In the two years since the Dobbs v. Jackson Women’s Health decision from the Supreme Court, state legislatures and courts have attempted to define the new post-Roe landscape in health care. That effort includes actions by states to enact health data privacy laws or to amend existing privacy laws to protect consumer health data that may not be covered by the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations.

These new and revised laws, with various effective dates, present novel considerations and compliance challenges for businesses that collect, use, and disclose consumer health data. We put together this alert to walk through some of those considerations including what types of information and businesses are covered by the laws. Additionally, Reed Smith’s San Francisco office will be hosting a comprehensive hybrid-CLE event on April 10 on recent legislation from Washington state and California as well as what to expect going forward with regard to health data privacy.

Reed Smith will continue to follow developments in health care privacy laws. If you have any questions, please reach out to the authors or to the health care lawyers at Reed Smith.

Not a question that we thought we would be asking more than a year after the large omnibus package was signed into law by President Biden. But here we are, with a federal judge in Texas ruling on Feb. 27 that the House’s passage of the Consolidated Appropriations Act, 2023 (P.L. 117-328) (CAA, 2023) violated the “quorum clause” of Article I, Section 5 of the U.S. Constitution.

The court’s ruling puts in jeopardy a number of substantive health policy provisions if it is allowed to stand. Many of the provisions of the act that could be overturned were designed to sunset at the end of 2024 and some have since been reauthorized. But some, like the FDA’s new cosmetic regulatory regime that was included in the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) are more permanent and are now under threat.

The court’s decision limited its impact to only one aspect of the law and enjoined that provision only as applied to public employees in Texas, but the court’s analysis of the way that the law was passed calls into question the entire appropriations act. The Department of Justice (DOJ) has 60 days from the court’s decision to appeal to the U.S. Court of Appeals for the Fifth Circuit. The agency has filed a notice of compliance with the court indicating that neither the DOJ or Equal Employment Opportunity Commission will enforce the law against the state or its agencies.

Continue Reading Was the Consolidated Appropriations Act, 2023 Legitimately Passed by the House?

The Federal Trade Commission (FTC), the Department of Justice’s Antitrust Division, and the U.S. Department of Health and Human Services jointly announced a cross-government inquiry into the impact of private equity investment and other forms of “corporate greed” in the health care sector. As part of the announcement of this effort, the agencies produced a public workshop, hosted by the FTC and entitled, “Private Capital, Public Impact: An FTC Workshop on Private Equity in Health Care.” Before the workshop, the agencies issued a request for information (RFI) seeking public comment on transactions in the health care sector involving private equity firms and other private corporate entities. Responses to the RFI are due by May 6, 2024.

Members of our Antitrust & Competition Team and the Life Sciences Health Industry Group have come together to provide an alert that will give you all that you need to know about this new effort by the enforcement agencies. Reed Smith will continue to follow developments on this inquiry. If you have any questions, please do not hesitate to reach out to any of the authors of the alert.

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 Department of Health and Human Services (HHS), Department of Labor, and Department of the Treasury (collectively, “the departments”) recently confirmed that they will hold firm to the March 14, 2024 extended deadlines for initiating both new and previously initiated batched disputes or single disputes involving air ambulance services in the No Surprises Act Independent Dispute Resolution (IDR) portal.

The extension came about when the departments reopened the portal for all dispute types on December 15, 2023 following four months where the departments suspended new initiations of disputes because of court rulings vacating the departments rules and guidance in part. New single and bundled disputes were reopened on October 6, 2023. However, because the departments had more work to do to conform guidance to the court rulings on both batched and air ambulance claims, they left those suspended until December.

The deadline applies to any party submitting a batched or single air ambulance dispute for whom the IDR initiation deadline fell on any date between August 3, 2023 and December 14, 2023. However, the departments clarified that, as of March 14, 2024, initiating parties who submitted a batched dispute before August 3, 2023, and received notification from a certified IDR entity that the dispute was improperly batched will have the standard 4-business-day period to resubmit, instead of the existing 10 business day time period that was previously mentioned in a guidance document.

