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Cutting Out the “Middleman”? HHS Resurrects Anti-Rebate Rule for Medicare Part D

[T]he Final Rule will modify the federal health care program’s Anti-Kickback Statute (“AKS”) safe harbors in three key ways:

First, it will remove safe harbor protection under the AKS for rebates that a pharmaceutical manufacturer provides to Medicare Part D plan sponsors (either directly or indirectly through the PBMs with which they contract). In apparent recognition of how disruptive this change will be to current business models, the Final Rule postpones the effective date for this change until January 1, 2022.

Second, it will create a new safe harbor to protect certain price reductions given by pharmaceutical manufacturers that are passed through to beneficiaries at the point-of-sale. This new safe harbor will become available on January 29, 2021.

Third, it will create a new safe harbor, also effective as of January 29, 2021, that protects certain fixed fees paid by manufacturers to PBMs for PBM services.

Source: Cutting Out the “Middleman”? HHS Resurrects Anti-Rebate Rule for Medicare Part D

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Direct Contracting Model Comes to Medicare

Under the model, healthcare providers — which CMS calls “direct contracting entities,” or DCEs — will competitively bid to manage 100% of the Medicare Part A and Part B costs for a certain number of Medicare beneficiaries within a geographic region, starting at a minimum of 30,000 enrollees. Who can be a DCE? “We anticipate interest from organizations that have significant experience taking risk in value-based care models including sophisticated Accountable Care Organizations (ACOs), health systems, health care provider groups and health plans,” CMS said in a fact sheet about the new model. “We also anticipate some applications might include innovative partnerships between health plans and health care providers.” Providers who join one of the DCEs will still be able to stay in any other value-based care programs they’re already in, including ACOs and Medicare Shared Savings Plans.

Source: Direct Contracting Model Comes to Medicare

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Jefferson County Doctor Convicted of Health Care Fraud Violations

The fraud and abuse laws can sometimes be obtuse, but this is a clear-cut case of intentional fraud.

Grigoriy T. Rodonaia, of Port Neches, Texas, was convicted by a jury of 12 counts of health care fraud, three counts of aggravated identity theft, one count of making a false statement, and two counts of accepting kickbacks.

Rodonaia, a physician practicing in Beaumont with Rodonaia Family Medicine and Aesthetics, was indicted on March 18, 2020.  According to information presented in court, beginning in January 2015, Rodonaia participated in a health care fraud scheme by issuing prescriptions for specially compounded scar creams using the names, dates of birth, and Health Insurance Claim Numbers of TRICARE beneficiaries, and caused the prescriptions to be forwarded directly to Memorial Compounding Pharmacy in Houston, Texas.

These prescriptions were issued without consultation with the patient and without the patient’s knowledge. The prescriptions were billed to the military health care program, TRICARE, by the pharmacy at approximately $9,000 to $13,000 per prescription, with multiple refills authorized per prescription.  Rodanaia issued over 600 prescriptions in the names of approximately 140 beneficiaries in furtherance of this scheme.

Before the scheme could be detected, TRICARE paid approximately $6.7 million in TRICARE funds to Memorial Compounding Pharmacy.  Further, to conceal his criminal activity, Rodonaia created fictitious patient files and records that falsely indicated that he had examined or consulted with those patients, and submitted those false records to the Defense Health Agency in response to an audit.

Source: The Gilmer Mirror – Jefferson County Doctor Convicted of Health Care Fraud Violations

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OIG Issues Final Rules on Anti-Kickback Statute and the Civil Monetary Penalty

In its final rule, the OIG defined what constitutes “telehealth technologies” more broadly than in its proposed rule, but otherwise chose to track the conditions for the exception contained in the underlying statute and not to implement any of the additional conditions that were included in the proposed rule.

Source: OIG Issues Final Rules on Anti-Kickback Statute and the Civil Monetary Penalty

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Fifth Individual Charged in Health Care Kickback Conspiracy

The defendants are alleged to have conspired to pay and receive kickbacks in exchange for physicians’ orders that were used to submit claims for payment to federal health care programs.  The conspirators obtained patient information, including protected health information and personally identifiable information, and used the information to create fictitious physicians’ orders.  The conspirators then sold the physicians’ orders to each other and to other durable medical equipment providers.  Within approximately eight months, the defendants collectively obtained more than $2.9 million in proceeds from the criminal scheme.

