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Showing 8 posts in Academic Medicine.

On February 22, 2019, the Centers for Medicare & Medicaid Services (“CMS”) and the Office of the National Coordinator for Health Information Technology (“ONC”) of the Department of Health and Human Services (“DHHS”) formally issued two proposed rules and related Requests for Information (RFIs) intended to advance interoperability and increase patient access to health information (the “CMS Proposed Rule” or “Proposed Rule” and the “ONC Proposed Rule,” respectively).   This alert focuses on the CMS Proposed Rule, while a subsequent client alert will address the ONC Proposed Rule. Read More ›

On Friday, February 15, 2019, CMS released a proposed decision memo to cover FDA-approved Chimeric Antigen Receptor (CAR) T-cell therapy, which uses a patient’s immune system T-cells to fight certain types of blood cancers, pursuant to a Coverage with Evidence Development (CED). Two CAR T-cell products are currently approved by the FDA for treatment of certain patients with relapsed or refractory acute myeloid leukemia and large B-cell lymphoma. In addition, multiple clinical trials involving CAR T-cell therapies are currently underway across the country, including FDA-required post-approval studies. There is no national Medicare policy currently regarding coverage for this therapy, and local Medicare Administrative Contractors currently determine whether to pay for it.

This announcement by CMS appears to be a generally positive development for stakeholders seeking more clarity regarding parameters for coverage of the therapy. If adopted, the CED does ensure coverage on a national basis for the near future for certain types of CAR T-cell therapy under certain conditions, and during that time stakeholders can continue to gather additional data to support an argument for broader coverage as appropriate, as well as to support an argument for an appropriate reimbursement methodology. Read More ›

On February 4, 2019, the California Court of Appeal affirmed a judgment awarding plaintiff, Dr. Kenneth Economy, substantial damages for his suspension and subsequent termination of his staff privileges at defendant Sutter East Bay Hospitals. The Court of Appeal held that, because Dr. Economy’s termination, even though done under the provisions of an exclusive contract, was based on “medical disciplinary cause or reason,” he was entitled to prior notice and a hearing in accordance with Business and Professions Code section 809 et seq. This decision flies in the face of the underlying premise for exclusive contracts: the ability for a hospital to enter into a contractual arrangement that allows it to set superior metrics in exchange for exclusive rights to provide services. Clinical issues have long been mandated to be within the purview of the medical staff but exclusive contracting gives hospitals the ability to contract for higher standards of quality of care. The severity of the Economy decision calls into question the accepted approach to exclusive contracts. Read More ›

On Friday, January 25, 2019, the Department of Managed Health Care (DMHC) published its latest draft of a proposed regulation that will dramatically expand the scope of arrangements subject to licensure under the Knox-Keene Act. The regulation breaks with the DMHC’s longstanding policies and threatens to disrupt common provider payment arrangements in California, including hospital risk pools, bundled payment arrangements, and accountable care organizations (ACOs), and to stifle innovation in the area of value-based payments.

Under the proposed regulation, a Knox-Keene license would be required for an entity to accept “global risk,” which is defined as the acceptance of a “prepaid or periodic charge” in exchange for assuming “both professional and institutional risk.” (28 C.C.R., proposed § 1300.49, subds. (a) & (b)(1).) The statute has long defined health care service plans in reference to providing or arranging for health care services in exchange for a “prepaid or periodic charge.” However, the regulation provides a new definition of that term that encompasses payments made “at the start or end of a predetermined period… that may be fixed either in amount or percentage of savings or losses in which the entity shares.” (28 C.C.R., proposed § 1300.49, subd. (a)(4).) Providers that engage in shared risk arrangements, which involve fee-for-service payments with shared savings payable after a set period of time, even those involving upside risk only, may be subject to licensure under the new rule. Read More ›

On December 14, 2018, the Department of Health and Human Services (“HHS”) issued a request for information (“RFI”), asking for feedback on how to change certain regulations issued pursuant to the Health Insurance Portability and Accountability Act (“HIPAA”). The RFI seeks information on how best to remove obstacles to efficient care coordination while also protecting patients’ health information, as well as how to encourage providers to share information for treatment and care coordination, making it easier to share information with parents and caregivers in dealing with the opioid crisis. Comments or information regarding changes to the HIPAA regulations must be submitted to HHS on or before February 12, 2019. Then, the agency will still need to go through the regulatory rulemaking process to implement any proposed changes after the RFI process is complete. Read More ›

For media assistance, please contact Maura Fisher at 202-580-7714.