In an important decision limiting the reach of the Federal Anti-Kickback Statute (42 U.S.C. 1320a-7b(b)) (“AKS”) and its application to violations of the False Claims Act (31 U.S.C. 3729, et seq.) (“FCA”), the U.S. Court of Appeals for the Sixth Circuit (“Sixth Circuit”) recently contended that, “[w]hile the word remuneration may be broad, it customarily requires a payment or transfer of some kind,” and mandated “but-for” causation standard for determining whether claims paid by Federal health care programs were tainted by an AKS violation such that they violated the FCA. See U.S. ex rel. Martin et al. v. Hathaway, et al., Case No. 22-1463, at 11 (6th Cir.) (appeal from 1:19-cv-00915, ECF Doc. No. 108 (W.D. Mich.)) (emphasis added).
Continue Reading Recent FCA and AKS Litigation Highlights Use of Different Standards in Different Circuits
Medicare Advantage 2024 Rate Announcement – Further Impacts to Risk Adjustment
On Friday, March 31, 2023, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2024 Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies (Rate Announcement). This Rate Announcement follows CMS’s February 1 notice of planned changes to rates and the risk adjustment methodology, which provided an opportunity for the public to submit comments during a 30-day period (Advance Notice), as required by Section 1853(b)(2) of the Social Security Act (the Act). The Rate Announcement — providing for 60 days prior to the bid submission deadline of June 5, 2023 — provides notice of the annual capitation for MA for CY2024 related to the benchmark, risk adjustment, and other factors to be used in adjusting rates and responds to all substantive comments received from the Advance Notice.
We summarize the key factors and adjustments to the overall expected average rate increase of 3.32% (which is about $13.8 billion more than CY2023, and an increase from the 1.03% in the Advance Notice), and comments from CMS. We also highlight other key developments affecting MA rates, notably relating to the MA risk adjustment methodology (the 2024 Risk Model). Major changes identified in the Rate Announcement include updates to the risk adjustment model that uses International Classification of Diseases (ICD)-10 codes instead of the ICD-9 system, using data from 2018 diagnoses and 2019 expenditures, and the removal or reclassification of codes disproportionately coded in MA compared to Medicare Fee-For-Service (FFS) that CMS does not consider to accurately reflect increased costs to care for beneficiaries.
Continue Reading Medicare Advantage 2024 Rate Announcement – Further Impacts to Risk Adjustment
Challenges to the No Surprises Act Continue: The Latest includes a Challenge to a 600% Increase in Administrative Fees
On February 6, 2023, a judge for the United States District Court for the Eastern District of Texas (“Texas District Court”) ruled in favor of the Texas Medical Association (“TMA”) and against the United States Departments of Treasury, Labor, and Health and Human Services (the “Departments”) over a challenge to the continued special status given
President Biden Announces the End of the COVID-19 Emergencies: The Health Care Industry Has Less Than Four Months to Prepare
After multiple extensions over the past three years, on Monday, January 30, 2023, President Biden announced that the COVID-19 national emergency and public health emergency (“PHE”) will officially end on May 11, 2023.
However, with less than four months until that date, providers must quickly review their operations and ensure their continued
Another Unique Integrity Agreement Signals a Trend towards HHS-OIG’s Comfort with a Belt and Suspenders
In recent years, there have been only a handful of corporate integrity agreements (“CIAs”) and integrity agreements (“IAs”) that have included a “conditional exclusion release” of the Office of the Inspector General for the United States Department of Health and Human Services’ (“HHS-OIG”) permissive exclusion authority under 42 U.S.C. § 1320a-7(b)(7) (“Permissive Exclusion Authority”).[1] Inclusion of a conditional exclusion release is atypical, as HHS-OIG’s historical practice has been to provide an outright release of its Permissive Exclusion Authority in exchange for a CIA or IA. It appears, based on an IA executed last month and the other recent CIAs and IAs, that a trend may be emerging.
Specifically, in December 2022, HHS-OIG entered into an IA with a Georgia-based physician, Aarti D. Pandya, M.D., and his practice, Aarti D. Pandya, M.D. P.C. (collectively, “Dr. Pandya”). In atypical fashion, however, HHS-OIG required the IA to be for five years (as opposed to three years) and held Dr. Pandya to a conditional exclusion release contingent upon Dr. Pandya’s satisfactory completion of the IA (as opposed to outright providing a release of its Permissive Exclusion Authority). This IA signals to the industry that HHS-OIG is not bound by precedent and that, perhaps, a belt and suspenders approach to resolving conduct allegedly violating the False Claims Act (“FCA”) may be emerging as HHS-OIG’s new norm.
The Saga of the No Surprises Act Continues to be … Surprising
We previously noted that the regulations implementing the No Surprises Act (“NSA”) appeared to be inconsistent with the NSA because they seemed to establish the qualifying payment amount (“QPA”) as the appropriate payment amount to be used in arbitrations by certified IDR entities (viz. the regulation-established independent dispute resolution (“IDR”) process) between plans and providers, and that the United States District Court for the Eastern District of Texas (“Texas District Court”) vacated portions of the NSA regulations relating to the QPA for purposes of the IDR process. The Federal government recently responded to the Texas District Court—by removing such portions of the NSA regulations.
