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Rx Drugs

June 15, 2018 | Daily News

Congressional advisers for Medicare and Medicaid sent their June 2018 reports to Congress Friday (June 15) with expected recommendations on reducing Medicare payment rates for some emergency departments and strengthening the Medicaid Drug Rebate Program.

June 14, 2018 | Daily News

The administration’s clarification that it does not plan to make pharmacy benefit managers act as fiduciaries means the drug channel middlemen don’t have to worry about being exposed to heavy legal liability, Pharmaceutical Care Management Association President and CEO Mark Merritt said.

June 14, 2018 | Daily News

The Senate Judiciary Committee voted Thursday (June 14) 16-5 to advance the highly watched Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act without amendments to the Senate floor, but the path to a floor vote on the bill remains unclear.

June 13, 2018 | Daily News

The Association for Accessible Medicines opposes three amendments being offered by Senate Republicans to the generic industry-supported Risk Evaluation and Mitigation Strategies (REMS) reform bill set to be marked up by the Senate Judiciary Committee Thursday (June 14).

June 13, 2018 | Daily News

American Medical Association delegates on Wednesday (June 13) asked the Justice Department and Federal Trade Commission to monitor insulin-pricing and -rebate practices of drug makers and pharmacy benefit managers, and the AMA plans to release a template for state legislators to reference as they write laws to lower insulin prices and ban so-called clawback fees and gag orders that pharmacy benefit managers impose on pharmacies.

June 13, 2018 | Daily News

Attorneys for both Allergan and Mylan faced pointed questions earlier this month from Federal Circuit judges, who are now tasked with deciding whether Allergan’s sale of its drug patents to a Native American tribe can shield those patents from inter partes review.

June 13, 2018 | Daily News

FDA Commissioner Scott Gottlieb said he is discussing with CMS the possibility of a new license-based reimbursement model for antibiotics that would spare drug makers some of the disincentives that come with antibiotic development, such as the low volume of sales that occur when providers try to use antibiotics sparingly.

June 13, 2018 | Daily News

The House passed a bill Wednesday (June 13) strengthening FDA’s authority over international mail facilities (IMFs), which the bill’s sponsors say will help stymie the flow of illicit opioids and other drugs being imported into the United States.

June 12, 2018 | Daily News

The House of Representatives passed 25 bills on Tuesday (June 12) that lawmakers say will help with the nationwide opioid crisis through a wide range of methods, from enhancing HHS and FDA’s seizure authority over imported drugs to amending the Public Health Service Act to provide for regional centers of excellence in substance-use disorder education.

June 12, 2018 | Daily News

More than 200 House lawmakers, including 50 Democrats, are urging congressional leadership to undo a recently passed law that makes brand drug makers pay 70 percent of Part D donut-hole costs, but a patient advocate group chided Democrats for their support of the brand-backed measure.

June 12, 2018 | Daily News

The Senate Finance Committee unanimously approved a package of opioid-related legislation Tuesday (June 12) that would make modest tweaks to Medicare and Medicaid in hopes of reducing opioid abuse in those programs.

June 12, 2018 | Daily News

Sen. Elizabeth Warren (D-MA) asked 10 major brand drug makers whether they plan to voluntarily lower prices, and none said yes -- and one said it will hike prices this year.

June 12, 2018 | Daily News

FDA finalized Tuesday (Jun 12) two guidances clarifying FDA’s rules for communicating health care economic information with payers and for promoting information that is consistent with, but absent from, a product’s label.

June 12, 2018 | Daily News

HHS Secretary Alex Azar told the Senate health committee Tuesday (June 12) that he believes the administration has the authority to mandate disclosure of list prices in direct-to-consumer ads, but added that he welcomes congressional action on the issue given he expects the idea will be challenged in court.

June 12, 2018 | Daily News

Rep. Doris Matsui (D-CA) on Tuesday (June 12) introduced a provider-friendly bill to reform the 340B drug discount program -- including explicitly laying out a purpose for the 340B program that says hospitals do not necessarily have to forward drug discounts to patients and reversing the CMS cut to hospitals' Medicare reimbursement for 340B drugs.

June 11, 2018 | Daily News

CMS issued guidance to states Monday (June 11) on ways Medicaid can treat infants who are born exposed to opioids and how states can use enhanced federal match rates to expand prescription monitoring and other health technology in their efforts to combat opioid abuse among adults.

June 11, 2018 | Daily News

The Senate Finance Committee will mark up a legislative package Tuesday (June 12) intended to reduce opioid abuse in Medicare and Medicaid. The package released by committee Chair Orrin Hatch (R-UT) and ranking Democrat Ron Wyden (OR) includes measures to identify over-prescribing of opioids, increase awareness of alternative pain management, expand coverage of telehealth services for substance use disorders and bar lifetime limits on medication-assisted treatment in Medicaid.

June 11, 2018 | Daily News

The National Institutes of Health plans to ask the National Academies of Sciences, Engineering and Medicine to study the effectiveness of medication-assisted treatment for opioid use disorder, heeding a request from Rep. Frank Pallone (D-NJ).

June 11, 2018 | Daily News

Top House Energy & Commerce members from both parties raised concerns FDA is not following through on its plan to use $94 million from Congress to double down on efforts to keep illegal opioids from entering the United States through international mail facilities.

June 06, 2018 | Daily News

The more than 800 generics approved by FDA in 2017 have saved $11.8 billion for drug purchasers, according to a new FDA report released Tuesday (June 5).

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