IDR Process has seen multiple litigation stops

The No Surprises IDR portal went live in February 28, 2022 only five days after a federal court in Texas invalidated portions of the interim final rule that established the IDR process. That court decision, a subject of an earlier blog post, vacated provisions of the rule that centered around the presumption in favor of IDR using a statutorily defined amount known in the original rule as the qualifying payment amount (“QPA”).

In July 2022 a different court decision vacated a section of the rule governing the use of the QPA that directly applied to air ambulance disputes. The departments responded by instructing certified IDR entities not to apply the vacated standard in any dispute related to air ambulance services.

The departments then issued a new final rule in August 2022 that sought to rectify the problems with the QPA provisions. Six months later, in February 2023, the same federal district court that vacated the rule in the first instance again vacated provisions of the rule. (We blogged about that decision too). The departments halted all IDR efforts for determinations issued on or after Feb. 3, 2023. However, it allowed the IDR entities to process any disputes for items or services furnished before October 25, 2022 since those were not impacted by the new court order.

By March 17, 2023, the departments had completed what they believed to be all of the necessary updates to the IDR portal and process guidance documents to bring them into compliance with the court rules. As a result, they instructed IDR entities to once again begin processing all determinations for disputes on or after October 25, 2022.

But, in August 2023, the same federal district court again vacated provisions of the rule and the guidance documents in two opinions issued three weeks apart. The first, issued on August 3, 2023 vacated the batching provisions of the rule and the $350 per party administrative fee guidance. The second ruling, issued August 25, 2023, vacated provisions relating to how to calculate the QPA.

The departments allowed single and bundled disputes submitted on or before August 3, 2023 to continue to be process, but suspended all batched dispute submissions. By October 2023, the departments had reopened the portal for new single and bundled dispute submissions but kept batched and single air ambulance disputes suspended as they worked to align their guidance to the court’s directives.

By December 2023, the departments finally reopened the portal for batched and air ambulance submissions. However, given the significant backlog of batched and air ambulance disputes that parties were unable to submit during the litigation stops, the departments granted a extension for the submission deadlines to March 14, 2024.

Reed Smith will continue to follow developments on the No Surprises Act and the IDR process. If you have any questions. Don’t hesitate to reach out to the health care lawyers at Reed Smith.

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

Building on prior requests for information and an increased focus on Medicare Advantage oversight, the Centers for Medicare and Medicaid Services (CMS) has issued another request for information (RFI) seeking input on data needed for Medicare Part C, also known as the Medicare Advantage (MA) program. The goal of this RFI, which was published in the Federal Register on January 30, 2024, is to provide CMS with feedback on both the format and types of data that will allow CMS to have better insight into MA organizations and their operations and to consider future rulemaking. Responses to the RFI are due by May 29, 2024.

This RFI is an extension of CMS’s General MA RFI published in August 2022, which generated over 4,000 responses from various stakeholders. The 2024 RFI broadly seeks input on “all aspects of data related to the MA program—both data not currently collected as well as data currently collected.” The eventual goal is to make MA data commensurate with data available from Medicare Parts A and B to ensure appropriate transparency into MA organizations and to address perceived shortcomings through additional rulemaking.

Continue Reading CMS Issues RFI for Medicare Advantage Data

The Department of Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) has published its first final rule on Health Data, Technology and Interoperability. The rule, known as the HTI-1 rule, takes effect on February 8, and governs updates to the ONC’s Health IT Certification Program, as well as regulations on information blocking.

Among the program criteria that the rule addresses include those related to decision support, electronic case reporting and standards-based application programming interfaces (APIs). To address the question of information blocking, the rule provides refined definitions of statutory terms and identifies practices that cannot constitute information blocking as they are considered by ONC to be “reasonable and necessary.”

Continue Reading ONC Finalizes Information Sharing and Algorithm Transparency Rule

On January 17, 2024, the Supreme Court of the United States heard oral argument in two cases—Relentless v. Dep’t of Commerce, and Loper Bright Enters. v. Raimondo—that could have far-reaching effects on administrative law jurisprudence and the authority of federal agencies in years to come.

