Policy & Regulations

This channel includes news coverage of healthcare policy and regulations set by Congress, the states, Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS), U.S. Food and Drug Administration (FDA), and medical associations and societies.

FTC sues drug middlemen over insulin prices, puts others on notice
The FTC alleges that pharmacy benefit managers have set up a system where they get rich, while patients are forced to pay rising insulin costs. The agency also called out drug manufacturers such as Eli Lilly, Sanofi and Novo Nordisk, saying their own actions have raised serious concerns.
Study ranks US health system dead last among wealthy nations
Low rankings for accessibility and outcomes earned the country the overall lowest ranking in an analysis of healthcare systems across 10 nations.
Landmark opioid trial in Baltimore set to begin; Johnson & Johnson settles to avoid jury
Six companies have settled with the city for as total of over $402M. Two remaining defendants, McKesson and AmerisourceBergen, will test their luck in court.
Coalition of 86 healthcare groups calls for change to Affordable Care Act rule
In a letter to Congress, the groups are urging lawmakers to support HR 9001 and lift the ban on physician-run hospitals.
FDA issues recall on infusion pump parts due to risk of uncontrollable drug flow
Due to a risk of fatal overdose, the recall is labeled as the most serious of its type. While no patients have died, two have reportedly been injured.

Sutter Health seeks to prevent self-insured companies from suing over prices

Sacramento, California-based Sutter Health is being accused of strong-arming companies into waiving their rights to sue the 24-hospital system, according to KQED.

November 4, 2016

Q&A: Deloitte's Andreaa Balan-Cohen on moving physicians towards value-based care

Some 94 percent of executives at provider organizations say they’re on the path towards value-based care, according to the Deloitte Center for Health Solutions, but only 27 percent say they’ve completed some stage of that transition. What may be holding the transformation back is how physicians are compensated.

November 4, 2016

Mylan settlement ‘irresponsible,’ says West Virginia Attorney General

The $465 million settlement over claims Mylan profited off an improper CMS classification of its EpiPen autoinjector isn’t good enough, according to West Virginia Attorney General Patrick Morrissey.

November 3, 2016

Part D prescriber enrollment requirement delayed to 2019

CMS has announced it will push back a requirement for prescribers be enrolled in Medicare for Part D to cover their prescriptions, marking at least the fourth time the agency has delayed the rule since it was finalized in March 2014.

November 3, 2016

HIMSS eyes 3 main topics to improve homeland security

The U.S. Department of Homeland Security released its Draft National Cyber Incident Response Plan (NCIRP) in September. Now, the Healthcare Information and Management Systems Society (HIMSS) has written a letter focusing on three main topics to improve the plan.

November 2, 2016

Health Care M&A Deal Volume and Value Slipped in Q3:2016, According to HealthCareMandA.com

NORWALK, CT – October 27, 2016 – Health care merger and acquisition activity slipped in the third quarter of 2016. Compared with the second quarter of 2016, deal volume fell 11%, to 369 transactions. Deal volume was also lower than in Q3:15, down 10% from the 411 transactions announced then. Combined spending in the third quarter totaled $48.0 billion, a decrease of 46% compared with the approximately $88.3 billion spent in the previous quarter, according to HealthCareMandA.com.

November 1, 2016

3-month limit on short-term insurance finalized as ACA enrollment begins

Just ahead of the fourth open enrollment period for the Affordable Care Act (ACA) insurance marketplace, HHS finalized a rule aimed at improving the risk pool on the exchanges and keeping consumers away from plans that don’t comply with the ACA.

November 1, 2016

Advocate, NorthShore merger halted by appeals court

A federal appeals court sided with the Federal Trade Commission (FTC) against the proposed merger of two Illinois hospital chains, Advocate Health Care and NorthShore University Health System, reversing a lower court’s decision that denied the FTC a preliminary injunction.

November 1, 2016

Around the web

Cardiovascular Business

FTC sues drug middlemen over insulin prices, puts others on notice

The FTC alleges that pharmacy benefit managers have set up a system where they get rich, while patients are forced to pay rising insulin costs. The agency also called out drug manufacturers such as Eli Lilly, Sanofi and Novo Nordisk, saying their own actions have raised serious concerns.

Cardiovascular Business

Cath lab techs and nurses see new normal with post-COVID pay

In the post-COVID era, wages for permanent RNs are rising, and wages for travelers are decreasing. A new report tracked these trends and more.

Cardiovascular Business

Merit Medical to purchase Cook Medical’s lead management portfolio for $210M

Two medical device companies have announced a transaction that could shake up the U.S. electrophysiology market.