What does it mean to “knowingly” or “recklessly” violate the law when that law consists of highly complex and ever-changing regulations, which may be open to interpretation? The U.S. Supreme Court recently agreed to review that question in two consolidated cases from the Seventh Circuit: U.S. ex rel. Tracy Schutte, et al. v. SuperValu Inc., et al. and U.S. ex rel. Thomas Proctor v. Safeway, Inc (collectively, “SuperValu”). The central question before the Supreme Court is whether a relator can allege a cognizable claim under the False Claims Act (FCA) if a defendant can prove that it acted in accordance with an objectively reasonable interpretation of regulations.
Important Update: Georgia Abortion Law Remains in Effect Until Judicial Review
Posted in Healthcare LitigationRuling on the State of Georgia’s November 18, 2022 Emergency Petition for Supersedeas, this past Wednesday (November 23, 2022) the Georgia Supreme Court enjoined the lower court’s decision thereby reinstating the prohibitions on abortion in Georgia codified by the LIFE Act. Briefly, the LIFE Act prohibits abortive care once cardiac activity is detectable in an embryo (typically at approximately six weeks). The Georgia Supreme Court’s ruling is procedural only. A substantive appeal remains pending. Nevertheless, this action by the Georgia Supreme Court, taken within eight days after the lower court’s decision, highlights for the public how rapidly state abortion laws can change. It is crucial for providers and patients to stay up-to-date on the developments of abortion laws in their respective state.
Breaking News: Georgia Court Overturns State Abortion Law
Posted in Healthcare LitigationOn June 24, 2022, the United States Supreme Court issued its seminal decision on abortion, Dobbs v. Jackson Women’s Health Organization, overturning Roe v. Wade and the right to terminate a pregnancy before viability, which Roe had seemingly codified. The Supreme Court’s decision fundamentally altered the constitutional landscape of a woman’s right to make reproductive health choices and created ambiguity about the scope and breadth of the right to privacy in the United States.
Recent FCA Settlements Warn Providers of Improper Billing Practices
Posted in Fraud & Abuse & False Claims ActTwo recent multi-million dollar False Claims Act (“FCA”) settlements demonstrate the vigor with which the Department of Justice (“DOJ”) is investigating and prosecuting allegedly fraudulent health care billing practices. These large settlements demonstrate how imperative it is that providers routinely review billing practices with the guidance of counsel.
Finally, More Certainty and Fewer Surprises – Final Rules Issued Under the No Surprises Act
Posted in Health Insurers & Managed Care Organizations, Healthcare Law, Healthcare Litigation, Hospitals & Health Systems, PhysiciansThe Departments of the Treasury, Labor, and Health and Human Services (the Departments) issued final rules related to the No Surprises Act on August 26, 2022, to be effective October 25, 2022 (Final Rules). These Final Rules come after months of uncertainty and legal battles regarding the Federal Independent Dispute Resolution (IDR) process, as we have discussed in recent blogs.
Florida Medicaid Providers: Action is Required by October 1, 2022
Posted in Health Insurers & Managed Care Organizations, Healthcare Law, Hospitals & Health Systems, PhysiciansCheck your mailboxes. AHCA is sending out postcards to existing Florida Medicaid providers (Providers) alerting them to upcoming changes in the Florida Medicaid program. These changes require Providers to pay certain of their employees a minimum wage of at least $15.00 per hour. Governor Ron DeSantis’s “Freedom First Budget for Fiscal Year 2022-2023” includes funding for AHCA to increase reimbursement rates and capitation rates in order to ameliorate the cost increases to Providers and Plans. AHCA has released guidance to assist Providers in complying with this new obligation.
More Turbulence for the No Surprises Act Thanks to Air Ambulance Providers
Posted in Healthcare Law, Healthcare Litigation, Hospitals & Health Systems, PhysiciansGiven the trajectory, it is no longer surprising that the No Surprises Act (the Act) continues its turbulent path through implementation. The U.S. District Court for the Eastern District of Texas, on July 26, 2022, again vacated provisions of the Federal Independent Dispute Resolution (IDR) process, this time relating to air ambulance payment disputes. (LifeNet, Inc. v. United States Department of Health and Human Services, et al., No. 6:22-cv-00162-JDK, slip op. (E.D. Tex. July 26, 2022).
Don’t Just Phone It In – Avoiding Fraud in Telehealth Contracts
Posted in Fraud & Abuse & False Claims Act, Healthcare Law, Healthcare Reform Legislation, Medical Devices & Equipment, Medicare & Medicaid, Physicians, TechnologyTo facilitate the provision of care during the pandemic, the federal government and many state governments enacted changes that encouraged physicians and other nonphysician practitioners (collectively, Practitioners) to use telehealth services. While this new flexibility increased access to care, it also increased opportunities for fraud. On July 20, 2022, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a Special Fraud Alert cautioning Practitioners about potential fraudulent telemedicine contracts (Fraud Alert).
The Fraud Alert is derived from the lessons learned during the OIG’s coordinated enforcement action with the Department of Justice (DOJ) and other agencies that resulted in criminal charges against 36 defendants involving more than $1.2 billion in fraudulent telemarketing services identified as telehealth. The Fraud Alert highlights these common themes in telehealth arrangements that raised red flags to the OIG and DOJ investigators:
Florida Legislation Authorizing Pharmacy Technicians to Administer Vaccines Contains Some Surprises
Posted in Government Affairs, Licensure & Regulatory, Healthcare Law, Pharmacy, Drugs, Medical Devices & EquipmentChapter 2022-60, Laws of Florida (http://laws.flrules.org/2022/60), that went into effect July 1, 2022, allows registered pharmacy technicians to seek certification to provide immunizations and become “Certified Registered Pharmacy Technicians.” These pharmacy technicians will be allowed to administer all of the vaccines listed by the CDC in the Adult Immunization Schedule or recommended by the CDC for international travel, as well as any vaccines authorized by the FDA under an emergency use authorization or by the Florida Board of Pharmacy in response to a state of emergency declared by the Governor. This is a big jump compared to the 2007 legislative session when the legislation first allowing pharmacists themselves to administer only the flu vaccine was enacted, and only after a hard-fought legislative battle when most other states already allowed pharmacists to administer vaccines. Fast forward to 2022 and pharmacy technicians are allowed to administer not just the flu vaccine, but nearly all the vaccines that a pharmacist can. The law still reserves to pharmacists the authority to vaccinate children 7 years of age and older.
Healthcare Providers: Add OCR’s Latest Right of Access Settlements to Your Summer Reading List
Posted in Electronic Health Records & Medical Records, HIPAA, Privacy, and Data Security, Hospitals & Health Systems, PhysiciansThe Office for Civil Rights (“OCR”) at the U.S. Department of Health and Human Services (“HHS”) announced on July 15, 2022, that it has resolved 11 investigations conducted under the Health Insurance Portability and Accountability Act (“HIPAA”) Right of Access Initiative. These settlements remind providers that, as OCR Director Lisa J. Pino stated, “OCR is serious about upholding the law and peoples’ fundamental right to timely access to their medical records.” With these latest settlements, OCR has resolved 38 enforcement actions in its Right of Access Initiative, which continues to have momentum.
