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Drug Pricing

January 26, 2018 | Daily News

Only three weeks into 2018, lawmakers in 20 states have introduced 43 bills aimed at curbing Medicaid drug spending, according to the National Academy for State Health Policy.

January 25, 2018 | Daily News

Attorneys for the generic drug industry and Maryland jostled over the scope of the state's first-in-the-nation generic drug price gouging law during oral arguments Wednesday (Jan. 24) in their ongoing legal battle over the law.

January 23, 2018 | Daily News

Republican leaders of the Senate Finance, House Energy & Commerce and House Ways & Means committees are asking CMS not to include feedback from a recent request for information on making pharmacy benefit managers share rebates and other pharmacy fees with beneficiaries in a final Medicare Advantage and Part D rule, as they say any changes the administration wants to make must first go through notice and comment rulemaking.

January 22, 2018 | Daily News

The Patent Trial and Appeal Board slammed the Saint Regis Mohawk Tribe, the holder of Allergan’s Restasis patents, for what it called a wasteful fishing expedition.

January 22, 2018 | Daily News

The Saint Regis tribe says its deal with Allergan over patents for the dry eye drug Restasis is not a sham because the tribe was granted “the ability to pursue, develop, commercialize, and control multiple off-label uses.”

January 17, 2018 | Daily News

Sen. Bill Cassidy (R-LA) introduced on Wednesday (Jan. 17) a bill to stop certain types of hospitals from entering the 340B program until the Health Resources and Services Administration puts forward regulations for the drug discount program with additional transparency measures and other program requirements.

January 12, 2018 | Daily News

Congressional Medicare advisers voted Thursday (Jan. 11) to recommend replacing the Merit-Based Incentive Payment Program with a voluntary system in fee-for-service Medicare that lets doctors form groups that could earn bonuses if they perform well on population-based measures.

January 10, 2018 | Daily News

The House Energy & Commerce Committee released a report Wednesday (Jan. 10) with several recommended changes to the 340B drug discount program -- including giving the Health Resources and Services Administration more authority, resources and staff; requiring more audits of manufacturers and providers; and clarifying the intent of the 340B program.

January 09, 2018 | Daily News

Hospital groups notified the federal DC district court Tuesday (Jan. 9) they are appealing the judge's dismissal of their lawsuit over CMS reimbursement cuts for 340B drugs now that those cuts are in effect.

January 08, 2018 | Daily News

Protect Our Care launched an ad campaign urging senators to vote against the confirmation of HHS Secretary-nominee Alex Azar, saying that Azar will “sabotage” the Affordable Care Act, gut protections to Medicaid and raise insurance premiums.

January 04, 2018 | Daily News

Despite the approval of multiple biosimilars, industry wins in payment policy and release of highly anticipated FDA guidance, some experts are skeptical that 2018 will be a tipping point for the nascent biosimilar industry, citing issues with payers, lack of final FDA guidance on key issues and litigation backlogs created by late-stage patents.

January 04, 2018 | Daily News

FDA hopes to make the generic drug review process more efficient by addressing “recurring deficiencies” in manufacturers' generic drug applications that may lead to approval delays, including deficiencies in patent and exclusivity information, product quality assessments and bioequivalency data, the agency says in draft guidance published Wednesday (Jan. 3).

January 03, 2018 | Daily News

How to curb drug price increases is expected to remain a topic of debate in 2018, though the policies with the most support among lawmakers and administration officials target pharmacy benefit managers instead of drug makers.

January 03, 2018 | Daily News

In the first quarter of 2018, FDA will develop guidance addressing tactics used by branded drug companies to prevent or delay generics from entering the market, including abusing the citizen petition process; restricting access to testing samples of branded drugs; and taking advantage of the single, shared Risk Evaluation and Mitigation Strategies (REMS) negotiation process, FDA Commissioner Scott Gottlieb said Wednesday (Jan. 3).

January 02, 2018 | Daily News

CMS’ reimbursement cuts for 340B drugs kicked in Jan. 1 after the federal district court in DC dismissed hospitals’ lawsuit over the policy and Congress didn’t include a measure to stop the cuts in its year-end funding package.

December 22, 2017 | Daily News

CMS is considering informal proposals by pharmacy benefit manager MagellanRx and a non-profit to use outcomes-based contracts for Medicaid drug reimbursement.

December 21, 2017 | Daily News

The federal D.C. district court on Thursday (Dec. 21) heard arguments in hospitals’ lawsuit over cuts to reimbursement for 340B drugs included in the outpatient pay rule, and the American Hospital Association -- one of the groups suing CMS -- says the judge indicated he would rule on their request for a preliminary injunction to keep the cuts from taking effect before Jan. 1 when the rule is set to kick in.

December 19, 2017 | Daily News

A panel of the Patent Trial and Appeal Board found Tuesday (Dec. 19) that an entity cannot claim sovereign immunity to shield itself from inter partes review if that party has brought a patent infringement action in federal court.

December 18, 2017 | Daily News

The administration’s recently released unified agenda says a new 340B proposed rule on ceiling prices and penalties in the program could be published as soon as this month.

December 18, 2017 | Daily News

FDA Commissioner Scott Gottlieb announced Friday (Dec 15) the agency's intention to work with the U.S. Pharmacopeial Convention to develop standards for drugs that FDA has highlighted as off-patent, off-exclusivity and without generic competition.