Last month’s leaked U.S. Supreme Court draft majority opinion from Justice Alito in Dobbs v. Jackson Women’s Health Organization that would overturn Roe v. Wade and Planned Parenthood v. Casey could have long reaching effects for health law beyond the obvious liability for providers who are involved in women’s health and abortion. If the opinion
SCOTUS Review of Rule 9(b) in False Claims Act cases may be on the way
Supreme Court review of Rule 9(b)’s application in False Claims Act cases may finally be coming whether the Executive Branch likes it or not.
In January, the Supreme Court, which is considering a certiorari petition in Johnson v. Bethany Hospice and Palliative Care, LLC, asked the Solicitor General to weigh in on whether the Court should accept the case. The case presents the question of what Rule 9(b) requires in cases arising under the False Claims Act, which is an important threshold question in many False Claims Act cases resulting in significant motions practice.
As past Solicitors General have done before her, the current Solicitor General’s brief filed late on May 24 argued that the Supreme Court should not grant plenary review because there really isn’t a meaningful circuit split on the issue. The brief also argues that the case is not a good vehicle for Supreme Court review because the district court dismissed the relator’s case on the alternative ground that the relator had not adequately pleaded violations of the federal anti-kickback statute, an issue the U.S. Court of Appeals for the Eleventh Circuit did not reach on appeal.
Continue Reading SCOTUS Review of Rule 9(b) in False Claims Act cases may be on the way
OSHA reopens comments on COVID-19 Healthcare Emergency Temporary Standard
The Occupational Safety and Health Administration (“OSHA”) has reopened the comment period on its June 2021 interim final rule establishing an Emergency Temporary Standard governing occupational exposure to COVID-19 in healthcare settings, codified at 29 C.F.R. § 1910 Subpart U (“Healthcare ETS”).
While this reopening reaches certain questions and issues presented by OSHA and not the entire rule, the reopening of the comment period signals the beginning of the effort to finalize a permanent standard by OSHA only three months after the agency withdrew the Healthcare ETS. The Healthcare ETS required healthcare organizations to develop a COVID-19 plan for its workplace that included health screening and management, masking, distancing, and support for vaccination. The Healthcare ETS was withdrawn in December 2021 because OSHA determined that its efforts to establish a permanent standard would exceed the six-month time period allowed under the Occupational Safety and Health Act.
The notice reopening the comment period gives stakeholders both an early view into potential regulatory outcomes of the final rule as well as a series of information requests.
Continue Reading OSHA reopens comments on COVID-19 Healthcare Emergency Temporary Standard
Portion of No Surprises Act IDR rule procedures set aside by federal district court
On February 23, 2022, a federal district court judge in Texas agreed with the Texas Medical Association that some provisions of the interim final rules implementing the No Surprises Act were promulgated in violation of the provisions of the Administrative Procedures Act (“APA”). As a remedy, the court ordered those provisions vacated and remanded the affected rules back to the federal agencies for further consideration.
In a memorandum issued February 28, the Centers for Medicare & Medicaid Services, one of the federal agencies that promulgated the rule (along with the Employee Benefits Security Administration and the Internal Revenue Service) indicated that it was still reviewing the court’s decision and considering next steps, which could include an appeal to the U.S. Court of Appeals for the Fifth Circuit. Additionally, CMS said that it was withdrawing any guidance documents based on the invalidated sections and will launch revised guidance and training for certified independent dispute resolution (“IDR”) entities and parties subject to the process. Those guidance documents will be edited to conform to the court’s decision and republished. Important to providers, CMS emphasized that the court’s order does not affect its other rulemaking related to the No Surprises Act.
Continue Reading Portion of No Surprises Act IDR rule procedures set aside by federal district court
OIG permits retailer to use Medicaid enrollment as qualification for discount program
In the first advisory opinion of 2022, the Department of Health and Human Services’ Office of Inspector General (OIG) allowed Medicaid beneficiaries to qualify for a benefit available to low-income individuals, even though the arrangement would not qualify as a “retailer reward.”
The OIG stated it would not seek enforcement of the federal Anti-Kickback Statute or the Beneficiary Inducements Civil Monetary Penalty Statute (CMP Law) for an arrangement proposed by a web-based retailer that that sells a wide variety of consumer goods and services, and that offers fee-based membership programs with a number of benefits, including pharmacy-related benefits.
The retailer requested an advisory opinion from OIG to allow individuals to use Medicaid enrollment to qualify as eligible for participation in the discount programs that provided certain expedited free shipping, and discounts on food and grocery items. In issuing a favorable advisory opinion, OIG determined that allowing individuals to use their Medicaid enrollment status as a qualification presented a minimal risk of fraud and abuse to federal health programs.
CMS health care staff vaccination rule enforceable as challenges continue UPDATED
UPDATE 1/20/22:
At the request of the state of Texas, the federal court has dismissed that state’s challenge to the Omnibus Covid-19 Health Care Staff Vaccination Rule. As a result, facilities within that state will now be subject to the requirements of the Rule. The CMS has set the following deadlines for compliance within the state:
Phase 1: As of February 22, 2022, all covered individuals must have either completed the initial dose of a primary series of vaccine or applied for an exemption for religious or health reasons.
Phase 2: As of March 21, 2022, all covered individuals must have either completed the primary series of vaccine or been approved for an exemption for religious or health reasons. The employee need not have passed through the two-week post-vaccination period that generally defines complete vaccination; they need only have received their complete series of vaccines.
The CMS Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule survived its initial trip to the U.S. Supreme Court on January 13 with a per curiam decision that stayed injunctions placed on the rule by federal district courts in December.
The Supreme Court took the rare action of holding oral argument and then issuing a full opinion (with dissents) on the emergency stay application that had been brought by the Centers for Medicare & Medicaid Services, asking the Court to allow the agency to enforce the rule while challenges to its validity continue in the lower federal courts.