At the core of both cases is the Supreme Court’s Chevron doctrine, which refers to how courts are to review an agency’s interpretation of a statute that it administers.  Under the test of Chevron v. Natural Resources Def. Council, if an agency’s construction of an ambiguous statute is deemed to be reasonable, a court defers to the agency’s construction—even if the court believes the agency’s construction was not the best reading of the statute. 

Over the last four decades, Chevron deference has faced criticism from those who argue that it is the role of courts, not federal agencies, to say what the law means.  Arguing on Wednesday in support of overturning Chevron, counsel for Loper Bright argued that the Court should instead simply ask one question: “What is the best reading of the statute?”

Continue Reading Supreme Court Tackles Chevron And Could Change How Agencies Regulate The Health Care Industry

The Department of Health and Human Services Office of Inspector General (OIG) kicked off the new year with four new advisory opinions covering retiring physicians, preferred hospital organization discounts for Medigap patients, and gift cards for the referral of potential physician practice customers of a non-clinical consulting company. While OIG published the favorable opinions last week, it issued them on December 28, 2023 to cap off a busy 2023 season.

Two opinions, Opinion 23-13 and Opinion 23-14, are substantially similar to each other and to two other opinions  issued earlier in the year (Opinion 23-09 and Opinion 23-10). All four opinions approve the use of discounts by a preferred hospital organization (PHO) within a “preferred hospital” network as part of Medicare Supplemental Health Insurance (Medigap) policies.

Specifically, the opinions approved of an insurance company contracting with the PHO to provide discounts on the otherwise-applicable Medicare inpatient deductibles for its policyholders and, in turn, the insurer providing a premium credit of $100 off the next renewal premium to those policyholders who used a network hospital for an inpatient stay. This flurry of PHO Medigap discount opinions likely reflects the fact that an OIG advisory opinion is binding only on its requestor, leading different PHOs to seek approval for the same proposal.

The other two opinions include Opinion 23-12, a favorable review of a one-time, voluntary redemption offer to physician partners reaching age 67 to have their partnership units repurchased by a partnership over a 2-year period, contingent upon the physician partners’ agreement to retire from the practice of medicine,  and Opinion 23-15, a favorable review of a consulting company’s gift card offer to physician practices for the referral of potential new customers.

Continue Reading OIG Publishes First Advisory Opinions of the Year

The Department of Health and Human Services (HHS) released a final rule today governing federal protections for health care workers exercising their right to nondiscrimination on the basis of conscience objections.

The rule, entitled, Safeguarding the Rights of Conscience as Protected by Federal Statutes, is scheduled to be published in the Federal Register on Thursday, January 11 and will take effect on March 11, 2024. The rule effectively repeals the majority of a Trump-era rule that was blocked by federal court orders before it even went into effect.

The new rule reinstates provisions of an Obama-era rule that placed the Office for Civil Rights (OCR), the HHS office that handles nondiscrimination enforcement, in charge of coordinating complaints for violations of the conscience protections of various federal laws. The rule also implements a voluntary notice provision that establishes an industry best practice to alert employees to their rights under the laws.

Continue Reading HHS Repeals Most of 2019 Health Care Conscience Protection Rule

On Nov. 8, 2023, the Senate Finance Committee voted 26-0 to approve the Better Mental Health, Lower Cost Drugs, and Extenders Act. Among its other provisions, the bill, for which final legislative text has not yet been released, would, for the first time, mandate minimum prices that Medicare Part D plans, and the pharmacy benefit managers (PBMs) with which they contract, must pay to certain types of pharmacies as reimbursement for the drugs they dispense to Part D plan enrollees.

This measure, together with new pharmacy contracting requirements and related enforcement provisions also included in the bill, would represent an important—albeit limited—modification to pharmacy network contracting rules under Part D, which have been limited by the statutory “non-interference clause” barring the Centers for Medicare and Medicaid Services (CMS) from interfering in contract negotiations between pharmacies and plans or their PBMs.

Floor on Reimbursement to Certain Pharmacies

Section 201 of the bill, entitled “Assuring Pharmacy Access and Choice for Medicare Beneficiaries,” would require that, beginning in 2028, the “total reimbursement” paid for a Part D covered drug to an “essential retail pharmacy” that is an “independent community pharmacy” may not be less than the “average National Average Drug Acquisition Cost (aNADAC)” for retail community pharmacies for such drug. When an aNADAC for retail community pharmacies is not available for the drug, the drug’s aNADAC for applicable non-retail pharmacies or wholesale acquisition cost (WAC) would be used to set the reimbursement floor.

