Albert Shay on Health Care Providers

Tick-Tock: CMS Overpayment Refund Final Rule and Practical Implications

The Centers for Medicare & Medicaid Services issued its long-anticipated final rule clarifying the 60-day overpayment refund obligation (the 60-Day Rule) first established in a 2016 regulation for Medicare Part A and B...more

12/23/2024 / Centers for Medicare & Medicaid Services (CMS) , False Claims Act (FCA) , Final Rules , Health Care Providers , Medicare Part A , Medicare Part B , Overpayment

CMS Proposes Additional Revisions to the 60-Day Rule

The Centers for Medicare & Medicaid Services has issued its Calendar Year 2025 Medicare Physician Fee Schedule Proposed Rule, scheduled for publication in the Federal Register on July 31, 2024. In response to industry...more

7/25/2024 / Centers for Medicare & Medicaid Services (CMS) , Health Care Providers , Medicare , Physician Fee Schedule , Physicians

OIG Approves Consultant’s Provision of Gift Cards to Physician Practices

The US Department of Health and Human Services Office of Inspector General (OIG) published favorable Advisory Opinion No. 23-15 on January 3, which concluded that a consultant’s proposal to provide gift cards to existing...more

1/19/2024 / Anti-Kickback Statute , Client Referrals , Department of Health and Human Services (HHS) , Gift-Cards , Health Care Providers , Medicare , OIG , Physicians

Medicaid Unwinding: CMS to Withhold Federal Medicaid Funding from Noncompliant States

Since our publication on disenrollments caused by the “unwinding” of Medicaid’s continuous enrollment condition, the Centers for Medicare and Medicaid Services (CMS) issued an interim final rule on December 6, 2023...more

12/20/2023 / Centers for Medicare & Medicaid Services (CMS) , Health Care Providers , Interim Final Rules (IFR) , Medicaid

OIG Approves Net Profit–Based Bonuses for Employed Physicians

The US Department of Health and Human Services Office of Inspector General (OIG) recently released Advisory Opinion No. 23-07, in which OIG approved a proposed arrangement to pay employed physicians bonuses based on net...more

10/27/2023 / Ambulatory Surgery Centers , Anti-Kickback Statute , Health Care Providers , OIG , Physicians

OIG Rejects the Formation and Operation of Surgeon-Owned IONM Businesses

The US Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently evaluated the risks associated with certain intraoperative neuromonitoring (IONM) services arrangements in its release of...more

8/30/2023 / Ambulatory Surgery Centers , Anti-Kickback Statute , Department of Health and Human Services (HHS) , Health Care Providers , Hospitals , OIG

End of the PHE: Preparing for Return to Normal for Stark Law and Anti-Kickback Statute

Concurrent with the termination of the COVID-19 Public Health Emergency, various regulatory flexibilities will also come to an end, including the blanket waivers to the Stark Law and related enforcement discretion under the...more

4/14/2023 / Anti-Kickback Statute , Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Health Care Providers , OIG , Public Health Emergency , Stark Law

CMS Proposes Small but Significant Change to 60-Day Overpayment Refund Rule

In a proposed rule issued on December 27, 2022 to make technical changes to the Medicare Advantage Program, the Centers for Medicare and Medicaid Services (CMS) buried in the regulatory arcana a material legal change to the...more

1/18/2023 / Centers for Medicare & Medicaid Services (CMS) , False Claims Act (FCA) , Health Care Providers , Medicare Advantage , Medicare Part A , Medicare Part B , Prescription Drugs

CMS Releases Physician Fee Schedule Proposed Rule, Continuing Emphasis on Equity and Value-Based Care

The Centers for Medicare & Medicaid Services on July 7 released its proposed rule for the Medicare physician fee schedule for Calendar Year 2023. Among other updates, the proposed rule contains significant programmatic...more

7/12/2022 / Centers for Medicare & Medicaid Services (CMS) , Health Care Providers , Medicare , Medicare Shared Savings Program , Physician Fee Schedule , Physicians , Proposed Rules

HHS Regulatory Sprint Crosses the Finish Line: New Stark and Anti-Kickback Rules Forecast Big Changes for Patients and Value-Based...

Powerfully illustrating the efforts of the US Department of Health and Human Services (HHS) to transform the US healthcare system to a value-based model, the Office of the Inspector General (OIG) and the Centers for Medicare...more

11/25/2020 / Anti-Kickback Statute , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Fraud and Abuse , Health Care Providers , Healthcare Fraud , Healthcare Reform , OIG , Rulemaking Process , Safe Harbors , Stark Law , Value-Based Care

CMS and OIG Offer Additional Details on Blanket Waivers and AKS Policy Statement

The Centers for Medicare & Medicaid Services and the US Department of Health and Human Services Office of Inspector General have provided additional guidance and clarification on the application of Stark Law blanket waivers...more

5/19/2020 / Anti-Kickback Statute , Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Health Care Providers , OIG , Stark Law , Waivers

Stark Law and Anti-Kickback Statute Enforcement: For HHS, It’s Not Business as Usual

The US Department of Health and Human Services recently announced the use of blanket waivers for healthcare providers under the Stark Law, and its Office of Inspector General noted it will exercise enforcement discretion in...more

4/16/2020 / Anti-Kickback Statute , Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Health Care Providers , Physicians , Relief Measures , Stark Law , Waivers

CMS Publishes Six Proposed Medicare Payment Rules: What It All Means

Key themes emerging from the hundreds of pages of proposed Medicare payment and policy rules impacting hospitals and post-acute providers include encouraging price transparency, promoting exchange of healthcare data, and...more

5/14/2018 / Centers for Medicare & Medicaid Services (CMS) , Health Care Providers , Hospitals , Inpatient Prospective Payment System (IPPS) , Medicare

Hurricane Recovery Client Alert: Regulatory Relief for Healthcare Providers in Disaster Areas

Hurricanes Harvey and Irma have led to the declaration of a public health emergency in various affected areas across the country. As healthcare providers continue to provide essential disaster response operations, CMS and HHS...more

9/11/2017 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , EMTALA , FEMA , Health Care Providers , Health Insurance Portability and Accountability Act (HIPAA) , Hospitals , Hurricane Harvey , Hurricane Irma

Senate Finance Committee Examines Repeal of the Stark Law

A new report suggests that the Stark law is obsolete in new payment models. On June 30, the US Senate Committee on Finance (the Committee) released the report Why Stark, Why Now? Suggestions to Improve the Stark Law to...more

7/7/2016 / Affordable Care Act , AHLA , Alternative Payment Models (APM) , Anti-Kickback Statute , Civil Monetary Penalty , False Claims Act (FCA) , Fraud Abuse and Waste , Health Care Providers , Legislative Agendas , Medicare , Medicare Access and CHIP Reauthorization (MACRA) , Physicians , Repeal , Stark Law

New Budget Bill May Signal End of Provider-Based Status

Hospitals that seek to establish provider-based OPDs should complete their work soon. A near-final discussion draft of a House budget bill, which the White House has apparently agreed to in principle, would end the...more

10/29/2015 / Billing , Drug Pricing , Federal Budget , Health Care Providers , Healthcare , Hospitals , Pending Legislation , Section 340B

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