Health Brief: FDA Deal Could Let Device Makers Delay Malfunction Reports

Washington Brief

  • Senate Majority Leader Mitch McConnell (R-Ky.) likely doesn’t have the votes to pass a health overhaul bill, but that hasn’t stopped him from pressing ahead with plans to vote on it next week. (Politico)
  • A handful of Republican and Democratic senators have huddled on an alternative health care bill that would address problems with the insurance markets if the leadership-backed effort dies. (Bloomberg)
  • Sen. Ted Cruz’s “Consumer Freedom Amendment” could cause premiums to skyrocket for about 1.5 million Americans who have pre-existing conditions, according to an analysis by the Kaiser Family Foundation. The Texas Republican’s proposal would render many people ineligible for subsidies. (The Hill)

Business Brief

  • A provision in the user fee reauthorization deal, slated for a House vote today, would allow medical device makers to delay reporting dangerous malfunctions to the Food and Drug Administration. (The New York Times)
  • The Trump administration approved a waiver to let Alaska create a reinsurance program intended to lower premiums for people covered by the Affordable Care Act. (Washington Examiner)
  • Novartis AG has a rare disease drug that could also be used to treat heart attack patients, but expanding its use would mean drastically cutting the cost — currently $16,000 a dose — and abandoning a reliable revenue stream. (The Wall Street Journal)

Chart Review

Events Calendar (All Times Local)

House Energy and Commerce subcommittee hearing on the opioid crisis 10 a.m.
House Energy and Commerce subcommittee hearing on medical product makers 10:15 a.m.
Town hall on opioid crisis hosted by Hazelden Betty Ford Foundation 7 p.m.
Bipartisan Policy Center event on state flexibility 10 a.m.
House Ways and Means Committee marks up two Medicare bills 2 p.m.
No events scheduled.



Reeling Republicans take one last shot at Obamacare
Burgess Everett and Jennifer Haberkorn, Politico

Twenty-three years ago, President Bill Clinton and Senate Democrats canceled two weeks of the August recess to pass a major health care bill. They got nowhere.

Senators Explore Bipartisan ‘Plan B’ to Troubled GOP Health Bill
Sahil Kapur and Laura Litvan, Bloomberg

More than half a dozen Republican and Democratic senators have discussed alternatives to the embattled GOP health-care bill, even as Majority Leader Mitch McConnell said he plans a vote next week to muscle the Obamacare repeal measure through the Senate. Talks about a bipartisan fallback are based on the idea that Obamacare insurance markets have problems and would need to be fixed if the health-care bill dies.

Republicans Are Still Seven Votes Shy On Health Care
Perry Bacon Jr., FiveThirtyEight

Republicans appear to be at least seven votes short of the 50 they need to get a health care bill through the Senate, which is basically where they were when Senate Majority Leader Mitch McConnell unveiled a draft bill more than two weeks ago. Soon after the draft bill’s release, one bloc of GOP senators (Ted Cruz of Texas, Ron Johnson of Wisconsin, Mike Lee of Utah and Rand Paul of Kentucky) argued that the bill was insufficiently conservative and did not repeal enough of the Affordable Care Act, aka Obamacare.

Analysis: GOP confronts no-win situation on health care
Erica Werner, The Associated Press

Republicans find themselves in a no-win situation as they struggle to pass health care legislation in the Senate: Success could alienate a majority of the population, but failure could anger the crucial group of GOP base voters the party relies on to build election victories. It’s a version of the dilemma now confronting Senate Majority Leader Mitch McConnell as he tries to maneuver between opposing poles in the GOP caucus to fashion an “Obamacare” repeal-and-replace bill that will satisfy everyone.

Senate parliamentarian deciding what can go in health bill
Caitlin Owens, Axios

Senate Republicans and Democrats are debating the GOP health care bill this week before the parliamentarian, who will then decide if certain provisions comply with budget rules. They’ll debate Tuesday through Thursday, with her opinions expected before the bill goes to the floor next week, according to senior GOP aides.

What’s Dividing Republican Senators on the Health Care Bill
Anjali Singhvi and Alicia Parlapiano, The New York Times

As Republican leaders plan to release a revised health care bill on Thursday, at least a dozen senators have expressed concerns about several major issues in the current draft.

The Senate health bill is almost an orphan with few real supporters
Paul Kane, The Washington Post

The Senate did not author the proverb about success having many fathers while failure is an orphan, but the words often typify how senators react to legislation that is struggling to win approval. On Tuesday, after a roughly 90-minute huddle with his caucus, Senate Majority Leader Mitch McConnell (R-Ky.) began his weekly news conference on “the news of the day” — the struggling effort to pass health-care legislation that would repeal and replace portions of the Affordable Care Act.

DNC Targets Louisiana, Cassidy on Medicaid Expansion
Eric Garcia, Roll Call

The Democratic National Committee is launching an ad campaign in Louisiana specifically focusing on Medicaid and putting pressure on one of its senators’ vote on the Republican health care bill. The ad by the DNC features a single mom named Krista who has three children — one of whom has autism, the other with seizures, and the youngest with behavioral problems — who benefited from Medicaid expansion in the state.

Stocks Rebound as Dollar Dips on Trump Revelations: Markets Wrap
Cecile Gutscher, Bloomberg

European equities rebounded with oil while the dollar slipped as a fresh bout of political uncertainty in Washington damped optimism about rebounding global growth. A gauge of the U.S. dollar was lower for a third day while Treasuries rose before a testimony by Janet Yellen that may provide clues about her plans to scale back the Federal Reserve’s balance sheet.


