Update on HRSA’s Oversight of 340B Program
The Health Resources and Services Administration (“HRSA”) improved its oversight of the 340B drug pricing program, which requires manufacturers of drugs covered by Medicaid to sell outpatient drugs at discounted prices, through audits as well as clarifying guidance for manufacturers. Back in 2011, the Government Accountability Office (“GAO”) found that HRSA oversight of the 340B program was inadequate and recommended actions that HRSA should take to improve program integrity. In the recent update, HRSA testified about steps it has taken to improve oversight, such as conducting audits of covered entities, 200 each year, to identify noncompliance with program requirements, as well as issuing clarifying guidance for manufacturers on restricted distribution of a drug. However, there are other recommendations that HRSA has yet to follow through on, such as providing clarifying guidance on the definition of an eligible patient and hospital eligibility criteria.
CMS Proposes Changes to CJR Model, CR Model and EPMs
The Centers for Medicare & Medicaid Services (“CMS”) announced proposed changes to the Episode Payment Models (“EPMs”), Cardiac Rehabilitation (“CR”) Incentive Payment Model, and Comprehensive Care for Joint Replacement Model (“CJR”). CMS proposes to cancel the EPMs and CR incentive payment model, and prospectively make participation voluntary for all eligible hospitals in approximately half of the geographic areas selected for participation in the CJR model. Certain hospitals selected for participation in the CJR model would be given a one?time option to choose whether to continue participation in the model. As a result, the CJR model would continue on a mandatory basis in approximately half of the selected geographic areas, with an exception for low volume and rural hospitals, and continue on a voluntary basis in other areas.
CMS Accepting 2017 QPP Hardship Exception Applications
The Centers for Medicare & Medicaid Services (“CMS”) is accepting applications for 2017 hardship exceptions to the Quality Payment Program’s (“QPP”) Advancing Care Information performance category. Clinicians eligible for participation in the QPP’s Merit-based Incentive Payment System (“MIPS”) may apply for the hardship exceptions due to several reasons, including internet connectivity, “extreme and uncontrollable” circumstances, or lack of control over the availability of certified electronic health record technology. However, MIPS-eligible clinicians that are considered Special Status, including, but not limited to, hospital-based MIPS-eligible clinicians, physician assistants, and nurse practitioners, will be automatically reweighted and do not need to submit a QPP Hardship Exception Application.