• September 18, 2026

• Written by AHLA Legal Staff

NextStep Arthoropedix, LLC must face a whistleblower action alleging it paid kickbacks to surgeons disguised as purported royalty payments for design development that were instead tied to their expected order volume of the company’s hip replacement system, the U.S. District Court for the Middle District of Florida held September 11.

Relator Christopher Fries was NextStep’s Vice President from October 2013 to August 2020. He brought the qui tam action against the company and its owner and CEO Randy Theken alleging they paid surgeon consultants royalties based on anticipated sales of NextStep’s total hip replacement system rather than for design and development input as claimed. Fries alleged Medicare likely paid NextStep more than $21 million between 2016 and 2024 for kickback-tainted claims that violated the False Claims Act.

As a threshold issue, the court refused to dismiss the action for lack of standing because Fries signed a general release in settling a state-court employment action. Fries signed the contract more than two years after filing the instant qui tam action.

The court agreed with the majority approach that because the government is the real party in interest in qui tam actions, which under the FCA may only be dismissed if the Attorney General gives written consent, a relator “cannot unilaterally settle or release a claim that never belonged to him in the first place.”

The court also rejected defendants’ argument that the Anti-Kickback Statute’s personal services and management contracts safe harbor applied to the royalty deals. While the outward terms appeared to qualify for safe harbor protection, Fries alleged the royalty rates took into account the “volume or value” of business that each surgeon was expected to generate. Those allegations were sufficient to survive dismissal.

Finally, the court held Fries alleged fraud with sufficient particularity to satisfy Fed. R. Civ. P. 9(b)' heightened pleading requirement. The complaint outlined “an eight-year-long scheme designed to pay surgeons depending on how many NextStep devices they used in their surgeries,” including “namedrop[ing] the executives and surgeons involved in the scheme and provid[ing] precise figures of each surgeons’ yearly kickbacks.” The complaint also offered “a handful of representative samples stocked with the specific dates and amounts surgeons submitted false bills to Medicare.”

Fries also alleged “direct and independent knowledge” of the scheme in his former position as the company's Vice President, which was “enough indicia of reliability to pass muster,” the court said.

The court also was not persuaded that the representative examples were too limited given the alleged breadth of the scheme. “Absent controlling caselaw to the contrary, there is simply ‘no basis for holding that the failure to allege examples over the entire span of an alleged fraudulent scheme requires dismissal of claims supported by otherwise representative’ and sufficiently pled examples.”

United States ex rel. Fries v. NextStep Arthoropedix, LLC, No. 2:22-cv-98-KCD-NPM (M.D. Fla. Sept. 11, 2026).

• September 18, 2026

• Written by AHLA Legal Staff

Remedi SeniorCare Holding Corporation has agreed to pay over $5.3 million to the United States to resolve allegations that it billed Medicare and Medicaid for prescription drugs without valid prescriptions, the Department of Justice announced September 17.

According to a press release, from January 1, 2015 through March 31, 2021, Remedi submitted false claims to the Medicare and Medicaid programs for prescription drugs that lacked valid prescriptions but were dispensed anyway to residents of assisted living facilities in various states.

The settlement resolves a whistleblower action filed by Maureen Gearhart and Laura Griffieth, former employees of Remedi. United States ex rel. Gearhart v. Remedi SeniorCare Holding Corp., No. 1:20cv970 (S.D. Ohio).

The settlement resolves allegations only and no determination of liability has been made.

• September 18, 2026

• Written by AHLA Legal Staff

Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. announced September 17 appointments of eight new members to the United States Preventive Services Task Force (PSTF), which issues Affordable Care Act (ACA) preventive services coverage recommendations.

One of the new members, Seth J. Corey, M.D., M.P.H., a pediatric hematologist-oncologist at the Cleveland Clinic, will chair the panel.

The other new panelists are Patrick K. Hunter, M.D., M.Sc., a Florida pediatrician; Ronald P. Karlsberg, M.D., a clinical professor of medicine at the Cedars-Sinai Medical Center’s Smidt Heart Institute; Venkatesh L. Murthy, M.D., Ph.D., preventive cardiology professor at the University of Michigan; Stephen T. Parente, Ph.D., a health finance professor at the University of Minnesota with expertise in health insurance; Goldie Stands-Over-Bull, M.D., a family medicine physician at Texas Native Health; Louis J. Wilson, M.D., an internist specializing in gastroenterology and managing partner of Wichita Falls Gastroenterology Associates in Texas, and Dennis W. Wulfeck, M.D., M.B.A., D.H.A., a diagnostic radiologist and president of the practice board at RadPartners MBB Radiology.

