The U.S. Court of Appeals for the Eighth Circuit recently weighed in on the causation standard for False Claims Act (“FCA”) cases premised on Anti-Kickback Statute (“AKS”) violations. United States ex rel. Cairns v. D.S. Med. LLC, 42 F.4th 828 (8th Cir. 2022). The panel adopted a strict interpretation, finding that the government or whistleblowers must show a “but-for” causal relationship between kickbacks and claims for payment to establish the requisite link in the FCA liability chain, creating a circuit split on an issue that courts have struggled with for years.

The decision is notable for FCA defendants as it offers support for a defense they have long asserted, and that courts have been reluctant to condone, including an opinion from the U.S. Court of Appeals for the Third Circuit that refused to require a direct causal link between an AKS violation and a false claim.

Continue Reading Eighth Circuit Finds “But-For” Causation Standard for AKS-Premised FCA Cases

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

The Department of Health and Human Services Office of Inspector General (HHS-OIG) recently published a Special Fraud Alert warning health care providers (e.g., prescribers, pharmacies, durable medical equipment providers, clinical laboratories) to steer clear of certain telemedicine arrangements and outlining seven “suspect” characteristics that may present heightened risk of fraud and abuse.

The alert coincides with a third round of criminal “telemedicine takedowns” announced by the Department of Justice (DOJ)  in the last several years, reflecting DOJ’s continued focus on identifying and dismantling fraudulent arrangements that exploit telemedicine technologies and related regulatory flexibilities in the wake of the COVID-19 pandemic.

Telemedicine technologies have created a multitude of opportunities for growth and innovation within the health care industry and are well-positioned to become an ongoing cornerstone of our health care delivery system. However, given the increased level of regulatory scrutiny of telemedicine arrangements, providers and telehealth technology companies, including drug and device manufacturers that offer telemedicine technologies (e.g., platforms, mobile applications) for prescribers and patients that facilitate virtual care,  should carefully plan and closely evaluate existing arrangements to ensure compliance with applicable state and federal laws and avoid implication amongst the recent uptick in enforcement.

Continue Reading Telehealth Under Scrutiny: OIG Special Fraud Alert and DOJ Enforcement Highlights Suspect Characteristics Associated with High-Risk Telemedicine Arrangements

After a long line of opinions scrutinizing the use of rewards programs offered by providers, the Department of Health and Human Services’ Office of Inspector General (“OIG”) issued Advisory Opinion 22-16 on August 19, 2022– a favorable opinion for the provision of gift cards to Medicare Advantage (“MA’) plan enrollees who complete educational modules as part of an online surgical treatment learning tool.

The opinion adds flexibility to existing opinions on gift cards and patient engagement programs and, while binding only on the requestor, provides insight into the OIG’s evolving view of these programs.

Continue Reading OIG Approves Rewards Program for Medicare Advantage Organizations

On August 26, 2022, the Departments of Health and Human Services, Labor, and Treasury (the “Departments”) issued the highly anticipated Requirements Related to Surprise Billing (“August 2022 Final Rule”) and associated guidance materials concerning the independent dispute resolution (“IDR”) process established by the No Surprises Act. The August 2022 Final Rule is narrow in scope and responds to two recent decisions by the Eastern District of Texas vacating portions of the October 2021 Interim Final Rule, Requirements Related to Surprise Billing: Part II (“IFR II”), and incorporates stakeholder comments solicited by the Departments.

Importantly, as discussed more below, the August 2022 Final Rule removes the qualifying payment amount (“QPA”) as the presumptive factor in IDR payment decisions and requires health plans to submit additional information in the IDR process for cases where a claim at issue was “downcoded” by the plan.   

The August 2022 Final Rule will take effect October 25, 2022, 60 days after its publication in the Federal Register

Continue Reading Departments issue new Final Rule and guidance materials for No Surprises Act IDR process

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.

Continue Reading Supreme Court judgment triggers abortion bans in states, legislative action in others

The U.S. Department of Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) released earlier this year the Trusted Exchange Framework and Common Agreement (TEFCA), which is intended to improve electronic interoperability among health information networks (HINs) and facilitate the exchange of health information among connected organizations. 

Importantly, TEFCA is not just about HINs.  Under TEFCA, any organization that connects to a HIN designated as a Qualified HIN (QHIN) may be able to meet many interoperability and information sharing obligations without implementing technology integrations on a request-by-request basis.  ONC believes that TEFCA will “reduce the need for duplicative network connectivity interfaces, which are costly, complex to create and maintain, and an inefficient use of provider and health IT developer resources.” ONC stated that connected organizations “will be able to share information with all other connected entities regardless of which QHIN they choose.” 

However, participation in TEFCA comes with a price.  Organizations that connect to QHINs, either directly or indirectly, will likely need to agree to new contractual requirements that flow-down from QHINs.

Continue Reading ONC’s Trusted Exchange Framework and Common Agreement (TEFCA): Impacts on Health Information Networks and Health Care Organizations

On June 29, 2022, the U.S. Department of Health & Human Services’ Office for Civil Rights (“OCR”) issued two pieces of guidance clarifying the applicability of the Health Insurance Portability and Accountability Act (“HIPAA”) related to privacy of information connected to an individual’s reproductive health. 

Through this guidance, HIPAA addresses both protected health information (“PHI”), which is subject to HIPAA’s rules, as well as general, personal information that is not directly protected by HIPAA.

Continue Reading New Guidance by OCR addresses HIPAA and Disclosures of Information relating to Reproductive Health

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.

Continue Reading Unanswered Questions on Privacy and Employment 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.

