On March 15, 2017, the United States District Court for the Western District of Pennsylvania issued an opinion that sheds insight on how courts view the “writing” requirement of various exceptions under the federal physician self-referral law (or “Stark Law”). The ruling involved the FCA qui tam case, United States ex rel. Emanuele v. Medicor Assocs., No. 1:10-cv-245, 2017 U.S. Dist. LEXIS 36593 (W.D. Pa. Mar. 15, 2017), involving a cardiology practice (Medicor Associates, Inc.) and the Hamot Medical Center. The Court’s detailed discussion of the Stark Law in its summary judgment opinion provides guidance as to what may … Continue Reading
On December 31, 2016, the U.S. District Court for the Northern District of Texas issued a nationwide preliminary injunction that prohibits the U.S. Department of Health and Human Services (HHS) from enforcing certain provisions of its regulations implementing Section 1557 of the Affordable Care Act that prohibit discrimination on the basis of gender identity or termination of pregnancy. This ruling, in Franciscan Alliance v. Burwell (Case No. 7:16-cv-00108-O), a case filed by the Franciscan Alliance (a Catholic hospital system), a Catholic medical group, a Christian medical association, and eight states in which the plaintiffs allege, among other allegations, that … Continue Reading
2016 is poised to be a major year in network adequacy developments across public and private insurance markets. Changes are ahead in the Medicare and Medicaid managed care programs, the Exchange markets and the state-regulated group and individual markets, including state-run Exchanges. The developing standards and enforcement will vary significantly across these markets.
Through 2014 and 2015, major news stories discussed concerns over the growing use of narrow provider networks by issuers on the Affordable Care Act’s insurance exchanges (“Exchanges”). Others reported on enrollees’ frustration with receipt of unexpected charges from out-of-network practitioners when receiving treatment at in-network facilities (often … Continue Reading
On September 28, 2015, the Centers for Medicare & Medicaid Services (“CMS”) issued a request for information (“RFI”) seeking comments on two key components of the physician payment reform provisions included in the Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”), the law enacted on April 16, 2015, repealing the sustainable growth rate formula used to update payment rates under the Medicare Physician Fee Schedule. The RFI was originally open for a 30-comment period. However, CMS has announced that it is extending the comment period for an additional 15 days. Comments to the RFI are now due to CMS … Continue Reading
On March 31, 2015, the Supreme Court of the United States decided Armstrong v. Exceptional Child Center, Inc. The Court handed down a hodgepodge of opinions but, in the end, five Justices concurred in the judgment that the Constitution’s Supremacy Clause does not confer a private right of action, and that Medicaid providers, therefore, cannot sue for an injunction requiring compliance with the reimbursement laws. This ruling will adversely affect at least those health care companies that have contemplated suing on the basis that the reimbursement they are getting is less than what the law entitles them to.
Recent enforcements in home health fraud have highlighted the need for home health companies of every state to engage the State Medicaid payment agency in pro-active affirmative discussion to work together to identify issues related to fraud and abuse. Such discussions will provide home health companies further insight regarding compliance with federal and state fraud and abuse laws. That being said, recent enforcement actions have shown that home health companies may be liable under fraud and abuse laws, despite efforts to comply with such laws.
On September 9th Lewis J. … Continue Reading
The U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) released a Report  on February 5th based on in-depth interviews with a sample of thirty 340B Covered Entities – half were disproportionate share hospitals (“DSH”) and half were community health centers (“CH”) – and eight contract pharmacy administrators to gain a better understanding of how contract pharmacy arrangements operate under the 340B Drug Discount Program, codified as Section 340B of the Public Health Service Act (“340B Program”).
By way of background, the 340B Program, created … Continue Reading
Speculation abounds with respect to the decision that states will make on the issue of whether to expand Medicaid coverage under the Affordable Care Act, now that the Supreme Court of the United States has made the option to abstain a meaningful one. This health reform alert highlights some key factors that may influence a state’s decision on whether to implement such an expansion.
Danielle Steele, a Summer Associate (not admitted to the practice of law) in Epstein Becker Green’s Washington, DC, office, contributed significantly to the … Continue Reading
The Recovery Audit Contractor (“RAC”) program is a national program aimed at identifying Medicare program overpayments and underpayments through a review of individual Medicare claims by contractors paid on a contingency fee basis. Over the next year, the RAC program will expand its reach beyond the current focus on fee-for-service payments under Medicare Parts A and B to include Medicare Part C (Medicare Advantage) and Part D (Prescription Drug Benefit) as well as state Medicaid programs. As Medicaid RAC programs get underway in the states, and private insurers … Continue Reading
This issue of Implementing Health & Insurance Reform summarizes and discusses some issues raised by the proposed rule ("Proposed Rule") that the Centers for Medicare & Medicaid Services ("CMS") published on February 2, 2012, to implement changes to the Medicaid Drug Rebate Program ("MDRP") and to reimbursement limits for outpatient drugs covered by Medicaid.
In Part 1, we discuss proposals relating to the MDRP that would change the manner in which pharmaceutical manufacturers calculate Average Manufacturer Price ("AMP") and Best Price for Medicaid-covered … Continue Reading