensing Standards, in Subchapter 14 Infection Control, at N.J.A.C. 8:43G-14.9, Sepsis protocols.  We previously reported that the Department confirmed receipt of the petition.  At this time, the Department has not decided on the petition and has referred the petition to the Division of Certificate of Need and Licensing to evaluate, and make recommendations as to the appropriateness of granting the petition.