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Wachler & Associates Health Law Blog

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HHS Expands Settlement Conference Facilitation

The Department of Health and Human Services (HHS) recently announced the annual expansion of the Settlement Conference Facilitation (SCF) program. SCF is an alternate dispute resolution mechanism used to resolve Medicare claims appeals. However, because SCF is meant to help reduce the appeal backlog, only appeals filed before a certain…

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Allegations Show Pitfalls of AKS Compliance

The Department of Justice (DOJ) recently announced a plea agreement regarding an alleged $73 million scheme to defraud Medicare that illustrates some of the pitfalls of compliance with the Anti-Kickback Statute (AKS). DOJ alleged that the owners of a clinical laboratory, Panda Conservation Group, LLC, and a telemedicine company, 1523…

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HHS Announces Another $25.5 Billion in COVID-19 Provider Funding, Grace Period for Provider Relief Fund

On September 10, 2021, the U.S. Department of Health and Human Services (HHS) announced that it would make $25.5 billion in new funding available for healthcare providers affected by the COVID-19 pandemic. This funding includes allocations of $8.5 billion in funding from the American Rescue Plan (ARP) for providers who…

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CMS Proposes to Expand Its Authority to Revoke Medicare Billing Privileges

As part of the 2022 Medicare Physician Fee Schedule Proposed Rule, the Centers for Medicare & Medicaid Services (CMS) has proposed to significantly expand its authority to deny or revoke a provider’s or supplier’s Medicare billing privileges. First, CMS proposed to modify the conditions that it considers when determining whether…

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Implications if Medicare Expands to Cover Dental Services

Significant changes could be coming to dentistry if dental benefits are added to Medicare. A proposal, currently before Congress as part of a large budget bill, would do just that. If this proposal becomes law and Medicare begins to cover dental benefits, it would likely have major implications on the…

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HHS Expands Its Capability to Audit the Provider Relief Fund

Demonstrating its commitment to audit Provider Relief Fund (PRF) recipients, the Department of Health and Human Services (HHS) has hired several outside contractors to provide audit or program integrity services relating to the PRF. The PRF is a $175 billion fund created by Congress through the CARES Act and administered…

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Biden Administration Proposes to Rescind “Most Favored Nation” Drug Rule

The Biden Administration is planning to rescind the “Most Favored Nation” rule, which would have employed a model that required Medicare to pay no more for certain drugs than the price paid for those drugs by other developed nations. On September 13, 2020, former President Trump signed an executive order…

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Audits Growing More Burdensome on Pharmacies

According to data from the Pharmacy Audit Assistance Service (PAAS) National, the Covid-19 Public Health Emergency (PHE) has negatively affected pharmacies navigating audits by Pharmacy Benefit Managers (PBM). PBMs are companies who are primarily responsible for developing and maintaining drug formularies, contracting with pharmacies, negotiating discounts and rebates with drug…

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CMS Relaunches TPE Audit Program After Public Health Emergency Pause

The August 12, 2021 issue of the Medical Learning Network (MLN) Connects newsletter indicates that CMS is planning to resume the Targeted Probe and Educate (TPE) audit program. CMS temporarily suspended pre-payment reviews under the TPE program in response to the Covid-19 public health emergency (PHE) in March 2020. While…

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Updated 2021 PhRMA Code Echoes HHS OIG Guidance on Speaker Programs

The Pharmaceutical Research and Manufacturers of America (PhRMA) issued an updated August 2021 Code on Interaction with Health Care Professionals, which takes effect January 1, 2022. Section 7 of the PhRMA Code’s guidance on speaker programs largely echoes a Special Fraud Alert regarding health care speaker programs which was issued…

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