House Bipartisan Act Would Amend Stark Law and Medicare Part B

By Melissa (Lisa) Thompson on Posted in Fraud and Abuse, Legislation, Medicare and Medicaid, Reimbursement, Stark Law, Telemedicine

On July 25, 2017, the U.S. House of Representatives passed by voice vote a bipartisan bill which is now in the Senate’s hands for consideration, the Medicare Part B Improvement Act of 2017. The bill would amend the Stark Law (Section 1877(h)(1) of the Social Security Act) and impact other provisions governing Medicare Part B.

The bill would amend the Stark Law:

  • to provide that the writing requirement for certain compensation arrangements may be satisfied by means determined by the HHS Secretary, including “a collection of documents, including contemporaneous documents evidencing the course of conduct between the parties;”
  • to include provisions for “indefinite” holdovers involving certain personal service arrangements and leases of office space or equipment; and
  • to provide for up to 90 days to obtain missing signatures in certain compensation arrangements that have become noncompliant.

These changes codify certain Stark Law changes previously made by the Centers for Medicare and Medicaid Services in the Medicare Physician Fee Schedule that took effect on January 1, 2016 (see related article here).  Continue Reading

OIG Settles EMTALA Allegations Involving Psychiatric Care

By Meaghan Mary Cooper and Guest Contributor on Posted in EMTALA, Government Enforcement, Hospitals and Health Systems

On June 2, 2017, AnMed Health and the Office of Inspector General (OIG) for the United States Department of Health and Human Services agreed to a $1.295 million settlement of allegations that AnMed had violated the Emergency Medical Treatment & Labor Act (EMTALA) (Section 1867 of the Social Security Act). The OIG alleged that AnMed failed to provide appropriate medical screening and stabilizing treatment to individuals presenting to the ED with unstable psychiatric emergency medical conditions. Continue Reading

Ninth Circuit Relies on Escobar to Revive False Claims Act Suit Against Pharmaceutical Manufacturer

By Conor Duffy on Posted in FDA, Fraud and Abuse, Government Enforcement, Life Sciences, Medicare and Medicaid, Pharmaceuticals and Biologics, Reimbursement

On July 7, 2017, the U.S. Court of Appeals for the Ninth Circuit reversed a federal district court’s dismissal of a False Claims Act (FCA) whistleblower suit in United States ex rel. Campie v. Gilead Sciences, explaining that the district court did not have “the benefit of” the Supreme Court’s 2016 decision in Escobar at the time the suit was dismissed for failure to state a claim under Federal Rule of Civil Procedure 12(b)(6). Continue Reading

Public Act 17-241 — An Act Concerning Fairness in Pharmacy and Pharmacy Benefits Manager Contracts

By Robinson+Cole's Health Law Group on Posted in Health Information Technology, Privacy and Security

Connecticut Governor Dannel P. Malloy recently signed into law Public Act 17-241 (PA 17-241), which contains provisions concerning facility fees, the sending and receiving of electronic health records between hospitals and health care providers, and restrictions on contractual provisions between health care providers and insurance companies.

We recently covered  PA 17-241 in our Health Law Pulse, it can be accessed here.

New OIG Advisory Opinion Allows Waiver of Cost Sharing in Research Studies

By Robinson+Cole's Health Law Group on Posted in Clinical Research, Fraud and Abuse, Medical Devices, Medicare and Medicaid, Office of Inspector General

The Office of Inspector General (OIG) recently issued Advisory Opinion 17-02, allowing waivers or reductions of cost-sharing amounts owed by financially needy Medicare beneficiaries in connection with certain clinical research studies conducted at a non-profit medical center.  In the advisory opinion, the OIG reiterated its longstanding concern about routine waivers of Medicare beneficiary cost-sharing amounts in the absence of financial hardship, and noted this can lead to liability under the anti-kickback statute (AKS).  The research studies were conducted utilizing protocols under the Medicare Coverage with Evidence Development (CED) framework and involved a wound care system used to treat chronic, non-healing wounds.

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Connecticut Enacts Legislation Intended to Curb Opioid Drug Abuse

By Robinson+Cole's Health Law Group on Posted in Connecticut Legislative Update 2017, Fraud and Abuse

On June 30, 2017, Connecticut Governor Dannel P. Malloy signed into law An Act Preventing Prescription Opioid Diversion and Abuse (Public Act No. 17-131). This legislation addresses opioid drug abuse in Connecticut by revising current laws related to controlled substance prescribing and disposal and enacting new laws regarding opioid abuse prevention and treatment.

We recently covered PA 17-131 in our Health Law Pulse, it can be accessed here.

Third Circuit Recognizes Escobar “Heightened Materiality Standard” in Dismissal of False Claims Act Case Tied to Avastin

By Conor Duffy on Posted in Clinical Research, Fraud and Abuse, Government Enforcement, Life Sciences, Medicare and Medicaid, Pharmaceuticals and Biologics, Physicians and Allied Health Professionals, Reimbursement

In May 2017, the U.S. Court of Appeals for the Third Circuit relied on the “heightened materiality standard” endorsed by the U.S. Supreme Court in its 2016 Escobar decision in dismissing a False Claims Act (FCA) whistleblower suit filed against pharmaceutical giant Genentech related to its billion dollar cancer drug Avastin. In Escobar, the Supreme Court upheld the validity—“at least in some circumstances”—of the “implied false certification” theory of FCA liability, and provided that this theory can attach where at least two conditions are met: a defendant must (1) make a specific representation on a claim for payment to the government, and (2) fail to disclose noncompliance with a material requirement for payment, which failure renders that representation a “misleading half-truth” (even if the representation is true on its face). Continue Reading

FTC Intervenes in Physician Practice Acquisition in North Dakota

By Conor Duffy on Posted in Antitrust, Government Enforcement, Hospitals and Health Systems, Reimbursement

On June 22, 2017 the Federal Trade Commission (FTC) filed an administrative complaint and a request for a preliminary injunction in federal court to block a proposed physician practice acquisition in North Dakota (the Transaction), the agency’s latest intervention in opposition to consolidation at the physician practice level. In this case, the FTC (accompanied by the Attorney General of North Dakota) opposes a proposed acquisition of Mid Dakota Clinic, P.C. (MDC) by Sanford Bismarck (a subsidiary of multi-state health system Sanford Health, collectively Sanford) on the grounds that the Transaction, if consummated, would represent an unfair method of competition in violation of Section 5 of the FTC Act (15 U.S.C. § 45) and may substantially lessen competition in violation of Section 7 of the Clayton Act (15 U.S.C. § 18). Continue Reading

The Joint Commission Releases Pain Assessment and Management Requirements

By Nathaniel Arden on Posted in Hospitals and Health Systems

The Joint Commission (TJC) recently released new and revised pain assessment and management standards and elements of performance for its hospital accreditation program. These standards, effective January 1, 2018, follow an extensive review by TJC of current pain assessment and management guidelines compared with TJC’s standards. Continue Reading

Supreme Court Decision Allows Faster Marketing of Biosimilars

By Pamela Del Negro on Posted in FDA, Life Sciences, Pharmaceuticals and Biologics

On Monday, June 12, 2017, the United States Supreme Court in a unanimous decision held that manufacturers making biosimilars of biologic drugs did not have to wait until after gaining federal approval of the biosimilar to notify the manufacturer of biologic reference products (Sponsor) that they intend to commercially market a biosimilar drug. The Court’s decision addresses two cases in the same opinion: Sandoz v. Amgen and Amgen v. Sandoz.  Continue Reading

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