On March 15, a federal district court in the Western District of Pennsylvania endorsed CMS commentary from November 2015 that dramatically liberalized the “written agreement” requirement of core Stark exceptions, thus providing some new insights as to what may be
March 2017
Bill to repeal and replace the Affordable Care Act fails to pass
On Friday, March 24, the American Health Care Act (“AHCA”), the bill to repeal and replace President Obama’s Affordable Care Act (“ACA”), failed to garner enough support in the House of Representatives for passage. Late Friday afternoon, Speaker Ryan announced…
NICE to fast-track more medicine approvals but wider changes do not impress industry
The National Institute for Health and Care Excellence (NICE) produces guidance in a number of forms including technology appraisals. Technology appraisals are recommendations on the use of medicines and treatments within NHS England. The recommendations are based…
CVS customers denied class certification in lawsuit alleging overcharging for generic prescriptions
On Tuesday, March 21st, the U.S. District Court for the Northern District of California denied class certification in a suit alleging that CVS had overcharged insurance companies for generic prescriptions, resulting in higher copayments for customers. Corcoran, et…
CBO releases assessment on American Health Care Act; FDA fees double under President Trump budget proposal
On Monday, March 13, 2017, the Congressional Budget Office (CBO) and the Joint Committee on Taxation (JCT) released an assessment on the impact of the American Health Care Act (AHCA), the Republican proposed legislation to repeal and replace the Affordable…
Republicans advance ACA repeal and replace legislation through 2 House Committees; House Budget Committee will take up Bill this week
On Thursday, March 9, the U.S. House of Representatives’ Ways and Means Committee approved by a party-line vote the tax provisions in the American Health Care Act (AHCA). The AHCA is the Republican legislation to repeal and replace the Patient…
European and US regulators’ agreement on mutual recognition of inspections of medicines manufacturers
In the European Union (EU), inspections of medicines manufacturing sites are carried out by national competent authorities from EU Member States. Each year, EU competent authorities and the US Food and Drug Administration inspect many manufacturing sites in the EU,…
Six legal and regulatory risks facing specialty pharmacies
“Specialty drugs” are a fast growing sector of the pharmaceutical industry and are predicated to represent 50 percent of drug expenditures in the United States by 2020.[1] Specialty drugs are typically dispensed by specialty pharmacies. Although there is no agreed-upon…
House Republicans release Affordable Care Act replacement legislation
On Monday evening, March 6, House Republicans released proposed legislation that would replace the Affordable Care Act (ACA). The proposed legislation would:
- Eliminate the individual and large employer mandates
- Permit insurers to impose a surcharge up to 30 percent on
…
News from DC – President Trump addresses a Joint Session of Congress and House Republicans revise ACA replacement legislation and schedule hearings
On Tuesday, February 28, President Trump addressed a Joint Session of Congress and outlined his Affordable Care Act (ACA) replacement legislation principles. The President endorsed a tax credit and expanded Health Savings Accounts to help people purchase health care insurance. …