Articles and Blogs

On August 25, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released an Interim Final Rule with comment period (“Rule”) with new requirements and enforcement for Medicare and Medicaid Programs, Clinical Laboratory Improvement Amendments (“CLIA”) and Patient Protection and Affordable Care Act, as well as additional policy and regulatory revisions in response to the…Read More

On August 25, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released over 200 pages of interim final regulations (the “Interim Final Regulations”) to clarify new enforcement requirements for nursing homes, add requirements for labs to report COVID-19 test results during the public health emergency and require nursing homes to test residents and staff…Read More

Mergers and acquisitions in the health care industry present unique challenges that are not often present when undertaking similar transactions in other industries. Because of health care’s highly regulated nature, parties may falter if a health care transaction is not reviewed and negotiated carefully with respect to the distinct concerns that health care presents. This…Read More

On August 17, 2020, just one day before a Health and Human Services (“HHS”) Patient Protection and Affordable Care Act (“ACA”) rule retracting discrimination protections for transgender people and pregnant women (“2020 Rule”)[1] was set to go into effect, Judge Frederic Block of the U.S. District Court in the Eastern District of New York issued…Read More

As the health care system moves from volume-based to value-based care models, the industry is eager to modify federal laws and regulations to enhance patient-centered collaboration. HHS, CMS and OIG have been considering changes to the Stark Law and Anti-Kickback Statute regulations for several years now and finally came out with the proposed rules in…Read More

The Department of Health and Human Services (“HHS”) proposed a rule that would require HHS components to inform the public when issuing a “guidance document” and to clarify the document’s legal impact. The new procedures also create a process for “any interested party” to petition HHS to review guidance documents that go too far in…Read More

Last week, the D.C. Circuit Court of Appeals (the “Court”) reinstated a rule cutting reimbursement rates for drugs purchased at a substantial discount under Section 340B of the Public Health Service Act (the “340B Program”) that had previously been ruled unenforceable by the District Court. In American Hospital Association v. Azar,[1] the Court held that…Read More