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Wachler & Associates Health Law Blog

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Michigan to Distribute COVID-19 Vaccine to Skilled Nursing Home Facilities through the Pharmacy Partnership for Long-term Care Program

On December 28, 2020, the Michigan Department of Health and Human Services (MDHHS) announced that skilled nursing home residents and staff members would begin to receive the Moderna COVID-19 vaccine immediately. This effort is made possible by the state of Michigan’s participation in the Pharmacy Partnership for Long-term Care (LTC)…

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CMS Releases New Measures Under Consideration Focusing on Increasing Data Innovation and Reducing Provider Burden

On December 22, 2020, Centers for Medicare & Medicaid Services (CMS) released the 2020 list of Measures Under Consideration (MUC). The MUC is a list of quality and efficiency measures, based on data collected from providers, under consideration for adoption as rules under Medicare. The 2020 measures focus on reducing…

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Michigan Releases New COVID-19 Tools to Reduce Exposure and Risk

The Michigan Department of Health and Human Services (MDHHS) has released two new tools to help reduce COVID-19 infections, deaths, and identify exposure risks, amidst the COVID-19 pandemic. The MI COVID Alert App is a free, anonymous app that alerts users if they have had a recent COVID-19 exposure. In…

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HHS Increases Phase 3 of Provider Relief Fund and Will Begin Distribution

On December 16, 2020, the Department of Health and Human Services (“HHS”) announced that it would begin Phase 3 of general distributions under the Provider Relief Fund (“PRF”) and that Phase 3 would be larger than initially planned. The PRF is a $175 billion fund created Congress through the CARES…

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CMS Expands Telehealth Services and Flexibility for Non-Physician Providers

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…

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HHS Proposes HIPAA Modifications to Better Serve Patients

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…

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FDA Asserts Authority Over At-Home Collection Kits for COVID-19 LDTs

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…

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CMS Finalizes 2021 OPPS Rule, Officially Phasing Out the Inpatient Only List

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…

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Final Rule for Medicare Physician Fee Schedule

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…

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CMS Releases Finalized Stark and Anti-Kickback Rules

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.…

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