Author: WadeEmmert

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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 Finalizes Rebate Rules: Removal of Safe Harbor Protections for Rebates and Creation of New Safe Harbors for Other Discounts and Service Fees

As the title implies, this final rule clarifies and amends the discount safe harbor at 42 C.F.R. § 1001.925(h) under the federal Anti-kickback statute (AKS) such that rebates paid from drug manufacturers to Medicare Part D prescription drug plan sponsors or their pharmacy benefit managers (PBMs) are not protected from liability under the discount safe harbor. The rule also adds a new safe harbor for point-of-sale reductions in price that are passed on directly to a buyer (a defined term under the rule) and an additional safe harbor for “legitimate” service fees paid to PBMs by drug manufacturers.

Source: OIG Finalizes Rebate Rules: Removal of Safe Harbor Protections for Rebates and Creation of New Safe Harbors for Other Discounts and Service Fees

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Reimbursement Pressure in Radiation Therapy & Block Lease Arrangements

The finalized Radiation Oncology payment model and the Final CY 2021 Medicare Physician Fee Schedule (“MPFS”) have now been made public. Many in the industry will continue to face downward pressure on reimbursement during the coming year under the new MPFS payment rates set by Medicare which will drive overall cuts estimated to average 5.0% for all Medicare revenues.

Source: Reimbursement Pressure in Radiation Therapy & Block Lease Arrangements

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HHS Finalizes Highly Anticipated Final Rules Amending AKS and Stark Law Regulations, Part III: Value-Based Arrangements

A value-based arrangement is an arrangement entered into between a value-based enterprise (VBE) and one or more of its participants, or among VBE participants in the same VBE, for the provision of one or more value-based activities for a target patient population. The final rule defines a VBE participant as an individual or entity that engages in at least one value-based activity as part of a value-based enterprise, other than a patient acting in their capacity as a patient.

For purposes of the OIG’s new safe harbors, a VBE is two or more participants that: (1) are collaborating to achieve at least one value-based purpose; (2) are each a party to a value-based arrangement with the other (or at least one other participant in the same VBE); (3) have an accountable body or person responsible for financial and operational oversight of the VBE; and (4) have a governing document describing the VBE and how its participants intend to achieve the VBE’s value-based purpose(s).

The size and structure of a VBE can vary greatly from a large network of providers and suppliers; a separate legal entity, like an Accountable Care Organization (ACO); or just two providers contracting together to form a value-based arrangement.Finally, a value-based purpose is (1) coordinating and managing the care of a target patient population; (2) improving the quality of care for a target patient population; (3) appropriately reducing the costs to, or growth in expenditures of, payors without reducing the quality of care for a target patient population; or (4) transitioning from health care delivery and payment mechanisms based on the volume of items and services provided to mechanisms based on the quality of care and control of costs of care for a target patient population.

Source: HHS Finalizes Highly Anticipated Final Rules Amending AKS and Stark Law Regulations, Part III: Value-Based Arrangements | Mintz

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HHS Amends PREP Act Declaration, Including to Expand Access to COVID-19 Countermeasures Via Telehealth

On December 3, the U.S. Department of Health and Human Services (HHS) issued a fourth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to increase access to critical countermeasures against COVID-19.

Source: HHS Amends PREP Act Declaration, Including to Expand Access to COVID-19 Countermeasures Via Telehealth | Holland & Hart Health Law Blog

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New Stark and Anti-Kickback Statute Comparisons

A great resource of the a redline versions of the regulations that highlight the changes for the new revisions to Stark and the Anti-Kickback Statute. The documents may be accessed here:

The Federal Register versions of the revised regulations and accompanying commentary may be accessed here:

Hat tip to Holland and Hart.

Source: New Stark and Anti-Kickback Statute Comparisons

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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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Ways your Healthcare Company is Breaking the Law — Without Realizing it

According to the U.S. Department of Health & Human Services’ Breach Portal, sometimes called the “Wall of Shame,” 418 breaches of HIPAA were reported in 2019. Some 34.9 million Americans had their protected health information (PHI) compromised. How is this still happening?

Healthcare companies and practices make the biggest mistake by believing human behavior can be perfect all the time. … [R]esulting from this assumption about human behavior, healthcare providers cheap out and refuse to pay for sufficient security measures for their network. A cheap security system may not contain proper firewalls and leave devices vulnerable, while wholly unencrypted devices can be a nightmare. Healthcare employees leave their cell phones, laptops, or iPads in their vehicles while they run out for coffee or to the grocery. And what happens next? The vehicles are broken into, and PHI is at risk.

I think there is another erroneous assumption that employers make: they assume their business model will continue to be the same.

It is so easy when putting a deal together, to come up with workflows and policies that make the deal compliant. But as time goes on, the business model shifts, even slightly, in a way that makes the previously workflow and policy no longer compliant.

As a result, as part of their ongoing Compliance Program, Covered Entities should routinely audit their HIPAA Privacy and Security standards to ensure they are evolving with their business.

Source: Ways your Healthcare Company is Breaking the Law — Without Realizing it

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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