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Former Owner of Health Care Staffing Company Indicted for Wage Fixing

A federal grand jury returned an indictment charging Neeraj Jindal, the former owner of a therapist staffing company, for participating in a conspiracy to fix prices by lowering the rates paid to physical therapists and physical therapist assistants in north Texas, including the Dallas-Fort Worth metropolitan area, the Department of Justice announced today.  The indictment also charges Jindal with obstruction of the Federal Trade Commission’s separate investigation into this conduct.

Price fixing is per se illegal under Section 2 of the Sherman Act. This appears to be an alleged horizontal price-fixing claim. One element in this type of charge is that the conduct must “unreasonably” restraint trade. That inquiry depends on the degree of the restraint’s adverse effect on competition and on the degree of any pro-competitive effects from restrain.

Source: Former Owner of Health Care Staffing Company Indicted for Wage Fixing | Department of Justice

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Health care company owner to pay $1 million to settle False Claims Act case

The former owner of Providence Home Health and Providence Hospice has agreed to pay $1.05 million to settle claims she knowingly and willfully paid improper kickbacks for referrals of Medicare patients to her businesses, announced U.S. Attorney Ryan K. Patrick along with Special Agent in Charge Miranda Bennett of the Department of Health and Human Services – Office of Inspector General (DHHS-OIG).

This is a whistleblower case filed by two employees. They alleged that Teresita Alquero paid kickbacks to a medical director for Providence. The payments exceeded fair market value, so as to induce him to refer Medicare patients to Providence for home health and hospice services.

Alquero also allegedly submitted false claims under the name of a physician who was apparently incarcerated at the time. Thus, he could not have performed the services for which she was reimbursed.

Source: Health care company owner to pay $1 million to settle False Claims Act case | Woodlands Online

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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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CMS final 2021 physician fee schedule rule

CMS issued the final rule for the 2021 Physician Fee Schedule and doctors will see a conversion factor of $32.41, a decrease of $3.68 from the 2020 PFS conversion factor of $36.09.According to CMS, the lower conversion factor is a result of the budget neutrality adjustment, as required by law, to account for changes in RVUs, including significant increases for E/M visit codes.

The decreased conversion factor is concerning to many physician advocacy groups.

Source: CMS final 2021 physician fee schedule rule

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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