Justia Health Law Opinion Summaries

Dr. Ron Elfenbein, who runs an urgent-care clinic in Maryland, was charged with healthcare fraud for allegedly overbilling insurers by using high-level codes for simple COVID-19 tests and submitting false medical records. The clinic, which shifted to primarily COVID-19 testing during the pandemic, billed five patient visits at level four, which is typically reserved for more complex medical decision-making.In the United States District Court for the District of Maryland, a jury found Elfenbein guilty on all charges after an 11-day trial. However, the district court acquitted him, reasoning that the evidence was insufficient to support the jury's verdict. The court also conditionally granted a new trial, citing the close nature of the case and the significant evidence that came from Elfenbein's own witnesses.The United States Court of Appeals for the Fourth Circuit reviewed the case. The court found that the jury had enough evidence to convict Elfenbein, as the government presented sufficient testimony and documentation to support the charges of overbilling and submitting false records. The court noted that the jury could reasonably conclude that the level-four codes were inappropriate for the simple COVID-19 tests and that the medical records were materially false.However, the Fourth Circuit also affirmed the district court's decision to grant a new trial. The appellate court acknowledged that the district court did not abuse its discretion in ordering a new trial, given the weaknesses in the government's case-in-chief and the significant evidence that came from the defense. The case was remanded for a new trial. View "United States v. Elfenbein" on Justia Law

GenBioPro, Inc., a manufacturer of generic mifepristone, filed a complaint against West Virginia officials, arguing that the state's law prohibiting most abortions was preempted by federal law. The company claimed that the FDA Amendments Act of 2007 (FDAAA), which regulates the distribution of high-risk drugs like mifepristone, preempted the state law. GenBioPro contended that the FDAAA established a comprehensive scheme for regulating REMS drugs with safe-use elements, leaving no room for state regulation.The U.S. District Court for the Southern District of West Virginia dismissed GenBioPro's complaint, finding no preemption. The court held that abortion regulation is a matter of health and safety traditionally occupied by the states. It determined that Congress had not expressed an intent to occupy the field of drugs subject to a REMS in a manner that would preempt West Virginia's abortion restrictions. The court also found that the FDAAA's requirement to consider patient access was a limitation on the FDA's own restrictions, not a command to ensure access for all patients.The United States Court of Appeals for the Fourth Circuit affirmed the district court's decision. The Fourth Circuit held that the FDAAA did not preempt West Virginia's abortion law. The court emphasized the presumption against preemption in areas of traditional state regulation, such as health and safety. It found that the FDAAA did not demonstrate a clear intention to displace the state's historic and sovereign right to regulate abortion. The court concluded that the FDAAA's focus on drug safety did not create a right to access specific high-risk drugs, and the statute did not preempt state laws regulating the incidence of abortion. View "GenBioPro, Inc. v. Raynes" on Justia Law

Plaintiffs, limited liability companies, filed class action lawsuits in the United States District Court for the District of Maryland seeking relief under the Medicare Secondary Payer (MSP) provisions. These provisions make Medicare a secondary payer when a beneficiary has other insurance coverage. Plaintiffs obtained assignments from Medicare Advantage Organizations and other secondary payers to seek reimbursement from primary payers like the defendants, Government Employees Insurance Company and its affiliates (GEICO). Plaintiffs had no preexisting interest in the claims and were compensated on a contingency basis.The United States District Court for the District of Maryland denied GEICO's motion to dismiss the case, which argued that the assignments were void as against Maryland public policy based on the doctrines of maintenance, champerty, and barratry. The court found no clear statement of Maryland law on this issue and certified questions to the Supreme Court of Maryland.The Supreme Court of Maryland held that Plaintiffs did not violate Maryland’s barratry statute, which prohibits soliciting another person to sue for personal gain without an existing relationship or interest. Plaintiffs did not solicit secondary payers to file lawsuits but obtained the right to sue in their own names through assignments. The court also held that the common law doctrines of maintenance, champerty, and barratry, to the extent they still apply, do not invalidate Plaintiffs’ assignments. The court concluded that the assignments are not void as against public policy and did not address the enforceability of choice-of-law provisions in the agreements. View "GEICO v. MAO-MSO Recovery II" on Justia Law

