On October 29, 2020, the Department of Health and Human Services (“HHS”), the Department of Labor, and the Department of the Treasury (collectively, the “Departments”) released the Transparency in Coverage Final Rules (the “Final Rules”), which require non-grandfathered group health plans and health insurance issuers offering non-grandfathered health insurance coverage in the individual and group markets to disclose certain information including negotiated rates with providers and estimated out-of-pocket expenses to enable consumers to make informed health care purchasing decisions.…

As highlighted in a May 2020 Milbank Memorial Fund white paper titled, “How Payment Reform Could Enable Primary Care to Respond to COVID-19,” the COVID-19 public health emergency has driven transformation in the provision of primary care services across the country.  Whether it’s the use of telehealth technology to facilitate “virtual visits” or the development of new treatment protocols to identify and treat patients who need behavioral health support to manage the emotional challenges endemic to the public health emergency, changes in primary care delivery have drawn increased attention to the need for concomitant changes in the way…

G force is used to describe the acceleration of an object relative to gravity. The Wright brothers understood that the lift of the airplane had to be greater than the force of gravity.  In much the same way, the pull of gravity that healthcare providers are facing today is COVID-19.…

In an effort to provide additional relief to a health care system strained by the COVID-19 pandemic, the Office of the National Coordinator for Health IT (“ONC”) released an Interim Final Rule with Comment Period (“IFC”) on October 29, 2020 that extends the compliance dates under the 21st Century Cures Act Interoperability, Information Blocking, and ONC Health IT Certification Program Final Rule (the “Final Rule”) and offers some technical corrections and clarifications.…

In a setback to hospitals challenging deep cuts to reimbursement for prescription drugs acquired through the 340B drug pricing program (“340B Program”), the U.S. Court of Appeals for the District of Columbia, on October 19, denied a request to reconsider a decision by three-judge panels of the Court upholding these cuts.  Short of a Supreme Court appeal, this decision effectively ends hospital challenges to these reimbursement reductions, and makes the implementation of additional cuts in 2021 a near inevitability.…

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.”…

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.…

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…

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.…

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.”…