Kennedy began overhauling the panel after the Supreme Court’s decision last year in Kennedy v. Braidwood Mgmt., Inc., No. 24–316 (U.S. June 27, 2025), which found task force members are “inferior officers” who can be appointed and removed by the HHS Secretary.

“We are strengthening the Task Force to ensure it asks hard questions, follows the evidence wherever it leads, and maintains the highest standards of scientific integrity,” Kennedy said.

“The composition of this new slate represents a significant departure from the Task Force’s traditional membership,” the American Medical Association (AMA) said in a September 17 statement. “We believe maintaining a strong primary care voice must remain central to its work. As the USPSTF moves forward, its recommendations must continue to be based on a transparent, rigorous, independent scientific process and informed by the perspective of physicians who deliver preventive care to patients every day. This is essential for ensuring that task force recommendations are trusted by clinicians and followed by patients.”

• September 18, 2026

• Written by AHLA Legal Staff

A physician did not have to exhaust administrative remedies to pursue a claim that the Centers for Medicare & Medicaid Services (CMS) violated his due process rights when it barred him from participating in Medicare for ten years, the Ninth Circuit held in a nonpublished opinion issued September 15.

The Ninth Circuit reversed the dismissal of his due process claim, although it agreed with the lower court that Dr. Mansur H. Lee could not move forward with his ultra vires claim without satisfying the exhaustion requirement.

Lee, a board-certified internal medicine and hospice and palliative medicine physician, served as the medical director at Passion and Love Hospice from July 2019 through March 2025. After concluding that the Passion and Love’s reimbursement claims lacked documentation to support patients’ terminal illness prognoses, CMS notified Lee that the agency was revoking his Medicare billing privileges and imposing a ten-year enrollment bar because his medical director role at the hospice was an affiliation that posed an undue risk of fraud and abuse to the program.

Lee sued in federal district court after CMS denied reconsideration and upheld its initial determination, alleging that due process required a pre-deprivation hearing and that the imposition of sanctions amounted to ultra vires agency action. The district court dismissed the action for lack of subject matter jurisdiction because Lee, whose appeal was still pending before an administrative law judge, had not exhausted his administrative remedies.

Unlike the ultra vires claim, the Eighth Circuit found the exhaustion requirement was waived as to his due process claim, which challenged the amount of process he received before being subject to public sanction and therefore was collateral to his substantive claim of entitlement.

Lee also made a colorable showing of irreparable injury, including that he lost his job as a hospitalist following the Medicare enrollment bar.

Finally, Lee demonstrated that exhaustion would be futile for his due process claim. Given the constitutional nature of the due process challenge, “‘there [is] nothing to be gained from permitting the compilation of a detailed factual record, or from agency expertise,’” the appeals court observed.

Lee v. Kennedy, No. 26-1820 (9th Cir. Sept. 15, 2026).

• September 18, 2026

• Written by AHLA Legal Staff

Dr. Scott Jensen, who was the Republican nominee for Minnesota Governor in 2022, can proceed with a lawsuit against the state’s medical practice board alleging its repeated investigations of him stemming from his public opposition to COVID-19 mandates and shutdowns violated the First Amendment, the Eighth Circuit held September 15.

Reversing a lower court decision, the Eighth Circuit found Jensen alleged “concrete and particularized” injuries—in the form of the time and costs he incurred to respond to the Minnesota Board of Medical Practice’s probes as well as the chilling effect on his speech as a candidate—to support standing at the motion-to-dismiss stage of the litigation.

Spanning the start of the pandemic until mid-2022, the board initiated four investigations—one of them lasting more than a year—against Jensen after receiving 18 complaints that he was “spreading misinformation” about COVID and posed a “danger to public health.”

Jensen sued alleging multiple constitutional claims and seeking an injunction preventing future interference with his speech made outside the physician-patient relationship, as well as compensatory damages. The district court granted the board’s motion to dismiss for lack of standing.

The district court set the “bar too high” in holding Jensen failed to demonstrate standing, the Eighth Circuit said.

Jensen alleged “classic pocketbook injuries”—i.e., the time and money he spent, including hiring a lawyer at one point, to “cooperate fully” with the board’s investigations, which he was obligated to do under state law.

