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HHS Publishes Significant Updates to Anti-Kickback Statute Safe-Harbors and Beneficiary Inducement CMP Regulations

On November 30 and December 2, 2020, the Department of Health and Human Services Office of Inspector General (OIG) published two final rules (available here: November 30 Final Rule and December 2 Final Rule) which modify the safe harbor regulations to the federal Anti-Kickback Statute (AKS) and codify a new exception to the Civil Monetary Penalty (CMP) Rules related to beneficiary inducements. Most of the changes are effective January 19, 2021.

Together with the new physician self-referral law (also known as Stark) regulations published by the Centers for Medicare …

CMS Publishes Monumental Changes and Updates to the Physician Self-Referral (Stark) Law Regulations

On November 20, 2020, the Centers for Medicare and Medicaid Services (CMS) published its long-awaited and highly anticipated final rule updating regulations promulgated under the Physician Self-Referral or “Stark” law (the OIG simultaneously published updates to the Anti-Kickback Statute regulations). Among other things, CMS introduced new Stark exceptions for certain “value-based arrangements,” the donation of cybersecurity technology and services and limited remuneration to physicians; introduced new definitions and updated key terms, including “commercial reasonableness,” the “volume and value” standard and “fair market value”; and updated several existing exceptions, including …

Massachusetts Federal Court Declines to Apply State Medical Peer Review Privilege in Federal Whistleblower Case

On November 3, 2020, a Massachusetts Federal District Court issued a notable decision on the applicability of the state’s medical peer review privilege in a federal proceeding, determining that the privilege does not apply to documents requested in discovery as part of a qui tam False Claims Act (FCA) case. In United States ex rel. Wollman v. Massachusetts General Hospital, Inc. et al., Case Number 1:15-cv-11890-ADB, the court reviewed the purpose of the peer review privilege and precedent addressing the applicability of state privileges under the Federal Rules of …

Physician Self-Referral Law (Stark), Anti-Kickback Statute, and Beneficiary Inducement CMPs – HHS Releases Final Rules

On November 20, 2020, the Department of Health & Human Services (HHS) released heavily anticipated final rules revising the regulatory exceptions to the Physician Self-Referral Law (also known as the Stark Law), the Anti-Kickback Statute (AKS) safe harbors, and the Beneficiary Inducements Civil Monetary Penalties (CMP) regulations.  The changes to the regulations go into effect on January 19, 2021 (except for one change to the Physician Self-Referral Law that becomes effective January 1, 2022). In a separate rule also released November 20th, HHS removed safe harbor protection for rebates involving …

Government fraud alert for physicians: Watch out for speaker programs

Excerpt of a contributed article published in Medical Economics on November 18, 2020.

Past Special Fraud Alerts have portended heightened enforcement activity.

On November 16, 2020, the Office of Inspector General of the Department of Health & Human Services (OIG) issued a Special Fraud Alert (Alert) highlighting the fraud and abuse risks posed by speaker programs sponsored by pharmaceutical and medical device companies. The Alert appears to be a clear signal to health care professionals, as well as pharmaceutical and medical device companies, that the OIG will closely scrutinize remuneration …

The benefit of COVID-19 waivers to Stark Law, anti-kickback statute

Excerpt of a contributed article published in Medical Economics on November 3, 2020.

These waivers could lead to lasting flexibilities for physicians — if a few bad apples don’t spoil the bunch

On October 19, 2020, the Administrator of the Centers for Medicare & Medicaid Services (CMS) highlighted recent actions taken by the federal government to criminally charge, and revoke billing privileges of, health care providers nationwide for alleged involvement in fraudulent schemes. The recent crackdown resulted from coordination between the Department of Justice (DOJ), the Office of Inspector General …

CMS Extends Timeline for Finalizing Changes to Physician Self-Referral (Stark) Law Regulations to August 2021

On August 24, 2020, the Centers for Medicare & Medicaid Services (CMS) announced an “extension of the timeline” for publication of a final rule addressing changes to the Physician Self-Referral Law (or Stark Law) regulations.  In its announcement, CMS set a new deadline of August 31, 2021 for publication of a final rule.…

HHS Extends Compliance Deadline for Providers Receiving CARES Act Provider Relief Funds and Reminds Providers of June 3 Deadline Related to Additional Relief Fund Payments

On May 22, 2020 the U.S. Department of Health and Human Services (HHS) issued a 45-day extension of the deadline for providers who receive payments from the CARES Act Provider Relief Fund to accept the Terms and Conditions attached to such payments. Providers now have up to 90 days from the date a payment is received to accept the Terms and Conditions or return the funds to HHS.  In its announcement, HHS reiterated its prior position that “Providers that do not accept the Terms and Conditions after 90 days of …

CMS Issues Explanatory Guidance of Blanket Physician Self-Referral (Stark) Law Waivers for COVID-19 in Response to Industry Feedback

