Articles and Blogs

Just three days before its effective date, the United States Court of Appeals for the District of Columbia affirmed the legality of the Department of Health and Human Services (“HHS”) price transparency rule requiring hospitals to publicly disclose the prices they charge for items and services, including their negotiated reimbursement rates with third-party payers... READ MORE

Following a Notice of Enforcement Discretion (“NED”) issued earlier this year (discussed in our previous article here), the Office for Civil Rights (“OCR”) has issued detailed guidance addressing the sharing of protected health information (“PHI”) through health information exchanges (“HIEs”) for public health activities of a public health authority (“PHA”). An HIE enables participants... READ MORE

On January 19, 2021, health care organizations nationwide will need to start complying with new regulations aimed at modernizing and streamlining key regulations under the federal Stark Law. The Centers for Medicare & Medicaid Services (“CMS”) announced the new regulations in a much-anticipated final rule (“Final Rule”) on November 20, 2020. As we noted... READ MORE

On December 22, 2020, Congress passed a government funding deal, which includes a long-awaited federal fix for “surprise billing.” Most of the new requirements take effect with plan years beginning January 1, 2022, and they apply to group health plans (including self-insured plans) and health insurance issuers of group and individual plans. The statute... READ MORE

On December 10, 2020, the Supreme Court of the United States (the “Supreme Court”) unanimously overturned an Eighth Circuit decision in the case of Rutledge v. Pharmaceutical Care Management Association. In the case, the Supreme Court held that an Arkansas law known as Act 900, which regulates the rates at which pharmacy benefit managers... READ MORE

As illustrated by two recent cases, there has been an uptick in Government enforcement action related to pharmaceutical manufacturer donations to patient assistance funds designed to assist patients with copay obligations. Earlier this month, the U.S. District Court for the District of Massachusetts denied Regeneron Pharmaceuticals’ motion to dismiss a lawsuit in which the... READ MORE

After weeks of negotiations, the Senate and House passed a legislative package combining a $900 billion COVID-19 relief bill with a $1.4 trillion omnibus bill. The massive 5,500+ page bill officially titled the Consolidated Appropriations Act, 2021 (the “Act”), passed both the Senate and House with overwhelming bipartisan support. President Trump is expected to... READ MORE

On December 2, 2020, CMS released final regulations (“Final Rule”) that permit increased expansion opportunities for certain physician-owned hospitals (“POHs”). CMS’s goal with these modifications was to remove unnecessary regulatory restrictions on high Medicaid physician-owned facilities. Background Under the Affordable Care Act’s amendments to the Stark Law, a POH cannot expand the aggregate number... READ MORE

Lawmakers in Washington have reached an agreement on a legislative package that will provide $900 billion in COVID-19 relief and approximately $1.4 trillion in government funding in 2021. Highlights of the health care-related provisions include $3 billion more for the Provider Relief Fund, suspension of the Medicare sequester for the first three months of... READ MORE

Following the recent Emergency Use Authorizations (“EUAs”) issued by the FDA for the Pfizer/BioNTech and Moderna COVID-19 vaccines, the Centers for Medicare & Medicaid Services (“CMS”) issued payment allowances and effective dates for vaccines, antibodies and their administration during the Public Health Emergency (“PHE”). Payment and effective date information can be found on the... READ MORE