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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

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 …

CMS Passes Final Rule Reducing Regulations Burdensome on Health Care Providers

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 that have become extraneous or burdensome on health care providers, allowing providers to increase and …

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).

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

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 monetary penalties law because no claims for reimbursement from federal programs would be sought by …

D.C. Circuit Court of Appeals Allows HHS Rule that Includes Payments Received from Third Parties in DSH Payment Cap Calculation

On August 13, 2019, the D.C. Circuit Court of Appeals (the D.C. Circuit) issued an opinion in Children’s Hospital Association of Texas v. Azar (No. 18-5135), allowing the Department of Health and Human Services (HHS) to include payments from third parties, including Medicare and private insurers, in calculations of Disproportionate Share Hospital (DSH) payment caps. The D.C. Circuit had previously ruled against HHS’ implementation of its 2017 rule, which included third-party payments in the calculation of the hospital-specific caps on allowable DSH payments. …

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.…

Allscripts Announces $145 Million Preliminary Settlement with DOJ Related to an Investigation of Practice Fusion, a Recently Acquired EHR Company

In its second quarter Securities Exchange Commission (SEC) filing, Allscripts addressed its announced agreement in principle with the Department of Justice (DOJ) to resolve investigations into certain alleged practices of Practice Fusion, an electronic health records (EHR) vendor acquired by Allscripts in February 2018 for $100 million. Allscripts indicated the agreement is still subject to further negotiation and government approval, and would likely include additional non-monetary terms, including a deferred prosecution agreement, if a finalized settlement is reached.…

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 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.…

Connecticut Codifies Nursing Home Daily Posting Requirements, Adds Requirement for Reinstatement after Retaliation

On July 1, 2019, Connecticut Governor Ned Lamont signed into law Public Act No. 19-89 “An Act Concerning Nursing Home Staffing Levels” (PA 19-89). PA 19-89 sets forth new state-level daily nurse staffing level disclosure requirements for nursing home facilities (including nursing homes and rest homes with nursing supervision as set forth in Conn. Gen. Stat. § 19a-521), authorizes the Department of Public Health (DPH) to take disciplinary action against or issue citations to nursing home facilities for non-compliance with nurse staffing requirements, and newly requires nursing home …

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 Enacts Budget that Includes Provisions Affecting Health Care Providers

Connecticut Governor Ned Lamont recently signed into law Public Act No. 19-117 (PA 19-117), which contains provisions affecting health care providers, including revisions to the hospital provider tax, a prohibition on non-compete agreements for home care workers and an expansion to Connecticut’s current surprise bill law. Highlights of PA 19-117, including the effective dates for each provision, are described below.…

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 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 …

White House Issues Executive Order to Increase Transparency in American Healthcare

On June 24, 2019, President Donald Trump issued an “Executive Order on Improving Price and Quality Transparency in American Healthcare to Put Patients First” (the Order). The Order requires multiple federal agencies to issue regulations and take other actions as part of an ongoing focus of the Trump Administration to “enhance the ability of patients to choose the healthcare that is best for them” through transparency and competition. The Order addresses the following five initiatives.…

New York Legislature Passes Bill Allowing Employees to Place a Lien on Employer’s Property for Wage Claims

The New York Senate and Assembly recently passed Senate Bill S2844B to strengthen current laws for employees who are victims of wage theft to secure and collect unpaid wages from their employers for work already performed. This bill would amend five sections of the law (Lien Law; Labor Law; Attachment under the Civil Practice Law and Rules; the Business Corporations Law; and the Limited Liability Law). If signed by the Governor, this bill would create a broad right for any employee to obtain a lien on an employer’s property based …

Eighth Circuit Affirms Preliminary Injunction Blocking Physician Practice Acquisition in North Dakota

On June 13, 2019, the U.S. Court of Appeals for the Eighth Circuit affirmed a preliminary injunction granted to the Federal Trade Commission (FTC) and North Dakota Attorney General (NDAG) blocking the proposed acquisition of Mid-Dakota Clinic, P.C. (MDC) – a multispecialty physician group in North Dakota – by Sanford Health, a large South Dakota-based health system (Sanford). This decision may foreclose continued pursuit of MDC by Sanford, and represents another success for the FTC in challenging health care consolidation (see our previous analysis of the granting of the injunction …

Connecticut Enacts Law to Increase Access to Epinephrine Auto Injectors

On June 13, 2019, Connecticut Governor Ned Lamont signed into law Public Act No. 19-19 “An Act Concerning Epinephrine Auto Injectors” (PA 19-19), which went into effect on the same date.

This legislation expands access to epinephrine, which can be lifesaving when treating anaphylactic allergic reactions. PA 19-19 permits “authorized entities” to acquire and maintain a supply of epinephrine cartridge injectors, subject to certain conditions. With a few exceptions, authorized entities are for-profit or nonprofit entities or organizations that employ at least one “person with training.” …

Supreme Court Rejects HHS Proposal that Could Have Significantly Lowered Certain Medicare DSH Payments to Hospitals

In a 7-1 decision released June 3, 2019, the U.S. Supreme Court vacated a proposal of the U.S. Department of Health and Human Services (HHS) that would have had the effect of significantly reducing Disproportionate Share Hospital (DSH) payments to thousands of hospitals for care furnished to low income patients in 2012.

In Azar v. Allina Health Services, Et Al., the Supreme Court held that HHS needed to comply with statutory notice and comment rulemaking procedures under the Social Security Act (Act) when making interpretive changes, because HHS sought …

U.S. Supreme Court Clarifies Scope of False Claims Act Statutes of Limitations

In a unanimous decision issued on May 13, 2019, the U.S. Supreme Court sought to resolve lingering confusion over the statute of limitations under the False Claims Act (FCA) for qui tam suits in which the federal government declines to intervene. In Cochise Consultancy, Inc. v. United States Ex Rel. Hunt, the Court held that a relator’s claim may be brought within 3 years after the government was made aware of underlying material claims, even where the government did not intervene in the case, because 10 years had not …

Seeking to Incentivize Self-Disclosures, DOJ Issues Guidance on Credit for Cooperation with FCA Investigations

On May 7, 2019, the U.S. Department of Justice (DOJ) provided important new guidance addressing cooperation credit that may be available to defendants in False Claims Act (FCA) investigations (Guidance).  The Guidance – issued in the form of an update to DOJ’s Justice Manual – explains how defendants in an FCA investigation may be awarded credit by DOJ for certain disclosures, cooperation, and remedial activities.

The Guidance is intended to incentivize companies and individuals to (i) be forthcoming with the government upon discovery of potential FCA violations, (ii) aid ongoing …

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