Mark Schena operated Arrayit, a medical testing laboratory in Northern California, which focused on blood tests for allergies. Schena marketed these tests as superior to skin tests, despite their limitations, and billed insurance providers up to $10,000 per test. To maintain a steady flow of patient samples, Schena paid marketers a percentage of the revenue they generated by pitching Arrayit’s services to medical professionals, often misleading them about the tests' efficacy. During the COVID-19 pandemic, Schena transitioned to COVID testing, using similar deceptive marketing practices to bundle allergy tests with COVID tests.The United States District Court for the Northern District of California denied Schena’s motion to dismiss the EKRA counts, arguing that his conduct did not violate the statute as a matter of law. The jury convicted Schena on all counts, including conspiracy to commit healthcare fraud, healthcare fraud, conspiracy to violate EKRA, EKRA violations, and securities fraud. The district court sentenced Schena to 96 months in prison and ordered him to pay over $24 million in restitution.The United States Court of Appeals for the Ninth Circuit reviewed the case and affirmed Schena’s convictions. The court held that 18 U.S.C. § 220(a)(2)(A) of EKRA covers payments to marketing intermediaries who interface with those who do the referrals, and there is no requirement that the payments be made to a person who interfaces directly with patients. The court also concluded that a percentage-based compensation structure for marketing agents does not violate EKRA per se, but the evidence showed wrongful inducement when Schena paid marketers to unduly influence doctors’ referrals through false or fraudulent representations. The court affirmed Schena’s EKRA and other convictions, vacated in part the restitution order, and remanded in part. View "United States v. Schena" on Justia Law

Janice Hollabaugh authorized her attorney to request her medical records from a health care provider for a personal injury claim. The provider contracted with MRO Corporation to fulfill the request. MRO sent a "Cancellation Invoice" to Hollabaugh’s attorney, stating that the request was canceled and charged a $22.88 fee for searching for the records, even though no records were produced. Hollabaugh reimbursed her attorney for the fee and subsequently filed a class action lawsuit against MRO, alleging that the fee violated the Confidentiality of Medical Records Act.The Circuit Court for Baltimore County determined that Hollabaugh had standing but concluded that the Act authorized MRO’s fee, leading to the dismissal of the case. The Appellate Court of Maryland affirmed the standing decision but also upheld the fee's authorization under the Act. Hollabaugh then petitioned the Supreme Court of Maryland, which granted certiorari to review the case.The Supreme Court of Maryland held that Hollabaugh had standing to sue because she reimbursed her attorney for the fee, creating a reasonable inference of injury. The Court further held that the Confidentiality of Medical Records Act does not permit a health care provider to charge a preparation fee for a search that does not result in the production of any medical records. The Court reasoned that the statutory language and context imply that fees are only authorized for the retrieval and preparation of existing records. Consequently, the Court affirmed the lower court's decision on standing but reversed the decision regarding the fee's authorization, remanding the case for further proceedings consistent with its opinion. View "Hollabaugh v. MRO Corporation" on Justia Law

Dr. Alan Braid, a Texas OB/GYN, admitted in a Washington Post editorial to performing an abortion in violation of the Texas Heartbeat Act (S.B. 8). This led to three individuals from different states filing lawsuits against him under the Act's citizen-suit enforcement provision, seeking at least $10,000 in statutory damages. Facing potential duplicative liability, Dr. Braid filed a federal interpleader action in Illinois, seeking to join the claimants in a single suit and also sought declaratory relief to declare S.B. 8 unconstitutional.The United States District Court for the Northern District of Illinois dismissed Dr. Braid’s suit, citing the Wilton-Brillhart abstention doctrine due to the existence of parallel state-court proceedings. The court reasoned that the Texas state courts were better suited to resolve the issues, particularly given the unique enforcement mechanism of S.B. 8. The district court also questioned whether Dr. Braid had a reasonable fear of double liability but ultimately found that it had jurisdiction before deciding to abstain.The United States Court of Appeals for the Seventh Circuit affirmed the district court’s dismissal. The appellate court agreed that the district court had jurisdiction over the interpleader action but concluded that abstention was appropriate under the Colorado River doctrine, which allows federal courts to defer to parallel state-court proceedings in exceptional cases. The court emphasized that the Texas courts were better positioned to resolve the complex state-law issues and that abstention would avoid piecemeal litigation and conflicting judgments. The court also noted that the Texas courts could adequately protect Dr. Braid’s rights and that the federal suit appeared to be an attempt to avoid the state-court system. View "Braid v. Stilley" on Justia Law

Mississippi Methodist Hospital and Rehabilitation Center Inc. appealed the Hinds County Chancery Court's decision affirming the Mississippi State Department of Health's grant of a certificate of need (CON) to Encompass Health Rehabilitation Hospital of Flowood LLC. The Department identified a need for additional comprehensive medical rehabilitation (CMR) beds, prompting Encompass to apply for a CON to build a new facility in Flowood. Methodist opposed the application, arguing that Encompass's proposed facility would not meet indigent care requirements and would unnecessarily duplicate existing services.The Hinds County Chancery Court initially reversed the Department's decision, finding that the hearing officer failed to consider the relevance of a CON granted to Baptist Memorial Rehabilitation Hospital - Madison LLC. However, the Mississippi Supreme Court vacated this decision, ruling that the hearing officer had considered the relevance of the Baptist CON and found it irrelevant. On remand, the chancery court affirmed the Department's grant of the Encompass CON, finding that the decision was supported by substantial evidence.The Mississippi Supreme Court reviewed the case and affirmed the chancery court's decision. The Court held that the hearing officer's findings were based on substantial evidence, including Encompass's commitment to providing indigent care and the unmet need for CMR services in the Jackson metro area. The Court also rejected Methodist's argument that the state health officer should have considered the impact of the Baptist CON, noting that this issue had already been resolved in the previous appeal. The Court remanded the case to the chancery court to determine the amount of attorneys' fees to which Encompass is entitled under Section 41-7-201(2)(f). View "Mississippi Methodist Hospital and Rehabilitation Center Inc. v. Mississippi State Department of Health and Encompass Health Rehabilitation Hospital of Flowood, LLC" on Justia Law

