On the eve of trial, and after years of litigation (including an appeal to the Sixth Circuit), all claims by Dayton, Ohio hospital The Medical Center at Elizabeth Place (“MCEP”) against Premier Health Partners (“Premier”) have been dismissed with prejudice. This case represents an important development in the body of case law addressing the antitrust risk introduced by joint ventures.  Continue Reading District Court Finds Hospital’s Joint Venture Not “Per Se” Unlawful

Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent trends in FDA enforcement and guidance related to off-label promotion.  Not surprisingly, FDA has taken a hard-line approach in its guidance on off-label communications, similar to the Agency’s forceful January 2017 memo. This aggressive stance has not, however, translated into increased enforcement. Continue Reading The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 4

In the recently published proposed rule related to the CY 2018 Hospital Outpatient Prospective Payment System (OPPS), the Centers for Medicare & Medicaid Services (CMS) announced that it is considering changes to the regulation governing the date of service (DOS) for clinical laboratory and pathology specimens.  The DOS rules are important to laboratories and hospitals because they dictate which party must bill Medicare for certain laboratory testing performed on stored specimens collected during a hospital procedure but ordered after the patient has left the hospital.  If revisions are ultimately finalized, the proposal could have significant business implications for independent laboratories and hospitals.

Continue Reading CMS May Decide to Permit Labs to Bill for Certain Tests Provided to Outpatients

Last week, Mintz Levin’s Health Care Enforcement Defense Group published a new Qui Tam Update, which analyzes 21 health care-related False Claims Act qui tam cases unsealed in May 2017, and the findings include:

  • long delays in unsealing remain the norm;
  • relators overwhelmingly consisted of current and former employees (and physicians); and
  • the most common alleged violation was billing fraud (which was claimed in two-thirds of the 21 unsealed cases).

Also of note in this Update:

  • The targeted entities in these 21 cases included outpatient medical and psychological providers, laboratory testing companies, inpatient hospitals, and home health care providers.
  • Of the 21 cases, the government intervened, in whole or in part, in seven cases and declined to intervene in 10.  (Intervention status could not be determined from the docket in four cases.)
  • The cases were filed in 17 different courts (including the Central District of California, the District of South Carolina, the Eastern District of Michigan, and the Northern District of California).

This Update provides in-depth analysis of three of the unsealed cases, which involve allegations regarding (1) “up coding” by a hospital that allegedly billed routine transport as emergency transport, which was reimbursed at a higher rate; (2) billing for medically unnecessary tests that purported to identify susceptibility to opioid addiction and engaging in a kickback scheme; and (3) processing prior authorization requests for MCOs using automated procedures to expedite processing and circumvent medical necessity determinations, resulting in submission of false claims.

A few months ago, two states that previously imposed onerous telemedicine requirements – Texas and Oklahoma – enacted laws that loosen restrictions on telemedicine providers and generally fall into line with what a vast majority of states already permit. However, these laws continue a pattern in which each state’s telemedicine laws use different definitions for what constitutes telemedicine and imposes disparate restrictions on telemedicine providers. This lack of uniformity imposes an ongoing challenge for telemedicine providers.

The Texas law, passed by the state legislature on May 12, 2017, permits telemedicine providers to establish a valid patient-provider relationship via telemedicine and without the need a prior in-person visit. This law follows a long and arduous court battle between the Texas Medical Board and Teladoc Inc. A summary of the case can be found here. At the crux of the controversy were Board regulations that prohibited physicians from establishing a valid physician-patient relationship in the absence of an in-person visit.  Continue Reading Holdout States Loosen Restrictions on Telemedicine but Obstacles Remain

Our colleague Bethany Hills recently discussed the Food and Drug Administration’s Digital Health Innovation Plan, which sets forth the agency’s new approach to regulating digital health. Her discussion appears in a FierceHealthcare article published earlier this week entitled “9 Companies Will Play a Huge Role in Shaping the FDA’s Novel Approach to Digital Health.” The full article can be found here. Stay tuned for additional coverage related to the agency’s evolving digital health strategy.

It has been some time since we provided a detailed update on the status of FDA’s user fee legislation making its way through Congress, so that’s what is on tap for today. The House passed the lengthy FDA Reauthorization Act (FDARA) on July 13, 2017 as H.R. 2430, and House members have now left Washington, D.C. for the traditional August recess.

Although the previous self-imposed congressional deadline of completing work on FDARA by the end of July has passed, FDA Commissioner Scott Gottlieb informed agency employees via email on July 24th that he would not be sending out any lay-off notices to user fee-funded staff “unless and until September 30 passes without reauthorization.” The publicizing of this policy decision by the Commissioner may have been intended to signal to the Senate that the sky is not falling (yet), but that they need to get to work.  Continue Reading August 2017 Is Here – Will FDARA Get Done Soon?

Our colleagues at ML Strategies have provided their Health Care Weekly Preview for the week of July 31, 2017.  This week’s preview focuses on the fallout from the failed vote to repeal the Affordable Care Act (ACA), including the issue of whether the federal government will continue to pay cost-sharing reduction subsidies (CSRs), as well a new proposal by Senators Lindsey Graham (SC), Bill Cassidy (LA) and Dean Heller (NV).

Last week, the HHS Office for Civil Rights (OCR) launched an improved version of their HIPAA Breach Reporting Tool (HBRT), commonly referred to by OCR and regulated entities alike as the HIPAA “Wall of Shame.” OCR has also made minor changes to the interface for breach reporting.

The HBRT now makes it easy to navigate and mine information on all reported data breaches (breaches must be reported when they involve the protected health information of 500 or more people). Continue Reading The HIPAA “Wall of Shame” is Now Easier to Navigate

On July 18, 2017, just days after CMS went public with its proposal to reduce Medicare Part B reimbursement to certain 340B covered entities, Congress held its first hearing on 340B Program Oversight since March 2015.  A common thread ran through the testimony of the three testifying witnesses:  Erin Bliss, Assistant Inspector General with HHS-OIG; Dr. Debra Draper, Director of Health Care at the GAO; and, Captain Krista Pedley, Director of the Office of Pharmacy Affairs at HRSA:  Congress needs to legislatively grant HRSA more administrative authority over the 340B Drug Discount Program.  Continue Reading Witnesses at Congressional Hearing on 340B Urge Congress To Give HRSA Broader Regulatory Authority