Continue Reading The Saga of the No Surprises Act Continues to be … Surprising
OIG Issues Special Fraud Alert Regarding Telemedicine Arrangements
On July 20, 2022, the Office of Inspector General for the Department of Health and Human Services (“OIG”) issued a special fraud alert (“Alert”) advising “practitioners to exercise caution when entering into arrangements with purported telemedicine companies.” The Alert is only one of four such “special fraud alerts” that the OIG has issued in the past decade and it illustrates the importance of OIG’s statements.
OIG Flags Seven Characteristics of Telehealth Fraud
In the Alert, OIG cautions that certain companies that purport to provide telehealth, telemedicine, or telemarketing services (collectively, “Telemedicine Companies”) have carried out fraudulent schemes by: (i) aggressively recruiting physicians and non-physician practitioners (collectively, “Providers”) and (ii) paying kickbacks to such Providers in exchange for the ordering of unnecessary items or services, including durable medical equipment, genetic testing, and other prescription items. According to OIG, the fraudulent schemes have varied in design and operation and involved a variety of individuals, Providers, and health care vendors, including call centers, staffing companies, and marketers.
Continue Reading OIG Issues Special Fraud Alert Regarding Telemedicine Arrangements
The Supreme Court Denies Petition Challenging CMS’s Overpayment Rule
This past week, the Supreme Court of the United States (Supreme Court) denied UnitedHealthcare Insurance Company’s (UnitedHealthcare) petition for a writ of certiorari (Petition) challenging, in part, the Centers for Medicare & Medicaid Services’s (CMS) Overpayment Rule, which requires Medicare Advantage (MA) plans, such as UnitedHealthcare, to return identified “overpayments” to CMS within 60 days. With this denial, the Overpayment Rule remains in full force and effect, and UnitedHealthcare, among other MA plans, must comply or potentially face False Claims Act (FCA) liability.
Continue Reading The Supreme Court Denies Petition Challenging CMS’s Overpayment Rule
Health Care Providers on Alert: Two Hospitals Penalized for Continuous Noncompliance with the Hospital Price Transparency Rule
We previously discussed the requirements of the Hospital Price Transparency Rule (“Rule”) on health care providers and health plans, as well as CMS’s proposal to increase penalties for a hospital’s failure to comply with the Rule. About a year and a half after the Rule became effective, CMS has now imposed its first set of civil monetary penalties (“CMPs”) on Northside Hospital Atlanta and Northside Hospital Cherokee, which have been fined $883,180 and $214,320, respectively.
The Rule requires, in part, hospitals to make public a machine-readable file containing a list of all standard charges for all items and services, such as, e.g., supplies, room and board, and use of the facility, among other items. See 45 C.F.R. § 180.40(a); id. at § 180.20. The Rule also requires hospitals to display shoppable services in a consumer-friendly manner. See id. at § 180.60(d)(2); id. at § 180.60(b). The goal of these specific requirements, in addition to those set forth in the remainder of the Rule, is to provide consumers with sufficient information about the charges for certain items and services by requiring health care providers and health plans to be publicly transparent about such charges.
Based on CMS’s CMP letters, dated June 7, 2022, Northside Hospital Atlanta and Northside Hospital Cherokee were non-compliant with the aforementioned specific requirements of the Rule. The chronology of events is important to understand how CMS ended up issuing its CMP letters.
OIG Approves Cash Equivalents Paid to Patients Participating in Contingency Management Program Offered Through Digital Health Technology
Contingency management (CM) is a form of intervention treatment program that incentivizes patients with substance use disorders to observe certain conditions—such as non-use of drugs or alcohol confirmed via urine drug screening or breathalyzer test, or even drug therapy adherence—in exchange for something of monetary value. Adherence is often tracked and confirmed by those that provide the incentive payment through digital health technologies—including apps that can be downloaded to the patient’s smart phone or that are already downloaded to a smart phone provided to the patient as part of a CM program. While many contend that CM is an effective, evidence-based treatment, certain legal barriers limit, and often prevent, its widespread adoption and use. When there is the potential for patients to receive items and services payable by Federal health care programs (FHCPs), CM incentives are subject to scrutiny under the Federal anti-kickback statute (AKS) and the Beneficiary Inducements CMP. A recent advisory opinion issued by the United States Department of Health and Human Services (HHS), Office of Inspector General (OIG), approved a digital health company’s offer to provide cash equivalents to patients participating in a CM program. This favorable result continues to demonstrate OIG’s flexibility notwithstanding regulatory precedent or guidance appearing to the contrary.
Continue Reading OIG Approves Cash Equivalents Paid to Patients Participating in Contingency Management Program Offered Through Digital Health Technology