He also alleged that the investigations chilled his speech during the run-up to the 2022 election to avoid triggering new probes of his medical license. General allegations that Jensen changed his message, declined multiple invitations to public speaking events, and clarified his remarks were as a candidate not a physician were enough to support standing on his First Amendment claim.

“The chilling effect he continues to experience also qualifies as an ‘ongoing’ injury supporting injunctive relief,” the appeals court said, noting Jensen is again a candidate for public office. “It is hard to imagine a situation in which the ‘threat of future enforcement’ could be more credible,” the Eighth Circuit added.

However, the appeals court declined to rule on the merits and remanded to the district court for further proceedings.

Jensen v. Minn. Bd. of Med. Practice, No. 25-1812 (8th Cir. Sept. 15, 2026).

• September 18, 2026

• Written by AHLA Legal Staff

The Second Circuit affirmed September 17 that an out-of-network plastic surgery practice could not sue to enforce a $3 million arbitration award under the No Surprises Act (NSA) against Cigna Health and Life Insurance Company.

Joining most federal courts to consider the issue, including the Fifth Circuit, the Second Circuit found the NSA contains no express or implied right of action to enforce or confirm an independent dispute resolution (IDR) award. But see SpecialtyCare, Inc. v. CareFirst of Maryland, Inc., No. 25-cv-130-ABA (D. Md. June 9, 2026); PHI Health, LLC v. Optimum Choice, Inc., No. 25-cv-2320-ABA (D. Md. Mar. 27, 2026).

The NSA specifically provides that an IDR award is automatically “binding upon the parties involved” and “shall not be subject to judicial review” except in certain limited circumstances set forth in the Federal Arbitration Act (FAA). While the NSA incorporated the FAA’s provision for vacating arbitral awards, the statute did not do so for confirming them, which “strongly suggests that Congress did not intend to create a private right of action to enforce IDR awards,” the appeals court reasoned.

The fact the NSA delegates enforcement authority to multiple federal agencies and to states further reflects Congress’ intent that IDR awards “be enforced through administrative action rather than private litigation.”

East Coast Advanced Plastic Surgery, LLC (ECAPS) also could not seek a declaration under the Declaratory Judgment Act (DJA) that Cigna violated the NSA. It is well-established that the DJA does not provide an independent cause of action, the appeals court said in affirming the decision below. East Coast Advanced Plastic Surgery, LLC v. Cigna Health and Life Ins. Co., No. 25 Civ. 255 (PAE) (S.D.N.Y. Aug. 14, 2025).

The consolidated action started when Cigna filed a complaint under the Employee Retirement Income Security Act (ERISA) against ECAPS, a New Jersey-based medical practice that specializes in post-mastectomy breast reconstruction surgery, alleging it engaged in fraudulent billing practices—including fee forgiveness, unbundling, and duplicate claims—that caused the insurer and claims administrator to overpay $8.5 million for the out-of-network provider’s services.

ECAPS countersued, alleging Cigna failed to fully pay for breast reconstruction services provided to patients enrolled in employer health plans that it administered. ECAPS brought its claims against Cigna under the NSA and the DJA for violating its obligation to pay IDR determinations within 30 days as required by the statute.

East Coast Advanced Plastic Surgery, LLC v. Cigna Health and Life Ins. Co., No. 25-2204 (2d Cir. Sept. 17, 2026).

• September 18, 2026

• Written by AHLA Legal Staff

Seventeen researchers have filed a proposed class action against the National Institutes of Health (NIH) for alleged “viewpoint discrimination” in terminating grants and in awarding new funding based on the administration’s political preferences rather than scientific merit.

The complaint, filed in the U.S. District Court for the Northern District of California, alleges that NIH employs an algorithmic screen that flags existing grants or pending applications for an extensive list of “disfavored terms,” including “gender,” “diverse,” “trans,” and “climate change.” Grantees or applicants must remove the terms to avoid termination or a denial of funding, according to the lawsuit.

Plaintiffs are individual researchers with a record of receiving NIH awards seeking to represent two nationwide classes—researchers whose projects were terminated and those affected by the policies—“to challenge ongoing and widespread violations of the First Amendment and the Administrative Procedure Act” (APA).

While acknowledging that the administration can set funding priorities, the complaint argues that the First Amendment does not allow the government to use “its funding power to target or silence the expression of disfavored viewpoints within the biomedical research community.”

