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Rx Drugs

May 22, 2019 | Daily News

After legislative talks between House Speaker Nancy Pelosi (D-CA) and President Donald Trump ground to a halt Wednesday morning, Senate Finance Chair Chuck Grassley (R-IA), who is helping lead negotiations on health care policy, said the Senate was always in the driver’s seat in the drug-pricing debate.

May 22, 2019 | Daily News

President Donald Trump said Wednesday (May 22) that legislative negotiations on drug pricing are on hold until Democrats stop investigations into his potential role in his campaign’s ties to Russia and into other actions he has taken while in office.

May 22, 2019 | Daily News

The Trump administration’s spring regulatory agenda, released Wednesday (May 22), shows that two of HHS’ most disruptive drug-pricing regulatory actions -- its proposal to base Medicare Part B pay rates on foreign drug prices and its overhaul of the rebate system -- are set to be released later than originally anticipated.

May 21, 2019 | Daily News

HHS will not publish a rule banning drug rebates before bids from Medicare Part D plans and Medicaid managed care plans are due June 3, according to a memo CMS sent insurers Monday (May 20).

May 21, 2019 | Daily News

Republican senators call on FDA to expand access to investigational drugs to treat Alzheimer’s, cancer and amyotrophic lateral sclerosis (ALS) by widening the scope of a generations-old Parallel Track program that currently grants only patients with AIDS and other HIV-related diseases access to certain drugs shown to be safe but which haven’t completed FDA efficacy trials.

May 20, 2019 | Daily News

Several lobbyists on Monday suggested the Senate health committee could unveil a discussion draft of policy proposals to lower health care costs as soon as Thursday (May 23).

May 20, 2019 | Daily News

The Supreme Court punted back to the lower court the Merck Sharp & Dohme Corp. v. Albrecht case, which focuses on whether Fosamax maker Merck should be held liable for injury to consumers even though FDA rejected the company’s proposal to include warnings on its drug label.

May 17, 2019 | Daily News

The House Energy & Commerce Committee will consider seven pieces of drug-pricing transparency legislation at a hearing on May 21, the committee announced Friday (May 17).

May 17, 2019 | Daily News

CMS delayed, without explanation, the national Medicare coverage policy for new expensive hospital-administered cancer drugs that was due to be published Friday (May 17).

May 17, 2019 | Daily News

Sen. Bill Cassidy (R-LA) urged stakeholders at a 340B reform conference to help him find a Democrat to cosponsor legislation to change the drug discount program if they want it to move forward, while Rep. Buddy Carter (R-GA) said he’s not optimistic the program will be dealt with this Congress.

May 17, 2019 | Daily News

The Senate on Thursday (May 16) passed Sen. Richard Burr’s (R-NC) pandemic preparedness bill, which reups hazard preparedness programs at HHS, but the bill, unlike the House counterpart, does not include language to reform FDA’s over-the-counter monograph regulations.

May 16, 2019 | Daily News

Senate committee leaders are looking to include surprise billing legislation and several drug-pricing bills in an upcoming health care cost-reduction package.

May 16, 2019 | Daily News

House lawmakers debated and adopted more than two dozen amendments to the drug-pricing and Affordable Care Act fix package of seven bills that passed the floor Thursday (May 16), most of which focused on further steps to shore up the marketplace and received no GOP support although Republicans did not oppose a few of the ideas.

May 16, 2019 | Daily News

Two consecutive administrations have failed to follow through with proposals to weaken Medicare Part D coverage protections in six drug classes.

May 16, 2019 | Daily News

The Trump administration did not follow through on an informal proposal to make pharmacy benefit managers subtract pharmacy concessions from the prices that seniors pay for drugs when they pick up their prescriptions.

May 16, 2019 | Daily News

Senate Finance Committee ranking Democrat Ron Wyden (OR) introduced a bill Wednesday (May 15) that would require traditional Medicare, Medicare Advantage (MA) plans, Medicare Part D plans and insurance companies to provide information to individual enrollees about the costs, including out-of-pocket costs, of services and prescription drugs via online tools.

May 16, 2019 | Daily News

The House Committee on Oversight and Government Reform on Thursday (May 16) debated the more than $2,000 monthly price of the only drug on the market to prevent HIV infection, and whether the government should strip the drug’s patent protections to allow generic competitors.

May 15, 2019 | Daily News

A key industry standard-setting group paved the way for wholesalers and other third-party entities to compete with pharmacy benefit managers for a new role in the Trump administration’s proposed rebate system in Part D and Medicaid managed care.

May 15, 2019 | Daily News

Pharmacy benefit managers often don't favor drugs with lower list prices, even when the discounted (net) price equals that of an identical drug with a higher list price, because patients pay more to insurers for the high-list-price drug, and that bigger patient cost sharing amount is factored into net prices used to gain placement on formularies, an Amgen executive told House Energy & Commerce health subcommittee members Thursday (May 9).

May 15, 2019 | Daily News

Biosimilar maker Mylan and several experts in the field say FDA should allow insulin products shown to be biosimilar to reference products to simultaneously get interchangeability status, arguing insulins are less complex than most other biologic products and should be regulated more like small-molecule drugs.

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