Morning Consult Health, Presented by PhRMA: Judge Might Give House Standing In Obama Suit; Insurers Rail Against Medicaid’s New Medical Loss Ratio

Today’s Washington Brief

  • The $550 million funding boost to the FDA granted in 21st Century Cures falls short of the agency’s cost estimate, Morning Consult reports. The FDA said it would cost about $880 million to implement the reforms. Experts say the FDA could get by with a little help from its friends, but what if that means relying on external parties to evaluate new medical devices?
  • During oral arguments in a case challenging the Obama administration’s use of executive actions, a federal judge questioned the administration’s argument that the House lacks the “legal standing to challenge how the administration implements Obamacare,” National Journal reports.
  • A new report said plans being floated by Republicans to stop chaos from ensuing if the Supreme Court strikes down Obamacare subsidies in 34 states would most likely not prevent a “massive disruption of the healthcare marketplace,” The Hill reports.

Today’s Business Brief

  • Insurers are fighting a new rule announced by CMS on Tuesday that would incorporate the medical-loss ratio into Medicaid health plans, thus requiring insurers to spend “85 percent of their revenues on medical care,” The Hill reports.
  • The Teva-owned pharmaceutical company Cephalon agreed to $1.2 billion to settle a lawsuit by the FTC accusing the drug maker of buying off generic competitors of its sleep disorder drug Provigil, New York Times reports.
  • The FDA on Thursday approved a new Pfizer drug that treats a rare form of lung disease, Reuters reports. It is the first drug approved for that particular disease.

Today’s Chart Review

Coverage Expansions and the Remaining Uninsured: A Look at California During Year One of ACA Implementation
from Kaiser Family Foundation by Rachel Garfield, Melissa Majerol and Katherine Young

Mark Your Calendars (All Eastern Times)

No events.



Is the FDA Ready For 21st Century Cures?
from Morning Consult by Jon Reid

Legislation to expedite the approval of new drugs passed its first hurdle last week, but Food and Drug Administration officials say the funds granted by the overhaul effort aren’t enough.

Judge Initially Skeptical of Plea to Dismiss House GOP’s Obamacare Lawsuit
from National Journal by Dylan Scott

A federal judge on Thursday challenged the Obama administration’s opening efforts to dismiss the lawsuit brought by House Republicans over the Affordable Care Act.

Actuaries: GOP plans won’t prevent an ObamaCare meltdown
from The Hill by Sarah Ferris

Republicans have spent months pitching ideas on how to limit the potential fallout from next month’s Supreme Court decision that could wipe out ObamaCare insurance subsidies in at least 34 states.

Welcome to the Red State HIV Epidemic
from Politico by Adam Wren

It wasn’t supposed to happen here. Not in Austin, a one-doctor-and-an-ice-cream-shop town of 4,200 in southeastern Indiana, nestled off Interstate 65 on the road from Indianapolis to Louisville, where dusty storefronts sit vacant and many residents, lacking cars, walk to the local market

Lawmakers demand answers on anthrax scare
from The Hill by Martin Matishak

Leaders of the House Energy and Commerce Committee are demanding answers from the government’s top health and defense officials about how the Army accidentally shipped live anthrax to research facilities in nine states and South Korea.

Top Dem: Trade deal could restrict access to cheaper medicines
from The Hill by Peter Sullivan

Rep. Sandy Levin (Mich.), the top Democrat on the Ways and Means Committee, says a new trade deal could be a “major step backwards” on access to affordable medicines.

U.S. Stock-Index Futures Are Little Changed Before GDP Report
from Bloomberg Business by Sofia Horta E Costa

U.S. stock-index futures were little changed, paring an earlier drop, before data that may show the economy contracted in the first quarter.


New rule ignites fight over insurer profits
from The Hill by Peter Sullivan

A sweeping new Obama administration regulation is reigniting the debate over the profits of health insurance companies.


Bipartisan think tank prescribes prevention as best chronic disease cure
from Modern Healthcare by Andis Robeznieks

Chronic disease treatment accounts for more than 80% of U.S. healthcare costs. With the intent of preventing rather than treating those conditions to improve care and lower costs, the Bipartisan Policy Center has released its white paper “A Prevention Prescription for Improving Health and Health Care in America” outlining its strategies for a healthier nation.

Pharma, Biotech & Device

Teva Settles Cephalon Generics Case With F.T.C. for $1.2 Billion
from New York Times by Rebecca R. Ruiz and Katie Thomas

The pharmaceutical company Cephalon had a cash cow on its hands. In the United States alone, its prescription drug Provigil, which treats sleep disorders, generated over $475 million in sales in 2005 and almost double that in 2007. It made up about half of Cephalon’s business.

Justice Department investigates Olympus over superbug outbreaks
from Los Angeles times by Chad Terhune and Melody Petersen

The Justice Department is investigating embattled scope-maker Olympus Corp. in connection with recent superbug outbreaks at U.S. hospitals.

FDA approves Pfizer drug to treat very rare lung disease
from Reuters by Toni Clarke

The U.S. Food and Drug Administration on Thursday approved the first drug to treat a rare, progressive lung disease that mainly affects women of childbearing age.

AstraZeneca and Lilly to test new cancer drug combination
from Reuters by Ben Hirschler

AstraZeneca and Eli Lilly are to combine two of their cancer drugs in a new clinical trial against solid tumors in the latest sign that such cocktails may be the way forward in fighting the disease.

Health IT

A Womb With a View: App to Help Monitor Growing Embryo
from Wall Street Journal by Rebecca Thurlow

A new smartphone app could allow doctors and would-be parents receiving in vitro fertilization treatment to monitor the growth of embryos in a lab thousands of miles away.

A Message from PhRMA: 

Tess had worked in the medical field for 20 years when she received her own devastating diagnosis: hepatitis C. “I have conducted clinical trials across the globe, but I did not know was what it was like to be an actual patient,” she says. In 2013, a novel therapy not only treated her illness. It ended it. Every year, biopharmaceutical industry research yields new treatments for society’s deadliest diseases. In 2015, Tess remains virus free.

Opinions, Editorials & Perspectives

Why doctors quit
from Washington Post by Charles Krauthammer

About a decade ago, a DOCTOR friend was lamenting the increasingly frustrating conditions of clinical practice. “How did you know to get out of medicine in 1978?” he asked with a smile.

A Message from PhRMA:

Although it’s normal for any 15-month-old to be tired after a day of playing, Rhys’s parents felt his extreme sluggishness just wasn’t right. When they brought him to the pediatrician, their hearts sank at the diagnosis: Rhys had type 1 diabetes and Celiac Disease. Fortunately for their family, both autoimmune diseases can be managed with innovative new medicines. These medicines are enriching patient outcomes and changing the fight against our country’s deadliest diseases.

Research Reports, Issue Briefs & Case Studies

Implications of Proposed Changes to the ACA in Response to King v. Burwell
from American Academy of Actuaries

Policymakers are considering changes to the Affordable Care Act (ACA) in case the Supreme Court rules in King v. Burwell that federal premium subsidies are not available for individual market plans in states participating in the federally-facilitated marketplace (FFM).

Coverage Expansions and the Remaining Uninsured: A Look at California During Year One of ACA Implementation
from Kaiser Family Foundation by Rachel Garfield, Melissa Majerol and Katherine Young

Under the ACA, millions of individuals have gained coverage through new provisions, effective as of January 2014, to expand Medicaid and provide premium tax credits for coverage purchased through Health Insurance Marketplaces.

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