Executive Orders and the Biden Administration’s promises to postpone or withdraw certain last-minute, so-called “midnight rules” promulgated by the Trump Administration are currently grabbing everyone’s attention, especially those in the healthcare space.  But while President Biden may have success in reversing much of his predecessor’s last minute regulatory activity, he is likely to face at least some headwinds as it relates to one of those midnight rules – the “Department of Health and Human Services Transparency and Fairness in Civil Administrative Enforcement Actions” (the “Final Rule”) – that was published in the Federal Register on January 14, 2021 and became effective on January 12, 2021.
Continue Reading Secret Rules and Hidden Penalties: Biden Executive Order Takes Aim at the Trump Administration’s Efforts to Limit HHS’s Use of Guidance Documents in Civil Enforcement Actions

This week, Rep. Mike Thompson (CA-05), founder and co-chair of the Congressional Telehealth Caucus reintroduced the Protecting Access to Post-Covid-19 Telehealth Act of 2020 (the “Act”) with support from Co-Chairs Rep. Peter Welch (VT-AL), Rep. Bill Johnson (OH-06), and Rep. David Schweikert (AZ-06) and caucus member Rep. Doris Matsui (CA-06).  The Act was originally introduced in the House of Representatives on July 16, 2020. The focus of the Act is to do away with certain restrictions on providing telehealth services, and to permanently expand coverage for telehealth services both during and beyond the COVID-19 Pandemic. Among other things, the Act:
Continue Reading Re-Introducing the Protecting Access to Post-Covid-19 Telehealth Act

Over the last year, we have seen volatility in the healthcare industry overall, and Medicare Advantage (“MA”) and Medicare Part D plans (together, “Plans”) have not been immune. Particularly because of their risk adjustment payment models, and metrics by which they are measured, it was unclear how the Centers for Medicare and Medicaid Services (“CMS”) would respond.
Continue Reading CMS to the Rescue for MA and Part D Plans – Rate Announcement Includes Significant Increase in Plan Payments for 2022

On December 28, 2020, the Consolidated Appropriations Act, 2021 (“Appropriations Act”) was passed into law. The Appropriations Act included the No Surprises Act (“Act”), which seeks to protect patients from surprise medical bills in situations where patients have little or no control over who provides their care, including nonemergency services provided by out-of-network providers at in-network facilities, emergency services provided by out-of-network providers and facilities, and air ambulance services. The Act, a rare piece of bipartisan, bicameral legislation, has been a long time in the making, and has undergone multiple iterations. Particularly during the public health emergency, the issue of surprise medical bills is especially pertinent, as the COVID-19 pandemic has increased the occurrence of surprise bills in a time where people are less likely to be able to shoulder the unexpected costs.
Continue Reading No Surprises Act Comes as a Surprise – Consolidated Appropriations Act Includes New Restrictions on Surprise Bills

In our December 7, 2020 Blog Post, “Permanent Expansion of Medicare Telehealth Services,” we discussed the 2021 Medicare Physician Fee Schedule Final Rule (the “Final Rule”) and the regulatory changes made therein by the Centers for Medicare and Medicaid Services (“CMS”) to expand Medicare telehealth coverage within the confines of existing Medicare statutory law.  The Final Rule was first posted on December 2, 2020 and was formally published in the Federal Register on December 28, 2020.
Continue Reading The Permanency for Audio-Only Telehealth Act: A Matter of Healthcare Equity?

On September 13, 2020, President Trump issued an Executive Order (the “Executive Order”) directing the Department of Health and Human Services (“HHS”) to issue regulations instituting two most-favored-nations (“MFN”) payment
Continue Reading Medicare Part B Most Favored Nation Drug Pricing Model: New Rules, New Lawsuits, New Tweets

On December 2, 2020, the Centers for Medicare & Medicaid Services (“CMS”) finalized policies that “aim to increase choice, lower patients’ out-of-pocket costs, empower patients, and protect taxpayer dollars” with changes to the Medicare Hospital Outpatient Prospective Payment System (“OPPS”) and the Ambulatory Surgical Center (“ASC”) Payment System in the Medicare OPPS and ASC Final Rule (“Final Rule”). These changes include: elimination of the “Inpatient Only List” and additions and revisions to the “ASC Covered Procedures List” – two key areas of “site neutrality”. Site neutrality is a move to diminish or eliminate the reimbursement differences between different sites of service.
Continue Reading Forthcoming Medicare Rule Furthers Push for Site Neutrality

On December 1, 2020, the Centers for Medicare and Medicaid Services (“CMS”) released the annual Physician Fee Schedule final rule (“Final Rule”) which, among other things, aimed to further President Trump’s October 3, 2019 Executive Order #13890 on “Protecting and Improving Medicare for Our Nation’s Seniors” (the “EO”) by expanding the use of proven alternatives like telehealth services to Medicare beneficiaries even after the conclusion of the COVID-19 Public Health Emergency (the “Pandemic”).
Continue Reading Permanent Expansion of Medicare Telehealth Services

On November 30, 2020, the United States Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a final rule (“Final Rule”) that makes significant changes to the federal Antikickback Statute (“AKS”) safe harbor regulations as such regulations relate to the cost of prescription drugs as covered by the Medicare and Medicaid programs.  More specifically, the Final Rule amends the AKS discount safe harbor (“Discount Safe Harbor”) at 42 C.F.R. §1001.952(h) to eliminate safe harbor protection for drug discounts and rebates offered by pharmaceutical manufacturers to pharmacy benefit managers (“PBMs”) and  Medicare Part D prescription drug plan (“Medicare Part D”) sponsors.  In addition to making significant changes to the Discount Safe Harbor, the Final Rule creates two new pharmaceutical-related safe harbors: (i) a safe harbor applicable to certain prescription drug point-of-sale discounts as offered to Medicare and Medicaid beneficiaries to reduce their direct out-of-pocket prescription drug costs (the “Point-of-Sale Safe Harbor”) and (ii) a safe harbor applicable to flat fee arrangements paid by drug companies directly to PBMs for PBM services (the “PBM Service Fees Safe Harbor”).

Continue Reading Eleventh Hour Rulemaking: HHS Eliminates Safe Harbor Protections for PBM Drug Rebates and Creates Two New Safe Harbors for Point-of-Service Discounts and PBM Fixed-Fee Arrangements

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

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.

Continue Reading HHS Releases Rural Action Plan