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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 Issues Final Regulations for Hospital Price Transparency

On November 15, 2019, the U.S. Department of Health and Human Services (HHS) Centers for Medicare and Medicaid Services (CMS) announced final regulations implementing greater price transparency requirements for hospitals. Issued on the heels of a Trump Administration Executive Order directing HHS to propose regulations on increased price transparency, the new regulations modify and finalize CMS’ earlier guidance implementing section 2718(e) of the Public Health Service Act, to further expand price transparency requirements for hospitals. (See our previous analysis of the Executive Order here.) Effective January 1, 2021, the …

DOJ Announces FCA Lawsuit Settlement with Spinal Device Manufacturer and Senior Executives for Alleged Kickbacks Paid to Surgeons

On November 7, 2019, the Department of Justice (DOJ) announced it had settled a False Claims Act (FCA) lawsuit against Life Spine, a spinal device manufacturer, and two of Life Spine’s senior executives. The settlement totaled $5.99 million and included various admissions of responsibility to settle allegations of kickbacks paid by Life Spine that the DOJ claimed were designed to induce surgeons to utilize Life Spine devices and submit claims to federal health programs for these improperly-induced utilizations in violation of the federal anti-kickback statute (AKS) and FCA. The settlement …

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 …

Massachusetts Board of Registration in Medicine Adds New Physician Credentials Verification Requirement for First Time Licensure

On October 11, 2019, the Massachusetts Board of Registration in Medicine (BORIM) announced a new requirement for initial physician licensure in the state. Effective January 1, 2020, all first-time applicants in Massachusetts will be required to also complete an application through the Federation Credentials Verification Service (FCVS). FRVS’s website indicates it is “a Lifetime Repository of Verified Core Credentials … that can be used for multiple state medical boards.” The new BORIM requirement will require first-time applicants to apply for a verified profile with FCVS that designates BORIM as …

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 …

New Connecticut Legislation Affecting Healthcare Providers and Entities Effective October 1, 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 “An Act Concerning the Use of Automatic External Defibrillators” (previous post available here).

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 …

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

“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 determination of the “standard for falsity [under the FCA] in the context of the Medicare …

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

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 care professionals a per-click or per-booking fee to be listed in the directory. The directory …

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

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.…

Massachusetts Board of Registration in Medicine Makes Significant Changes to Regulations Governing Licensure and Practice of Medicine

The Massachusetts Board of Registration in Medicine (BORM) recently approved significant changes to regulations governing the licensure and practice of medicine. The new regulations became effective on August 9, 2019. Physicians and health care organizations in Massachusetts would be well-advised to review the updated regulations closely – among the new provisions are regulations that potentially will affect current practices regarding the delegation of services to non-licensed individuals, procedures for obtaining informed consent, and other aspects of medical practice.…

Connecticut Expands Minors’ Confidential Access to Treatment for HIV and AIDS, Adds Reporting Requirement

On July 1, 2019, Connecticut Governor Ned Lamont signed into law Public Act No. 19-109 “An Act Concerning The Prevention Of The Human Immunodeficiency Virus” (PA 19-109) which increases access to preventative and prophylactic human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) interventions for minor patients, and adds two exceptions to the confidentiality requirements for HIV/AIDS treatment of a minor patient. The Act is effective July 1, 2019.…

Connecticut Empowers DSS to Expand Medicaid Coverage of Telehealth Services

On June 28, 2019, Connecticut Governor Ned Lamont signed into law Public Act No. 19-76 “An Act Expanding Medicaid Coverage of Telehealth Services” (PA 19-76).  PA 19-76 revises the criteria and process by which the Connecticut Department of Social Services (DSS) determines the telehealth services covered by the Medicaid program. PA 19-76 is effective July 1, 2019.…

Connecticut Revises Physician Assistant Statute to Clarify Collaborative Nature of Practice Relationship Between Physician Assistants and Physicians

On July 9, 2019, Connecticut Governor Ned Lamont signed into law Public Act 19-144, “An Act Concerning A Collaborative Relationship Between Physician Assistants And Physicians” (19-144). This legislation revises the statutory definition of a “physician assistant” (PA) under Connecticut law to provide that a PA functions in a “collaborative” relationship with a physician – not a “dependent” relationship – effective July 1, 2019.  The legislation retains the current requirement that a PA is also an individual licensed under Connecticut law “to provide patient services under the supervision, control, …

