Health Brief: Supreme Court Rules to Cut Wait Time for Copycat Biologics

Washington Brief

  • Iowa officials are seeking approval from the Trump administration to change major aspects of the Affordable Care Act in the state to ensure that about 72,000 Iowans have coverage options next year. (The Wall Street Journal)
  • Ohio Gov. John Kasich, an influential centrist Republican, said he could support a gradual rollback of Obamacare’s Medicaid expansion, but only if Congress gives states more flexibility to manage the health program and more funding than what is provided in the House health care bill. (The New York Times)
  • Senate Republicans are trying to rein in expectations for their Obamacare repeal effort, wary of missing a deadline or failing to muster the necessary 50 votes to secure its passage. GOP leaders still hope to hold a vote on the bill in June, but that deadline could slip into July. (Politico)

Business Brief

  • The Supreme Court ruled to cut the time that it takes for copycat versions of biologic drugs to enter the market. (Reuters)
  • The Centers for Medicare and Medicaid Services may have mistakenly paid out more than $729 million in incentive payments to providers whose electronic health records systems didn’t comply with federal standards, according to a federal watchdog. (Modern Healthcare)
  • Crowdfunding platforms such as GoFundMe could benefit if Republicans replace Obamacare with a system that increases the number of uninsured, prompting more Americans to seek donations to pay for health care. (Bloomberg News)

Chart Review

Events Calendar (All Times Local)

The Hill, PhRMA event on outcomes-based care with Sen. Cassidy 7:45 a.m.
Politico briefing on Medicaid 8 a.m.
Senate HELP Committee hearing on drug prices 10 a.m.
NIH research conference on best practices 8 a.m.
Brookings Institution event on drug distribution chain 9 a.m.
Manhattan Institute, U.S. Chamber of Commerce forum on drug prices 9 a.m.
Senate Finance Committee confirmation vote on Deputy HHS Secretary Nominee Hargan 10 a.m.
House Energy and Commerce subcommittee hearing on extending health safety net programs 10:15 a.m.
House Appropriations subcommittee hearing on Indian Health Service 1 p.m.
NIH research conference on best practices 8 a.m.
Bloomberg Law event on the ACA 8:30 a.m.
Senate Appropriations subcommittee hearing on HHS budget request 10 a.m.
No events scheduled



Senate GOP reins in expectations for killing Obamacare
Burgess Everett, Politico

Senate Republicans are aggressively trying to rein in expectations for their Obamacare repeal effort, wary of blowing a deadline or falling short of 50 votes on a promise that has driven the GOP’s political strategy for much of the past decade. Senate Majority Leader Mitch McConnell is still aiming for an Obamacare repeal vote in June, though his lieutenants acknowledge that deadline could slip into July.

Trump, Pence to meet with GOP senators on ObamaCare repeal
Jessie Hellmann, The Hill

President Trump and Vice President Mike Pence will meet with 13 GOP senators on Tuesday to discuss the status of ObamaCare repeal efforts in the upper chamber, a White House spokesperson told The Hill. Senators expected to attend the meeting at the White House include five from Medicaid expansion states: Sens. Rob Portman (Ohio,) Pat Toomey (Pa.), Cory Gardner (Colo.), Lisa Murkowski (Alaska) and Tom Cotton (Ark.).

Republican Senators Unaware of Health Care Details
Joe Williams, Roll Call

Several Republican senators have no knowledge of the specific policy proposals GOP leadership is weighing for inclusion in the pending legislation to overhaul the U.S. health care system. The lack of widespread knowledge among members about the exact policy under review calls into question whether Republicans will be able to advance a bill before the Fourth of July recess, the timeline that GOP aides say Senate Majority Leader Mitch McConnell is operating under.

Why Republicans might let their health care bill fail
MJ Lee and Lauren Fox, CNN

Donald Trump’s top campaign promise of repealing Obamacare remains unfinished as the President heads into Washington’s sweltering summer months. With the Republican Party’s most pressing undertaking stuck in limbo, GOP senators and aides are beginning to wonder about one undesirable outcome: that the Senate takes a vote on a health care bill in the coming weeks knowing full well it could fail.

