The McGuireWoods Women’s Health Newsletter delivers information on the latest legal and regulatory developments affecting the women’s health industry. The publication provides timely analysis of legislative changes,...more
3/11/2026
/ Acquisitions ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Diagnostic Tests ,
Drug Pricing ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Healthcare Fraud ,
Initial Public Offering (IPO) ,
Investment ,
Investors ,
Medicare ,
Medicare Fraud ,
New Legislation ,
Pharmaceutical Industry ,
Private Equity ,
Private Equity Firms ,
Proposed Legislation ,
Regulatory Oversight ,
Reproductive Healthcare Issues ,
Telehealth ,
Venture Capital
On Jan. 1, 2026, several significant changes from the Centers for Medicare & Medicaid Services (CMS) took effect for suppliers of Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS). A key change is the...more
2/18/2026
/ Accreditation ,
Acquisitions ,
Centers for Medicare & Medicaid Services (CMS) ,
Competitive Bidding ,
Durable Medical Equipment ,
Final Rules ,
Healthcare ,
Medicare ,
Mergers ,
Prior Authorization ,
Regulatory Oversight ,
Regulatory Requirements
The market for maternal healthcare offers providers, payors and investors an opportunity to address pressing social needs while unlocking business growth and expansion. U.S. maternal mortality remains unacceptably high while...more
1/7/2026
/ Alternative Payment Models (APM) ,
Artificial Intelligence ,
Digital Health ,
Health Care Providers ,
Health Insurance ,
Healthcare Costs ,
Investors ,
Machine Learning ,
Medicaid ,
Popular ,
Privacy Laws ,
Regulatory Requirements ,
Reproductive Healthcare Issues ,
Telehealth ,
Telemedicine ,
Value-Based Care
On August 25, 2025, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued a report analyzing Medicare billing practices for remote patient monitoring (“RPM”) services during 2024. As RPM...more
The convergence of wellness, aesthetics and preventive care is creating new growth avenues for investors and operators, especially in the women’s health space. This space includes heavily cash-pay services, such as weight...more
Women’s healthcare during menopause and midlife, a once neglected sector, is experiencing unprecedented growth, fueled by increased awareness, consumer demand, innovation in clinical care and a surge in investment activity....more
The fertility and reproductive health sectors are experiencing dynamic growth, driven by shifting demographics, evolving societal attitudes and rapid technological advancement. The global fertility market size is expected to...more
Most maternal health complications happen after delivery, but for decades, postpartum care remained one of medicine’s most neglected phases of life. That is changing fast. The first 12 weeks after delivery, long overlooked,...more
On July 14, 2025, the Centers for Medicare & Medicaid Services (CMS) issued the 2026 Medicare Physician Fee Schedule (PFS) Proposed Rule (PFS Proposed Rule). The PFS Proposed Rule proposes to reduce requirements for several...more
For years, women’s health was often siloed into OB/GYN care and absent from mainstream investment theses, but that landscape is changing. New platforms and care models are addressing women’s health in a more comprehensive...more
Remote patient monitoring (“RPM”) continues to see increased growth and evolution. With that industry growth, the government has begun to examine whether certain RPM models may have fraud and abuse concerns when others will...more
On December 27, 2024, the United States Court of Appeals for the Second Circuit decided United States ex rel. Camburn v. Novartis Pharmaceuticals Corporation and joined a growing list of federal circuit courts that have...more
On September 24, 2024, the Department of Health and Human Services Office of Inspector General (“OIG”) published a report (the “Report), reviewing and recommending increased oversight of remote patient monitoring (“RPM”)...more
The Centers for Medicare & Medicaid Services (CMS) recently released data on its 2023 settlements of voluntary self-disclosures related to past violations or potential violations of the physician self-referral law (the Stark...more
On Jan. 1, 2024, California’s Proposition 12 (Prop 12) went into full effect, requiring certain farm owners, operators and distributors of covered farm animals such as egg-laying hens, commercial breeding pigs and veal calves...more
On Jan. 12, 2024, the U.S. Department of Health and Human Services (HHS) officially released unredacted documents detailing the U.S. Food and Drug Administration’s (FDA) reasons for recommending that the Drug Enforcement...more
On Oct. 23, 2023, the U.S. Food and Drug Administration (FDA) issued draft guidance in the form of questions and answers (Q&A) regarding manufacturers’ (Firms) dissemination of scientific and medical information on unapproved...more
A large damage award serves as a significant reminder to file an appearance in a False Claims Act (FCA) case.
In late August of 2022, the Government filed suit against AZ Diabetic and the owner, Hisham Zaghal (Zaghal),...more
In late August 2023, the Department of Health and Human Services (HHS) recommended rescheduling marijuana from a Schedule I substance to a Schedule III substance under the Controlled Substances Act (CSA), signaling the...more