On October 6, 2020, the Centers for Medicare and Medicaid Services (“CMS”) released guidance regarding the requirements and enforcement process for hospital reporting of COVID-19 data elements (the “Guidance”). The Guidance follows the September 2, 2020 Interim Final Rule, which included new requirements for Medicare and Medicaid participating hospitals and critical access hospitals (“CAHs”) to report data that allows CMS “to monitor whether individual hospitals and CAHs are appropriately tracking, responding to, and mitigating the spread and impact of COVID-19 on patients, the staff who care for them, and the general public.”…
Continue Reading Clarity on Reporting and Enforcement: CMS Issues Guidance Regarding Hospital COVID-19 Reporting Requirements

As the pandemic rages on, and the United States has seen a spike in coronavirus cases in recent days, many healthcare providers are still struggling to care for patients and remain afloat. In response, HHS is continuing support and extending flexibility. …
Continue Reading More Relief on the Way for Healthcare Providers: Provider Relief Fund Payment Opportunities and Flexibility in Repayment Requirements

On September 19, 2020, the Health Resources and Services Administration (“HRSA”) of the Department of Health and Human Services (“HHS”) issued guidance (“September Guidance”) regarding the post-payment reporting requirements applicable to providers who received more than $10,000 in relief fund payments from the Provider Relief Fund (“PRF”) – a fund created by the Coronavirus Aid, Relief, and Economic Security (CARES) Act (the “CARES Act”) and the Paycheck Protection Program and Health Care Enhancement Act (the “PPP Act”) to provide financial relief to hospitals, physicians, and other health care providers.  In addition to the reporting requirements, the September Guidance includes information regarding the PRF audit procedures applicable to PRF recipients.…
Continue Reading Department of Health and Human Services Releases New Provider Relief Fund FAQs: Reporting, Single Audits and What You Can Do Now

On September 3, 2020, the Department of Health and Human Services (HHS) released its Rural Action Plan (the “Plan”). The Plan: (i) details the challenges rural communities endure; (ii) provides an assessment of current and upcoming rural healthcare efforts; (iii) lays out a “Four Point Strategy” to address the disparities between rural and urban communities; and (iv) lays out an action plan featuring 71 action items for remediating the disparities consistent with the Four Point Strategy.
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Continue Reading HHS Releases Rural Action Plan

In a December 12, 2017 Advisory Board article, “The 340B drug pricing controversy, explained,” Scott Orwig wrote, “the 340B Drug Pricing Program is one of the most contentious issues in health care: Its critics say it ‘hurts patients’ and is being ‘abused’ by hospitals. Its defenders say it’s ‘vital’ to the health of low-income patients and essential to helping safety net hospitals care for their communities.”…
Continue Reading Maneuvers on the 340B Drug Pricing Program Battlefield: Duplicate Discounts and Contract Pharmacies

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 The Death of RBG…and the ACA?

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 CMS Issues the 2022 Medicare Advantage Advance Notice Part I – Risk Adjustment

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 HHS OIG Issues Report Critical of Medicare Advantage Risk Adjustment Practices

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 The Next in the Series of Executive Orders Affecting the Pharmaceutical Industry

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.
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Continue Reading CMS Finalizes Medicare Advantage Price Transparency Requirements, Despite Industry Criticism

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.
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Continue Reading The Scope-of-Practice Debate Takes Center Stage: The 2021 Medicare Inpatient Rehabilitation Facility Prospective Payment System Final Rule