On January 5, 2023, the U.S. Department of Health and Human Services (“HHS”) published a notice of proposed rulemaking entitled “Safeguarding the Rights of Conscience as Protected by Federal Statutes” (the “Proposed Rule“). In this article we provide a brief summary of the Proposed Rule, while also examining the statutory amendments and previous rulemakings that create its foundation.Continue Reading HHS Issues Proposed Rule to Provide Clarity on Rights of Conscience in Healthcare
Jarrod Brodsky is an associate in the Corporate Practice Group in the firm's Washington, D.C. office.
Overall, healthcare professionals are 10-15% more likely to develop substance abuse issues than the general population. As addiction to prescription medication has reached nation-wide epidemic proportions, it has become a major driver of drug diversion. Drug diversion occurs when prescription medicines are obtained or used illegally. Healthcare practitioners and facilities are the gatekeepers tasked with safeguarding prescription controlled substances. The failure of a facility to effectively prevent drug diversion leads to substandard care, the denial of essential pain medication or therapy, risk of infection, and even death. Continue Reading Don’t Let Drugs Bring You Down: The Importance of an Effective Drug Diversion Program
On Friday, August 26, 2022, the Department of Health and Human Services’ Centers for Medicare and Medicaid Services (“CMS”), the Department of Labor’s Employee Benefits Security Administration and the Department of Treasury’s Internal Revenue Service (the “Departments”) published a final rule updating key regulations pertaining to the No Surprises Act (the “Final Rule”). The Final Rule changes requirements promulgated through prior interim final rules[i] to conform with two rulings by the U.S. District Court for the Eastern District of Texas.[ii] The Final Rule addresses specific disclosure requirements for group health plans and health insurance issuers related to the Qualified Payment Amount (“QPA”) for out-of-network (“OON”) services and sets forth the factors and information which certified Federal Independent Dispute Resolution (“IDR”) entities must consider in arbitrating disputes for OON services or items.Continue Reading Final Rule Changes No Surprises Act Requirements
The Eighth Circuit Court of Appeals recently tossed a $5.5 million jury verdict finding that a physician violated the False Claims Act (“FCA”) by submitting claims for items and services ordered subsequent to a violation of the Federal health care program anti-kickback statute (“AKS”). According to the appellate court, the trial court’s jury instruction “brushed aside causation” and “misinterpreted” a 2010 amendment to the AKS.Continue Reading Eighth Circuit: In False Claims Act Cases Based On Kickback Violations, the Kickback Violation Must Be the “But For” Cause of the Items and Services Subject to the Claim
On June 15, 2022, in a win for hospitals, the Supreme Court issued its opinion in American Hospital Association et. al. v. Becerra (“Becerra”), overturning massive reimbursement reductions in the 340B drug pricing program (“340B Program”).Continue Reading Supreme Court Saves Hospitals from $1.6B Cut to 340B Program
On April 29, 2022, the Centers for Medicare and Medicaid Services (“CMS”), issued the final rule on Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (the “Final Rule”). CMS promotes the Final Rule as advancing “CMS’ strategic vision of expanding access to affordable health care and improving health equity in Medicare Advantage (MA) and Part D through lower out-of-pocket prescription drug costs and improved consumer protections.” With a few exceptions, the Final Rule is a wholesale codification of the proposed rule. Except as noted below, the requirements of the Final Rule are effective January 1, 2024.
Continue Reading CMS Issues Contract Year 2023 Final Rule for Medicare Advantage Organizations and Prescription Drug Sponsors
Last month, a three-judge panel in the Ninth Circuit reversed the Northern District of California’s ruling in Wit v. United Behavioral Health. In Wit, the district court ruled that United Behavioral Health (“UBH”) breached its fiduciary duties under ERISA to insureds by denying their mental health and substance use disorder claims as a result of allegedly pervasively flawed medical necessity criteria that the court concluded are not consistent with generally accepted standards of care (“GASC”). The district court ordered UBH to reprocess over 60,000 claims.
Continue Reading Less is More: Brevity is the Soul of Wit
In our November 9, 2021, blog post on the No Surprises Act (“NSA”), we discussed new consumer protections against surprise out-of-network bills. In addition to protecting insured consumers from balance billing, the NSA protects uninsured (or self-pay) individuals from many unexpectedly high medical bills. Specifically, effective January 1, 2022, a provider must furnish a self-pay patient with notice and a good faith estimate (“GFE”) of the cost of care prior to all scheduled services. This includes, among other things, a GFE of the cost of office visits, therapies, diagnostic tests, infusions, surgeries and any services reasonably expected to be provided in conjunction with such scheduled services. On December 21, 2021, the Centers for Medicare & Medicaid Services (“CMS”) issued guidance on the Good Faith Estimate and the Patient-Provider Dispute Resolution (“PPDR”) process for people without insurance or who plan to pay the costs themselves.
Continue Reading Q&A: The No Surprises Act’s Protections for Uninsured (or Self-Pay) Individuals
On January 6, 2022, the Centers for Medicare and Medicaid Services (“CMS”) issued the proposed rule on Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (the “Proposed Rule”). Per CMS, the Proposed Rule will reduce out-of-pocket prescription drug costs, improve price transparency and market competition under the Part D program, strengthen consumer protections to ensure Medicare Advantage (“MA”) and Part D beneficiaries have accurate and accessible information about their health plan choices and benefits, strengthen CMS oversight of MA and Part D plans, and improve the integration of Medicare and Medicaid programs for individuals enrolled in dual eligible special needs plans (“D-SNPs”). CMS failed to mention that the Proposed Rule will also result in additional administrative burdens and increased costs for MA organizations (“MAOs”) and Part D sponsors.
Continue Reading CMS’s Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs
Physicians and other providers can take a deep breath as Congress has acted to prevent the trio of Medicare payment cuts that were set to take effect at the beginning of 2022—a 3.75% cut due to scheduled changes in the Medicare Physician Fee Schedule (“PFS”), a 2% cut for Medicare sequestration, and a 4% Statutory Pay-As-You-Go (“PAYGO”) Act cut would have slashed Medicare payments by nearly 10% during a tumultuous time for healthcare. The Protecting Medicare and American Farmers from Sequester Cuts Act (S. 610) was approved by the U.S. House of Representatives on December 7 and passed the U.S. Senate on December 9, 2021. The bill has been sent to President Biden’s desk for his signature.
Continue Reading News Flash: Last Minute Congressional Action Saves Physicians from a Nearly 10% Cut to Medicare Payments
This post originally appeared as an article in the Los Angeles Daily Journal on October 29, 2021.
As of January 1, 2022, patients will no longer be at risk for one of the most detested practices in healthcare: surprise out-of-network bills.Continue Reading Relief from Surprise Bills – Congress Passes the No Surprises Act What Providers and Insurers Need to Know