In addition, under the APA, the agency may not “contradict Congressional mandates designed to prevent the politicization of the NIH award process, ignore regulations limiting the circumstances in which termination is allowed, or impose arbitrary and capricious grant-screening mechanisms without explanation or even public disclosure.”

The lawsuit follows similar challenges after NIH terminated certain grant funding last year because they “no longer effectuate[d] administrative priorities.” 

According to plaintiffs, despite court orders partially blocking those efforts, “viewpoint-based terminations have restarted and new awards are also [being] impacted.”

The complaint asks the court to declare the challenged policies unlawful and to enjoin their future application.

• September 18, 2026

• Written by AHLA Legal Staff

Rita Ntusa Anagho, who owned addiction treatment center Tusa Integrated Clinic, LLC, was sentenced to 14 years in prison for her role in fraudulently billing Arizona’s Medicaid agency more than $69 million for addiction treatment therapy, the Department of Justice announced September 17.

Anagho, a licensed nurse practitioner, deliberately targeted patients who were covered under the American Indian Health Care Program, which provided higher reimbursement rates. 

According to a press release, Anagho submitted false claims for purported addiction treatment services that were either not provided or not provided as billed. In addition, Anagho and her co-conspirators paid illegal kickbacks to owners of numerous area sober homes for patients who were referred to her clinic.

• September 18, 2026

• Written by AHLA Legal Staff

Excluded provider Emory Matthews was charged with conspiracy to commit health care fraud and three counts of health care fraud for his role in conspiring to bill Medicare for psychotherapy services that were never provided to patients of an adult day care center owned by his wife, the Department of Justice announced September 15.

Matthews was previously convicted of soliciting and receiving illegal health care kickbacks and bribes stemming from his earlier operation of the adult day care center. As a result of that conviction, he was excluded from billing Medicare. 

However, Matthews allegedly submitted false claims for individual and group psychotherapy services that were not provided, including for times that beneficiaries were hospitalized or deceased, and used the names of former employees on false claims submitted to Medicare.

An indictment contains allegations only and all defendants are presumed innocent until proven guilty beyond a reasonable doubt in a court of law.

• September 18, 2026

• Written by AHLA Legal Staff

Optometric physician Helen Boerman was sentenced to 42 months in federal prison for defrauding Medicare and other government health care programs out of nearly $7 million, U.S. Attorney for the Middle District of Tennessee Braden H. Boucek announced September 14.

Boerman was also ordered to pay $6,970,583.50 in restitution and a $100 special assessment.

According to court documents, Boerman, through her practice Brentwood Eye Care, submitted false claims to Medicare seeking reimbursement for dates of service where patients did not in fact receive services and for wound care products that she had not actually purchased or used because she split wound care products intended for single use.

• September 18, 2026

• Written by AHLA Legal Staff

Pharmaceutical manufacturer Dompé U.S. Inc. has agreed to pay $32 million to resolve allegations that it paid Medicare beneficiary co-pays through two patient assistance foundations to induce the purchase of its drug Oxervate in violation of the Anti-Kickback Statute, the Department of Justice announced September 10.

As part of the settlement, Dompé admitted that, around the time of Oxervate’s 2018 launch in the United States, two foundations opened funds that paid co-pays for Oxervate, and Dompé made contributions to those foundations. Dompé also solicited patient assistance foundation data directly from the foundations and from the specialty pharmacy that provided hub services to Dompé U.S. patients.

Dompé is the U.S. subsidiary of Dompé farmaceutici S.p.A., which self-disclosed the conduct to the United States.

The settlement resolves allegations only and there has been no determination of liability.

• September 18, 2026

• Written by AHLA Legal Staff

The Food and Drug Administration (FDA) is now accepting applications for a new pilot program that will test partnering U.S. research institutions with drug companies as a way to shorten the time from drug identification to first-in-human clinical trials.

The Expediated Investigational New Drug (IND) Pilot Program is part of the Department of Health and Human Services’ Operation Trailblazer, an agency-wide effort to accelerate the drug development timeline and reverse the growing share of early-stage clinical research that has moved overseas.

Under the IND Pilot, drug sponsors partner with “qualified research institutions” (QRIs) such as academic medical centers in developing Phase 1 IND submissions with the goal of minimizing the need for clinical holds by leveraging QRIs' specialized expertise to help identify and resolve issues with an application sooner in the process and by encouraging earlier planning and coordination.

