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The Department of Justice (DOJ) reported that its False Claims Act (FCA) recoveries for civil cases raked in approximately $2.7 billion for fiscal year 2023, representing a $450 million jump from 2022 recoveries.  Of the $2.7 billion recovered by the DOJ for 2023, approximately $1.8 billion (67%) came from the health care sector.

The real headline, however, may be the record-setting number of new FCA cases initiated in 2023 ­–– 500 initiated by the government and 712 initiated by private relators, for a total 1,212 new cases, over 250 more than the next-highest year (2022). Previous trends aside, this signals busy times ahead for the FCA.Continue Reading DOJ Announces $2.7 Billion in FCA Recoveries and Enforcement Priorities

The Substance Abuse and Mental Health Services Administration (SAMHSA) has issued a final rule governing the use of medications for the treatment of opioid use disorder (OUD). In the rule, the first major update in 20 years, the agency made permanent some of the telehealth flexibilities that were put into place to respond to the COVID-19 pandemic and made a number of other changes similarly aimed at improving patient access to and reducing stigma of OUD treatment.

Additionally, with this rule, SAMHSA updated accreditation and certification requirements for opioid treatment programs (OTPs) as required by the Consolidated Appropriations Act, 2023 (CAA). The rule, which was printed in the Federal Register on February 2, 2024, takes effect April 2, 2024, and has a compliance date of October 2, 2024.Continue Reading SAMHSA Finalizes Major Update to Rules Governing Opioid Treatment Program Requirements

On Nov. 5, 2021, the U.S. Supreme Court consolidated and granted certiorari to a pair of cases involving physicians who were criminally prosecuted for prescribing controlled substances (specifically, opioids) in violation of the Section 841(a)(1) of the Controlled Substances Act (“CSA”).  The consolidated cases—Ruan v. United States and Kahn v. United States—present questions regarding the requisite state of mind for a jury to convict a prescriber under the CSA and the availability and nature of a “good faith” defense to criminal liability under the statute.  By agreeing to hear these cases, the Court positions itself to resolve, or at minimum weigh in on, the current circuit splits regarding these issues.

Under the CSA, as interpreted by the Supreme Court in United States v. Moore, 423 U.S. 122 (1975), practitioners who are registered to legally prescribe controlled substances can nonetheless be found to have violated the CSA if they prescribe in a manner that “fall[s] outside the usual course of professional practice.”  However, petitioners argue that the state of mind necessary to convict varies by circuit.  Judicial willingness to issue a specific jury instruction on the availability of a “good faith” defense similarly varies.Continue Reading SCOTUS to examine “good faith” defense in criminal opioid prescription cases

The Department of Health and Human Services (HHS) has modified HIPAA retail pharmacy transaction requirements to differentiate between partial fill and full refills of opioids and other Schedule II drug prescriptions.  Specifically, HHS has finalized the requirements for use of the National Council for Prescription Drug Programs (NCPDP) Telecommunication Standard Implementation Guide, Version D, Release …

Health policy has been the focus of several House Energy and Commerce Committee hearings this month.  Notably, the Energy and Commerce Health Subcommittee held its first legislative hearing on cannabis policy, although much of the hearing focused on the status of marijuana research under the Controlled Substances Act, as discussed in a recent Reed…

The Centers for Medicare & Medicaid Services (CMS) has published its proposed Medicare physician fee schedule (PFS) rule for calendar year (CY) 2020.  In addition to updating rates for physician services, CMS proposes changes to numerous other Medicare Part B policies.  Highlights of the proposed rule include the following:

  • The proposed 2020 conversion factor (CF)

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Prior to the 4th of July break, Senate and House Committees approved more than a dozen health policy bills, covering topics including:  surprise medical bills, health pricing transparency, drug prices and competition, various Medicare policies, and public health program reauthorization, among others.  The following are highlights of recent action.  Note that none of the bills has yet been considered by the full House or Senate, and all are subject to change during the legislative process.