Obamacare is in real danger
Sarah Kliff, Vox

The Affordable Care Act is in deep trouble — in Washington and large swaths of the country. Senate Republicans began to coalesce around the framework of a plan to repeal and replace the law last week.

Sens. Murray, Warren Request Probe of Whether Trump ‘Undermined’ Obamacare
Michelle Hackman, The Wall Street Journal

Two Senate Democrats have sent a letter to the Department of Health and Human Services’s independent watchdog, asking for an investigation into Trump administration actions that could have “undermined” the Affordable Care Act. Sen. Patty Murray (D., Wash.), the top Democrat on the Senate’s Health, Education Labor and Pensions Committee, and Sen. Elizabeth Warren (D., Mass.), a member of the committee, requested that the department’s inspector general make public any actions taken by the Trump administration to destabilize the individual health-insurance market.

U.S. Stock-Index Futures Edge Higher as Fed Meeting Begins
Lisa Pham, Bloomberg News

U.S. index futures inched higher, signaling stock gains for the first time in three days, as investors awaited tomorrow’s Federal Reserve policy decision. S&P 500 contracts expiring in September gained 0.2 percent at 6:01 a.m. in New York.


Iowa Seeks to Revamp Affordable Care Act
Anna Wilde Mathews and Louise Radnofsky, The Wall Street Journal

Iowa officials are seeking federal permission to implement a plan that would alter major aspects of the Affordable Care Act in the state, ​in what could be a key test of the ability to modify the health law through executive authority. Trump administration officials said they were open to supporting the Iowa proposal to the extent possible under the current health law.

John Kasich Backs Slow Medicaid Rollback, but With More Money
Robert Pear, The New York Times

Ohio’s influential Republican governor, John R. Kasich, said on Monday that he could accept a gradual phaseout of the expansion of Medicaid under the Affordable Care Act, but only if Congress provides states with more money than the House health care bill included and more flexibility to manage the health program for the poor. Mr. Kasich’s statement could prove significant as Senate Republicans try to find near unanimity on a bill to repeal and replace President Barack Obama’s signature domestic achievement.

America’s Health-Care Crisis Is a Gold Mine for Crowdfunding
Suzanne Woolley, Bloomberg News

Crowdfunding platforms such as GoFundMe and YouCaring have turned sympathy for Americans drowning in medical expenses into a cottage industry. Now Republican efforts in Congress to repeal and replace Obamacare could swell the ranks of the uninsured and spur the business of helping people raise donations online to pay for health care.

Obamacare enrollment slides to 10.3 million
Tami Luhby, CNN

Some 10.3 million people actually enrolled in Obamacare, as of mid-March, Trump administration officials said Monday. That’s down from the 12.2 million who signed up for coverage when open enrollment ended on January 31.

The tiny health insurance company holding Obamacare together
Sarah Kliff, Vox

Across broad swaths of the Midwest, the fate of the Affordable Care Act increasingly rests on the shoulders of a small nonprofit health insurance plan headquartered in suburban Minneapolis. Medica is not a household name.

Not-for-profit health insurers warn Medicaid cuts would endanger essential care-management programs
Shelby Livingston, Modern Healthcare

Not-for-profit health insurers warned Monday that federal Republican lawmakers’ proposed Medicaid funding cuts would endanger programs essential to caring for members who are elderly, disabled or suffering from substance use disorders. Vulnerable Medicaid members would go without necessary care and some would even lose coverage, driving up the cost of uncompensated care at hospitals throughout the states, medical directors at regional health plans Geisinger Health Plan and UCare said during a teleconference organized by the Alliance of Community Health Plans, which represents not-for-profit insurers.


Health groups band together to highlight concerns with House Obamacare repeal
Rachel Roubein, The Hill

Eight influential healthcare and consumer advocate groups are partnering to their highlight concerns about the House-passed ObamaCare repeal-and-replace bill. As the Senate works to dismantle ObamaCare, the groups plan to host events in four states — Ohio, Colorado, Nevada and West Virginia — aimed at showcasing the need for affordable and adequate healthcare.