The Court was definitive that the rule as published falls within the authority of the Secretary of Health and Human Services to promulgate based on the statutory authority conferred by Congress through the Social Security Act (SSA). Specifically, the court found that the various statutory provisions within the SSA allow the Secretary to impose conditions of participation on the receipt of Medicare and Medicaid funds that are necessary in the interest of the health and safety of individuals who furnish services reimbursable under those programs and the federal program beneficiaries that they serve.
However, the Court’s opinion still leaves some questions unanswered about whether the rule will be enforceable in Texas and whether eventually some facilities may be exempted.
Continue Reading CMS health care staff vaccination rule enforceable as challenges continue UPDATED
Pending investigations/cases no longer prevent OIG advisory opinions
The Department of Health and Human Services’ Office of Inspector General (OIG) will be lifting its long-standing refusal to accept requests for advisory opinions if the request describes a course of action that is “the same or substantially the same” as a course of action that is either under investigation by OIG, or is the subject of a proceeding involving a governmental agency. As of February 10, 2022, a new final rule issued by the OIG will do away with that restriction and allow entities to request an advisory opinion, even if the requested course of action is the same or substantially the same as one under investigation or is the subject of a proceeding involving a governmental agency. Previously, the OIG’s policy deliberately left unsettled many fraud-and-abuse issues implicated by pending investigations or litigation.
As the final rule points out, however, seeking clarity during a pending investigation or litigation will carry risk: the mere fact that a course of action is the subject of a qui tam case or under investigation “will weigh against the issuance of a favorable advisory opinion because such circumstances generally indicate that the arrangement does not present a sufficiently low risk of fraud and abuse.”
This warning seems to assume that all investigations and litigation have equal merit, which is certainly not the case with matters initiated by self-appointed whistle-blowers under the False Claims Act, who often bring cases with very little merit. Nevertheless, the new rule provides flexibility, and provides opportunities for the OIG to provide guidance to health care companies seeking to develop business opportunities that, for example, a long-pending and/or declined qui tam case may have stymied.
Continue Reading Pending investigations/cases no longer prevent OIG advisory opinions
CMS issues interim final rule on SARS-CoV-2 vaccination for health care workers
The Centers for Medicare and Medicaid Services (CMS) has published an interim final rule that changed the conditions of participation in Medicare and Medicaid to require vaccination of certain healthcare workers. The rule, title “Omnibus COVID-19 Health Care Staff Vaccination Rule” was published in the Federal Register on November 5, 2021.
The rule requires all employees of certain health care entities that are regulated by CMS to obtain their first vaccination shot or apply for a religious or other health or disability related exemption by December 6, 2021. Additionally, the rule requires either completed vaccination series or approved exemption by January 4, 2022.
Covered Entities and Individuals
The rule is not a blanket vaccine mandate for all health care workers and Medicare sites of service as had been speculated in various media reports. Instead the rule is limited to only those entities who are surveyed by CMS and have Conditions of Participation, Conditions for Coverage, or Requirements for Participation in the Medicare and Medicaid programs.
Continue Reading CMS issues interim final rule on SARS-CoV-2 vaccination for health care workers
HHS authorizes pharmacy technicians and interns to administer flu vaccines
The flurry of Covid-19 vaccine administration that marked the mid spring to early summer resulting in millions of doses administered daily has given way to a steady stream of approximately 700,000 doses of vaccine administered daily, according to some analysis of CDC data.
But now that August has arrived so has the need for regularly scheduled pediatric vaccines to be administered as schools open up again. Also, next month marks the beginning of flu season and its flood of vaccine requests. All of this demand for vaccine administration could threaten to overwhelm some of the pharmacies that have typically been a destination for quick and easy vaccine administration.
On August 4, the HHS officially amended the PREP Act declaration on medical countermeasures against Covid-19 in an effort to stave off any bottle-necking at pharmacies that administer flu vaccines. The declaration amendment, which took immediate effect and last until the end of the public health emergency officially included qualified pharmacy technicians and interns as “qualified persons” permitted to administer seasonal influenza vaccines to adults age 19 and older. Additionally, the amendment officially identifies the same techs and interns as authorized to administer the Covid-19 vaccine as well as pediatric vaccines that are on the Advisory Committee on Immunization Practices (ACIP) schedule.
Continue Reading HHS authorizes pharmacy technicians and interns to administer flu vaccines
CMS Gives the IPO List the Godfather 3 Treatment
Just when the procedures thought they were out(patient), CMS pulls them back in(patient).
Last year, in the final CY 2021 Outpatient PPS rule, CMS announced its intention to eliminate the Inpatient Only (IPO) List by January 1, 2024. The IPO list featured more than 1,700 procedures that were surgically invasive or required more than 24 hours of post-operational recovery time. As a result, any procedure on the list would only be paid for by Medicare on an inpatient basis.
With the CY 2021 rule, those procedures would be released to outpatient providers in stages, allowing physicians to clinically determine whether inpatient admission was indicated for a particular procedure.
However, in the proposed CY 2022 Outpatient PPS rule, announced on July 19, 2021, CMS reversed that decision and announced that it will now keep the IPO List, reinstating the 298 procedures that were removed by the 2021 rule. CMS said it was responding to concerns from stakeholders about patient safety. In particular, CMS indicated that the 2021 rule removed the procedures on too steep of a timeline. The agency said it wanted to provide “greater consideration of the impact removing services from the list has on beneficiary safety and to allow providers impacted by the COVID-19 PHE additional time to prepare to furnish appropriate services safely and efficiently before continuing to remove large numbers of services from the list.”
Continue Reading CMS Gives the IPO List the Godfather 3 Treatment