As we approach the conclusion of another transformative year, we are excited to present our comprehensive year-end review, shedding light on the trends shaping the healthcare market in 2023. Our team’s keen insights and...more
1/19/2024
/ Antitrust Litigation ,
Artificial Intelligence ,
Biotechnology ,
Cannabis Products ,
Centers for Medicare & Medicaid Services (CMS) ,
Complex Corporate Transactions ,
Coronavirus/COVID-19 ,
Corporate Transparency Act ,
Electronic Protected Health Information (ePHI) ,
False Claims Act (FCA) ,
Health Care Providers ,
Hospitals ,
Information Blocking Rules ,
Medical Research ,
Medicare ,
PHI ,
Private Equity ,
Recovery Audit Contractors (RACs) ,
Regulatory Oversight ,
Section 340B ,
SNF ,
US ex rel Tracy Schutte et al v SuperValu Inc et al
On Jan. 9, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) finalized a 2023 proposed rule titled “Safeguarding the Rights of Conscience as Protected by Federal Statutes” (“Final Rule”)....more
The Supreme Court of Georgia issued an opinion reversing the Superior Court of Fulton County’s 2022 ruling that Sections 4 and 11 of the Georgia LIFE Act (the Act) were void ab initio....more
On June 16, 2023, the United States Supreme Court issued an 8-1 decision in the case of United States, ex rel. Polansky v. Executive Health Resources, Inc., which held that the Department of Justice (DOJ) can move to dismiss...more
6/21/2023
/ Article II ,
Constitutional Challenges ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Rules of Civil Procedure ,
Healthcare Fraud ,
Judicial Intervention ,
Lack of Authority ,
Motion to Dismiss ,
Qui Tam ,
Regulatory Authority ,
Relators ,
SCOTUS ,
United States ex rel Polansky v Executive Health Resources Inc ,
Whistleblowers
In April 2022, CMS announced an initiative to pay for Medicare beneficiaries to receive free OTC COVID-19 test kits. Specifically, Medicare established a demonstration project to pay various eligible healthcare providers to...more
6/12/2023
/ Audits ,
Centers for Medicare & Medicaid Services (CMS) ,
CID ,
Coronavirus/COVID-19 ,
Criminal Investigations ,
Department of Justice (DOJ) ,
Diagnostic Tests ,
False Claims Act (FCA) ,
Government Investigations ,
Health Care Providers ,
Medicare ,
Over The Counter Drugs (OTC) ,
Reimbursements ,
Subpoenas ,
Virus Testing
On Friday, April 7, the Northern District of Texas issued a decision blocking the prescribing and dispensing of mifepristone nationwide. The court held that plaintiffs had a substantial likelihood of success on the merits...more
On Friday, April 7, both the Northern District of Texas and the Eastern District of Washington issued decisions impacting the Food and Drug Administration’s (FDA) approval of the abortion drug mifepristone. The Texas decision...more
4/17/2023
/ Abortion ,
Dobbs v. Jackson Women’s Health Organization ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Injunctive Relief ,
Judicial Intervention ,
Patient Access ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Authority ,
Regulatory Standards ,
Reproductive Healthcare Issues ,
Stays
Key Takeaways:
..The FDA has finalized a rule permitting abortion pills to be sold at certified retail pharmacies.
..Mifeprex and its approved generic can now be dispensed by certified pharmacies or by or under the...more
On Nov. 23, the Supreme Court of Georgia reinstated the state’s ban on abortions after the detection of a fetal heartbeat. The Supreme Court of Georgia issued a one-page order granting the State of Georgia’s Emergency...more
Key Takeaways -
..On Nov. 15, The Superior Court of Fulton County declared sections of Georgia’s 6-week abortion ban void and unenforceable.
..The Court held that because the ban was unconstitutional at the time it...more
On Aug. 24, the United States District Court for the District of Idaho issued a preliminary injunction blocking the enforcement of Idaho’s new abortion law. The law was set to take effect on Aug. 25, 2022....more
On Aug. 2, the U.S. Department of Justice (DOJ) filed suit against the state of Idaho to block a state abortion law set to take effect on Aug. 25, claiming that it violates the federal Emergency Medical Treatment and Labor...more
8/4/2022
/ Abortion ,
Department of Justice (DOJ) ,
Emergency Rooms ,
EMTALA ,
Federal Funding ,
Hospitals ,
Medicare ,
New Legislation ,
Pending Litigation ,
Preemption ,
Supremacy Clause
On Monday, July 11, 2022, the secretary of Health and Human Services (HHS) issued a letter to healthcare providers regarding the Emergency Medical Treatment and Active Labor Act (EMTALA), indicating that when a state law...more
To help guide entities through the significant confusion and changes that will be evolving for the next several years, BakerHostetler has assembled the Dobbs Decision Task Force (DDTF), led by attorneys in five major areas...more
On Nov. 2, 2021, the Centers for Medicare & Medicaid Services (CMS) published the Calendar Year (CY) 2022 Medicare Physician Fee Schedule (MPFS) final rule. This final rule will take effect on Jan. 1, 2022, and will include...more
On Nov. 2, 2021, the Centers for Medicare & Medicaid Services (CMS) issued the calendar year (CY) 2022 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System (OPPS) final rule....more
Earlier this year, the Centers for Medicare & Medicaid Services (CMS), in collaboration with the Centers for Disease Control and Prevention (CDC), issued emergency regulations requiring COVID-19 vaccination for all nursing...more
The Accelerated and Advance Payment (AAP) program is a Medicare loan program that the Centers for Medicare & Medicaid Services (CMS) typically uses in emergency situations. On March 28, CMS expanded the AAP program to help...more
Earlier this month, the U.S. Department of Health & Human Services (HHS) published updated reporting guidance for entities that received $10,000 or more in payments under the Provider Relief Fund (PRF) created by the CARES...more
On Friday, April 10, 2020, the United States Department of Health and Human Services (HHS) announced the release of the provider relief funds authorized by the CARES Act. These funds will provide $100 billion to hospitals and...more
On March 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule that outlined additional flexibilities for providers to address the ongoing global COVID-19 pandemic. CMS believes that these...more
On Mar. 25, the Senate passed H.R. 748, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). The House of Representatives passed the CARES Act on Mar. 27, and President Trump signed the bill later in the day,...more
3/30/2020
/ Accelerated Payments ,
CARES Act ,
Clinical Laboratory Testing ,
Coronavirus/COVID-19 ,
Durable Medical Equipment ,
Health Care Providers ,
Health Insurance ,
Healthcare Facilities ,
Medicare ,
Physician Medicare Reimbursements ,
Telehealth
On Mar. 13, the Centers for Medicare and Medicaid Services (CMS) issued an updated memorandum titled “Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in Nursing Homes.”...more
Healthcare providers nationwide now have an additional tool to promote social distancing in patient care. On Mar. 17, the Centers for Medicare and Medicaid Services (CMS) confirmed that practitioners nationwide may conduct...more
Under Section 1135 of the Social Security Act, the Secretary of the U.S. Department of Health and Human Services (HHS) is authorized to temporarily waive or modify certain Medicare, Medicaid and Children’s Health Insurance...more