In the proposed CY 2025 Physician Fee Schedule (PFS) published in the Federal Register on July 31, the Centers for Medicare & Medicaid Services (CMS) is soliciting comments on a proposal to revise the Medicare Claims...more
On July 10, the Centers for Medicare & Medicaid Services (CMS) proposed to extend virtual direct supervision—i.e., the ability to provide direct supervision through real-time, audio-visual technology (rather than in-person...more
Asembia’s 20th Annual Specialty Pharmacy Summit once again brought investors and operators in the specialty pharmacy ecosystem to Las Vegas for learning sessions and networking. Bass, Berry & Sims brought a team of four...more
5/15/2024
/ Acquisitions ,
Ambulatory Surgery Centers ,
Health Care Providers ,
Healthcare ,
Inflation Reduction Act (IRA) ,
Investment ,
Investors ,
Life Sciences ,
Medicare ,
Mergers ,
Pharmaceutical Industry ,
Pharmacies ,
Section 340B ,
Technology Sector
On November 2, the Centers for Medicare & Medicaid Services (CMS) extended virtual direct supervision—i.e., the ability to provide direct supervision through real-time, audio-visual technology (rather than in-person presence)...more
11/8/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Final Rules ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Medicare ,
New Regulations ,
Physician Fee Schedule ,
Physicians ,
Regulatory Agenda ,
Telehealth
On November 3, a federal district court issued a monumental decision endorsing an expansive view of who is a “patient” of a 340B program covered entity eligible to receive a 340B drug. In Genesis Healthcare, Inc. v. Becerra,...more
11/6/2023
/ Audits ,
Comment Period ,
Covered Entities ,
Drug Pricing ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
HRSA ,
Patients ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B
With the May 11, 2023 expiration of the federal public health emergency (PHE) for COVID-19, many operational flexibilities healthcare providers used during the PHE will now sunset. Some flexibilities end immediately while...more
5/12/2023
/ Ambulatory Surgery Centers ,
Billing ,
Coronavirus/COVID-19 ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Medicare ,
Medicare Part B ,
Public Health Emergency ,
Remote Working ,
Supervision
Bass, Berry & Sims attorney Shannon Wiley, with Carine Leslie and Katie Garmon of PYA, P.C., recently discussed the complexities associated with billing, coding, and collecting for infusion services as part of the Infusion...more
In January, a federal jury in the Northern District of Illinois convicted Mark Sorenson, owner of durable medical equipment (DME) pharmacy Symed Inc., for participating in a conspiracy to obtain $24.8 million in illegal...more
The U.S. House of Representatives is expected today to pass legislation passed by the U.S. Senate that will significantly alter the landscape for pharmaceutical pricing and reimbursement under the Medicare program for certain...more
8/15/2022
/ Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Pharmaceutical Industry ,
Pharmacies ,
Physician Medicare Reimbursements ,
Physicians ,
Prescription Drugs ,
Proposed Legislation ,
Section 340B
On June 15, the U.S. Supreme Court issued a unanimous decision finding Medicare payment cuts to hospitals participating in the 340B drug pricing program illegal. The decision in favor of 340B hospitals is the culmination of a...more
On March 18, the Office of Inspector General (OIG) issued a favorable Advisory Opinion No. 21-01 (Opinion) regarding a free drug program sponsored by a pharmaceutical manufacturer of a personalized cell and gene therapy...more
4/8/2021
/ Advisory Opinions ,
Anti-Kickback Statute ,
Civil Monetary Penalty ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare Facilities ,
Manufacturers ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
REMS ,
Specialty Healthcare
In a coordinated effort, on November 27, 2020, the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) published final rules to modernize regulations implementing the federal...more
12/22/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Final Rules ,
Health Care Providers ,
New Value Exception ,
OIG ,
Pharmacy Benefit Manager (PBM) ,
Physicians ,
Rebates ,
Safe Harbors ,
Stark Law ,
Technology Sector
On November 16, the Department of Health and Human Services Office of Inspector General (OIG) took a shot across the bow of the healthcare industry when it published a Special Fraud Alert highlighting some of the fraud and...more
Recent enforcement actions focus attention on the importance of fundamental operational processes to ensure only valid prescriptions and refills are processed. This month, Omnicare, Inc. (Omnicare), a subsidiary of CVS...more
In an effort to respond to prescription drug pricing concerns, on January 31, 2019, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) released a highly anticipated, 123-page...more
2/5/2019
/ Anti-Kickback Statute ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Flat Fees ,
Health Care Providers ,
Health Insurance ,
Health Plan Sponsors ,
Manufacturers ,
MCOs ,
Medicaid ,
Medicare ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Rules ,
Public Comment ,
Rebates ,
Safe Harbors ,
Trump Administration