Author: WadeEmmert

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.

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.

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.

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.

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.

Press Release for the Eastern District of Texas:

Oscar Simon Ndereva, 45, pleaded guilty to wire fraud and was sentenced to 54 months in federal prison by U.S. District Judge Sean D. Jordan.

According to information presented in court, Ndereva was involved in an intricate scheme to defraud private pay health insurance payors.  Specifically, he used a fraudulent healthcare pharmacy called “Healogix” to submit fraudulent claims.  Ndereva caused the fraudulently obtained funds to be paid directly to bank accounts he opened in the name of another individual.

Over the course of the scheme, Ndereva moved money through various accounts in order to conceal the nature and source of those funds, and also structured check cashing transactions to avoid financial reporting requirements and to evade law enforcement detection.

In all, Ndereva’s company Healogix submitted over 780 fraudulent claims totaling over $5 million.

Joseph Choi, for The Hill:

More than two years after federal hospital price transparency rules went into effect, only about a third of hospitals are currently in compliance, according to a report released this week.
The nonprofit Patient Rights Advocate (PRA) released its fifth semi-annual report, which found that only 36 percent of 2,000 surveyed hospitals were in complete compliance with the rule.

Since Jan. 1, 2021, hospitals have been required to give “clear, accessible pricing information” on their products and services, either through an online file or a “consumer-friendly” display of shoppable services.

Press Release for U.S. Attorney’s Office, Northern District of Texas:

Certain amniotic products have been approved by the U.S. Food and Drug Administration for wound care, but not for pain management. (In fact, the FDA has issued repeated consumer alerts warning that biologics like amniotic fluid “have not been approved for the treatment of any orthopedic condition, such as osteoarthritis, tendonitis, disc disease, tennis elbow, back pain, hip pain, knee pain, neck pain, or shoulder pain,” nor for “chronic pain or fatigue.”) Because amniotic products have not been approved to treat pain, Medicare considers amniotic injections administered to treat pain medically unnecessary and does not reimburse for them. They do reimburse for some – but not all – amniotic injections administered to reduce inflammation of damaged tissue, as in a wound.

These types of injections happen all the time under the umbrella of “Regenerative Medicine.” The idea is that the amniotic fluid contains stem cells which can help regenerate cartilage in the joints.

Clearly, the U.S. Attorney’s Office was dubious about the efficacy of the injections. But what got the PA in hot water is the submission of the charges to Medicare for reimbursement.

Charles Honart, for Stevens & Lee:

On July 14, the Federal Trade Commission (“FTC”), as anticipated, announced that it was withdrawing two antitrust policy statements related to enforcement in health care markets:

Statements of Antitrust Enforcement Policy in Health Care (August 1996)
Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program (October 2011)
The FTC’s withdrawal follows the Department of Justice’s (“DOJ”) decision to rescind the same statements in February 2023. (See our previous blog post.)

In withdrawing the policy statements, the FTC stated that it had determined that the withdrawal of the statements is the best course of action for promoting fair competition in health care markets. According to the FTC, much of the statements are outdated and no longer reflect health care market realities, and, given what it describes as the “profound changes” in the market over the last 30 years, the statements no longer serve their intended purpose of providing accurate guidance to market participants