The Daily Scan

August 17, 2018

Last Updated: 8:55 AM EST

Legislation

  • U.S. Secretary of Health and Human Services Alex Azar authored a strongly worded op-ed piece published in The Washington Post this week titled: "Obamacare forgot about you. But Trump didn’t." He asserts: "Starting about two months from now, thanks to this president, insurers and states will have more freedom to offer consumers more options. Obamacare remains broken at its core, but this administration isn’t shutting out the law’s forgotten Americans. Instead, we’re finally giving them affordable choices." (WashingtonPost.com)

Regulation

  • The U.S. Food and Drug Administration yesterday approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pediatric patients who weigh more than 33 pounds. Teva Pharmaceuticals USA gained approval to market its generic epinephrine auto-injector in 0.3 mg and 0.15 mg strengths. “Today’s approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the U.S. is part of our longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval,” said FDA Commissioner Scott Gottlieb, M.D. (FDA.gov)

Litigation

  • In a Cabinet meeting yesterday, President Trump asked Attorney General Jeff Sessions to initiate federal lawsuits against pharmaceutical companies contributing to the opioid crisis, with a particular focus on imports from China and Mexico: "I'd like us to look at some of the litigation that's already been started with companies. Rather than just joining them, I'd like to bring a federal lawsuit against those companies. I'd also like to have you take a look at the fentanyl that's coming out of China and Mexico. And whatever you can do from a legal standpoint -- whether it's litigation, lawsuits, for people and companies. But, in China, you have some pretty big companies sending that garbage and killing our people. It's almost a form of warfare. And I'd like to do whatever you can do legally to stop it from China and from Mexico." (Full Transcript: RealClearPolitics.com)

 

  • The Department of Justice and U.S. Drug Enforcement Administration (DEA) announced yesterday that they have proposed a reduction for controlled substances that may be manufactured in the U.S. next year. Consistent with President Trump’s “Safe Prescribing Plan” that seeks to “cut nationwide opioid prescription fills by one-third within three years,” the proposal decreases manufacturing quotas for the most six frequently misused opioids for 2019 by an average ten percent as compared to the 2018 amount. The Notice of Proposed Rulemaking (NPRM) marks the third straight year of proposed reductions, which help reduce the amount of drugs potentially diverted for trafficking and used to facilitate addiction. (Justice.gov)

 

  • Post Acute Medical, LLC, a Pennsylvania-based operator of long‑term care and rehabilitation hospitals across the country, and certain affiliated entities through which the company operates its facilities (collectively, “PAM”), have agreed to pay the United States, Texas, and Louisiana a total of $13,168,000 to resolve claims that they violated the False Claims Act, and the Texas and Louisiana false claims statutes, by knowingly submitting claims to the Medicare and Medicaid programs that resulted from violations of the Anti‑Kickback Statute and the Physician Self‑Referral Law, the Justice Department announced yesterday. (Justice.gov)

Medicaid

  • Acting Director of the Center for Medicaid and CHIP Services Timothy B. Hill issued a memo yesterday titled "Update on State Plan Amendment and Section 1915 Waiver Process Improvements." This is the second Informational Bulletin CMS has issued related to SPA and 1915 waiver process improvements. This Bulletin provides an update on CMS’ collaboration with states since release of the first Bulletin, outlines the initial strategies CMS adopted to implement more efficient SPA and 1915 waiver review and adjudication processes, and highlights additional long term process improvements CMS has implemented. (Medicaid.gov)

 

  • Yesterday CMS approved New Jersey's 1332 State Innovation Waiver. CMS Administrator Seema Verma commented on Twitter: "New Jerseyans...will see their premiums in the individual market ↓ by about 15% from the expected premiums because @NJGov took action to address the failures of Obamacare." (CMS.gov, Twitter.com)

 

 

 

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