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Health Law Newsletter #2020-47

COVID CORNER

HHS Issues Guidance on Vaccine-related COVID-19 Countermeasures

To that end, HSS considers state-licensed pharmacists and pharmacy interns to be qualified persons under the PREP Act. Pharmacists or pharmacist interns who otherwise might not be eligible to administer such vaccinations, are permitted to do so under the PREP Act, provided that the pharmacist has undergone 20 hours of specified training. However, if a state permits such vaccinations with a lesser amount of training, the PREP Act does not preempt state law in that regard.

MEDICARE

COVID-19 Vaccine Billing Codes Released

This week, the American Medical Association (AMA)’s CPT Editorial Panel, in collaboration with CMS and the CDC, released new CPT codes in advance of the anticipated release of two immunizations for the disease caused by the novel coronavirus (SARS-CoV-2, also known as COVID-19) projected as early as the next few months. AMA created two new CPT codes for two different vaccines as well as two sets of unique administration codes—one for each vaccine.

Eleventh Circuit Extends Scope and Time Limits for People Who Sue under the Medicare Secondary Payer Act

Medicare is the Secondary Payor when other insurance is available to pay the claim. However, when the Primary Payor delays payment, Medicare will make a “conditional payment.” If the Primary Payor fails to reimburse Medicare within 60 days, Medicare and other Medicare Advantage Organizations (MAOs) can recover double damages from the Primary Payor. This Eleventh Circuit decision opens the door to allow “downstream actors” (the physician groups who contract with MAOs to provide care) to recover double damages from the Primary Payor.

wRVU Compensation Formulas: Time to Review

Many hospitals, physician groups, or other providers compensate employed or contracted practitioners based on the work relative value units (“wRVUs”) they generate, e.g., a physician may be paid $x per wRVU performed. Depending on the contract terms, those wRVU values may soon be affected by the 2021 Medicare Physician Fee Schedule. If you have not already done so, you should review your wRVU compensation formula for: 1) Changes to RVU values; 2) Personally Performed Services; 3) wRVUs Performed, Billed, or Collected; 4) wRVU Modifies; 5) Unlisted Procedures; 6) Authority to Determine CPT Codes; 7) Duplication; 8) Computation Period; 9) Value-Based or Quality Metrics; and 10) Cap the Compensation.

ANTITRUST

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

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.

PRIVACY & ACCESS

HIPAA Compliance Considerations During the Pandemic

As health care providers continue to face new challenges relating to the COVID-19 pandemic, it is important for providers to maintain compliance with HIPAA. Although the Department of Health and Human Services Office for Civil Rights (“OCR”) has loosened some requirements to allow health care providers flexibility during the COVID-19 pandemic, a majority of the patient protections under the HIPAA Privacy Rule have remained intact.

OCR Settles Eleventh Investigation in HIPAA Right of Access

Dr. Rajendra Bhayani, who is a private practitioner specializing in otolaryngology in Regal Park, New York, has agreed to take corrective actions and pay $15,000 to settle a potential violation of the HIPAA Privacy Rule’s right of access standard.

Office of the National Coordinator for Health IT Extends Compliance Deadlines under Interoperability Final Rule

In an effort to provide additional relief to a health care system strained by the COVID-19 pandemic, the Office of the National Coordinator for Health IT (“ONC”) released an Interim Final Rule with Comment Period (“IFC”) on October 29, 2020 that extends the compliance dates under the 21st Century Cures Act Interoperability, Information Blocking, and ONC Health IT Certification Program Final Rule (the “Final Rule”) and offers some technical corrections and clarifications.

PRICE TRANSPARENCY

New Transparency in Pricing Rules Require Health Insurers to Disclose Health Care Cost and Cost-Sharing Information

Most non-grandfathered group health plans, health insurance issuers offering coverage in the individual and group markets, and employer self-funded plans will be required to make new additional information regarding the costs of items and services available to the insureds. These disclosures will be made on an internet-based, self-service tool that consumers may access or request in paper form. The information must be searchable by billing code, name of provider, and other factors that may affect cost-sharing liability.

Sunlight on Drug Prices Negotiated by Health Plans: The “Transparency in Coverage” Final Rule

The Final Rule imposes two requirements on Payors relating to drug pricing. First, Payors must make certain drug pricing information publicly available through machine-readable files. Second, upon the request of a participant, a Payor must make available certain pricing disclosures to the individual participant at the participant’s request.

FRAUD & ABUSE

California Doctor Pleads Guilty to EKRA Violations

Doctor Akikur R. Mohammad, a California resident and drug treatment facility owner, pled guilty before the U.S. District Court of New Jersey for violating the Eliminating Kickbacks in Recovery Act (“EKRA”), one of the country’s first convictions under this statute targeting opioid kickbacks. Enforcement under EKRA can help shed light on questions remaining concerning the statute’s broad definitions, particularly around laboratory services, and its application in light of other federal laws such as the federal anti-kickback statute (“AKS”). Thus far, known enforcement cases under EKRA have focused on opioid and drug treatment cases.

San Antonio ER hospital sued for alleged overbilling

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.

By Wade Emmert

Wade Emmert is a board certified health law attorney with more than 25 years of experience. He is a partner in the Dallas law firm of Carrington, Coleman, Sloman & Blumenthal, L.L.P. Please contact Wade at (214) 855-3040 or at wemmert@ccsb.com.