Amidst the cavalcade of regulatory and policy changes from federal and state governments intended to help health care providers confront the COVID-19 pandemic, on April 21, 2020 the Centers for Medicare & Medicaid Services (CMS) published “Explanatory Guidance” (Guidance) of the applicability of the blanket waivers of the federal Physician Self-Referral Law (PSR Law) CMS previously issued on March 30, 2020. See our analysis of the PSR Law blanket waivers here.…

OIG Will Not Impose Administrative Sanctions for AKS Violations for Conduct Covered by Certain Blanket Waivers of the Stark Law

On April 3, 2020 the Office of Inspector General (OIG) issued a Policy Statement to notify health care providers and other parties subject to the Anti-Kickback Statute (AKS) that the OIG will not impose administrative sanctions for potential AKS violations for COVID-19-related arrangements that are covered by some – but not all – of the Blanket Waivers of the Physician Self-Referral (Stark) Law issued on March 30 (see here for our analysis of the Blanket Waivers).…

CMS Issues Blanket Waivers of Physician Self Referral (Stark) Law Penalties to Support COVID-19 Response Efforts

On March 30th, the Centers for Medicare and Medicaid Services (CMS) issued blanket waivers (Blanket Waivers) of sanctions under the federal physician self-referral law (Stark Law) to relax regulatory requirements related to health care providers’ response to the COVID-19 pandemic. The Blanket Waivers were issued under the Department of Health and Human Services Secretary’s authority in Section 1135 of the Social Security Act to ensure that (i) sufficient health care items and services are available to federal health care program beneficiaries, and (ii)  health care providers are reimbursed for providing …

OIG Issues FAQs on its Policy for Waiver of Patient Cost Sharing Obligations for Telehealth During COVID-19 Public Health Emergency

On March 25, 2020, the Office of Inspector General, Health and Human Services (OIG) issued two frequently asked questions (FAQs), clarifying its March 17th Policy Statement Regarding Physicians and Other Practitioners That Reduce or Waive Amounts Owed by Federal Health Care Program Beneficiaries for Telehealth Services During the 2019 Novel Coronavirus (COVID-19) Outbreak (Policy Statement).…

Federal Government Significantly Expands Telehealth Reimbursement During COVID-19 Public Health Emergency

On March 17, the Trump Administration announced expanded reimbursement for clinicians providing telehealth services for Medicare beneficiaries during the COVID-19 Public Health Emergency. The Centers for Medicare and Medicaid Services (CMS) published an announcement, a fact sheet and Frequently Asked Questions.  To further facilitate telehealth services, the Office for Civil Rights (OCR) issued a notification describing certain technologies that would be permitted to be used for telehealth without being subject to penalties under the Health Insurance Portability and Accountability Act regulations (HIPAA). In addition, the Office of Inspector …

HHS Issues Section 1135 Waiver, and CMS Issues Blanket Waivers of Health Care Laws, in Response to Coronavirus (COVID-19) Emergency

Following the President’s proclamation on March 13 that the COVID-19 outbreak constitutes a national emergency, Secretary of the Department of Health and Human Services (HHS) Alex Azar issued a Waiver or Modification of Requirements Under Section 1135 of the Social Security Act (full text available here) that waives or modifies certain health care laws and regulations in connection with the COVID-19 pandemic.  This “1135 Waiver” applies nationwide and took effect on March 15 at 6:00 p.m., but its applicability is retroactive to March 1, 2020.  The 1135 Waiver applies …

DOJ Announces Settlement with EHR Company to Resolve Criminal and Civil Kickback Investigations Tied to Opioid Prescribing

On January 27, 2020, the Department of Justice (DOJ) announced a $145 million settlement with Practice Fusion Inc., an electronic health records (EHR) software company that resolves parallel criminal and civil investigations involving allegations of kickbacks, false claims, and non-compliance with federal EHR program requirements. We previously discussed a preliminary settlement in this case here, and in announcing the finalizing of that settlement the DOJ has shed more light on the allegedly improper conduct at issue. According to the DOJ, this is the first criminal action ever brought against …

DOJ Reaches Settlement with Patient Assistance Foundation Resolving Allegations of FCA Violations

On January 21, 2020, the Department of Justice (DOJ) announced a $3 million settlement with Patient Services, Inc. (PSI) to resolve allegations of False Claims Act (FCA) violations. The DOJ alleged that PSI enabled three pharmaceutical companies to pay kickbacks to patients by funneling money to patients taking drugs manufactured by those same pharmaceutical companies. In addition to the $3 million, PSI has entered into a three-year integrity agreement with Health and Human Services’s Office of the Inspector General. The settlement involved no determination of liability.…

DOJ Announces $26.67 Million Settlement with Laboratory to Resolve FCA Allegations

