On November 20, 2020, the Centers for Medicare and Medicaid Services (“CMS”) and the Office of Inspector General (“OIG”) promulgated much-anticipated and significant final rules intended to “modernize” and “clarify” regulations regarding the Physician Self-Referral Law (“Stark Law Final Rule”) and the Anti-Kickback Statute (“AKS Final Rule”).  In the immediate future, Sheppard Mullin will post on this Healthcare Law Blog a comprehensive critical analysis of both the Stark Law Final Rule and the AKS Final Rule and their practical impacts.
Continue Reading Big Changes for Health Care Fraud and Abuse: HHS Gifts Providers Updates to the Stark Law and the AKS, Just in Time for the Holidays

The Physician Payment Sunshine Act (the “Sunshine Act”) – a federal law first adopted as Section 6002 of the Patient Protection and Affordable Care Act of 2010 (“PPACA”) – requires the Centers for Medicare and Medicaid Services (“CMS”) to collect and display information reported by applicable manufacturers and group purchasing organizations about the payments and other transfers of value these organizations have made to physicians and teaching hospitals. Currently, CMS fulfills its Sunshine Act obligations to collect and report data to the public through the “Open Payments” program.
Continue Reading On Your Mark, Get Set, Go: Life Science Companies Face A Challenging Year For Compliance With New Open Payment Program Data Collection And Reporting Requirements

On November 10, 2020, the U.S. Supreme Court heard oral arguments for California v. Texas, a case that will potentially decide the fate of the Patient Protection and Affordable Care Act (“ACA”).
Continue Reading Texas v. California: SCOTUS Hears Oral Arguments About the Constitutionality of the ACA

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.
Continue Reading Trump Administration Finalizes The Transparency in Coverage Rule

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 primary care is financed.
Continue Reading Primary Care First: CMS’s New Value-Based Approach to Primary Care

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.
Continue Reading And We Have Lift-Off: Improvements in Healthcare Revenue Cycle Management to Address COVID-19 Challenges

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.
Continue Reading Office of the National Coordinator for Health IT Extends Compliance Deadlines under Interoperability Final Rule

On October 6, 2020, the US Supreme Court (the “Court”) heard arguments on an Employee Retirement Income Security Act (“ERISA”) case that has the potential to curtail the rights of states to regulate their individual healthcare markets, in Rutledge v. Pharmaceutical Care Management Association (the “Case”).
Continue Reading ERISA: The Erosion of State Health Regulation Rights

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.
Continue Reading The U.S. Court of Appeals Denies Rehearing on Cuts to 340B Drug Pricing Program

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