On April 8, 2024, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited favorable Advisory Opinion (AO 24-02) for a charitable patient assistance program (PAP) focused on rare...more
5/13/2024
/ Advisory Opinions ,
Anti-Kickback Statute ,
Cost-Sharing ,
Department of Health and Human Services (HHS) ,
Inflation Reduction Act (IRA) ,
Manufacturers ,
Medicare Part D ,
OIG ,
Patients ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Requirements
On April 29, 2024, FDA finalized the long-awaited rule to assert authority over the regulation of laboratory developed tests (LDTs) under FDA’s existing regulatory framework for medical devices under the Federal Food, Drug,...more
Members from both parties in the House and Senate have introduced legislation in both houses (H.R. 7085 / S. 3558) to bar federal agencies from entering into:
Contracts, loans, or grant agreements for biotechnology...more
On December 7, the White House announced “New Actions to Lower Health Care and Prescription Drug Costs by Promoting Competition,” which included “a proposed framework for agencies on the exercise of march-in rights on...more
On February 7, 2023, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published a report entitled, “Technical Assistance Brief: Implementation of Inflation-Indexed Rebates for Part B Drugs.” ...more
In a historic presidential election that began during the COVID-19 pandemic and ended with record voter turnout and mail-in ballots, former Vice President Joseph Biden of Delaware was declared the 46th president of the United...more
On Friday, November 20, 2020, 60 calendar days prior to the inauguration of President-Elect Biden, the Trump administration released three rulemakings with significant implications for life sciences companies and healthcare...more
11/30/2020
/ Anti-Kickback Statute ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Life Sciences ,
OIG ,
Pharmaceutical Industry ,
Rulemaking Process ,
Stark Law ,
Trump Administration
President Donald Trump signed an Executive Order (EO) on Thursday, August 6, 2020 directing federal agencies to “Buy American” when purchasing “essential” drugs, medical supplies and equipment rather than purchase these...more
8/7/2020
/ Buy American Act ,
Environmental Protection Agency (EPA) ,
Essential Goods ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Medical Equipment ,
Medical Supplies ,
OMB ,
Prescription Drugs ,
Trump Administration ,
United States
On April 24, 2020, President Trump signed into law the Paycheck Protection Program and Health Care Enhancement Act (HCEA), which appropriated an additional $75 billion to the Public Health and Social Services Emergency Fund...more
On March 27, 2020, Congress passed the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), the third and by far the largest stimulus package passed by Congress to respond to the COVID-19 outbreak. As discussed...more
On May 8, 2019, the Centers for Medicare & Medicaid Services (“CMS”) finalized the regulation (“Final Rule” or “DTC Rule”) requiring direct-to-consumer (“DTC”) prescription drug television advertisements to include the...more
5/14/2019
/ Acquisitions ,
Advertising ,
Centers for Medicare & Medicaid Services (CMS) ,
Direct to Consumer Sales ,
Drug Pricing ,
First Amendment ,
Lanham Act ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Wholesale
On October 15, 2018, the Centers for Medicare & Medicaid Services (CMS) published a Proposed Rule requiring disclosures by pharmaceutical manufacturers of the list price for certain drugs and biologicals directly or...more
While the Biologics Price Competition and Innovation Act (BPCI) was originally enacted under the Obama Administration as part of the Affordable Care Act, it appears that the Trump Administration will continue to take steps to...more
On November 13, 2017, a group of hospital trade associations (the American Hospital Association, the Association of American Medical Colleges, and America’s Essential Hospitals), along with two health system providers, filed...more
Centers for Medicare & Medicaid Services -
Overview -
On June 29, 2016, the Center for Medicare and Medicaid Innovation (CMMI or the Innovation Center) formally launched the Oncology Care Model (OCM) at the Cancer...more
Market Based Payment for Clinical Diagnostic Laboratory Tests -
Summary -
On June 17, 2016 the Centers of Medicare & Medicaid Services (CMS) issued the long awaited Medicare Clinical Diagnostic Laboratory Tests...more
7/5/2016
/ ADLT ,
Algorithms ,
Centers for Medicare & Medicaid Services (CMS) ,
CLFS ,
Clinical Laboratories ,
Clinical Laboratory Testing ,
Comment Period ,
Data Collection ,
Diagnostic Tests ,
MACs ,
Medicaid ,
Medicare ,
Medicare Advantage ,
PAMA ,
Payment Systems ,
Proposed Regulation ,
Provider Payments ,
Reporting Requirements
On December 5, 2014, the Centers for Medicare & Medicaid Services (CMS) issued a final rule titled “Requirements for Medicare Incentive Reward Program and Provider Enrollment” (“the Rule”). The Rule implemented several...more
On April 1, the Protecting Access to Medicare Act of 2014 was enacted into law (Pub. L. 113-93). Section 216, entitled Improving Medicare Policies for Clinical Diagnostic Laboratory Tests, modernizes the Medicare payment...more