Senate HELP Committee

The Senate Health, Education, Labor and Pensions (HELP) Committee approved S 1895, the Lower Health Care Costs Act of 2019.  This high-profile, bipartisan legislation would hold patients harmless from “surprise” medical bills for out-of-network services provided at an in-network facility, with payment to out-of-network providers set at the median contracted rate for in-network providers in the geographic area (a controversial “benchmark rate” proposal).  The bill contains separate protections regarding costs for emergency room and air ambulance services.  Additionally, S 1895 seeks to improve health care transparency by, among other things, banning what are described as “anticompetitive” terms in contracts between insurers and providers; providing patients with additional information on out-of-pocket costs; and regulating certain pharmacy benefit manager (PBM) pricing practices.  The legislation also includes numerous provisions intended to promote generic drug and biosimilar biological product innovation; improve health information exchange and strengthen health entity cybersecurity practices; and authorize various public health programs.  The Committee approved the bill on June 26, 2019 on a vote of 20-3.  Committee Chairman Lamar Alexander expressed hope for full Senate consideration of the bill in July.

During the same markup, the HELP Committee also approved S 1173, the Emergency Medical Services for Children Program Reauthorization Act, and S 1199, the Poison Center Network Enhancement Act of 2019.

Senate Judiciary Committee

The Senate Judiciary Committee approved the following four bills that are intended to help reduce prescription drug prices:

  • S 1227, the Prescription Pricing for the People Act of 2019, which would require the Federal Trade Commission (FTC) to study the role of PBMs in the pharmaceutical supply chain and provide Congress with related policy recommendations.
  • S 440, the Preserving Access to Cost Effective Drugs Act, which would bar patent owners from asserting sovereign immunity, including the sovereign immunity accorded to an Indian tribe, in certain drug patent disputes.
  • S 1224, the “Stop STALLING Act,” to authorize the FTC to take action against entities that file “sham” citizen petitions to attempt to interfere with approval of a competing generic drug or biosimilar.
  • S 1416, Affordable Prescriptions for Patients Act of 2019, which would authorize the FTC to challenge certain brand manufacturer practices (e.g., “product hopping” and “patent thickets”) that could discourage generic drug and biological use.

House Ways and Means Committee

The House Ways and Means Committee recently passed the following health policy bills:
Continue Reading Congressional Committees Advance Multiple Bills Addressing Surprise Medical Billing, Prescription Drug Policy, and Other Health Policy Issues

The Medicare Payment Advisory Commission (MedPAC) has issued its annual report to Congress with recommendations for updates to Medicare fee-for-service rates for 2020.

With regard to hospital services, MedPAC recommends that Congress update Medicare inpatient and outpatient prospective payment system (PPS) rates by 2% in 2020.  MedPAC also proposes a new hospital value incentive program (HVIP) to replace Medicare’s current inpatient hospital quality programs.[1]  In short, the HVIP would include a small set of population-based outcome, patient experience, and value measures; score all hospitals based on the same prospectively-set performance targets; and account for social risk factors by distributing payment adjustments through peer grouping.  MedPAC believes the HVIP “will be simpler and will produce more equitable results compared with existing quality payment programs.”

MedPAC recommends no change to Medicare physician fee schedule rates in 2020, in accordance with the Medicare Access and CHIP Reauthorization Act of 2015.  MedPAC reiterates its criticism of current Merit-based Incentive Payment System measures, stating that they “are neither effective in assessing true clinician quality nor appropriate for Medicare’s value-based purchasing programs.”