Karen Jean Anderson, a licensed advanced practice registered nurse (APRN), was accused by the Utah Division of Professional Licensing (DOPL) of unlawfully practicing medicine and exceeding her APRN license by performing tumescent liposuction and fat grafting procedures. These procedures are classified as ablative cosmetic medical procedures under Utah law. DOPL barred Anderson from performing these procedures and imposed a fine. Anderson sought agency review with the Department of Commerce, which reduced the fine but upheld DOPL’s order. Anderson then sought judicial review.The Utah Board of Nursing initially found that Anderson did not unlawfully practice medicine or exceed her APRN license, reasoning that the Nurse Practice Act (NPA) allows APRNs broad authority, including the ability to perform procedures like tumescent liposuction and fat grafting. However, DOPL rejected this recommendation, stating that the legislature had granted exclusive authority to perform non-exempt ablative cosmetic medical procedures to medical and osteopathic doctors. The Department of Commerce affirmed DOPL’s decision, leading Anderson to file a petition for judicial review with the Utah Court of Appeals, which certified the case to the Utah Supreme Court.The Utah Supreme Court held that the Utah Code bars APRNs from independently performing ablative cosmetic medical procedures. The court found that the statutory scheme limits such procedures to those licensed to practice medicine or those whose scope of practice includes the authority to operate or perform surgery. Since the scope of practice for APRNs does not include such authorization, Anderson unlawfully practiced medicine and exceeded her APRN license. The court affirmed the Department’s order, maintaining the restrictions and fine imposed on Anderson. View "Anderson v. Department of Commerce" on Justia Law

Ferida H. Moy suffers from severe PTSD due to her experiences during the Yugoslav Wars. She applied for disability insurance benefits and supplemental security income, citing her PTSD and related mental health issues. An administrative law judge (ALJ) denied her application, finding that she had the residual functional capacity to perform simple, routine tasks with minimal contact with supervisors and co-workers. This decision was upheld by the district court, leading Moy to appeal.The ALJ found that Moy had moderate limitations in concentrating, persisting, or maintaining pace but concluded that she could work at a consistent production pace. The ALJ's decision was based on the testimony of a vocational expert who stated that a person with Moy's limitations could work as a dining room attendant, bus person, scrap sorter, industrial cleaner, or dishwasher. However, the vocational expert also testified that regular absences or being off-task for more than 15% of the workday would result in job loss. The ALJ's decision was affirmed by the district court.The United States Court of Appeals for the Seventh Circuit reviewed the case and found that the ALJ failed to build a logical bridge between Moy's limitations and the conclusion that she could work at a consistent production pace. The court noted that the ALJ's determination did not adequately account for Moy's limitations in concentration, persistence, and pace. The court emphasized that the ALJ's reasoning was internally inconsistent and did not reflect Moy's documented symptoms and treatment needs. Consequently, the Seventh Circuit vacated the judgment and remanded the case to the Commissioner of Social Security for further consideration consistent with its opinion. View "Moy v Bisignano" on Justia Law

In the wake of the U.S. Supreme Court's decision in Dobbs v. Jackson Women’s Health Organization, which held that the U.S. Constitution does not protect the right to abortion, plaintiffs filed a lawsuit seeking a declaration that Wisconsin Statute § 940.04(1), which criminalizes the intentional destruction of an unborn child, does not ban abortion. The plaintiffs included the Attorney General, the Department of Safety and Professional Services, the Medical Examining Board, and three physicians. They argued that the statute either does not apply to abortion or has been impliedly repealed by subsequent legislation.The Dane County Circuit Court denied the defendant's motion to dismiss, concluding that the plaintiffs stated a claim upon which relief could be granted because § 940.04 does not prohibit consensual medical abortions. The court later issued a declaratory judgment that the statute does not prohibit abortions.The Wisconsin Supreme Court reviewed the case de novo. The central question was whether § 940.04(1) bans abortion. The court concluded that comprehensive legislation enacted over the last 50 years, which regulates various aspects of abortion, impliedly repealed the 19th-century near-total ban on abortion. The court held that the legislature's detailed regulation of abortion was meant as a substitute for the earlier statute, and therefore, § 940.04(1) does not ban abortion in Wisconsin.The court affirmed the circuit court's judgment and order, holding that the comprehensive legislative framework governing abortion impliedly repealed the near-total ban on abortion in § 940.04(1). View "Kaul v. Urmanski" on Justia Law