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Keeping you afloat amidst the rising sea of regulations

First-Of-Its-Kind Decision: Medicare Will Now Cover Certain Diagnostic Tests Utilizing Next Generation Sequencing for Cancer

As a result of the FDA-CMS Parallel Review Program, and representing a first-of-its-kind decision, the Centers for Medicare & Medicaid Services (CMS) issued a National Coverage Determination (NCD) on March 16, 2018 approving Medicare coverage and payment for diagnostic laboratory tests utilizing next generation sequencing, or NGS, for patients with certain types of advanced cancer. According to CMS, “NGS oncology panel test

Is the Discount Safe Harbor No Longer “Safe?”

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. Organon USA, Inc., et al.

Cutting Class: California Health Provider Overcomes Class Action Treatment of Patient Billing Claims

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.

Hospital System Responds in ‘Reverse False Claims Act’ Overpayment Suit

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.

UPDATE: CMS Provides New Guidance to Hospitals on How to Settle Inpatient Appeals

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.

Government Gives Health Care Companies More Leverage in Their Negotiations with Physicians

Recent Cases Demonstrate Potential Exposure for Both Physicians and ProvidersHealth care organizations that contract with physicians can face potential liability (including millions of dollars in civil, criminal, and administrative penalties), as well as exclusion from participation in federal health care programs, under various laws (such as the Stark Law), the anti-kickback statute, and the False Claims Act (FCA).

Medical Emergency Teams Can Recoup Their Costs by Reducing Adverse Events

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)).

OIG Finds Commercial Drug Copay Coupons Are Being Used by Medicare Part D Beneficiaries and Warns of Anti-Kickback Statute Exposure

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).