For these purposes:

  • “Essential community pharmacy” would be defined as a retail pharmacy that (1) is not an affiliate of a PBM or Part D plan sponsor, (2) is located in a medically underserved area, and (3) is designated as an essential retail pharmacy by CMS for a plan year, in a list published prior to the beginning of the plan year, based upon these criteria, subject to removals made by CMS when a pharmacy no longer satisfies these criteria.
  • “Independent community pharmacy” would be defined as a retail pharmacy with fewer than four locations that is not affiliated with any person or entity other than its owners.  Franchisees and pharmacies associated with pharmacy services administrative organizations (PSAOs) that meet the relevant requirements can qualify as independent community pharmacies.
  • “Affiliate” would mean “any entity that is owned by, controlled by, or related under a common ownership structure with a pharmacy benefit manager or [Part D plan] sponsor or that acts as a contractor or agent to such pharmacy benefit manager or [Part D plan] sponsor, if such contractor or agent performs any of the functions described” in the bill’s definition of “pharmacy benefit manager.”
  • While “total reimbursement” is not defined in the description of the provision passed by the Committee, a separate discussion draft of the bill released prior to the markup would define it as the “negotiated price” for the drug (essentially, the reimbursement amount the pharmacy is entitled to receive for the drug, including any dispensing fees) plus any incentive payments the pharmacy is entitled to receive and less any fees, pharmacy price concessions, discounts or other forms of remuneration paid by the pharmacy.

Accordingly, the bill’s reimbursement floor would appear to apply only to pharmacies located in a medically underserved area which are part of a chain that includes no more than three pharmacies.  We expect that “medically underserved areas” will be based upon designations made by the Health Resources and Services Administration (HRSA) under Section 330(b)(e)(A) of the Public Health Service Act, which includes a significant portion of the United States, primarily in rural areas.  Further, since the floor is generally set at the aNADAC for the drug, the guaranteed reimbursement such pharmacies would be entitled to receive would only be an approximation of their drug acquisition cost, and not include any reimbursement for other costs of operating a pharmacy or pharmacy profit.

The bill does not specifically define “average NADAC” or “aNADAC,” but the discussion draft of the bill would implement it as the average NADAC for the most recent plan year, when such NADAC was published for the drug for a full plan year.  That draft bill would also provide that when a NADAC for a drug is available but has not been available for a full plan year, the ”most recent” NADAC would be used instead, and when no NADAC is available, the drug’s WAC (i.e., manufacturer list price) would be used.  However, it is not clear whether those provisions will be part of the final legislative text of the bill. 

CMS currently publishes NADACs for retail community pharmacies for Medicaid reimbursement purposes, based upon survey data collected from such pharmacies. In general, a single NADAC is calculated and published for each strength and dosage form of a brand name drug and separately for all generic drugs as a group (including authorized generics) of a given strength and dosage form, subject to availability of adequate survey data.  Section 202 of the bill would separately require that NADAC data also be collected and published for “applicable non-retail pharmacies,” defined to include mail order and specialty pharmacies but exclude long-term care, hospital and certain other types of pharmacies. Further, NADAC would be based upon pharmacy acquisition costs “net of all discounts and rebates (to the extent discount and rebate information is available)”; since current NADACs are based only upon pharmacy invoice prices, the inclusion of rebate data in the calculation potentially could reduce current NADACs for some drugs. While pharmacy submission of data in response to NADAC surveys is currently voluntary, the bill would require all retail community pharmacies and applicable non-retail pharmacies receiving any Medicaid reimbursement to provide information in response to such surveys.

