On March 11, 2021, President Biden signed the $1.9 trillion American Rescue Plan, a legislative package to help fund vaccinations, provide immediate relief to families during the COVID-19 pandemic, increase COVID-19 testing and identify new and emerging strains of COVID-19. The final bill includes several sources of funding for COVID-19…
As part of the response to the COVID-19 pandemic, Congress provided funding for testing of patients without health insurance. To receive this reimbursement for testing, providers must attest that the patient is uninsured. However, it is not clear how providers must gather this information, exposing providers to risk of enforcement…
Targeted Probe and Educate (TPE) reviews are a popular audit tool for Medicare Administrative Contractors (MACs) to assess a healthcare provider or supplier’s compliance with Medicare billing requirements. A TPE review consists of up to three rounds of claims review, with education to the provider after each round. A provider…
On January 14, 2021, the Centers for Medicare & Medicaid Services (CMS) issued a final rule codifying a definition for “reasonable and necessary” coverage under Medicare Part A and Part B. CMS hopes codifying the meaning of “reasonable and necessary” will provide clarity and consistency to the current process of…
On Tuesday, December 1, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released the 2021 Physician Fee Schedule (PFS) final rule, confirming an expansion to telehealth coverage and the scope of non-physician providers. The use of telehealth services increased substantially during the COVID-19 public health emergency. Under the final…
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.…