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OIG Tackles New Issues in Its General Compliance Program Guidance: What Companies Need to Know

On November 6, 2023, U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a General Compliance Program Guidance (GCPG) as part of its plan to renovate its library of compliance program...more

CMS Proposes a Novel Replacement for Rescinded Pathway to Expedited Reimbursement of Breakthrough Devices

In November 2021, the Centers for Medicare & Medicaid Services (CMS) rescinded a short-lived program to expedite national Medicare coverage for innovative devices amid safety concerns for Medicare patients. CMS has strived...more

Medicare Contractors Buy Additional Time for the Digital Health Industry

The explosive growth in telehealth over the past five years has resulted from, among other things, the Centers for Medicare & Medicaid Services’ (CMS) extension of Medicare reimbursement to remote monitoring of patients by...more

HHS OIG Announces Modernization of Compliance Program Guidance Documents

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) is continuing its long-laid plans to update its existing compliance program guidance documents (CPGs). On April 24, 2023, OIG...more

2022-2023 Medical Product and Service Regulatory Initiatives

The medical product and healthcare service industry is one of the most closely regulated sectors in the U.S. Several agencies actively exercise authority with constantly changing legislation and policies to keep pace with...more

DOJ Antitrust, OIG Announce Collaboration to Protect Healthcare Markets

On December 9, 2022, the Department of Justice Antitrust Division (DOJ) and the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) announced they are joining forces to protect...more

New Reimbursement Rules Will Likely Impact Digital Health and Telemedicine

On November 1, 2022, the Centers for Medicare & Medicaid Services (CMS) issued the 2023 Physician Fee Schedule (PFS) Final Rule. CMS publishes a PFS annually so as to make changes in federal healthcare reimbursement and...more

CMS Releases 2023 Proposed Medicare Physician Fee Schedule (PFS) Rule Announcing and Soliciting Comments on Planned Payment and...

On July 7, 2022, the Centers for Medicare & Medicaid Services (CMS) issued the 2023 Physician Fee Schedule (PFS) Proposed Rule. CMS publishes the PFS annually, informing healthcare providers about federal reimbursement and...more

Forecasting Healthcare Regulatory Developments in a Biden Administration

President Joe Biden was sworn into office on January 20, 2021. As with any incoming administration, new policies will be pursued while those of the previous administration are furthered, abandoned, or undone. The federal...more

OIG Turns up the Volume on Industry-Sponsored Speaker Programs

On November 16, 2020, the Office of Inspector General (OIG) issued a Special Fraud Alert (the Alert) regarding speaker programs hosted by pharmaceutical and medical device companies. Speaker programs are company-sponsored...more

CMS Proposes Basic Changes for Medicare Coverage, Including a New Reimbursement Pathway for FDA-designated Breakthrough Medical...

On August 31, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that, if finalized, would entail changes in Medicare coverage. (“Medicare Coverage of Innovative Technology (MCIT) and Definition...more

CMS Budgets an Extra Year for Updating Stark: Why Life Sciences Companies and Healthcare Providers Should Prepare for Big Changes

The Centers for Medicare & Medicaid Services (CMS) has pushed back its plan for issuing a final rule updating the Physician Self-Referral law (the "Stark Law") by one year to August 31, 2021. Ostensibly the rule, when...more

CMS Further Loosen Restrictions and Lighten Burdens on Providers During the COVID-19 Emergency

On April 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued new regulatory waivers and rule changes aimed at expanding access to care and allaying regulatory burdens on healthcare providers during the...more

CMS Issues Phase 1 Recommendations for Re-Opening Certain Healthcare Facilities

On April 19, 2020, the Centers for Medicare & Medicaid Services (CMS) issued Phase 1 of recommendations for re-opening certain healthcare facilities that provide non-emergent healthcare following COVID-19 related...more

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