The FDA said the pilot could help inform future policy initiatives like a formal accreditation model.

“The pilot not only pairs industry innovators with top research institutions to accelerate high-quality data being submitted to the FDA, it also tests if the partnership can accelerate what happens after the FDA allows a clinical trial to proceed,” said Acting FDA Commissioner Kyle Diamantas, J.D.

Drug sponsors and prospective QRIs must apply as a pair. Drug sponsors must submit the applications on behalf of the pair to the FDA by October 30. FDA expects to select eight to ten sponsor-QRI pairs as initial participants. 

• September 18, 2026

• Written by AHLA Legal Staff

The Centers for Medicare & Medicaid Services (CMS) is expanding its newly launched outcome-aligned payment model aimed at increasing access to technology-supported care for managing chronic conditions to Medicare beneficiaries with heart failure, chronic obstructive pulmonary disease (COPD), substance use disorders, and nicotine dependence.

CMS unveiled the ten-year voluntary Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model, operated through the Center for Medicare and Medicaid Innovation, in December 2025 for beneficiaries in original Medicare. The first performance period began July 1, 2026, with the model slated to run through June 30, 2036.

The agency said 160 organizations currently are participating in the ACCESS model, with more to be added as the model moves forward. While the model is limited to original Medicare, Medicare Advantage plans “may offer similar programs,” CMS said.

“We built ACCESS because too many people with chronic conditions were falling through the cracks between appointments,” said CMS Administrator Dr. Mehmet Oz. “ACCESS is one of the tools we are using to bring healthcare into the digital age, giving patients and their providers greater access to AI-enabled technologies, remote monitoring, connected devices, and other innovative tools that can help identify problems earlier and improve care. This latest expansion of the program will help more Americans get the care they need and reward providers who deliver actual results.”

According to the agency, three out of four people with Medicare qualify for at least one ACCESS track. Tracks for the new conditions will be available starting in spring 2027.

• September 18, 2026

• Kenneth R. Marcus

The U.S. District Court for the District of Columbia issued its decision on the merits in Montefiore Medical Center v. Kennedy[1] on September 30, 2025. The court held that the Centers for Medicare & Medicaid Services’ (CMS’) 2023 rule for treating Medicare Part C patients as entitled to benefits under Medicare Part A in the disproportionate share hospital (DSH) adjustment computation was consistent with the DSH statute but was arbitrary and capricious and impermissibly retroactive to periods prior to October 1, 2013.[2] The court ordered the parties to brief on the appropriate remedy. Nearly a year after the decision on the merits, the court has now issued its opinion on remedy, i.e., vacatur and remand without further instruction.[3] The court, therefore, gave CMS still another opportunity to attempt to treat Medicare Part C patients as entitled to benefits under Medicare Part A for purposes of the DSH adjustment. One is reminded of the familiar Paul Simon lyric: “You know the nearer your destination/The more you’re slip slidin’ away.”

The Parties’ Positions and the Court’s Holding Regarding Remedy

The plaintiff hospitals contended that, in addition to vacatur, “the court should also remand with specific instructions to ‘direct recalculation of [its] DSH payment, with interest, using the pre-2004 policy’ of excluding Medicare Part C days in the Medicare fraction.”[4] The Department of Health and Human Services (HHS) Secretary, however, argued “that vacatur is an unlawful remedy under the APA [Administrative Procedure Act] and asks the court to remand the matter to HHS with only a ‘party-specific declaration that the challenged rule is unlawful.’”[5]

In response to the parties’ briefing, the court held “that binding precedent forecloses the Secretary’s frontline position on the permissibility of vacating agency action under the APA and, without any argument from the Secretary about the Allied-Signal factors, it concludes vacatur of the 2023 Rule is warranted.” However, the court agreed “with the Secretary that the remand order should not direct HHS to make any specific payment to Montefiore for Fiscal Year 2006.”[6]

CMS’ Continued Opportunity to Implement Its Part C Policy

It appeared that two conflicting yet equally important legal principles seemingly presented an impossible task for the court to fashion a remedy. On the one hand, in Allina II the Supreme Court ordered the Secretary to implement its Part C policy in compliance with notice-and-comment rulemaking requirements.[7] On the other hand, when the Secretary proceeded to do so the district court in Montefiore held that the rulemaking was prohibitively retroactive. 

