Hospitals & Health Systems

I previously said that the year 2014 may be a game-changer for the 340B Drug Discount Program. Increasing HRSA audits, a lawsuit over the 340B Orphan Drug Rule, and HRSA’s promise to issue a 340B mega-regulation, all pointed to major changes in how the 340B Program operates.  However, the HRSA audits had limited effect, the court invalidated the Orphan Drug Rule, and the reverberations of the Orphan Drug litigation killed the 340B mega-regulation.

January 2018 began with a new 340B reimbursement rule and new litigation over that rule posing a very real threat to how hospitals use 340B drugs.  Then Congress issued a formal Report on legislative and regulatory modifications needed in the 340B Program.  Will 2018 finally be the game-changing year for 340B? Continue Reading This Year May be a Game Changer for 340B Drug Discount Program, Take Two

The Department of Health and Human Services Office of the Inspector General (OIG) has issued an Advisory Opinion (Opinion) in connection with a hospital’s gainsharing arrangement (Arrangement) with a designated group of neurosurgeons who perform spinal fusion surgeries at the hospital. According to the Opinion, the OIG would not impose sanctions because the Arrangement, when viewed in its entirety, is not designed or likely to induce the neurosurgeons to (i) reduce or limit medically necessary services to their Medicare or Medicaid patients, or (ii) increase referrals to the hospital. This Opinion is the latest in a line of earlier advisory opinions to “bless” gainsharing arrangements that meet certain criteria for minimizing the risk of fraud and abuse. Continue Reading OIG Reaffirms Permissibility of Certain Gainsharing Arrangements

In both civil and criminal enforcement proceedings, 2017 was perhaps most notable for the cases brought against individual health care providers and small physician practice owners.  Among the factors that may have resulted in the uptick in cases against individuals are the Yates Memo issued in late 2015, improved and increased reliance on sophisticated data analytics, and the aggressive focus on opioid addiction and its causes. Continue Reading Health Care Enforcement Review and 2018 Outlook: Criminal and Civil Enforcement Trends

In this post, I will be focusing on the intersection of off-label communications with government enforcement of health care fraud through the False Claims Act. Over the past eight years, the U.S. Department of Justice (“DOJ”) has been particularly aggressive in using the False Claims Act to pursue recoveries from individuals, health care providers, and drug manufacturers that participate in federal health benefit programs. In fact, from 2009 to 2016, DOJ collected $19.3 billion from health care False Claims Act settlements and judgments, with $2.5 billion recovered in fiscal year 2016, alone. (More DOJ false claims statistics can be found here.) DOJ’s enforcement efforts are not solely targeted against garden variety billing fraud, but also involve claims arising from alleged violations of health care regulatory requirements. Among other things, the DOJ has been targeting claims for reimbursement for off-label uses of regulated products. DOJ’s aggressive policy of holding manufacturers accountable for off-label claims under the False Claims Act is entirely consistent with FDA’s stance on off-label communications as described in the January memo. However, recent court interpretations of off-label communications as protected First Amendment speech, as well as interpretations of the causality component of False Claims Act claims, have apparently caused DOJ to reconsider its strategy with respect to such cases. Continue Reading The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 5

As a part of our ongoing blog series we have provided details on the structure, funding, and outlook of several expiring health care provisions, that we’ve referred to as the health care minibus. The minibus includes all of the health care extenders left behind from the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Health care extenders refer to a number of temporary policies that need reauthorization or annual appropriations, including but not limited to, the Children’s Health Insurance Program (CHIP), the Maternal, Infant, and Early Childhood Home Visiting (MIECHV) program, community health center funding, therapy caps, special needs plans (SNPs), and Medicaid disproportionate share hospital (DSH) payment reductions.

In this post we will discuss Medicaid DSH funding cuts and recent activity to address such cuts. Continue Reading Disproportionate Share Hospital Payments: A Minibus Rider

Correction: An earlier version of this post incorrectly noted that the American Medical Association opposed the rule. The post has been updated to include the AMA’s full statement expressing support for proposed rule. [October 10, 2017]

The U.S. Department of Veterans Affairs (“VA”) is taking a significant step towards expanding needed services to Veterans by proposing a rule to preempt state restrictions on telehealth.

