340B Litigation, Nursing Home Visitation and other Updates

Conflicting Rulings in 340B Contract Pharmacy Challenges

On November 8, 2021, federal judges from the District of New Jersey and District of Columbia issued conflicting opinions as to whether pharmaceutical companies are required to offer discounts to third-party pharmacies under the 340B federal drug-pricing program. As to New Jersey, the Court concluded that “drug companies cannot unilaterally restrict sales of products discounted under the 340B program to contract pharmacies.”

Federal Court Halts Vaccine Mandate and Federal Regulatory Update

Federal Court Halts Vaccine Mandate for Healthcare Workers

A federal judge in the District Court for the Eastern District of Missouri granted an injunction yesterday that temporarily halted the implementation of the federal COVID-19 vaccine mandate for healthcare workers. The Court found, among other things, that the Centers for Medicare and Medicaid Services (“CMS”) had no clear authority from Congress to enact the vaccine mandate for providers and that the mandate could lead to staffing shortages. 

Federal Regulations on Opioid Treatment Programs, Guidance on Co-Locating for Hospitals, and More Transparency Rules

CMS Releases Final Guidance on Hospital Co-Locating

Centers for Medicare and Medicaid Services (“CMS”) released final guidance clarifying hospital co-locating, which is when two Medicare certified hospitals or a Medicare certified hospital and another healthcare entity are located on the same campus or in the same building and share space, staff, or services. The guidance does not apply to critical access hospitals or private physician offices in leased or shared space agreements with hospitals.

New Jersey Legislative Update

Governor Murphy Conditionally Vetoes Three Bills

A5353: Under this bill, temporary nurse aides could become certified nurse aides if they successfully complete an eight-hour training course, work a minimum of 80 hours under the supervision of a licensed professional nurse, pass a background check, and successfully complete a State-approved nurse aide written examination, within 45 days after the end of the public health emergency declared in response to COVID-19, which means that temporary nurse aides would have had to comply with the requirements of the bill by July 2021. 

Three New CMS Rules That Providers Should Know

On November 2, 2021, the Centers for Medicare & Medicaid Services (“CMS”) released three final payment rules updating the annual payment rate for physicians, outpatient services, and home health services, among other significant policy changes. Each rule will have a significant impact on these three segments of the healthcare system and providers should be aware of how these changes will affect their practice and their payment rates and methodologies.

FTC Attempts to Tighten Leash on Mergers

Our August 5, 2021 Health Care Update focused on President Biden’s Executive Order that addressed consolidation in the United States and touched on the health care industry. Not much has been done since the President executed that Executive Order in July 2021.  Recently, however, on October 25, 2021, the Federal Trade Commission (“FTC”) released a statement announcing the rescission of the 1995 Policy Statement on Prior Approval and Notice Provision (the “1995 Statement”).

Biden Administration Releases Vaccine Mandates for Health Care and Private Sector Workers

The much anticipated vaccine mandates are finally here. On November 4, 2021, the Centers for Medicare and Medicaid Services (“CMS”) released an interim final rule requiring COVID‑19 vaccination for all healthcare workers within Medicare and Medicaid‑certified facilities. Eligible staff must receive the first dose of a two‑dose COVID‑19 vaccine or a one‑dose vaccine by December 5, 2021, and must be fully vaccinated by January 4, 2022. 

More Federal Regulations to Be Rescinded and More

Biden HHS Seeks to Repeal Multiple Trump Era Regulations

The Department of Health and Human Services (“HHS”) has proposed 86 FR 58042, which repeals two final rules promulgated by the Trump administration: “Department of Health and Human Services Good Guidance Practices,” published on December 7, 2020; and “Department of Health and Human Services Transparency and Fairness in Civil Administrative Enforcement Actions,” published on January 14, 2021.

Expense Ratio Requirements for Nursing Facilities and Other New Jersey Regulatory Developments

Adopted New Ratio Requirements for Nursing Facilities

On September 14, 2021, the Division of Medical Assistance and Health Services adopted new rules codified under N.J.A.C. 10:49A. N.J.A.C. 10:49A applies to nursing facility patient care ratio (“PCR”) requirements and establishes the expense ratio reporting and rebate requirements for nursing facilities that service Medicaid/NJ FamilyCare beneficiaries.