In a ruling that could, if adopted by other courts, expose all pharmaceutical discount and rebate arrangements to anti-kickback liability, on August 23, 2016, Judge Rya Zobel in the United States District Court for the District of Massachusetts denied Omnicare, Inc.’s motion for summary judgment in United States ex rel. Banigan v.
Product Coverage & Payment
The successful launch and sale of a health care product or service depends largely on the availability of adequate Medicare, Medicaid, and third-party payer coverage and reimbursement. Whether a product or service is a state-of-the-art emerging technology or considered an established standard of care, Arent Fox attorneys have the experience to develop and implement local and national strategies to champion new reimbursement and to address existing coverage and payment inequities. We work with clients to ensure that clinical trials are designed to collect data critical to address the safety and efficacy standards for FDA approval as well as the medical necessity standards of payers. We also assist clients determine the most advantageous regulatory approval strategy to position a product for third-party reimbursement.
In a decision that is good news for California hospitals, the California Court of Appeal invalidated class certification when a San Diego-based hospital system proved that the only way to determine the members of an uninsured patient class was to review more than 120,000 patient records. In Hale v. Sharp Healthcare, the California Court of Appeal, Fourth Appellate District affirmed the trial court’s order decertifying a class of uninsured patients claiming unfair billing practices.
As part of a case we continue to follow, in which the US Department of Justice (DOJ) intervened in a False Claims Act (FCA) suit against Continuum Health Partners and Mount Sinai Health System, the defendant hospital system recently filed a motion to dismiss the DOJ’s complaint-in-intervention. In the motion to dismiss, the hospital system argued that the government failed to state a claim in arguing that the health care providers did not repay alleged overpayments within the 60-day period required by the FCA.
Representatives for the Centers for Medicare and Medicaid Services (CMS) held a conference call on October 9, 2014 to address ongoing questions and clarify the requirements for hospitals that want to settle the inpatient-status claims whose denials they have appealed. As discussed in a recent Arent Fox client alert,1 the CMS settlement offer will pay hospitals 68 percent of the amount at issue.
Recent Cases Demonstrate Potential Exposure for Both Physicians and Providers
Opens the Door to Pharmacy Rewards Programs for Federal Health Care Program Beneficiaries, Among Other Things
Studies analyzing the cost-effectiveness of certain medical practices can sometimes indirectly suggest other, seemingly-unrelated benefits to a health care organization’s bottom-line. Such is the case in a study (Study) of medical emergency teams (MET) published in Pediatrics (“Cost-Benefit Analysis of a Medical Emergency Team in a Children’s Hospital,” Pediatrics 2014; 134; 235 (Aug. 2014)).
On September 19, 2014, the Department of Health and Human Services Office of Inspector General (OIG) released a Special Advisory Bulletin (SAB) in tandem with the results of an OIG report entitled “Manufacturer Safeguards May Not Prevent Copayment Coupon Use for Part D Drugs” (Report on Copay Coupons) reinforcing the government’s position that the provision of cost-sharing assistance or “coupons” by pharmaceutical manufacturers to or for use by federal health care program beneficiaries implicates the federal Anti-Kickback Statute (AKS).
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Arent Fox LLP, founded in 1942, is internationally recognized in core practice areas where business and government intersect. With more than 350 lawyers, the firm provides strategic legal counsel and multidisciplinary solutions to clients that range from Fortune 500 corporations to trade associations. The firm has offices in Los Angeles, New York, San Francisco, and Washington, DC.