Most states currently restrict providers (including VA employees) from treating patients that are located in that state if the provider is not licensed there. As a result, the VA has had difficulty getting a sufficient number of providers to furnish services via telemedicine for fear that they will face discipline from those states for the unlicensed practice of medicine. Continue Reading Department of Veterans Affairs Aims to Trump State Telemedicine Rules

A New Jersey Supreme Court case earlier this summer has New Jersey lawyers re-examining their clients’ business structures under the State’s corporate practice of medicine doctrine.

Many states prohibit the corporate practice of medicine (“CPOM”) in order to prevent or limit a lay person from interfering with a physician’s independent medical judgment. In New Jersey, for example, the State Board of Medical Examiners’ regulations prohibit a licensee with a more limited scope of practice (e.g., physical therapists, chiropractors, nurse practitioners, etc.) from employing physicians.

In Allstate Ins. Co. v. Northfield Med. Ctr., P.C., 2017 BL 148804 (N.J. May 4, 2017), the New Jersey Supreme Court  ruled that a chiropractor (and his attorney that advised on the structure) may have violated the Insurance Fraud Prevention Act because, under the structure,  a chiropractor could terminate a physician’s employment at any time and had more control over the practice’s profits than the physician (who is required to own a majority interest of the practice in New Jersey).  Thus, the court ruled that the medical practice was controlled by the chiropractor instead of the physician in violation of the New Jersey CPOM prohibition.

Submitting claims while a practice is structured in violation of the CPOM doctrine can lead to insurers recouping payments as false claims. Individual physicians, corporations, and attorneys can also face disciplinary action for their involvement in setting up or operating the fraudulent entity.

It is important that the organizational documents are set up to give the physician control over the practice, but this control should be exercised in reality and not just on paper. Physicians often have managers run many of the business aspects of the practice, but the physician should have the final say with respect to the medical and financial decisions of the practice and the hiring and firing of professionals.  Courts may look past the face of the documents to see who is really calling the shots on a daily basis.

While this recent case is spurring attorneys to evaluate their clients’ structures in New Jersey, this is a good reminder to take a fresh look at CPOM restrictions in other states as well.  Make sure your structure works at the outset and re-examine every so often to adapt with evolving laws and court interpretations of such laws.

On September 19, 2017, the Tennessee Department of Health (“TDOH”) granted the request for a Certificate of Public Advantage (“COPA”) from Wellmont Health System and Mountain States Health Alliance.  This approval paves the way for the two entities to form a single corporate entity called Ballad Health.  According to the TDOH, both health systems “agreed through the legislative process to meet a clear and convincing standard that their merger would create a public benefit to the residents of Northeast Tennessee that would outweigh any downsides of a monopoly of services.”  Notably, the Department observed that a Terms of Certification document accompanying the approval “includes how active supervision by the state of the new entity will look.”  This fact is important because the Federal Trade Commission (“FTC”), which is not a fan of COPA regulations, has made clear that it will closely analyze and challenge defenses based on asserted state action immunity where the state fails to provide adequate active supervision.
Continue Reading Tennessee Department of Health Grants COPA Request for Health Care Alliance

On Monday, September 11, our colleagues in the Antitrust Section published an alert describing a developing antitrust lawsuit against Franciscan Health System (“CHI Fanciscan”): State of Washington v. Franciscan Health System, et al. No. 3:17-cv-05690 (W.D. Wash. Aug. 31, 2017). The Washington State Attorney General’s office accuses CHI Franciscan of accumulating a controlling share of the “Orthopedic Physician Services” market through incremental acquisition which has led to substantial lessening of competition and illegal price fixing, in violation of Section 7 of the Clayton Act and Section 1 of the Sherman Act, respectively, as well as Washington State antitrust laws.

The alert cautions that health care provider acquisition strategies may come under antitrust scrutiny, even when acquisitions target multiple small physician practices, if the cumulative effect of such acquisitions results in substantial condensation of market share in a particular area of health care services.

For greater insight on this issue, read the full alert here.

Last week, a number of health care industry associations sent letters to Congress detailing ways in which the government could relieve them of the burdens associated with “red tape.” The letters are in response to the first stage of a House initiative dubbed the “Medicare Red Tape Relief Project,” which was announced earlier this summer by the House Committee on Ways and Means’ Subcommittee on Health.  Continue Reading Hospitals and Others Respond to “Red Tape Relief Project” Requests