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The FCA Insider

Insights and updates on False Claims Act Litigation

Category Archives: CMS Guidance

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CMS Guidance, Damages

Federal Court Upholds CMS’ Use of Extrapolation to Claw-Back Improper Payments

A recent federal court decision should serve as an important reminder to providers that the Centers for Medicare and Medicaid Services (“CMS”) and its contractors have substantial authority to audit provider Medicare claims and to broadly apply extrapolation to calculate overpayments. In Palm Valley Health Care, Inc. v. Azar, No. 18-41067, 2020 BL 14097 (5th… Continue Reading
CMS Guidance, Regulatory

CMS Internal Memorandum Clarifies Impact of Supreme Court Decision on Enforcement Practices

The Deputy General Counsel and Chief Legal Officers at the U.S. Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) recently issued an Internal Memorandum clarifying that a recent Supreme Court ruling may limit HHS’s enforcement practices going forward. Consistent with the Court’s ruling, the Memorandum clarifies that subregulatory guidance… Continue Reading
CMS Guidance, Stark Law

HHS to Ease Fraud and Abuse Rules Part 5: CMS Proposes Value-Based Arrangement Stark Exceptions

As discussed in an Oct. 9 alert, the Department of Health and Human Services announced two proposed rules to significantly amend the Physician Self-Referral Law (Stark Law), the federal Anti-Kickback Statute and the Civil Monetary Penalties Law. This client alert, the fifth in McGuireWoods’ summary series on these proposed rules, focuses on the Centers for… Continue Reading
CMS Guidance

Changes to CMS’ Conditions of Participation Regulations for Providers Take Effect Nov. 29

Healthcare providers should begin finalizing plans to implement the Centers for Medicare and Medicaid Services’ Omnibus Burden Reductions (conditions of participation) final rule, which becomes effective Nov. 29, 2019. The final rule, issued Sept. 26, 2019, is intended to remove Medicare regulations, contained primarily in providers’ conditions of participation that CMS has identified as unnecessary,… Continue Reading
CMS Guidance, Stark Law

HHS to Ease Fraud and Abuse Rules Part 4: Proposed Revisions to the Stark Law

As discussed in a previous McGuireWoods alert, on Oct. 9, the Department of Health and Human Services announced two proposed rules to significantly amend the Physician Self-Referral Law (Stark Law), the federal Anti-Kickback Statute (AKS) and the Civil Monetary Penalties (CMP) Law. This client alert, the fourth in McGuireWoods’ summary series on these proposed rules,… Continue Reading
CMS Guidance, OIG, Regulatory, Stark Law

HHS to Ease Fraud and Abuse Rules Part 3: Flexibility for EHR Items and Services, Donated Cybersecurity Tech

As discussed in a previous McGuireWoods alert, on Oct. 9, the Department of Health and Human Services announced two proposed rules to significantly amend the Physician Self-Referral Law (Stark Law), the federal Anti-Kickback Statute (AKS) and the Civil Monetary Penalties Law. This client alert, the third in McGuireWoods’ summary series on these proposed rules, focuses… Continue Reading
Anti-Kickback Statute, CMS Guidance, Regulatory, Stark Law

HHS Proposed Rules Seek to Remove Stark Law, Anti-Kickback Burdens on Providers

On Oct. 9, the Department of Health and Human Services announced two proposed rules to significantly amend the Physician Self-Referral Law (Stark Law), the federal Anti-Kickback Statute (AKS) and the Civil Monetary Penalties (CMP) Law. The proposed rules intend to further incentivize value-based arrangements and patient care coordination by expressly permitting certain activities that could… Continue Reading
CMS Guidance

New CMS Guidance on Inpatient Engagement Necessary for Hospital Certification

On Sept. 6, 2017, the Centers for Medicare and Medicaid Services (CMS) issued an advanced copy of guidance to state survey agency directors that is intended to clarify how to determine whether a hospital seeking Medicare certification, or going through a continuing certification survey, is “primarily engaged in providing inpatient services” under the Social Security… Continue Reading
CMS Guidance

CMS Releases Data Regarding Hospital and Physician Utilization

CMS recently announced that it would be releasing Medicare hospital utilization and payment data, as well as physician and supplier utilization and payment data. This is the third year that the hospital data has been released and the second year that the physician data has been released. Acting CMS Administrator Andy Slavitt explained that “[t]hese… Continue Reading

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