Connecticut Expands Scope of Practice for Advanced Practice Registered Nurses

Connecticut Governor Ned Lamont recently signed into law Public Act No. 19-98 “An Act Concerning The Scope Of Practice Of Advanced Practice Registered Nurses” (PA 19-98), which generally expands the scope of practice for Connecticut-licensed advanced practice registered nurses (APRNs). Among other things, PA 19-98 addresses matters related to medical records, emergency treatment, insurance coverage, and workers’ compensation, as further described below. PA 19-98 becomes effective October 1, 2019.…

DOJ Intervenes in FCA Suit Against Spinal Device Manufacturer and Senior Executives that Allegedly Paid Kickbacks to Surgeons

In a complaint filed on July 22, 2019, the U.S. Attorney’s Office for the Southern District of New York (DOJ) intervened in a qui tam False Claims Act (FCA) suit against Life Spine Inc. (Life Spine), and senior executives of Life Spine. DOJ alleges that the company – a maker of spinal implants, devices and equipment – offered and paid kickbacks in the form of consulting fees, royalties, and intellectual property acquisition fees to surgeons to induce the use of its products in violation of the Anti-Kickback Statute (AKS). DOJ …

Connecticut Legislature Modifies Public Health Statutes

On July 9, 2019, Connecticut Governor Ned Lamont signed into law Public Act No. 19-118 “An Act Concerning the Department of Public Health’s Recommendations for Various Revisions to the Public Health Statutes” (PA 19-118). Certain relevant provisions of PA 19-118 are described below.…

Rhode Island Removes Supervision Requirements for PAs in Favor of Expanded “Collaboration” Standard for PA Practice

On July 15, 2019, Rhode Island Governor Gina Raimondo signed into law “An Act Relating To Businesses and Professions – Physician Assistants” (H5572/S0443), which significantly revises the supervision requirements and expands certain aspects of the scope of practice for physician assistants (PAs) in Rhode Island, effective immediately. Among other things, the Act removes the current supervision requirements for PAs, changes the nature of the relationship between PAs and physicians to a “collaborative” arrangement, and removes the requirement that hospitals and other health care practices have written …

Connecticut Legislature Modifies Statutes Relevant to Preventing and Treating Opioid Use Disorder

On July 9, 2019, Connecticut Governor Ned Lamont signed into law Public Act No. 19-191 “An Act Addressing Opioid Use” (PA 19-191). PA 19-191 makes various revisions to Connecticut’s opioid use prevention and treatment statutes, and also creates new legislation pertaining to opioid use prevention and treatment. …

Connecticut Legislature Extends Immunity for Emergency Assistance by Health Care Professionals to Cover Malfunctioning Automatic External Defibrillators

On July 1, 2019, Connecticut Governor Ned Lamont signed into law Public Act No. 19-113 “An Act Concerning the Use of Automatic External Defibrillators” (PA 19-113). This law takes effect October 1, 2019.…

Connecticut Legislature Places Restrictions on the Use of the Title “Social Worker”

On July 9, 2019, Connecticut Governor Ned Lamont signed into law Public Act No. 19-164 “An Act Concerning Social Workers,” (PA 19-164) which sets forth new restrictions on individuals seeking to hold themselves out as social workers in the State. This law takes effect October 1, 2019.…

Connecticut Legislature Permits Facilities to Administer Emergency Medication to Defendants Without Consent in Limited Circumstances

On July 1, 2019, Connecticut Governor Ned Lamont signed into law Public Act No. 19-99 “An Act Concerning the Recommendations of the Department of Mental Health and Addiction Services Regarding Emergency Medication” (PA 19-99). PA 19-99 went into effect on the same date.

Existing law provides for certain court procedures a facility must follow in order to provide treatment without informed consent for psychiatric disabilities to defendant patients in the custody of the Department of Mental Health and Addiction Services. A facility includes any inpatient or outpatient hospital, clinic or …

Connecticut Enacts Law Modifying CME Requirements to Include Alzheimer’s Disease and Dementia Training

On July 1, 2019, Connecticut Governor Ned Lamont signed into law Public Act No. 19-115, “An Act Concerning Alzheimer’s Disease and Dementia Training and Best Practices” (PA 19-115). This legislation modifies the continuing medical education (CME) requirements for Connecticut-licensed physicians and the continuing education (CE) requirements for advanced practice registered nurses (APRNs).…

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