New Preferred Pharmacy Network Contracting Requirements

Under the Part D statute and implementing regulations, a plan sponsor is subject to an “any willing pharmacy” obligation to contract with any pharmacy willing to agree to the plan’s standard terms and conditions for participation in its pharmacy network. However, CMS has indicated that this pharmacy contracting right does not extend to participating in a plan’s network as a “preferred pharmacy,” where enrollee cost-sharing for some or all drugs is lower than the cost-sharing they must pay at non-preferred pharmacies. Since many Part D enrollees have a strong financial incentive to use preferred pharmacies where they will pay less for their drugs, many pharmacies have complained that their statutory right has been undermined and they are disadvantaged to preferred pharmacies, including those that are affiliated with the plan sponsor or its PBM.

While the bill would not create an any-willing-pharmacy right for any individual pharmacy to participate in a plan’s network as a preferred pharmacy, it would create new aggregate network contracting obligations for Part D plans. Specifically, beginning in 2028, a Part D plan sponsor using a preferred pharmacy network would be required to contract with, as preferred pharmacies:

  • At least 80 percent of the “essential retail pharmacies” in its service area that are also “independent community pharmacies”; and
  • At least 50 percent of the “essential retail pharmacies” in its service area that are not also “independent community pharmacies.”

Consequently, taken together with the reimbursement floor noted above, essential retail pharmacies that are also independent community pharmacies (i.e., in a medically underserved area and part of a chain of three pharmacies or less) would have a good chance of being included in a preferred network as a preferred pharmacy (and thereby less disadvantaged in obtaining Part D enrollees’ business), and the plan must generally pay them reimbursement at or above their pharmacy acquisition cost. While pharmacies in medically underserved areas that are part of larger chains would not have any guaranteed reimbursement terms, the plan (or the PBM contracting on its behalf) would have to offer good enough terms to incentivize enough of such pharmacies to participate to meet the 50 percent threshold.

Clarification of “reasonable and relevant” any willing pharmacy contract terms

CMS has stated in guidance that the pharmacy network “standard terms and conditions” which a Part D plan sponsor must offer to any willing pharmacies must be “reasonable and relevant” to the given type of pharmacy, with additional explanation of what that means, but it has not codified those details in regulation. The bill would require that it undertake a notice-and-comment rulemaking to promulgate standards for such reasonable and relevant terms and conditions, to take effect beginning in plan year 2028, and for such purposes issue a request for information on those contract terms and conditions, as well as contracting practices between pharmacies and Part D plan/PBMs (including with respect to information on reimbursement and dispensing fees), by no later than Jan. 1, 2025.

Enforcement and Reports to Congress

Part D plans that violate these requirements would be subject to civil monetary penalties, in addition to an obligation to make a pharmacy whole for any failure to provide required reimbursement. Further, PBMs would be required to reimburse plan sponsors for any violations related to responsibilities the plan delegated to the PBM. CMS would establish a process by which pharmacies could submit an allegation, via a standardized template, that a plan was in violation of the standards for reasonable and relevant contract terms and conditions or the protections for essential retail pharmacies that are independent community pharmacies. 

These requirements would significantly enhance CMS policing of plans’ and their PBMs’ compliance with their any willing pharmacy contracting obligations, as well as ensure enforcement of these new contracting and reimbursement obligations. Additionally, CMS would be required to brief Congress and publish periodic reports, beginning no later than 90 days after the enactment of the bill, on topics relating to the implementation of the CMS negotiated price regulation that takes effect in 2024 (requiring that negotiated prices used to determine cost sharing reflect the lowest possible reimbursement payable to the pharmacy, taking into account post-adjudication pharmacy price concessions (“DIR fees”)). Topics to be covered include: (1) monitoring of changes to contract terms and conditions offered to pharmacies for preferred network participation; (2) CMS enforcement or oversight activities related to any willing pharmacy provisions; and (3) CMS plans, strategies or initiatives to address or mitigate concerns relative to convenient pharmacy access.

Implications for pharmacies, plan sponsors and PBMs

These provisions of the bill reflect a bipartisan interest to take actions to help “mom and pop” community pharmacies, particularly in rural areas where many pharmacies have closed, citing low levels of reimbursement from PBMs. That said, these measures represent relatively modest steps—e.g., a requirement to pay a portion of pharmacies at least their drug acquisition costs is hardly a bonanza for pharmacies—presumably reflecting the Committee’s interest in keeping the cost of the provision manageable. The Congressional Budget Office has scored this provision as increasing Federal expenditures by slightly more than $1 billion over the ten-year period 2024-2033, with most of its requirements taking effect in 2028.