Continue Reading Unanswered Questions for Employee Benefits Plans from Supreme Court overturn of Roe v. Wade

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.

Continue Reading Supreme Court Overturns Roe and Casey

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 issues that a Roe reversal may have for these providers. An earlier post on this blog shared Part I of that series that focuses on the issues facing pharmacies.

In Part II of the series, Scot Hasselman, Lesley Reynolds, Sarah Cummings Stewart, and John Kendzior analyze what the decision overturning Roe means generally for health care providers. Among the questions that are addressed are licensing issues, practice of medicine boundaries, oversight and compliance as well as issues for providers at long term care and other institutional settings.

In Part III of the series, Sarah Cummings Stewart, John Kendzior, Arielle Lusardi, and Kristin Parker consider the implications of the reversal on providers whose practice includes fertility care. Specifically, the group discusses the applicability of so-called fetal “personhood” laws as well as conflicts of laws and religious objections. Additionally, there are questions that arise for embryo storage and transportation.

All of the client updates are available here:

Unanswered Questions Part I: Pharmacies

Unanswered Questions Part II: Health Care Providers

Unanswered Questions Part III: Fertility

Reed Smith will continue to monitor any state or federal responses to this decision. If you have any questions about this topic or how the Court’s opinion will affect your organization legally, please reach out to the health care lawyers at Reed Smith.

The Centers for Medicare & Medicaid Services (“CMS”) issued the first round of civil monetary penalties to two hospitals in Georgia for failure to comply with the requirements of the Hospital Price Transparency Final Rule (the “Rule”) on June 7, 2022.

According to the Notices of Imposition of a Civil Monetary Penalty published on the CMS Price Transparency Website, Northside Hospital Atlanta (“Northside Atlanta”) and Northside Hospital Cherokee (“Northside Cherokee”) failed to publish their standard charges and provide access to a machine-readable searchable tool, which would include standard prices for the hospitals’ items and services. CMS took this action after both hospitals failed to respond to the Warning Notices and Requests for Corrective Action Plans issued by CMS.

Effective January 1, 2021, hospitals must publish a machine-readable file that discloses the hospital’s negotiated rates with health plans, gross charges, discounted cash prices, and de-identified minimum and maximum negotiated charges for all items and services. Additionally, hospitals must publish a consumer-friendly, searchable tool that displays in plain language the prices of 300 shoppable medical services that a consumer can schedule in advance.

Continue Reading CMS levies penalties for non-compliance with Hospital Price Transparency Rule

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 know the actual content or ruling of the decision until it is officially released, the leaked majority opinion gives a good indication that the precedent of Roe is either going to be overturned or severely limited. In anticipation of that occurring, Reed Smith has gathered a Reproductive Health Working Group consisting of attorneys and experts across the firm to provide analysis on the potential effects of the Dobbs decision.

As part of that effort, Scot Hasselman, Lesley Reynolds, Sarah Cummings Stewart, and John Kendzior have put together the first of a number of client updates that should provide some clarity for what the expected overturn of Roe will mean for various health care entities. This first installment covers the unanswered questions for pharmacies should Roe be overturned.

The client update is available here.

Reed Smith will continue to monitor Supreme Court decisions as well as any state or federal responses to those decisions. If you have any questions about this topic or how the Court’s eventual opinion will affect your organization legally, please reach out to the health care lawyers at Reed Smith.

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 use their apps.

Paul Pitts, Sarah Bruno, and Smita Patil discuss the AG’s request and how the broad protections of California’s Confidentiality of Medical Information Act impact the health information gathering and security for mobile app companies in this Reed Smith client alert.

Reed Smith will continue to monitor Supreme Court decisions as well as any state or federal responses to those decisions. If you have any questions about this topic or how the Court’s eventual opinion will affect your organization legally, please reach out to the health care lawyers at Reed Smith.

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

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.

Scot Hasselman, Nicole Aiken-Shaban, and Whitney Petrie explore the implications of the rule for both plans and third party marketing organizations in this Reed Smith client alert.

Reed Smith will continue to follow developments in the regulation of Medicare Advantage and Part D plans if you have any questions about this or any other CMS regulations please reach out to the health care lawyers at Reed Smith.

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 does reflect the judgment of a majority of the Court, then it could impact even drug and device companies in ways that were not obvious from the face of the opinion.

Reed Smith has established a working group to evaluate the impact of the decision on our health care and life sciences clients.  The group includes our products liability colleagues who author the Drug and Device Law Blog and have written a post about how the Court’s supposed action would affect medical product manufacturers.

That post is available on the Drug and Device Law Blog here.

Reed Smith will continue following developments as the Supreme Court term comes to a close this month. If you have any questions about what impact this pending decision may have on your practice or business or what the Court’s opinion will mean for you when it does eventually come out, please contact the health care lawyers at Reed Smith.

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

On May 10, 2022, FDA published draft guidance entitled, “Benefit-Risk Considerations for Product Quality Assessments”, which describes the benefit-risk principles applied by FDA when conducting product quality-related assessments of chemistry, manufacturing, and controls (CMC) information submitted for FDA’s review as part of original new drug applications (NDAs), original biologics license applications (BLAs), or supplements to such applications.

In the draft guidance, FDA reiterates its risk-based regulatory approach and applies it in the product quality assessment context.  Specifically, the draft guidance states that FDA continues to identify potential risks to product quality associated with the formulation, manufacturing process, and packaging components when conducting a product quality assessment as well as the proposed control strategy for mitigating those risks.

Continue Reading FDA issues draft guidance for use in product quality assessments