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Drug Pricing

May 18, 2018 | Daily News

CMS is writing another Part D rule, according to the unified agenda that outlines agency rulemaking plans, and Ross Margulies, an associate at Foley Hoag, expects that many of the president’s proposals to curb drug prices will be included in that rule.

May 17, 2018 | Daily News

CMS officially put drug plans on notice to stop using so-called gag orders that prohibit pharmacists from telling customers when it is more expensive to use insurance to buy drugs.

May 17, 2018 | Daily News

FDA's long-awaited list of brand drugs for which generics have sought the agency's help in obtaining the samples necessary for testing and approval confirms that Risk Evaluation and Mitigation Strategies are not the only tool used by brands to withhold samples.

May 17, 2018 | Daily News

CMS' Medicare Evidence Development & Coverage Advisory Committee will meet in August to consider a National Coverage Determination for chimeric antigen receptor (CAR)-T cell therapies after UnitedHealthcare requested such a determination to make sure there is a level playing field across Medicare for coverage of the expensive therapies.

May 17, 2018 | Daily News

Specialists with a big stake in Part B warn HHS that following through with the administration’s proposal to let Part D plans negotiate Part B drug prices would cause patients to face access restrictions in Part D that they don’t have to deal with in Part B.

May 16, 2018 | Daily News

HHS Secretary Alex Azar is explaining why the president’s newly released drug pricing plan doesn’t deliver on two of President Donald Trump’s campaign promises: direct drug price negotiation in Medicare and allowing importation of cheaper drugs from Canada.

May 16, 2018 | Daily News

HHS Secretary Alex Azar on Wednesday (May 16) hit back at the drug industry for criticizing the administration’s proposal to move Medicare Part B drugs into Part D, and he said the announcement on how HHS will execute that policy is coming soon.

May 16, 2018 | Daily News

HHS is weighing two opposing approaches for dealing with Medicare drug rebates -- doing away with rebates or making plans share them at the pharmacy counter -- and HHS Secretary Alex Azar seems to be leaning toward the former, which drug makers do not like.

May 16, 2018 | Daily News

A Pharmaceutical Research and Manufacturers of America executive on Tuesday (May 15) criticized several policies that HHS is considering to lower drug costs: moving Medicare Part B drugs to Part D, replacing the Part B doctor-reimbursement system with the Competitive Acquisition Program, encouraging plans to restrict the use of drugs in protected classes, removing the two-drug per-class rule in Part D, basing Medicaid’s average manufacturer price calculation on commercial-market net prices and removing the cap on price-inflation penalty in Medicaid.

May 16, 2018 | Daily News

Industry insiders and Medicaid experts are unsure how significantly the President Donald Trump's drug-pricing plan will affect Medicaid drug prices, because it is not clear which of the Medicaid-related proposals CMS or Congress will seriously pursue.

May 15, 2018 | Daily News

Senate health committee ranking Democrat Patty Murray (WA) and Sen. Elizabeth Warren (D-MA) on Tuesday (May 15) criticized President Donald Trump for tying the 340B program to higher drug prices while his administration has repeatedly delayed implementation of a rule on ceiling prices and manufacturer penalties and pulled back guidance to clarify aspects of the program, including the definition of a 340B-eligible patient.

May 15, 2018 | Daily News

Facing a White House mandate to study whether FDA can require disclosure of drug list prices in direct-to-consumer ads, FDA Commissioner Scott Gottlieb insinuated it was an open question whether list prices are the best way to inform consumers of a drug’s potential out-of-pocket cost.

May 15, 2018 | Daily News

FDA Commissioner Scott Gottlieb said Tuesday (May 15) that the upcoming guidance on waiving the requirement that brands and generics share a safety system will be short and simply put brands on notice that FDA is ready, willing and able to waive the requirement when it is blocking generic competition -- despite an earlier prediction from a policy watcher close to the issue that the guidance would lay out specific steps each party must go through before FDA can waive the requirement.

May 15, 2018 | Daily News

FDA Commissioner Scott Gottlieb has fulfilled his promise to contact supply chain intermediaries and discourage them from entering into so-called voluntary restricted distribution systems that block generic companies from buying samples needed for FDA-required testing, however his pressure to date has not been successful.

May 14, 2018 | Daily News

HHS Secretary Alex Azar said CMS will take a more permissive approach to the performance scores it gives drug plans that use medication management tools for drugs in Part D’s six protected classes.

May 14, 2018 | Daily News

FDA soon will announce a set of reforms intended to make the new drug approval process more efficient and spur innovation, FDA Commissioner Scott Gottlieb told reporters during a Monday (May 14) media briefing.

May 14, 2018 | Daily News

About 60 patient and consumer advocates told House and Senate leadership to reject proposals to cut back the number of patients and safety net providers that are eligible for the 340B drug discount program, though the groups say they support transparency in the program.

May 14, 2018 | Daily News

HHS Secretary Alex Azar said Monday (May 14) that HHS’ proposal to subject Part B drugs to price negotiations in Part D is the most important piece of the president’s plan to contain drug costs.

May 14, 2018 | Daily News

FDA is expected to, as early as Thursday (May 17), unveil a new web page on which it will initially publish 150 letters sent by the agency to brand companies explaining that a potential generic competitor has adequate safety protections in place to receive the brand drug samples for bioequivalence testing, FDA Commissioner Scott Gottlieb and HHS Secretary Alex Azar announced Monday (May 14).

May 14, 2018 | Daily News

President Donald Trump has directed U.S. Trade Representative Robert Lighthizer to ensure that intellectual property and market access policies in trade deals contribute to lower drug prices in the United States.

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