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),…

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CMS Passes Final Rule Reducing Regulations Burdensome on Health Care Providers

Posted on October 7, 2019

The Centers for Medicare and Medicaid Services (CMS) is moving forward with its Patients over Paperwork initiative, which was created in accordance with President Trump’s Executive Order directing federal agencies to reduce burdensome regulations in order to improve the patient and provider experience, and the health care system as a whole. On September 26, 2019, CMS passed the Omnibus Burden Reduction (Conditions of Participation) Final Rule (Final Rule), with the goal of removing CMS regulations…

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New Connecticut Legislation Affecting Healthcare Providers and Entities Effective October 1, 2019

Posted on September 25, 2019

Multiple public acts from Connecticut’s 2019 legislative session go into effect on October 1, 2019. Below is a list of public health legislation effective October 1, with links to our previous posts summarizing the acts: Public Act No. 19-89 “An Act Concerning Nursing Home Staffing Levels” (previous post available here). Public Act No. 19-98 “An Act Concerning The Scope Of Practice Of Advanced Practice Registered Nurses” (previous post available here). Public Act No. 19-113…

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

By Leslie Levinson & Conor Duffy on September 24, 2019

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…

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Government Continues to Closely Scrutinize Pharmaceutical Marketing Practices

By Conor Duffy on September 18, 2019

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.…

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Eleventh Circuit Endorses Objective Falsehood Standard for False Claims Cases Concerning Physician Judgment of Hospice Eligibility

By Leslie Levinson, David Gilboa & Conor Duffy on September 17, 2019

“A mere difference of opinion between physicians, without more, is not enough to show falsity.” In a 3-0 decision issued September 9, 2019, the U.S. Court of Appeals for the Eleventh Circuit affirmed a three-year-old district court ruling in United States v. AseraCare, Inc. that a Medicare claim for hospice services cannot be deemed false under the False Claims Act (FCA) based on a difference in clinical judgment. This decision – apparently the first circuit-level…

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HHS Issues Favorable Advisory Opinion Permitting Community Health Center to Purchase Real Estate from an Excluded Individual

By Nathaniel Arden on September 17, 2019

On September 6, 2019, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) issued OIG Advisory Opinion No. 19-05 (Advisory Opinion) permitting a community health center (Requestor) to purchase real estate from a limited liability company (LLC) owned and managed by an individual excluded from participation in federal health care programs (Proposed Arrangement). The OIG indicated the Proposed Arrangement would not result in the imposition of sanctions under the civil…

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HHS Issues Favorable Advisory Opinion for Online Health Care Directory Charging Per-Click Fees

By Nathaniel Arden on September 17, 2019

On September 5, 2019, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) issued OIG Advisory Opinion 19-04 (Advisory Opinion). The Requestor asked OIG if providing an online health care provider directory (Directory) to federal health care program beneficiaries (beneficiaries) would violate the Anti-Kickback Statute (AKS) or constitute a prohibited Beneficiary Inducement. The online directory would allow beneficiaries to search and book medical appointments, and the Requestor would charge health…

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For First Time Ever, Government Brings HIPAA Enforcement Action Alleging Violations of Right to Access Medical Records

By Conor Duffy on September 10, 2019

On September 9, 2019, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced that it had settled its first ever HIPAA enforcement action arising from alleged violations of the individual right to access health information under HIPAA. OCR entered into a settlement with Bayfront Health St. Petersburg (Bayfront) in response to allegations that it failed to provide a mother with timely access to medical records concerning her unborn child. Under…

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Spurred by Opioid Crisis, Government Proposes Additional Changes to Substance Use Disorder Confidentiality Regulations to Facilitate Provision of Coordinated Care

By Conor Duffy on September 3, 2019

On August 26, 2019, the Department of Health and Human Services Substance Abuse and Mental Health Services Administration (SAMHSA) published a notice of proposed rulemaking (NPRM) to “better align” its substance use disorder (SUD) confidentiality regulations at 42 C.F.R. Part 2 (Part 2) with the needs of providers and patients, and to “facilitate the provision of well-coordinated care” for individuals with SUD.…

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Monitoring the Pulse of Health Care and Life Sciences

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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

CMS Passes Final Rule Reducing Regulations Burdensome on Health Care Providers

New Connecticut Legislation Affecting Healthcare Providers and Entities Effective October 1, 2019

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

Government Continues to Closely Scrutinize Pharmaceutical Marketing Practices

Eleventh Circuit Endorses Objective Falsehood Standard for False Claims Cases Concerning Physician Judgment of Hospice Eligibility

HHS Issues Favorable Advisory Opinion Permitting Community Health Center to Purchase Real Estate from an Excluded Individual

HHS Issues Favorable Advisory Opinion for Online Health Care Directory Charging Per-Click Fees

For First Time Ever, Government Brings HIPAA Enforcement Action Alleging Violations of Right to Access Medical Records

Spurred by Opioid Crisis, Government Proposes Additional Changes to Substance Use Disorder Confidentiality Regulations to Facilitate Provision of Coordinated Care

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