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Wachler & Associates Health Law Blog

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CMS Codifies Definition of “Reasonable and Necessary” in Medicare Coverage Determinations

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…

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Uncertainty Surrounding CARES Act Reimbursement for Out-of-Network COVID-19 Testing

In response to the COVID-19 pandemic, Congress has attempted to make COVID-19 testing free to individuals by requiring commercial insurers to cover testing. However, federal guidance and action by commercial insurers have muddied the waters and left clinical laboratories in an unenviable position. The Families First Coronavirus Response Act (FFCRA),…

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CMS Implements New Prior Authorization Changes

On January 15, 2021, the Centers for Medicare & Medicaid Services (CMS) finalized the agency’s “CMS Interoperability and Prior Authorization” rule to improve the prior authorization process and give patients more control in accessing and understanding their health data. Under the rule, certain payers, such as Medicaid and CHIP managed…

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CMS Finalizes Changes to Medicare Advantage and Part D Prescription Drug Programs

On January 15, 2021, the Centers for Medicare & Medicaid Services (CMS) finalized a rule to help strengthen and streamline the Medicare Advantage and Part D prescription drug programs, with the goal to decrease enrollee cost sharing on expensive prescription drugs. Effective for the 2022 plan year, enrollees will be…

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HHS Increases Fairness and Notice in Civil and Administrative Proceedings

On January 12, 2021, the Department of Health and Human Services (HHS) issued sweeping new directives regarding the procedures the Department will follow when relying on guidance documents, initiating enforcement actions, making jurisdictional determinations, and allowing prior notice and opportunity to be heard on agency determinations. These directives apply to…

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OCR and HHS Issue Guidance on Health Information Exchanges

On December 18, 2020, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) issued new guidance on the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The guidance addresses important questions related to the definition of a health information exchange (HIE), when…

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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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