The death of Supreme Court Justice Ruth Bader Ginsburg, and alongside it the high probability of a conservative successor to the open seat she left behind, is likely to shift the Court substantially to the right. Among the most notable cases that will likely be presented before the newly constituted Court is the pending challenge to the Affordable Care Act (the “ACA”). Continue Reading
On September 14, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued the Advance Notice of Methodological Changes for Calendar Year (CY) 2022 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies – Part I, CMS-HCC Risk Adjustment Model (the “Advance Notice”). CMS is issuing the Advance Notice in two parts: Part I includes key information about the Medicare Advantage CMS-Hierarchical Condition Categories (“HCC”) risk adjustment model and the use of encounter data for CY2022. Part II, which will include other changes to the CY2022 payment methodologies, will be issued later this Fall. CMS will announce the CY2022 MA capitation rates and final payment policies no later than Monday, April 5, 2021. Continue Reading
Earlier this month, the U.S. Department of Health and Human Services Office of the Inspector General (the “OIG”) released a report highlighting concerns about the extent to which Medicare Advantage Organizations (“MAOs”) are using health risk assessments (“HRAs”) to improve care and health outcomes under the Medicare Advantage Program (“MA”), as intended, and about the sufficiency of oversight by the Centers for Medicare & Medicaid Services (“CMS”). Continue Reading
On Sunday, September 13, 2020, President Trump signed an Executive Order, the next in a series of Executive Orders targeting the pharmaceutical industry, which aims to lower prescription drug prices in the United States (the “Order”). The order repealed and replaced a similar Executive Order, which was previously signed on July 24, 2020 but was held back from release by the Trump administration, and follows the signing of the Buy American Executive Order mandating the purchase of U.S.-manufactured drugs that we analyzed here. Continue Reading
On September 2, 2020, the Centers for Medicare and Medicaid Services (“CMS”) filed the unpublished version of the forthcoming Inpatient Prospective Payment Systems (“IPPS”) Final Rule for 2021. One of the more controversial provisions in the IPPS Final Rule finalizes CMS’ proposal, with modification, to require hospitals to report certain market-based payment rate information on their Medicare cost report for cost reporting periods ending on or after January 1, 2021. Specifically, this includes requiring hospitals to report on the Medicare cost report, the median payer-specific charge that the hospital has negotiated with all of its Medicare Advantage organization (“MAO”) payers, by Medicare Severity Diagnosis Related Groups (“MS-DRGs”) (the classification system by which hospitals are paid for patients’ hospital stays). The payer-specific negotiated charges used by hospitals to calculate these medians would be the payer-specific negotiated charges for service packages that hospitals are already required to make public under the requirements finalized in the Hospital Price Transparency Final Rule and, therefore, CMS argues that “the additional calculation and reporting of the median payer-specific negotiated charge will be less burdensome for hospitals.” In addition, CMS also finalized the market-based MS-DRG relative weight methodology, which incorporates this market-based rate information, to inform its calculations for inpatient hospital rates beginning in 2024.
As noted in our March 31, 2020 blog article, “Strategies in Responding to COVID-19: Expanding Scope of Practice to Increase Patient Access to Healthcare” and in our May 8, 2020 blog article, “COVID-19: Medical Liability for Expanded Scope of Services,” the COVID-19 pandemic has revealed limitations in the healthcare system that have impeded access to medical care, often for rural, low-income, and minority communities. In order to increase healthcare access, many states and the federal government have worked to (i) expand the scope of practice for different types of non-physician practitioners (“NPPs”) to provide a wider range of healthcare services; (ii) eliminate or relax physician supervision requirements so that NPPs can practice independently without having to rely on physicians who are, themselves, scarce healthcare resources; and (iii) insulate NPPs from liability for the provision of those healthcare services that fall outside of their traditional scopes of practice.
On Thursday, August 6, 2020 President Trump signed an Executive Order, mandating that certain drugs and medical supplies purchased by federal agencies, including the Department of Health and Human Services, Department of Defense, and Department of Veteran’s Affairs must be US-manufactured (the “Buy American Order” or the “Order”). The list of “essential medicines, medical countermeasures and critical input” that fall under this Order will be determined by the Food and Drug Administration (“FDA”). The Order also calls on the FDA to conduct a greater amount of unannounced inspections of overseas drug plants to ensure that production of drugs is compliant with safety standards and to encourage more advanced drug manufacturing techniques. Continue Reading
On June 19, 2020, the Centers for Medicare and Medicaid Services (“CMS”) issued a proposed rule, “Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements” (the “Proposed Rule”). The Proposed Rule is designed to implement statutory amendments to the Medicaid Drug Rebate Program (“MDRP”) statute, and add new regulatory provisions to encourage value-based purchasing (“VBP”) arrangements between drug manufacturers and state Medicaid programs and Medicaid-contracting payors. Continue Reading
On August 3, 2020, President Trump signed Executive Order 13941 (the “Executive Order”) which expands access to certain telehealth services post-pandemic. The Executive Order focuses on telehealth access for individuals living in rural areas and implements the following mechanisms: Continue Reading
In July 2020, the Centers for Medicare & Medicaid Services (“CMS”) released part three of its ongoing Accountable Care Organization (“ACO”) Learning System and Toolkit Series: Provider Engagement Toolkit (the “Toolkit”), focusing on strategies to effectively engage healthcare providers in the ACO and in quality improvement activities. In particular, the Toolkit showcases the various effective strategies Medicare ACOs are currently using to help primary care and specialty providers in the ambulatory setting to improve health care quality and overall patient outcomes. Continue Reading