MedPAC continues to call for implementation of a unified PPS for post-acute care (PAC) providers, including skilled nursing facilities (SNFs), home health agencies (HHAs), inpatient rehabilitation facilities (IRFs), and long-term care hospitals (LTCHs).   Acknowledging that implementation of a unified PAC PPS “is on a longer timetable,” MedPAC recommends the following setting-specific interim payment updates for 2020:
Continue Reading MedPAC Recommends Medicare Payment Updates for 2020

Federal health policy is an early focus for Congressional committees.  In addition to several hearings held in January, Congressional hearings in February have concentrated on the Affordable Care Act (ACA) and primary care, including the following:

  • A House Energy and Commerce Committee hearing on the Texas v. United States court case challenging the constitutionality

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On February 14, 2019, CMS is hosting an educational call on new opioid policies for Medicare drug plans.  The call will focus on improved safety alerts when opioid prescriptions are dispensed at the pharmacy, and drug management programs for individuals at-risk for misusing or abusing “frequently abused drugs” (opioids and benzodiazepines).  The target audience for…

The Department of Health and Human Services (HHS) has issued a proposed rule that would modify the current HIPAA transaction standard for retail pharmacy transactions (the August 2007 revision of NCPDP telecommunications standard D.0) with respect to claims and similar transactions for Schedule II drugs.  HHS states that the change would enable covered entities to…

President Trump has just signed into law HR 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act.  The bipartisan legislation includes almost 200 provisions intended to strengthen opioid prevention and treatment efforts and bolster law enforcement tools.

Among many other things, the new law: 

  • Seeks to

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On August 15, 2018, CMS is convening a Special Open Door Forum on “Sharing Federal Strategies to Address the Opioid Epidemic.”  The conference call, which will feature representatives from several Department of Health and Human Services agencies, is intended to educate opioid prescribers on federal resources and strategies for safe prescribing as well…

The House of Representatives has overwhelmingly approved bipartisan legislation, HR 6, the SUPPORT for Patients and Communities Act, intended to bolster opioid prevention and treatment programs and strengthen law enforcement efforts.  Among many other things, the wide-ranging legislation would:
Continue Reading House Approves Sweeping Opioid Prevention/Treatment Legislation

Congress is considering a wide range of legislative proposals that seek to address the continuing opioid crisis. The following committees have tackled this topic recently:

  • Senate Committee on Health, Education, Labor and Pensions (HELP) approved S. 2680, the Opioid Crisis Response Act of 2018, comprised of 40 proposals to address the opioid crisis through

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Congressional committees with jurisdiction over health care legislation continue to focus on the opioid crisis:

  • The Energy and Commerce held a hearing on “Combating the Opioid Crisis: Improving the Ability of Medicare and Medicaid to Provide Care for Patients” and a roundtable discussion on “Personal Stories from the Opioid Crisis.”
  • The House Oversight Healthcare Subcommittee examined “Local Responses and Resources to Curtail the Opioid Epidemic.”
  • A Senate Judiciary Committee hearing focused on “Defeating Fentanyl: Addressing the Deadliest Drugs Fueling the Opioid Crisis.”
  • The Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing on S.2680, the Opioid Crisis Response Act of 2018; the Committee is scheduled to vote on the legislation April 24.
  • The House Ways and Means Trade Subcommittee will hold a hearing April 25 on “The Opioid Crisis: Stopping the Flow of Synthetic Opioids in the International Mail System.”

In other policy areas:
Continue Reading Congressional Hearings Focus on Health Care Innovation, Medicaid Fraud, Health Policy Legislation – But Spotlight Remains on Opioids

CMS has announced final Medicare Advantage (MA) and Part D plan policies and rates for 2019. The final 2019 rule, published on April 16, 2018, implements a Comprehensive Addiction and Recovery Act (CARA) provision that allows Part D plan sponsors to establish drug management programs. Under this policy, plan sponsors may limit at-risk beneficiaries’ access to coverage of “frequently abused drugs” (opioids and benzodiazepines) to selected prescribers and/or network pharmacies, and they may use of point-of-sale claim edits, subject to various conditions.

Other policies adopted in the final rule include the following:
Continue Reading 2019 Medicare Advantage/Part D Policies Finalized, Including Comprehensive Addition and Recovery Act Drug Management Requirements