The United States District Court for the Eastern District of Virginia recently dismissed an appeal by the Pharmaceutical Coalition for Patient Access (“PCPA”) that challenged a negative opinion issued by the U.S. Department...more
The Centers for Medicare & Medicaid Services (“CMS”) released the final rule on risk adjustment data validation (“RADV”) audits of Medicare Advantage (“MA”) organizations (the “Final Rule”) on January 30, 2023. Among other...more
On August 14, 2023, the Centers for Medicare & Medicaid Services (CMS) released guidance on changes to the Accountable Care Organization Realizing Equity, Access, and Community Health (ACO REACH) Model starting in performance...more
The intersection of patient satisfaction and quality of care is central to healthcare today, and a provider’s level of cultural competence can significantly impact his/her performance in both areas. Recent focus on diversity,...more
On July 13, 2023, the Centers for Medicare & Medicaid Services (“CMS”) issued its proposed rule (the “Proposed Rule”) for the 2024 Medicare Physician Fee Schedule (“PFS”). The Proposed Rule, which was issued in the Federal...more
On June 1, 2023, the Supreme Court issued a unanimous decision holding that the scienter element of the False Claims Act (“FCA”) is met if a defendant subjectively knew his or her claims were false and submitted them anyway....more
6/5/2023
/ Drug Pricing ,
False Claims Act (FCA) ,
Fraud ,
Healthcare ,
Oral Argument ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Qui Tam ,
Scienter ,
SCOTUS ,
US ex rel Thomas Proctor v Safeway Inc ,
US ex rel Tracy Schutte et al v SuperValu Inc et al
While government enforcement has traditionally been an indirect concern for private equity (“PE”) investors, such as looking at whether a target entity has been sanctioned or could be sanctioned in the future, the current...more
On January 30, 2023, the Centers for Medicare & Medicaid Services (“CMS”) released the long-delayed final rule on risk adjustment data validation (“RADV”) audits of Medicare Advantage (“MA”) organizations (the “Final...more
CMS announced today a further extension until February 1, 2023, of the deadline for its publication of the long-awaited final rule on the use of extrapolation and the application of a fee-for-service adjuster (FFS Adjuster)...more
Late last month, the Biden Administration announced the second installment of its recovery plan, dubbed the “American Jobs Plan” (the “Plan”). The Plan’s $2.3 trillion price tag includes $400 billion to revamp and reinvest...more
On February 4, 2021, the Department of Justice (“DOJ”), Office of Public Affairs, issued a Press Release (the “DOJ Press Release”) announcing that Kelly Wolfe, President of Regency, Inc., a medical billing company located in...more
3/11/2021
/ Anti-Kickback Statute ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
Durable Medical Equipment ,
False Claims Act (FCA) ,
Fraud ,
Healthcare Fraud ,
Medicare ,
OIG ,
Settlement ,
Telehealth ,
Telemedicine
Telehealth services and providers have been in high demand as the world copes with the COVID-19 public health emergency. Federal and state agencies have amended, and often loosened, regulations in an attempt to facilitate...more
In response to the ongoing COVID-19 public health emergency (the “PHE”) first declared on March 13, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued blanket Section 1135 Waivers to expand, albeit on a...more
On Thursday, April 16, 2020, the California Department of Managed Health Care (the “Department”) released an all plan letter (the “Letter”) regarding changes to the Department’s General Licensure Regulation (the “Regulation”)...more
On April 16, 2020, the Trump Administration issued its “Opening Up America Again Guidelines” (the “OUAA Guidelines”) as a self-styled roadmap to the staged reopening of the American economy.
On Sunday, April 19, 2020, the...more
On Tuesday, April 7, 2020, the California Department of Managed Health Care (the “DMHC”) released a guidance letter (the “Letter”) to all health care service plans regarding billing for and delivering telehealth services...more
On Thursday, March 12, 2020, the California Department of Managed Health Care (the “Department”) released a guidance letter (the “Letter”) to all health care service plans regarding the coronavirus (COVID-19) pandemic. The...more
On June 28, 2018, California’s new privacy bill A.B-375 was signed into law as the California Consumer Privacy Act of 2018 (“CCPA”). On October 10, 2019, the California Attorney General issued proposed regulations for...more
11/22/2019
/ California Consumer Privacy Act (CCPA) ,
Consumer Privacy Rights ,
Data Breach ,
Data Collection ,
Data Privacy ,
Data Protection ,
Health Care Providers ,
Hospitals ,
Information Requests ,
Information Sharing ,
Opt-Outs ,
Personally Identifiable Information ,
Privacy Laws ,
Private Right of Action ,
Proposed Regulation ,
Regulatory Requirements ,
Right to Delete
On July 10 2019, the Centers for Medicare & Medicaid Services (“CMS”) issued a Notice of Proposed Rulemaking (“NPR”) entitled, “Medicare Program; Specialty Care Models to Improve Quality of Care and Reduce Expenditures.” In...more
Access to healthcare information (or lack thereof) has always been touted as one of the key factors/necessities to realizing the promise of technology in the delivery of healthcare. Despite various legislative, judicial,...more
10/18/2019
/ 21st Century Cures Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Data Blocking ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Enforcement Actions ,
Health Care Providers ,
Health Information Technologies ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Breach ,
Medical Records ,
OCR ,
Proposed Rules ,
Public Policy ,
Records Request ,
Right of Access ,
Risk Management
On Monday, August 8th, the Deputy Director of Legislative Affairs of the Department of Managed Health Care (the “Department”) released a letter of opposition (the “Letter”) to Assembly Bill 1249 (“AB 1249”). The Letter was...more
Where does my prescription come from? Has it been altered or diluted? Can I trust the label? With millions of prescriptions filled each year, quality control and security across the pharmaceutical supply chain seems like a...more
7/15/2019
/ Blockchain ,
Data Management ,
Distributed Ledger Technology (DLT) ,
Drug Distribution ,
Federal Pilot Programs ,
Food and Drug Administration (FDA) ,
IBM ,
KPMG ,
Merck ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Supply Chain ,
Wal-Mart
As the excitement around blockchain technology continues to grow in the healthcare sector, there is an increasing realization that blockchain has the capability of addressing many of the data and information-related...more
After a protracted comment period, the California Department of Managed Health Care (the “Department”) formally adopted its much anticipated “global risk” regulation (the “Regulation”), which will go into effect on July 1,...more
In 2018, five major healthcare companies – Humana, MultiPlan, Optum, Quest Diagnostics, and UnitedHealthcare – formed the Synaptic Health Alliance (the “Alliance”) to explore how blockchain technology could resolve current...more