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April 10, 2018 | Daily News

FDA has created a new position in the agency's controlled substance office that will report directly to the drug center director and is expected to play a key role in devising the agency's policy response to the opioid crisis, Inside Health Policy has learned.

April 05, 2018 | Daily News

United States Surgeon General Jerome Adams on Thursday (April 5) issued an advisory encouraging expanded use of the overdose-reversing drug naloxone -- a move promptly backed by FDA Commissioner Scott Gottlieb, who is pressing drug makers to seek approval of over-the-counter versions of the product.

April 04, 2018 | Daily News

The Senate health committee unveiled bipartisan draft opioid legislation on Wednesday (April 4) that would expand FDA’s authority to require manufacturers package certain drugs to allow for a set duration of treatment, such as in blister packs for three- or seven-day supplies, and provide patients with a simple and safe way to dispose of unused opioids.

April 04, 2018 | Daily News

FDA Commissioner Scott Gottlieb calls on social media companies and internet service providers (ISPs) to help “crack down” on illegal opioid distribution via the internet, saying the agency wants to collaborate with these firms on responsible approaches to eliminate illegal opioid distribution.

April 04, 2018 | Daily News

CMS will for the first time allow Medicare Part D plans to restrict beneficiaries who may be at risk of opioid abuse to a single prescriber or pharmacy under a detailed regulatory scheme that the agency issued Monday (April 2) as part of the 2019 final Part D rule, but some beneficiary advocates are concerned the rule could hurt dual eligibles' ability to switch plans.

April 04, 2018 | Daily News

FDA hopes to spend $10 million in fiscal 2019 to advance its efforts to help stem opioid misuse and abuse by, among other things, accelerating development of generic abuse-deterrent formulations of opioids (ADFs), the agency states in a budget justification document unveiled Monday (April 2).

April 02, 2018 | Daily News

Medicare Advantage plan revenues next year will increase 3.4 percent, plus 3.1 percent in revenue from coding changes, thanks in large part to the Bipartisan Budget Act, CMS estimates.

March 29, 2018 | Daily News

The same day that the head of FDA attacked pharmacy benefit managers for high drug prices, HHS Secretary Alex Azar announced Thursday (March 29) that an executive of a big-three PBM will lead drug-price policy.

March 27, 2018 | Daily News

Senate health committee Chair Lamar Alexander (R-TN) on Monday (March 26) unveiled draft legislation to let FDA require opioids be sold in short-course supplies of unit-dose packages to curb overdoses.

March 22, 2018 | Daily News

During day one of the House Energy & Commerce health subcommittee’s two-day legislative hearing to discuss more than 20 bills intended to help stem the opioid crisis, lawmakers and FDA Commissioner Scott Gottlieb focused on legislation that would increase FDA’s footprint and authority in international mail facilities (IMFs).

March 22, 2018 | Daily News

Members of the House Energy & Commerce Committee vigorously debated Thursday (March 22) whether to loosen privacy protections for medical records related to substance abuse treatment -- a proposal that some industry groups say would improve coordination of care in Medicare.

March 21, 2018 | Daily News

Mental health advocates and Medicaid managed care plans are cheering the Trump administration's proposal to allow Medicaid to pay for substance abuse treatment in large residential facilities, but so far it has gotten little traction in Congress, and one industry analyst said its chances of passing remain less than 50 percent.

March 20, 2018 | Daily News

House Energy & Commerce ranking Democrat Frank Pallone (NJ) introduced legislation Tuesday (March 13) that would grant HHS and FDA more authority to refuse admission of controlled substances or other drugs into the United States if the agencies deem the products pose a health risk or are counterfeit.

March 19, 2018 | Daily News

President Donald Trump on Monday (March 19) announced his plan to combat the opioid crisis, which includes increasing federal funding for the development of non-addictive pain medicines, cutting nationwide opioid prescriptions by one-third over the next three years, and creating an educational campaign and commercials showcasing the harms of opioid abuse and addiction.

March 15, 2018 | Daily News

The House Energy & Commerce health subcommittee announced on Wednesday (March 14) the slate of 21 bills it intends to discuss during its two-day hearing on legislation that could help stem the opioid crisis.

March 08, 2018 | Daily News

The House Energy & Commerce health subcommittee will hold a two-day legislative hearing on March 21 and 22 to examine more than 20 bills intended to help combat the opioid crisis, the committee announced Thursday (March 8).

March 02, 2018 | Daily News

A group of 15 Democratic senators, led by Ed Markey (MA) and Sherrod Brown (OH), called on top insurers to revise their existing coverage policies in order to help stem the opioid epidemic.

March 02, 2018 | Daily News

In a Thursday (March 1) memo, Attorney General Jeff Sessions directed the Drug Enforcement Administration (DEA) to consider amending its regulations on manufacturing quotas for schedule I and schedule II substances, including prescription opioids.

March 02, 2018 | Daily News

CMS should more aggressively encourage lock-in programs that would restrict Medicare beneficiaries who are at risk of opioid addiction to a limited number of pharmacies or prescribers, top Republicans and Democrats on the House Ways & Means Committee said in a March 1 letter to CMS Administrator Seema Verma.

March 02, 2018 | Daily News

Congress’ Medicaid advisory commission is calling on HHS to clarify what the commission described as widespread confusion among providers and patients over a 46-year-old privacy law intended to protect the privacy of people treated for drug addiction.