In addition to the points noted above, these provisions could affect pharmacy network contracting for pharmacies that are not essential retail pharmacies. In particular, the reimbursement rates negotiated by larger pharmacy chains are sometimes based upon the number of competing pharmacies in a given network, with deeper discounts provided in exchange for a narrower network that drives more of the enrollees’ business to that chain. The requirements to contract with 80 percent/50 percent of essential retail pharmacies as preferred pharmacies would limit some plan and PBM flexibility to design such narrow networks.

More generally, many of the details of this provision remain to be finalized, ranging from details which will be fleshed out in the legislative text of this bill to further amendments that may be made, and of course implementation by CMS—assuming the provision is enacted into law in the first place. While the overall Finance Committee bill appears to have strong bipartisan support in the Senate, it is not clear what level of support it would have in the House of Representatives. Among other factors, there are other bills in the House that would impose various requirements on health plans and PBMs with respect to prescription drug pricing, which also have bipartisan support, presumably reflecting the desire of various Representatives to claim credit for taking action in this area.

Reed Smith will continue to track developments with respect to this legislation as well as other developments relating to regulation of drug pricing and coverage. If you have any questions about this bill or any other topic related to prescription drug coverage, please reach out to the authors of this post or to the health care lawyers at Reed Smith.

Recent efforts by the federal government to develop a strategy for guiding (and regulating) the use of artificial intelligence (AI) have targeted multiple industry sectors, with healthcare at the forefront. For example, under the President’s recent executive order, in 2024 the Department of Health and Human Services is required to educate itself, publish guidance, and develop a strategy to potentially regulate the development and use of AI within its areas of oversight. Congress, in comparison, is taking a more measured approach, and its future involvement in AI regulation remains unclear.

We discuss the recent federal executive and legislative efforts in the United States and their potential impact for companies that use AI in the health sector in a Reed Smith in depth perspective article.

Reed Smith will continue to follow developments related to the regulation of AI in the health care sector. If you have any questions, please reach out to the authors or to the health care lawyers at Reed Smith.

The Centers for Medicare & Medicaid Services (CMS) has published its final rule that requires nursing homes enrolled in Medicare and Medicaid to disclose additional ownership and management information to CMS and state Medicaid agencies. The rule finalizes CMS’s proposed rule from February, with just two differences, as we describe further below.

The rule implements Section 1124(c) of the Social Security Act, which was added by the Affordable Care Act to require the disclosure of additional information about ownership and oversight of nursing facilities. Medicare-enrolled skilled nursing facilities (SNFs) and Medicaid-enrolled nursing facilities (NFs) will soon be required to report many detailed aspects of their ownership and management structure, including both the executive leadership and any members of the facilities’ governing bodies.

CMS plans to gather the information in 2024, beginning when the revisions to the Form CMS-855A is completed, regardless of where a facility is on its current five-year revalidation schedule. The information will then be made publicly available within one year.

Of note in the final rule is that CMS declined to finalize a broad definition of “real estate investment trust” (also known an “REIT”) from its February proposed rule and instead has finalized a definition that it finds more consistent with current federal law and industry practice.

Continue Reading CMS Finalizes Nursing Home Ownership Rule

On October 26, 2023, the Department of Justice (“DOJ”) announced that a Miami federal grand jury returned an indictment charging a Medicare Advantage Organization’s (“MAO”) former director of Medicare risk adjustment analytics with six counts of criminal fraud. DOJ alleged that the MAO received more than $53 million in overpayments from the Centers for Medicare & Medicaid Services (“CMS”) due to false diagnoses submitted on reimbursement claims for beneficiaries enrolled in the MAO’s plans.

What’s perhaps most notable about this matter is that DOJ declined to prosecute the MAO because of the MAO’s significant and timely self-disclosure, cooperation, and remediation efforts, in addition to the MAO’s agreement to repay CMS the full amount of the estimated overpayments.