Source: Fifth Individual Charged in Health Care Kickback Conspiracy

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Stark + AKS Final Rules

The final rules for changes to the Stark Law and Anti-Kickback Statute (healthcare fraud & abuse laws) have been published and go into effect on January 19, 2020. Of course, health lawyers love this stuff, but it could impact other practice areas too.

Transaction attorneys, you already know to be very careful if your transaction or arrangement, in any way, involves a hospital, doctor, or any other healthcare provider or entity. Even if your deal does not involve a healthcare provider, but could impact reimbursement by any federal program, these statutes may be implicated.

Litigators, these statutes can apply to your cases too. If your case involves one of these improper payments or an improper business structures, you might have a contractual avoidance theory available to you, if you’re the defendant, or an additional claim of fraud, if you are the plaintiff.

The key point is that these statutes can apply in ways that don’t seem immediately obvious.

Source: Stark + AKS Final Rules

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OIG Fraud Concerns Over Physician Speaker Programs

In a Special Fraud Alert issued on November 16, 2020, the Department of Health and Human Services Office of Inspector General (HHS-OIG) raised significant fraud and abuse concerns with companies offering or providing remuneration in connection with physician speaker programs. Speaker programs typically involve one health care professional presenting to others on a company’s drug or device, or a disease state relevant to the company’s products, in exchange for a speaker honorarium. While speaker programs may have some legitimate purposes, HHS-OIG warned of risk the programs create for drug or medical device companies and health care professional participants, if one purpose of the program is to induce or reward federal health care program referrals.

This has been a long time coming. There have been various prosecutions and settlements involving speaker programs over the years. I’m surprised it has taken this long for OIG to issue a Special Fraud Alert.

Source: OIG Fraud Concerns Over Physician Speaker Programs

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Houston physician sentenced to prison for $17M billing fraud

Yolanda Hamilton, MD, was found guilty by a federal jury of participating in a Medicare scheme that involved signing false “plans of care” and other medical documents for home health services that were used to submit fraudulent claims to Medicare. She allegedly received $30,000 in kickbacks during the four-year scheme. Prosecutors alleged that Dr. Hamilton and her co-conspirators submitted more than 2,500 fraudulent claims to Medicare, according to the Houston Chronicle.

Source: Houston physician sentenced to prison for $17M billing fraud

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FTC sues to block $350 million sale of 2 Tenet Healthcare-owned hospitals in Memphis area

The Federal Trade Commission is suing to block Farmers Branch-based Tenet Healthcare’s $350 million sale of two hospitals in the Memphis area to another healthcare system.

I don’t know the specifics of the transaction, but the FTC likely objected after the parties filed a “Hart-Scott-Rodino Premerger Notification,” or just “Hart-Scott filing.” These filings, which must take place a certain amount of time prior to the closing of the transaction, give the FTC time to object.

Often, the FTC will object and also file an injunction in Federal Court to prohibit the transaction. The practical effect is that the preliminary injunction hearing becomes the “trial” for whether the transaction will be allowed. If the FTC is successful with the injunction, the deal is usually scuttled.

Source: FTC sues to block $350 million sale of 2 Tenet Healthcare-owned hospitals in Memphis area – Dallas Morning News

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San Antonio ER hospital sued for alleged overbilling

A former patient has sued Baptist Emergency Hospital in San Antonio and its owner alleging they fraudulently overcharged for lab work to generate higher reimbursements.

This is not a qui tam case, but rather a state court private action. The Plaintiff accuses Baptist Emergency Hospital at Shavano Park of carrying out a scheme known as “unbundling,” which is when a facility bills separately for some or all tests analyzed as part of a panel rather than billing for the panel.

The Plaintiff visited the hospital in December 2018. Although the hospital accepted his insurance, he received a “laboratory” bill for $4,500 nine months later. Most of the charge was related to a metabolic panel and a liver function test, together consisting of multiple components. The suit alleges that the components were billed individually rather than as a complete panel, resulting in a higher bill.

A “Pricing Transparency Document” posted on the hospital’s website in 2018 showed the cost of a basic metabolic panel as almost $754. Only seven of the eight tests in the panel were performed, the suit says, but Keslar was billed nearly $1,221, according to the suit.

The petition alleges that this same unbundling practice is occurring across all Baptist Emergency Hospital facilities. Plaintiff is seeking certification of a class-action.

Source: San Antonio emergency hospital sued for alleged overbilling