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Texas Medicaid Fraud Control Unit Helps Dismantle $142 Million Genetic Testing Fraud Scheme, Seizes $7.1M in Assets

Texas Attorney General Press Release:

ApolloMDx offered illegal kickbacks in order to purchase both recipient information from marketers and orders for genetic testing from doctors. In some cases, doctors made fraudulent diagnoses to make it appear as though recipients were eligible for testing when they were not. In addition, ApolloMDx altered dates of service on testing orders to make it appear that multiple DNA samples were collected on different dates to enable billing for multiple dates of service.

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Most Patients Using Weight-Loss Drugs Like Wegovy Stop Within a Year, Data Show

Medical weight-loss locations have skyrocketed, driven by semaglutide medications. But a recent article from Chad Terhune, for Reuters, calls into question its staying power:

Only about one-third of patients prescribed a popular weight-loss drug like Novo Nordisk’s (NOVOb.CO) Wegovy were still taking it a year later, while total healthcare costs for the group rose sharply, according to an analysis of U.S. pharmacy claims shared with Reuters.

The annual cost of overall care for patients prior to taking Wegovy or a similar drug was $12,371, on average, according to the analysis. The full-year cost after starting the medication jumped by 59% to $19,657, on average.

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New Stark Law Exception and Anti-Kickback Statute Safe Harbor Aim to Combat Physician Burnout

From Stevens & Lee:

The Stark Law exception requires that health care entities make their physician wellness program available to all physicians who practice in the geographic area served by the provider, not just physicians who are a member of the entity’s medical staff or hold clinical privileges. Further, because the AKS applies to all health care providers, not just physicians, the new safe harbor adds that the program must be made available to all physicians and other clinicians who practice in the geographic area. Also, the new exemptions require that the program is offered to all physicians (and, under the AKS, including other clinicians) without regard to the volume or value of referrals or other business generated by the provider for the entity.

Additional key requirements for physician wellness programs to meet both the Stark Law exception and the AKS safe harbor are identical, and include that the program must:

  • Be made available for the primary purpose of preventing suicide, improving mental health and resiliency or providing training in appropriate strategies to promote mental health and resiliency
  • Be set forth in a written policy that includes an estimation of the cost of the program, the content and duration of the program, the evidence-based support for the program’s design, the personnel conducting the program and the method for evaluating the success of the program
  • Consist of counseling, mental health services, a suicide prevention program or a substance use disorder prevention and treatment program

The new Stark Law exception and AKS safe harbor provide an additional mechanism for health care entities to address burnout and mental health issues within their provider populations. Furthermore, regulations pertaining to these new statutory exceptions may come in the summer or early fall, which may provide additional requirements or additional guidance on these programs.

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How Did This Happen? Understanding the Issue of Third-Party Tracking Tech in Healthcare

Jill McKeon, for Health IT Security:

In June 2022, journalists discovered that a third of Newsweek’s top 100 hospitals in America had the Meta Pixel installed on their websites, which allegedly sent a packet of data to Facebook whenever a visitor clicked a button to schedule a doctor’s appointment. …

The Markup, also observed the Meta Pixel operating inside the password-protected patient portals of seven health systems, sending patient names, medication information, and appointment details to Facebook. …

Following the article’s publication, an influx of breach notifications and lawsuits rolled in, with hospitals across the country admitting that tracking tech originally installed to measure and evaluate website visitor trends had inadvertently been disclosing sensitive information to tech companies such as Meta and Google.

In the year since these discoveries were made, healthcare data security and privacy experts have raised concerns not only about why this technology remains so widespread across healthcare, but why many hospitals were not even aware that this tech was quietly operating on their systems for years.

Understanding the root causes of this issue requires a deep dive into what this tracking tech promises to provide its customers, and the communication, technical, and regulatory gaps that contributed to this problem going unnoticed at some healthcare organizations.

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HHS Office of Civil Rights Requiring Healthcare Providers to Use HIPAA-compliant Telehealth Platforms by August 10

HHS Office of Civil Rights is requiring all healthcare providers to use HIPAA-compliant telehealth platforms by Aug. 10. When the Public Health Emergency ended in May, CMS provided a transition period for covered health care providers to come into compliance with the HIPAA Rules with respect to their provision of telehealth.

The transition period will expire at 11:59 p.m. on August 9, 2023.

Per CMS, the list below includes some vendors that represent that they provide HIPAA-compliant video communication products and that they will enter into a HIPAA BAA.

  • Skype for Business / Microsoft Teams
  • Updox
  • VSee
  • Zoom for Healthcare
  • Doxy.me
  • Google G Suite Hangouts Meet
  • Cisco Webex Meetings / Webex Teams
  • Amazon Chime
  • GoToMeeting
  • Spruce Health Care Messenger

Note: OCR has not reviewed the BAAs offered by these vendors, and this list does not constitute an endorsement, certification, or recommendation of specific technology, software, applications, or products. There may be other technology vendors that offer HIPAA-compliant video communication products that will enter into a HIPAA BAA with a covered entity. Further, OCR does not endorse any of the applications that allow for video chats listed above.