Study: Cruz amendment could raise premiums for 1.5M with pre-existing conditions
Jessie Hellman, The Hill

One and a half million people with pre-existing conditions could face higher premiums under an amendment to the Senate’s healthcare bill being pushed by Sen. Ted Cruz (R-Texas), according to a new analysis released Tuesday. The proposed amendment, which is being considered by GOP leadership, would essentially let insurers sell plans that don’t meet Affordable Care Act (ACA) requirements as long as they also sell plans that do.

Trump administration OKs Alaska waiver to stabilize health insurance market
Robert King, Washington Examiner

The federal government approved a waiver from Alaska to create a reinsurance program intended to reduce premiums for Obamacare customers. The Trump administration approved a waiver for the state to set up a reinsurance program that would help cover large medical claims.


Double-Booked: When Surgeons Operate On Two Patients At Once
Sandra G. Boodman, Kaiser Health News

The controversial practice has been standard in many teaching hospitals for decades, its safety and ethics largely unquestioned and its existence unknown to those most affected: people undergoing surgery. But over the past two years, the issue of overlapping surgery — in which a doctor operates on two patients in different rooms during the same time period — has ignited an impassioned debate in the medical community, attracted scrutiny by the powerful Senate Finance Committee that oversees Medicare and Medicaid, and prompted some hospitals, including the University of Virginia’s, to circumscribe the practice.

CMS delays rule to improve home health agency care
Virgil Dickson, Modern Healthcare

Home health agencies are getting an additional six months to prepare for a new CMS rule aimed at improving quality and patient care. The rule, first proposed by the Obama administration, required new training for staff and administrators and more coordination of care.

Pharma, Biotech and Devices

F.D.A. Deal Would Relax Rules on Reporting Medical Device Problems
Sheila Kaplan, The New York Times

Makers of cardiac defibrillators, insulin pumps, breast implants and other medical devices might be able to delay reporting dangerous malfunctions to the Food and Drug Administration under an agreement heading for a vote in Congress. Device makers will still have to quickly report any injuries or deaths related to their products.

The Price Dilemma Over a $16,000 Drug
Denise Roland, The Wall Street Journal

Novartis AG NVS -0.13% recently discovered that a drug it sells for a group of very rare diseases could be used to treat a much more common ailment. There is just one problem: its $16,000-per-dose price tag.

FDA rejects Ocular Therapeutix eye drug, citing manufacturing issues
Adam Feurstein, Stat News

Ocular Therapeutix failed for a second time to secure approval of its eye drug Dextenza. On Tuesday, the FDA rejected the drug, citing unresolved problems with manufacturing and quality control testing.

Novartis readies for FDA review of $1 billion CAR-T child cancer hope
John Miller, Reuters

Two decades ago in a Memphis, Tenn., hospital lab, cancer scientist Dario Campana and his team were hunting for a new way to fight deadly acute lymphoblastic leukemia (ALL). They began with several molecules, but finally settled on one, called 4-1BB, because it seemed to prime the human immune system to attack blood cancer more aggressively than others.

Health IT

Record-setting digital health funding in 2017 shows D.C. turmoil isn’t driving away investors
Evan Sweeney, Fierce Healthcare

The first half of 2017 saw a record number of deals and an unprecedented level of funding within the digital health sector. Analysts predicted the industry would build on that momentum despite the ongoing healthcare debate consuming the nation’s capital.

Opinions, Editorials and Perspectives

Scott Gottlieb’s Predictable Imaginarium
Peter Pitts, Morning Consult 

Scott Gottlieb’s still nascent tenure as Food and Drug Administration commissioner has, to date, been defined by two terms not generally associated with the agency that regulates more than a third of the U.S. economy — predictability and imagination. Let’s start with predictability.

JAMA Forum: Reforming Medicaid
Andy Slavitt, MBA, and Gail Wilensky, PhD, Jama Forum

We are 2 former Administrators of the Medicare and Medicaid programs, under Presidents Barack Obama and George H. W. Bush. Although we represent different political parties, we take pride in the accomplishments of these 2 programs, which collectively help millions of US residents get the health care they need.

Public wants GOP to work with Dems on health care
Drew Altman, Axios

Senate Majority Leader McConnell has given his fellow Republicans a warning: if they do not pass a bill to repeal and replace the Affordable Care Act, they will be forced to work with Democrats on more modest legislation to address challenges in the ACA’s marketplaces. A new Kaiser Family Foundation poll to be released Friday suggests that’s actually what the American people would like to see happen.

Research Reports

Uneven Playing Field: Applying Different Rules to Competing Health Plans
Karen Pollitz and Anthony Damico, Kaiser Family Foundation

As the Senate considers the Better Care Reconciliation Act (BCRA), a proposal to repeal and replace the Affordable Care Act (ACA), amendments have been discussed to further change private health insurance market rules that apply under current law. Under the BCRA, current law health insurance market rules would still apply: Insurers in the non-group health insurance market are prohibited from turning applicants down or charging higher premiums based on health status and from excluding coverage for pre-existing conditions.

Medicaid: How the Senate’s Reforms Would Retarget Federal Funding for America’s Most Vulnerable Citizens
Robert Moffitt, The Heritage Foundation 

The Senate Republicans’ Better Care Reconciliation Act of 2017 (BCRA) would partially repeal and replace Obamacare (also known as the Affordable Care Act, or ACA) and make major changes in the Medicaid program. The bill would secure a significant federal entitlement reform by addressing a central health policy issue: the structure, function, and financing of the Medicaid program.