Health Law Policy MattersRecently, HRSA publicly announced the issuance of a final rule clarifying when 340B covered entities can purchase and distribute orphan drugs through the 340B Drug Pricing Program. Separately, HRSA quietly posted a report on its completed audits of 340B covered entities through July 12, 2013. While the new rule does shed light on when 340B entities can purchase orphan … Read more
Written by Roy Albert and Karen Lovitch Last week, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule setting forth revisions to payment policies under the Medicare Physician Fee Schedule (MPFS) and other revisions to Medicare Part B for calendar year 2014. The rule proposes several changes that, if finalized, would have grave consequences for independent laboratories. Pathology laboratories … Read more
Adhering to the axiom that the best defense is a good offense, SNHPA (Safety Net Hospitals for Pharmaceutical Access), an organization of close to 1000 hospitals participating in the 340B Drug Pricing Program, is attempting to defend its members’ 340B Program operations. Through the 340B Program, qualified safety net providers obtain deep discounts on outpatient … Read more
This week, reports have arisen that Chinese authorities in the cities of Shanghai, Beijing, and Changsha detained high-level GlaxoSmithKline (GSK) managers as part of an investigation into potential “economic crimes.” The detentions occurred two weeks after the Wall Street Journal reported that a whistleblower claimed in a disclosure sent to the company’s board that the sales staff in China had engaged … Read more
In U.S. ex rel. Repko v. Guthrie Clinic et al., the Third Circuit recently ended an attempt by Rodney Repko, former general counsel and executive vice president for Guthrie Healthcare System and its related entities, to bring a qui tam case against his former employer. After he left his job at Guthrie, Repko allegedly attempted to steal two million … Read more
One month from today, the law that permits independent laboratories to bill and receive payment from Medicare Part B for the technical component of certain anatomic pathology, cytopathology, and surgical pathology services (“TC Services”) provided to patients of “covered hospitals” will expire. Medicare pays hospitals a per-discharge amount for inpatient services pursuant to the inpatient prospective payment system. … Read more
In another step toward implementation of Accountable Care Organizations (ACOs), on April 10, 2012, the Centers for Medicare & Medicaid Services (CMS) selected 27 ACOs in 18 states to participate in the Medicare Shared Savings Program (Shared Savings Program). These ACOs will serve an estimated 375,000 beneficiaries and, according to CMS, are comprised of 10,000 physicians, 10 hospitals, and … Read more
Written by Theresa Carnegie, Ellyn Sternfield and Nili Yolin On February 2, 2012, CMS issued proposed regulations that further refine and define how pharmaceutical manufacturers must calculate Medicaid drug rebates in the wake of health care reform (the Proposed Rule). Specifically, the Proposed Rule changes the definition of “bona fide services fee,” which is a key component in determining a manufacturer’s … Read more
Written by Karen Lovitch and Stephanie Willis In OIG Advisory Opinion 11-16, the OIG found that a Domiciliary Services Program (the “Program”) offered by a non-profit research hospital (the “Requestor”) is protected from enforcement under the Anti-Kickback Statute and the prohibition on beneficiary inducement found in the civil monetary penalties law (the “CMP law”). Through the Program, the Requestor (described by the OIG as … Read more
Adhering to the axiom that the best defense is a good offense, SNHPA (Safety Net Hospitals for Pharmaceutical Access), an organization of close to 1000 hospitals participating in the 340B Drug Pricing Program, is attempting to defend its members’ 340B Program operations. Through the 340B Program, qualified safety net providers obtain deep discounts on outpatient … Read more