On December 10, 2020, the Office of Civil Rights (“OCR”) at the Department of Health and Human Services (“HHS”) announced a proposal to modify the Health Insurance Portability and Accountability Act (“HIPAA”) Privacy Rule. The overarching goal of the proposed rule is to get patients more engaged in their own…
Despite a determination by the Department of Health and Human Services (“HHS”) that laboratory developed tests (“LDTs”) do not require premarket approval, the Food and Drug Administration (“FDA”) has asserted that the at-home collection kit portion of a COVID-19 LDT does require FDA pre-market approval. Testing by clinical laboratories is…
On December 2, 2020, The Centers for Medicare & Medicaid Services (CMS) released the 2021 Outpatient Prospective System (OPPS) Final Rule. The main goals of the rule are to (1) provide patients more choice in where they can receive affordable, quality health care, and (2) reduce their out-of-pocket costs. The…
On Tuesday, December 1, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released the final rule for the 2021 Medicare physician fee schedule. As part of the updated physician fee schedule, CMS changed quality reporting requirements to the Medicare Shared Savings Program—specifically with regards to telehealth services. In the…
On November 20, 2020, the Centers for Medicare & Medicaid Services (CMS) released the final rules amending the Stark Law and Anti-Kickback Statutes (AKS). Efforts to clarify these outdated laws began in 2018, with the goal to reduce regulatory obstacles for care coordination, following a general move toward value-based care.…
On November 16, 2020, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a special fraud alert targeting remuneration associated with speaking arrangements paid for by pharmaceutical and medical device companies. The alert addressed both honoraria paid to the speaking physician and benefits provided to…
On October 22, 2020, Michigan Governor Gretchen Whitmer signed legislation reducing the liability of businesses and governmental agencies as it relates to COVID-19 exposure. There were three Acts passed that dealt with responding to COVID-19 risks and liabilities, all three of which retroactively apply beginning March 1, 2020. Public Act…
On November 16, 2020, the Centers for Medicare & Medicaid Services (CMS) released its 2020 Estimated Improper Payment Rates. Under the 2019 Payment Integrity Act, CMS is required to review Medicare Fee-For-Service (FFS), Medicare Part C, Medicare Part D, Medicaid, and the Children’s Health Insurance Program (CHIP) and estimate the…
A change in the White House means changes to healthcare policy and changes to healthcare regulatory actions taken by the Department of Health and Human Services (“HHS”) and other federal agencies. Although a changing healthcare landscape, COVID-19 pandemic, and political wrangling are likely to alter the goals and actions of…
On November 9, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released the 2020 Medicaid and Children’s Health Insurance Program (“CHIP”) managed care final rule. The previous rule was released in 2016 and was extremely strict with its requirements, causing some states to struggle to comply. Since 2016, CMS’s…