Pharma, Biotech and Devices

Supreme Court speeds copycat biologic drugs to market
Andrew Chung, Reuters

The U.S. Supreme Court on Monday cut the time it will take for copycat versions of biologic drugs to get to the market in a pivotal ruling about an expensive class of medicines that can yield billions of dollars in sales for drug companies. The justices, in a 9-0 ruling, overturned a lower court’s decision that had prevented Swiss pharmaceutical company Novartis AG (NOVN.S) from selling its copycat version of California-based Amgen Inc’s (AMGN.O) Neupogen until six months after the U.S. Food and Drug Administration approved it.

Seizing on Opioid Crisis, a Drug Maker Lobbies Hard for Its Product
Abby Goodnough and Kate Zernike, The New York Times

The ads have been popping up on billboards, buses and subways and in glossy magazines, with portraits of attractive men and women and a simple question in bold letters: What is Vivitrol? Five years ago, Vivitrol was a treatment for opioid addiction that was struggling to find a market.

Q&A: Pharma and PBMs are in a ‘two-step dance’ that raises drug prices
Ed Silverman, Stat News

Over the past several months, drug makers have been particularly vocal in blaming pharmacy benefit managers — the middlemen who negotiate favorable insurance coverage for medicines — for rising prices. PBMs and insurers, in turn, blame drug makers. The truth lies somewhere in between, according to Linda Cahn, a consultant who advises health plans and employers on PBM contract negotiations.

Health IT

CMS may have mistakenly paid $729 million in EHR payments
Virgil Dickson, Modern Healthcare

The CMS may have paid providers more than $729 million in incentive payments for electronic health record systems that didn’t comply with federal standards, according the HHS Inspector General’s office. Approximately 500,000 providers participated in the Health Information Technology for Economic and Clinical Health Act, an incentive program for using certified EHR technology.

A Message from PhRMA:

Key finding from investigation led by former FBI Director Louis Freeh: Former law enforcement, FDA, DEA and FBI officials agree “Drug importation proposals would worsen the opioid crisis.” Read the full report.

Opinions, Editorials and Perspectives

Don’t Leave Them Waiting: How to Bring New Cancer Drugs to Kids
Elena Gerasimov, Morning Consult 

My mom just got home from the hospital. She received excellent care, including round-the-clock infusions of antibiotics that saved her life.

The Senate Hides Its Trumpcare Bill Behind Closed Doors
The Editorial Board, The New York Times

A coterie of Republicans is planning to have the Senate vote before July 4 on a bill that could take health insurance away from up to 23 million people and make changes to the coverage of millions of others. And they are coming up with the legislation behind closed doors without holding hearings, without consulting lawmakers who disagree with them and without engaging in any meaningful public debate.

The Halfhearted Opposition to the G.O.P.’s Health Care Misery
David Leonhardt, The New York Times

The Republican health care bill now sneaking its way through the Senate has a good chance of becoming law, even though it would do miserable damage. And it has a good chance partly because some of the bill’s most influential opponents have not had the courage of their convictions.

The FDA takes a stand against an opioid that fueled an epidemic
The Editorial Board, The Washington Post 

Opioids continue to ruin lives, and end them, in Maryland. New official figures show that 2,089 people died from drug and alcohol overdoses last year, a 66 percent increase over 2015.

It’s time to make it legal for Americans to order prescription drugs from abroad
Ed Silverman, Stat News

Every day, countless people across America order prescription drugs from pharmacies in other countries as they hunt for something increasingly elusive — affordable medications. But there’s a problem.

A Message from PhRMA:

Did you know? The government has authority to allow drug importation if the secretary of HHS certifies imports would not threaten the health and safety of Americans and would generate cost savings for consumers. To date, no secretary – Democrat or Republican – has been able to do that. Get the facts.

Research Reports

Health Effects of Overweight and Obesity in 195 Countries over 25 Years
The New England Journal of Medicine 

The prevalence of overweight and obesity is increasing worldwide. Epidemiologic studies have identified high body-mass index (BMI, the weight in kilograms divided by the square of the height in meters) as a risk factor for an expanding set of chronic diseases, including cardiovascular disease, diabetes mellitus, chronic kidney disease, many cancers, and an array of musculoskeletal disorders.