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 CMS’ Proposed Rule Promoting Value-Based Purchasing for Medicaid-Covered Drugs: The Comments are In!

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 It’s Official: Telehealth Benefits Have Been Expanded For Medicare Beneficiaries

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 CMS Launches New ACO Toolkit Highlighting Effective Strategies For Achieving Provider Engagement

On Friday, President Trump announced four executive orders directed at decreasing prescription drug prices by ordering certain actions by the Department of Health and Human Services (“HHS”).  One order – which has received the most negative reaction from the pharmaceutical industry – would create a “most-favored nation” policy to limit the price Medicare Part B pays for certain drugs to the lowest price paid in another Organization for Economic Cooperation and Development country.  The White House did not release the text of this order on Friday and stated that it would not take effect until August 24, or at all if pharmaceutical companies can offer an alternative proposal to substantially reduce drug prices or if Congress acts.
Continue Reading A Shot Across the Bow of the Pharmaceutical Industry: President Trump Issues a Quartet of Executive Orders on Drug Pricing that Might Eventually (OR NEVER?) Take Effect

On July 17, 2020, in a blow to health care providers, the U.S. Court of Appeals for the D.C. Circuit overturned a lower court’s more favorable ruling and held that the Department of Health and Human Services (“HHS”) “site-neutral payment” policy may stand.
Continue Reading Site-Neutral Payments Stand: D.C. Court of Appeals Overturns Ruling and Allows Lower Payments to Off-Campus Provider-Based Departments

On June 25, 2020, the Centers for Medicare & Medicaid Services (“CMS”) announced its proposed Home Health Prospective Payment System Rule, for calendar year 2021 (the “Rule”), which aims to increase home health agency Medicare payment rates.  This Rule also includes a provision to make permanent the regulatory changes related to telecommunication technologies in providing care under the Medicare home health benefit beyond the expiration of the COVID-19 public health emergency (“PHE”), which is set to time out at the end of July 2020.
Continue Reading CMS Issues Proposed Home Health Agency Rule On Making Certain Telehealth Flexibilities Permanent, Increasing Medicare Payment Rates And Home Infusion Therapy Service Payment Rates For CY 2021

On November 15, 2019, CMS issued a final rule that requires hospitals to disclose to patients the hospital’s “standard charges,” which include the reimbursement rates the hospitals negotiate privately with insurers.  This rule is in line with President Trump’s Executive Order, dated June 24, 2019, which focused on increasing price and quality transparency for American healthcare consumers.  The Final Rule goes into effect as of January 1, 2021, at which time hospitals will have to post their standard charges online.  Any hospital that refuses to do so will be subject to a fine of up to $300 per day.  While CMS believes that the Final Rule will lower healthcare costs by allowing customers to compare prices and proactively shop for care, the Final Rule has been met with strong resistance from hospitals that claim that it is beyond the scope of CMS’ power to promulgate.
Continue Reading Balancing Provider Pricing Transparency and Anti-Competitive Behavior

As the COVID-19 emergency continues to heavily impact the U.S. and its health care system, CMS has issued additional flexibilities for providers and payors seeking to respond to the pandemic.  These new flexibilities are described both in revisions to CMS’ blanket waivers and in a new Interim Final Rule with comment period, both issued on April 30.  Many of these flexibilities are responsive to questions and requests submitted to CMS over the past few weeks, providers’ experiences with developing and implementing pandemic response plans, and the regulatory obstacles they have encountered.  While these new flexibilities will not eliminate all of the regulatory challenges currently facing providers responding to COVID-19, and providers must be careful to continue to track the scope of CMS’ flexibilities, they will be very helpful to many providers in their ongoing COVID-19 response efforts.  In particular, and among other things, CMS’ new guidance expands flexibility for telehealth services, provides additional support for COVID-19 testing, relaxes additional regulatory requirements applicable to certain payors, provides other key regulatory flexibilities, and offers guidance to MSSP ACOs on payment calculations for periods affected by the public health emergency.
Continue Reading CMS Updates Waivers, Provides More Flexibility for Providers Responding to COVID-19

In an evening email that is sure to ruin the weekend for many, CMS announced on February 5, 2020, that it is proposing changes to the Medicare Advantage and Part D Programs for CY 2021 and 2022. CMS will not issue a Call Letter for CY2021. The unpublished version of the proposed rule is available for inspection, and is scheduled to be published in the Federal Register on February 18, 2020. Comments are due April 6, 2020.
Continue Reading CMS Proposes Changes to the Medicare Advantage and Part D Programs for CY 2021 and 2022

Information Collection Request. On November 27, 2019, 340B Health, a nonprofit membership organization comprised of hospitals and health systems that participate in the federal 340B drug pricing program (“340B Program”), submitted comments (“340B Comments”) to Seema Verma, the Administrator of the Centers for Medicare & Medicaid Services (“CMS”), objecting to an announcement by CMS on September 30, 2019, which proposed an information collection request (“ICR”) to survey the drug acquisition cost data for hospitals participating in the 340B Program.
Continue Reading 340B Program-Participating Hospitals Object to CMS’s Proposed Cuts to 340B Program Reimbursement: CMS’s Recent Information Collection Request