Continue Reading No Criminal Charges for Cooperative Medicare Advantage Organization

New minimum wage requirements have been signed into law by Governor Gavin Newsom, establishing five comprehensive minimum wage schedules for “covered health care employees,” which includes both contracted and subcontracted employees. Effective June 1, 2024, “covered health care facilities” will be required to implement the applicable minimum wage schedule, as set forth by the law.

To learn more about the changes to the law and what health care employers, contractors, and subcontractors have to do to come in to compliance with the law by its June 1, 2024 effective date, visit our blog on Employment Law Watch.

As promised back in April in an announcement of its plans to modernize compliance program guidance, the Department of Health and Human Services Office of Inspector General (OIG) issued the first of its new guidance documents for the health care industry on November 6, 2023. The first release is a general compliance program guidance (GCPG) designed to serve as a resource to all segments of the health care industry, regardless of the particular items or services offered.

In its newest release, OIG reiterates its view that the GCPG is by its very nature a voluntary guidebook that can act as a roadmap for a compliance program to follow, but that it is not binding on any individual or entity in the health care industry. This updated GCPG includes the following information for health care compliance programs, which we summarize further below: (1) key Federal authorities for entities engaged in health care business; (2) the seven elements of a compliance program; (3) adaptations for small and large entities; (4) other compliance considerations; and (6) OIG processes and resources.

Additional industry specific compliance guidance documents will be forthcoming, according to OIG, with its first updated guidance setting the stage for those to follow.

Continue Reading HHS OIG Issues General Guidance as First Step in Effort to Modernize Compliance Guidance

On September 28, 2023, the Office of Inspector General of the Department of Health and Human Services (OIG) issued Advisory Opinion 23-06, involving a proposed services arrangement between a pathology laboratory (the Requestor) and third-party referring pathology laboratories. 

The OIG determined that, if the requisite intent were present, the proposed purchase of the technical component of anatomic pathology services from certain laboratories would generate prohibited remuneration under the federal Anti-Kickback Statute (AKS). In doing so, the OIG highlighted the proposal’s lack of commercial reasonableness and reaffirmed its longstanding suspicion over arrangements that “carve out” federal health care program business.

Continue Reading OIG Issues Unfavorable Advisory Opinion Concerning Pathology Lab’s Proposed Purchased Services Arrangements

In an advisory opinion released on October 13, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) approved a plan by a muti-specialty practice to pay its employed physicians bonuses related to outpatient procedures performed by those physicians at ambulatory surgical centers (ASCs) operated by the physician practice entity requesting the opinion (the Requestor).

According to the facts as presented by the Requestor, the practice employs a group of physicians across a range of specialties. The Requestor also operates two ASCs as corporate divisions of the practice’s legal entity and not as subsidiaries or affiliates. The Requestor plans to pay each employed physician who performs a procedure at either of the ASCs a quarterly bonus equal to 30% of the net profits generated by the facility fees that are directly attributed to that physician’s procedures performed at the ASCs during the preceding quarter.

Notably, there is no indication in the request that the bonus payments would be based solely on the professional component of services personally performed by the physicians; the measurement of profit per physician would be expected to include the technical component of the procedures.

Continue Reading OIG Permits Multi-Specialty Practice to Pay Doctors Bonuses for Outpatient Procedures

On October 31, FDA will be offering a webinar on its proposed rule ”Medical Devices; Laboratory Developed Tests.”

This webinar comes about a month after FDA issued a proposed rule revising 21 C.F.R. Part 809 (specifically, 21 C.F.R, § 809.3) to state, explicitly, that in vitro diagnostics (IVDs) are medical devices, even if they are developed and manufactured in a laboratory setting.

This category of tests is generally referred to as “laboratory developed tests” (LDTs) and FDA has historically extended enforcement discretion, accepting the availability of certain LDTs outside of the FDA device clearance and approval pathway.

Of course this has not been a straightforward situation: we have seen decades of debate among FDA and industry stakeholders about the exact boundaries of FDA’s expressed enforcement discretion—where those boundaries should lie, and even interpretation (gleaned from enforcement action) of more precisely where they do, in FDA practice, actually lie.

Continue Reading The Latest Episode of the LDT Drama: FDA Issues Long-Awaited Proposed Rule for Laboratory Developed Tests