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Rx Drugs

January 30, 2019 | Daily News

CMS wants Part D plans to expand access to naloxone, the opioid overdose reversal drug, through reduced cost-sharing and increased co-prescribing, and the agency is encouraging Medicare Advantage plans to offer pain management options like acupuncture and massage as supplemental benefits that the agency says can be opioid alternatives.

January 30, 2019 | Daily News

House Energy & Commerce Democrats launched an investigation into rising insulin prices on Wednesday (Jan. 30), one day after two other committees highlighted the plight of diabetics who can’t afford new versions of the drug.

January 30, 2019 | Daily News

A think tank president says HHS’ proposal to index Medicare Part B drug prices to those in foreign countries references the wrong 15 countries, and his proposal for tweaking the administration’s proposal caught the attention of Freedom Caucus Chair Mark Meadows (R-NC).

January 29, 2019 | Daily News

Sens. Bill Cassidy (R-LA) and Mark Warner (D-VA) are seeking comments on a draft bill to exempt performance-based drug-reimbursement contracts from the Medicaid best price rule, anti-kickback law and the so-called Stark law against doctor self-referrals, the senators announced Tuesday (Jan. 29).

January 29, 2019 | Daily News

Sen. Chuck Grassley (R-IA), the new Senate Finance Committee chairman, said that HHS Secretary Alex Azar is likely using the administration’s International Price Index model for Medicare Part B to extract concessions from pharmaceutical companies after the committee’s first in a series of planned hearings on prescription drug pricing.

January 29, 2019 | Daily News

The Center for Medicare & Medicaid Innovation (CMMI) said the expanded 2020 Value-Based Insurance Design model announced Jan. 18 will include new opportunities for plans to reduce beneficiary cost-sharing and add supplemental benefits based on chronic conditions and socioeconomic status.

January 29, 2019 | Daily News

The Senate Finance Committee kicks off its first hearing on prescription drug pricing Tuesday (Jan. 29), but Sen. John Cornyn (R-TX) already tweeted that a future topic of investigation will be abuses of the rebate system by pharmacy benefit managers -- an announcement that would typically be made by committee chairman Sen. Chuck Grassley (R-IA).

January 28, 2019 | Daily News

FDA drug center chief Janet Woodcock warned her staff on Monday (Jan. 28) that progress on rules and guidances might be slower than usual as the agency recovers from a month-long partial government shutdown that left 41 percent of its staff furloughed.

January 28, 2019 | Daily News

Lobbyists say a BioCentury report Friday (Jan. 25) that the board of the Pharmaceutical Research and Manufacturers of America is considering a cap on drug price increases is correct, but a brand drug lobbyist said it is difficult to determine whether the board will vote to commit its members to such a pledge.

January 28, 2019 | Daily News

FDA is taking new steps to advance the use of real-world evidence and real-world data in the digital technologies and drug product labeling space, agency chief Scott Gottlieb announced Monday (Jan. 28).

January 28, 2019 | Daily News

Washington state’s health care authority is in the final stages of a plan to pay a subscription for hepatitis C drugs that would cover its Medicaid beneficiaries, prisoners and state employees, including teachers, and the winner-take-all model could be extended to the commercial market and other states.

January 25, 2019 | Daily News

Ensuring generic drug manufacturers have access to samples necessary for drug development, allowing personal drug importation, banning settlements that delay generic competition and improving transparency of the rebate system are realistic legislative goals this session, a health policy aide to Rep. Lloyd Doggett (D-TX) said.

January 25, 2019 | Daily News

Massachusetts Governor Charlie Baker (R) is requesting state legislation to let its Medicaid program negotiate supplemental rebates for expensive drugs.

January 25, 2019 | Daily News

The generic, brand and biologic drug lobbies have joined a coalition that is organizing against Medicare for All proposals.

January 24, 2019 | Daily News

Brand-drug lobbyists are warning new House lawmakers to steer clear of Rep. Lloyd Doggett (D-TX) and not sign on to his drug-pricing bills, a staff member for the House Ways & Means health subcommittee chair said Thursday (Jan. 24) at the Families USA Health Action Conference.

January 24, 2019 | Daily News

FDA issued two draft guidances on Thursday (Jan. 24) that lay out a framework for drug and biologic companies to evaluate their risk management programs, one describing how to develop an assessment plan and the second proposing ways to gauge patient or health care provider knowledge.

January 24, 2019 | Daily News

As FDA and Congress take steps toward enhancing reliance on over-the-counter and nonprescription medicine, the OTC drug lobby group, Consumer Healthcare Products Association, continues to advocate for passage of OTC monograph reform legislation, incentivizing OTC drug makers to help spur prescription-to-OTC switches, and oversight of dietary supplements, CHPA President and CEO Scott Melville told Inside Health Policy.

January 23, 2019 | Daily News

The president, HHS secretary and other administration officials touted the administration’s efforts to lower drug prices at a White House meeting Wednesday (Jan. 23) where the president talked of his amazement upon recently learning that generics work as well as the brands they copy.

January 23, 2019 | Daily News

Despite opposition from industry, FDA is not budging from its plan to require that drug and biologics makers with a product approved through the accelerated approval pathway disclose that information on the product’s Indications and Usage section and include a statement explaining that continued approval may be subject to additional trials to confirm the drug’s clinical benefit.

January 22, 2019 | Daily News

In a win for the generic drug industry, the Supreme Court unanimously ruled Tuesday (Jan. 22) that secret sales of inventions start the one-year clock to file patents.

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