The court side stepped resolution of these irreconcilable principles by essentially kicking the proverbial can down the proverbial road by remanding without a payment order. Although aware that hospitals have in large part successfully challenged the DSH Part C policy for upwards of 20 years, the court nonetheless expressed sympathy with CMS’ efforts to lawfully implement the DSH Part C policy: “Although roughly twenty years of litigation have unfolded over different aspects of HHS’s Part C policy, the agency has tried to adhere to a unique statutory scheme.”[8] 

Despite 20 years of adverse decisions, the Secretary asserted that upon remand it would have available two methods to lawfully implement its Medicare Part C DSH policy retroactively: “first, by avoiding rulemaking altogether, because the court ‘did not address’ whether ‘rulemaking is necessary’ if the Secretary thinks that his interpretation of the DSH provision is unambiguously correct and there is no ‘Chevron-style gap to fill; and second, by relying exclusively on Empire Health, because the court ‘did not resolve’ whether the Secretary can adopt the same interpretation from the 2023 Rule solely on the theory that Empire Health is binding precedent . . . .”[9]

The court expressed favor with the Secretary’s argument. In essence, the court narrowly interpreted the scope of its merits decision to mean simply that the regulation at issue was impermissibly retroactive, not the policy. Thus, if the policy may be implemented in an otherwise lawful fashion, without a duly promulgated regulation, so be it.

CMS Available Action Upon Remand

The court concluded that “[f]ollowing remand, the Secretary may consider any new action that complies with [42 U.S.C.] Section 1395hh(e)(1)(A).”[10] Thus, it appears that CMS will have carte blanche to rationalize retroactive application of its Medicare Part C DSH policy. 

Either or both parties have the right to appeal the now final decision. Whether an appeal is taken or the parties agree to a remand, this litigation is far from over. 

About the Author

Kenneth R. Marcus, an AHLA Fellow, is retired from the practice of law. This article is not intended to furnish legal advice. Readers wishing to discuss the subject matter of this article are welcome to contact the author at [email protected]. 

• September 18, 2026

• Written by AHLA Legal Staff

The Centers for Medicare & Medicaid Services (CMS) has released an example approach that states can use to implement the medical frailty exemption to new Medicaid work requirements set to take effect on January 1, 2027.

In a slide-deck posted September 8, CMS detailed a three-tiered framework that appears to hew more closely to verification models for medical frailty that some states had been pursuing before an interim final rule CMS issued in June, see 91 Fed. Reg. 33348.

The rule, which currently is facing a legal challenge from more than two dozen states, includes a “significantly impairs” component to determining whether individuals’ physical, mental, or other behavioral health conditions qualify them for a “medically frail” exemption to the 80-hour per month community engagement requirement that will become a condition of eligibility for certain adult Medicaid beneficiaries next year under the One Big Beautiful Bill Act.

The states have argued that the rule adopts a more restrictive definition of medically frail than the statute envisioned and departs from previous guidance and discussions with federal officials that they relied on in developing their implementation plans.

Under the interim final rule, states must, where possible, verify medical frailty on an ex parte basis using data, for example Medicaid or managed care claims, that they already have without requiring individuals to submit additional information.

The latest CMS guidance details the following framework that states could use for medical frailty verification:

Tier 1: conditions the state can confirm, based on diagnosis alone and without additional documentation, significantly impair an individual’s ability to work (examples include amyotrophic lateral sclerosis (ALS) and end-stage renal disease).

Tier 2: conditions that may indicate an individual is medically frail but require additional information to show significant functional impairment such as acute care utilization, use of durable medical equipment, or other factors like co-morbidities or chronic conditions (examples include individuals with multiple serious chronic conditions in conjunction with high service utilization or repeated inpatient admissions for serious or complex conditions).

Tier 3: available data is lacking or insufficient to establish medical frailty, requiring a manual, individualized assessments where additional documentation may be required such as health records, provider certifications, and managed care plan care management information.

“We encourage states to use the ICD-10 code set to identify diseases, diagnoses, disorders, or other health conditions (conditions) that are likely to identify individuals who may qualify as medically frail in conjunction with functional- and utilization-related code sets that may more accurately identify the severity of a condition,” according to the guidance.

CMS also emphasizes that the tiered medical frailty framework is only an example of various “data-driven approaches” that states could use to verify the exemption.