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HHS Limits Use of Guidance Documents in Civil Enforcement Actions and Issues First Good Guidance Practices Petition Response

On January 14, 2021, the Department of Health and Human Services (“HHS”) published the Transparency and Fairness in Civil Administrative Enforcement Actions final rule (“Rule”). The Rule amends and supplements the HHS Good...more

CMS Proposes to Expand the Scope of Medicare Coverage Determinations

On September 1, 2020, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule that would, for the first time, establish formal criteria to define the “reasonable and necessary” standard for Medicare...more

Supreme Court Rules That Providers and Suppliers Cannot Challenge Medicaid Reimbursement Rates in Federal Court

On March 31, 2015, a 5-4 plurality of the Supreme Court of the United States ruled that Medicaid providers do not have a private right of action under the Medicaid statute to challenge reimbursement rates. The Supreme Court’s...more

CMS Publishes Additional (but Limited) Guidance on the Coverage with Evidence Development Process

On November 20, 2014, the Centers for Medicare and Medicaid Services (“CMS”) published its latest round of guidance on its Coverage with Evidence Development (“CED”) policy for selected items and services under the Medicare...more

D.C. Circuit Requires Greater Disclosure of Changes in Medicare Regulations

The rulemaking process often accommodates a variety of interests, including the preference of regulatory agencies to maintain some flexibility and the rights of interested parties to participate in the regulatory process. On...more

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