On November 26, 2019, the Department of Justice (DOJ) announced a $26.67 million settlement with a laboratory testing corporation, Boston Heart Diagnostics Corporation (Boston Heart). The settlement resolves allegations of False Claims Act (FCA) violations related to alleged payments for patient referrals in violation of the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (PSR Law) – commonly known as the Stark Law – and other improper billing.…

DOJ Announces Physician Self-Referral (Stark) Law Settlement in Excess of $46 Million with California Health System and Surgical Group

On November 15, 2019, the Department of Justice (DOJ) announced it had reached a settlement with Sutter Health (Sutter) and Sacramento Cardiovascular Surgeons Medical Group Inc. (Sac Cardio) to resolve alleged violations of the Physician Self-Referral Law (PSR Law), commonly known as the Stark Law. Sutter is a California-based health services provider; Sac Cardio is a Sacramento-based practice group of three cardiovascular surgeons. The total settlement in excess of $46 million includes $30.5 million from Sutter to resolve allegations of an improper financial relationship specific to compensation arrangements with Sac …

CMS Proposes to Newly Define Commercially Reasonable, and Tweak Definition of Fair Market Value, in New Physician Self-Referral Law (Stark Law) Regulations

On October 17, 2019, the Centers for Medicare & Medicaid Services (CMS) formally published its proposed rule (PSR Rule) to update exceptions to the Physician Self-Referral Law (PSR Law, also known as the Stark Law). For our initial overview of the PSR Rule (and of the Office of Inspector General’s corresponding proposal to update the Anti-Kickback Statute) see here. The PSR Rule contains a number of important proposals to update the PSR Law, including putting forward a definition of the term “commercially reasonable” and revising the definition …

CMS Proposes Rule Clarifying Physician Self-Referral Law Rules for Group Practice Profit Sharing

On October 9, 2019 the Department of Health and Human Services Centers for Medicare and Medicaid Services (CMS) published a proposed rule making changes to the Physician Self-Referral Law (PSR Rule), also called the Stark Law. Among other revisions to the PSR Rule, the proposed rule would modify the group practice special rule that allows physician profit sharing in certain circumstances. Under the proposed rule, the “overall profits” group practice physicians can share must be a combination of all designated health services (DHS) profits, not just the DHS profits from …

HHS Proposes Changes to Permit Donation of Cybersecurity Technology

On October 17, 2019, the Department of Health and Human Services (HHS) published proposed rules to update the regulatory Anti-Kickback Statute (AKS) safe-harbors and exceptions to the Physician Self-Referral (PSR) Law, known commonly as the Stark Law (AKS proposed rule available here; PSR proposed rule available here). In an earlier blog post, we described each of the proposed rules. Among the proposed changes are a new safe harbor/exception that would generally permit entities to donate certain cybersecurity technology and related services to physicians, subject to compliance with …

Government Releases Proposed Rules on Physician Self-Referral Law (Stark Law), Anti-Kickback Statute and CMP Law; Significant Regulatory Changes Intended to Encourage Care Coordination and Value-Based Care

On October 9, 2019, the Department of Health and Human Services (HHS) released its long-awaited proposals (the Proposed Rules) to update regulatory exceptions and safe harbors, for the federal Physician Self-Referral Law (also known as the Stark Law), the Anti-Kickback Statute (AKS), and the beneficiary inducement Civil Monetary Penalties Law (CMP). The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to update exceptions to the Physician Self-Referral Law (the PSR Rule), and the HHS Office of Inspector General (OIG) issued a proposed rule to update the …

DOJ Reaches $21.36 Million Agreement with Compounding Pharmacy, Two of its Executives, and Managing Private Equity Firm to Resolve FCA Allegations

On September 18, 2019, the Department of Justice (DOJ) announced a $21.36 million settlement with compounding pharmacy Patient Care America (PCA), as well as PCA’s Chief Executive, PCA’s former Vice President of Operations, and a private equity firm (PE Firm) that managed PCA on behalf of investors. The settlement resolves a False Claims Act (FCA) lawsuit alleging involvement in a kickback scheme designed to generate unnecessary referrals for prescription pain creams, scar creams, and vitamins reimbursed by TRICARE, the federal health care program for military members and their families. No …

Government Continues to Closely Scrutinize Pharmaceutical Marketing Practices

On September 4, 2019, the Department of Justice (DOJ) announced a $15.4 million settlement with pharmaceutical company Mallinckrodt ARD LLC (Mallinckrodt) to resolve alleged violations of the Anti-Kickback Statute (AKS) in two whistleblower suits filed under the False Claims Act (FCA). The settlement addresses allegations of AKS violations between 2009-2013 by sales representatives of a company later acquired by Mallinckrodt via the “wining and dining” of physicians to induce Medicare prescriptions of that company’s drug. Interestingly, the settlements do not cover related allegations within those FCA suits that Mallinckrodt improperly …

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