Health care and life science companies operating globally should be aware of the increased regulatory scrutiny in the U.S., the UK and Asia-Pacific when considering their obligations to monitor and retain business communications conducted through messaging platforms on employees’ personal devices. It is vital for these companies review the effectiveness of their compliance policies and
Analysis of Medicare Prescription Drug Pricing Changes in Inflation Reduction Act
The Inflation Reduction Act included some very significant changes to the ways in which the Medicare program handles drug pricing.
Among the changes are a redesign of the Medicare Part D (prescription drug benefit) program, as well as requirements that certain drug prices be negotiated with the Centers for Medicare & Medicaid Services and a provision that drug manufacturers pay inflation rebates to on utilization of drugs covered by Medicare Part B and Part D in certain circumstances.
To address these changes to the law, Reed Smith has put together a series of alerts and webinars on the topics.
Continue Reading Analysis of Medicare Prescription Drug Pricing Changes in Inflation Reduction Act
Agencies Look for Input on No Surprises Act Good Faith Estimate Rules
Following closely after the clarifying independent dispute resolution process Final Rule, the four executive branch entities tasked with implementing the provisions of the No Surprises Act, the Office of Personnel Management, the Centers for Medicare & Medicaid Services (CMS), Employee Benefits Security Administration and the Internal Revenue Service have issued a request for information to help the agencies craft the next stage of regulations for the surprise billing law.
The request is the latest effort by agencies to seek stakeholder input on the contours of the regulations implementing the No Surprises Act, this time with a focus on the requirements in the law for providers to issue a good faith estimate (GFE) to plans for services that their covered patients will submit for reimbursement and for insurers to issue an advanced explanation of benefits (AEOB) to their plan participants based on estimated charges relayed to them by providers.
Specifically, the entities are looking for information and recommendations on the process of transferring data from providers and facilities to plans, issuers and carriers to facilitate the GFE and AEOB processes, as well as the economic impacts of implementing these requirements. The notice was added to the Federal Register on Friday, Sept. 16 and comments are due to the agencies by November 15.
Continue Reading Agencies Look for Input on No Surprises Act Good Faith Estimate Rules
Supreme Court judgment triggers abortion bans in states, legislative action in others
The U.S. Supreme Court on July 26 issued its judgment in the case of Dobbs v. Jackson Women’s Health, officially setting in motion abortion bans in at least four states.
A “judgment” is distinct from the opinion and typically follows issuance of the opinion by about a month. This certified document from the clerk of The Supreme Court is usually simply a formality to allow the Court of Appeals from which the case originated to either close its docket or begin the process of implementing what was ordered on remand.
In the Dobbs case, the Supreme Court issued its opinion (142 S. Ct. 2228) on June 28, but the judgment issued from the clerk’s office to the Fifth Circuit about 30 days later.
Because of the way the trigger bans in at least four states were worded, the issuance of the judgment on July 26 also started the clock on the enforcement of those states’ laws. The trigger laws in Texas, Tennessee, Idaho, and North Dakota will each take effect 30 days after the judgment was issued, i.e., on August 25, 2022.
Unanswered Questions on Privacy and Employment from Supreme Court Overturn of Roe v. Wade
As the health care industry as a whole comes to grips with the fallout from the U.S. Supreme Court’s decision to overturn Roe v. Wade in Dobbs v. Jackson Women’s Health, here at Reed Smith we have formed a Reproductive Health Working Group to bring expertise from the across our many specialty areas to help our clients to prepare for the post-Dobbs reality.
To that end, we have generated a series of “unanswered questions” client updates to reflect the issues that a Roe reversal may have for the health care industry. Earlier posts on this blog have shared the parts of that series that focused on pharmacies, health care providers, and fertility practices, and employee benefit plans.
The Working Group has put together two new updates to branch into the employment and privacy areas.
Unanswered Questions for Employee Benefits Plans from Supreme Court overturn of Roe v. Wade
Now that U.S. Supreme Court has overturned Roe v. Wade in Dobbs v. Jackson Women’s Health, the implications of that action will be felt by employee benefit plans and the companies that offer them. Among those implications are the logistics of how to offer coverage for employees who must travel out of state to obtain a legal abortion.
The Reed Smith Reproductive Health Working Group has generated a series of “unanswered questions” client updates to reflect the issues that a Roe reversal may have for the health care industry. Earlier posts on this blog shared the first three parts of that series that focused on pharmacies, health care providers, and fertility practices, respectively.
In Part IV of the series, Allison Warden Sizemore considers the implications of the reversal on employee benefits plans. Specifically she highlights issues arising from an employer’s offer to cover travel costs for employees who travel for an abortion.