Also note, Facebook Live, Twitch, TikTok, and similar video communication applications are public facing, and should not be used in the provision of telehealth by covered health care providers.

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Next-Gen Weight-Loss Drugs Receive Tentative Embrace by Medicaid

Medicare does not currently cover Wegovy or other medications specifically for obesity. But some Medicaid programs, which are administered by individual states, are negotiating discounts for the popular semaglutide treatments.

Ganny Belloni for Bloomberg Law:

Nine states from California to Rhode Island have begun to cover expensive, next-generation weight-loss drugs like Novo Nordisk’s Wegovy on their Medicaid preferred drug lists. Preferred drug status allows patients to receive coverage for weight-loss drugs without the need to undergo step therapy, where patients are required to try less expensive and potentially less efficacious drugs before receiving their original drug of choice.

The move to cover weight-loss medication comes as states find new ways to grapple with the high yearly costs for patient care stemming from obesity-related comorbidities like diabetes ($9,601), heart disease ($18,953), and cancers ($21,503). The Milken Institute, an economic think tank, estimates the ensuing health costs and lost productivity of the obesity epidemic cost the US over $1.7 trillion in 2019.

With 44% of Medicaid beneficiaries qualifying as obese, expanding coverage to all eligible beneficiaries will present a significant financial challenge for state Medicaid programs. Wegovy, the most recent weight-loss drug to be added to Medicaid formularies, retails at over $1,300 per month and must be taken indefinitely to maintain results.

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Think Like a Prosecutor: How Physicians Can Address the Threat of Data Mining-Based Fraud Investigations

Dan Martin, for Medical Economics:

When you deviate from your peers, be especially sure to document the legitimate reasons for that deviation. Expect that insurance companies, regulatory agencies, and law enforcement officials will examine such deviations. Note any relevant information that supports why your treatment might differ from that of your peers. Such information might include the unique characteristics of your patient population, the nature of your referral network, the unique training you completed, or the difference in availability/unavailability of certain treatment options.

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OIG: HRSA Made Improper Payments Through COVID-19 Uninsured Program

Victoria Bailey, for RevCycle Intelligence:

The COVID-19 Uninsured Program, administered by HRSA, allowed providers to enroll and submit claims for reimbursement of COVID-19 testing and treatment provided to uninsured individuals. OIG conducted the audit to determine if claims reimbursed through the program complied with federal requirements.

The audit covered claims for 19 million patients with associated Uninsured Program provider payments totaling $4.2 billion between March 1 and December 31, 2020. OIG reviewed a stratified sample of 300 patients with associated provider payments totaling $2.8 million. …

Based on the sample results, OIG estimated that nearly $784 million of the $4.2 billion in Uninsured Program payments made to providers were improper.

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U.S. Supreme Court Clarifies DOJ’s Authority to Dismiss Whistleblowers’ False Claims Act Suits, Questions Constitutionality of Qui Tam Provisions

Edwin O. Childs, Michael J. Podberesky, Jonathan Ellis, Gretchen Heinze Townshend, Todd R. Steggerda, Charles Wm. McIntyre and Jason M. Vespoli, for The FCA Insider – McGuireWoods:

In United States ex rel. Polansky v. Executive Health Resources, Inc., the U.S. Supreme Court recently resolved a circuit split by holding that in a False Claims Act (“FCA”) action (1) the Government may seek dismissal of a qui tam case in which it initially declined to intervene over the relator’s objection as long as the Government later intervened in the litigation, and (2) that in considering such a dismissal motion, district courts should apply the rule generally governing voluntary dismissal of suits: Federal Rule of Civil Procedure 41(a).  Under Rule 41(a), the Court explained that the Government has broad latitude to seek dismissal stating that “motions will satisfy Rule 41 in all but the most exceptional cases.”  The decision is an important one for the Government and FCA defendants.  But perhaps as important as the Court’s central holding in the Polansky case (and certainly more surprising), was the view expressed by Justice Thomas in dissent (and echoed by Justice Kavanaugh in a concurring opinion joined by Justice Barrett) that the FCA’s qui tam provision permitting a private citizen to litigate a case on behalf of the United States may be unconstitutional.

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Stark Law Changes Ramp Up in 2023

Patsy Newitt, for Becker’s ASC Review:

The Consolidated Appropriations Act of 2023 updated exceptions to Stark law and anti-kickback law that will allow hospitals and healthcare providers to improve mental health services for physicians. The law issues a new exception for physician wellness programs offered by healthcare entities, including ASCs, hospitals and physician practices.

To satisfy the exception, the program must also include a written policy, which must include a description of the content and duration of the program, a description of the evidence-based support, and the estimated costs, among other stipulations.