Supreme Court Overturns Roe and Casey
In an opinion authored by Justice Samuel Alito and joined by four of the other conservatives, The Supreme Court in Dobbs v. Jackson Women’s Health Organization held that there is no federal constitutional right to an abortion, and that the decision to regulate abortion should be governed exclusively by state law. In doing so, the decision overruled The Supreme Court’s previous decisions of Roe v. Wade decided in 1973 and Planned Parenthood of Southeastern PA v. Casey decided in 1992.
The Dobbs opinion tracks closely with the previous leaked draft opinion from The Supreme Court and includes concurring opinions from Justice Thomas, Justice Kavanaugh, and Chief Justice Roberts, as well as a dissent by Justices Breyer, Sotomayor and Kagan.
The Chief Justice concurred in the judgment but wrote separately to indicate that he would have only upheld the Mississippi law, and stopped short of overturning the precedents of Roe and Casey.
Decision changes landscape of reproductive health care rights
The Court’s decision, which was effectively 6-3 given the Chief Justice’s concurrence in the judgment, changes the landscape of reproductive health care rights throughout the country.
Unanswered questions for health care and fertility providers from Supreme Court overturn of Roe v. Wade
Now that U.S. Supreme Court has overturned Roe v. Wade in Dobbs v. Jackson Women’s Health, the implications of that action will be far reaching both for fertility practices and for health care providers in general.
The Reed Smith Reproductive Health Working Group has generated a series of “unanswered questions” client updates to reflect the
Unanswered questions for pharmacies if Supreme Court decides to overturn Roe v. Wade
As noted in an earlier post here, the U.S. Supreme Court is expected to issue an opinion in the Dobbs v. Jackson Women’s Health case sometime before its recess in July. A draft majority opinion, authored by Justice Samuel Alito and overturning Roe v. Wade, was leaked to news media in May.
While we won’t
California AG urges mobile app companies to safeguard reproductive health data
As the U.S. Supreme Court inches closer to the end of its term and a decision in a Mississippi abortion law case that is expected to either limit or eliminate the precedent of Roe v. Wade, the California Attorney General has urged mobile health app companies to safeguard the reproductive health data of people who
FTC announces inquiry into PBM practices and orders PBMs to provide information
On June 7, 2022, the Federal Trade Commission (FTC) announced that it would conduct an inquiry into the competitive impact of contracting and other business practices of pharmacy benefit managers (PBMs), including their effects on access to and affordability of prescription drugs. As part of the inquiry, which is similar to FTC inquiries into other aspects of the health care industry, the FTC issued orders under Section 6(b) of the FTC Act requiring the six largest PBMs to provide information and records to the Commission.
The five FTC commissioners voted unanimously on June 6, 2022 to conduct the study and issue the Section 6(b) orders. According to the FTC mission statement, Section 6(b) “enables [the FTC] to conduct wide-ranging studies that do not have a specific law enforcement purpose.”
In February, an earlier proposed review of PBMs failed to receive approval on a 2-2 party-line vote, with the two Republican Commissioners, Noah J. Phillips and Christine S. Wilson, voting against the proposed study. Commissioner Alvaro Bedoya was confirmed by the Senate in May, giving Democrats three seats on the Commission.
Commissioners Phillips and Wilson issued a statement indicating that they had voted to approve the current inquiry because it has a different scope than the previously proposed study, including relationships between PBMs and both pharmacies and pharmaceutical manufacturers, “including, critically, how those practices might impact out-of-pocket costs for consumers.”
The FTC stated that its inquiry will examine PBMs’ role as middlemen who are hired by health plans to negotiate rebates and fees with drug manufacturers, create drug formularies and related policies, and reimburse pharmacies for patients’ prescriptions. The Commission said that PBMs “often have enormous influence on which drugs are prescribed to patients, which pharmacies patients can use, and how much patients ultimately pay at the pharmacy counter.” Chair Linda M. Khan stated that the FTC had received complaints about PBM practices from patients and professionals across the healthcare system, several of which the inquiry will examine.
Continue Reading FTC announces inquiry into PBM practices and orders PBMs to provide information
Recent Medicare Advantage and Part D rule increases regulatory oversight on third party marketers
The Centers for Medicare and Medicaid Services has published a final rule that governed the way that Medicare Advantage and Medicare Part D plans interact with third-party marketing organizations. The rule, which goes into effect on June 28, 2022, will have a wide ranging impact on the insurers who run these plans.
Supreme Court overturn of Roe v. Wade could impact drug and device makers
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