D.C. Week: Final MACRA Rule Issued

— Also, FDA warns on cardiac surgery heater-cooler device

MedpageToday

WASHINGTON -- The Centers for Medicare & Medicaid Services announced the final rule for physician payment, the first major overhaul of the system in decades.

CMS Launches Final MACRA Rule

It's here! The Centers for Medicare & Medicaid Services released the long awaited final MACRA rule on physician payment on Friday morning.

Compared with a previous draft rule issued last April, the final version eases the reporting burden for clinicians and triples the "low-volume" threshold dollar amount for mandating participation to practices that bill more than $30,000 in a year or care for more than 100 patients. CMS also announced an interactive website and additional resources and training for small and rural practices.

"This is a landmark effort to move the healthcare system forward," said Andy Slavitt, acting CMS administrator, on a press call Friday. "But it's also a promise to the millions of taxpayers, including the 10,000 people who turn 65 every day, to be here when we need it," he said, underscoring the need to build a sustainable Medicare program.

Election 2016: Obamacare Back on Debate Stage

Healthcare finally made an appearance on the presidential debate stage Sunday, with a spirited exchange between the two major parties' nominees about the value of the Affordable Care Act (ACA).

Although the subject was missing in the first debate between Republican nominee Donald Trump and Democratic nominee Hillary Clinton, Sunday's "town hall"-style debate at Washington University in St. Louis included a question from an audience member about the ACA.

Clinton answered first, noting that although Trump has said he wants to repeal the law, "I'm going to fix it because I agree with you -- premiums have gotten too high, co-pays, deductibles, prescription drug costs. And I have laid out a series of actions that we can take to try and get those costs down."

On the flip side, Trump called Obamacare a "disaster."

"You know it; we all know it. It is going up at numbers that nobody has ever seen worldwide. Nobody has ever seen numbers like this for healthcare. It is only getting worse," Trump said, adding that "in [2017], it implodes by itself."

FDA Warns on Cardiac Surgery Heater-Cooler Device

After further investigating Mycobacterium chimaera infections associated with the Sorin/LivaNova Stöckert 3T Heater-Cooler System used for temperature control during cardiothoracic surgery, the FDA updated the safety warning.

Facilities should immediately stop using any 3T device or accessory that has tested positive for M. chimaera or has interacted with an infected patient, the agency recommended.

Hospitals should also "strongly consider" moving away from use of any 3T device manufactured before September 2014, when it might have been shipped from a contaminated facility, and should use them only when there is no other option in emergent or life-threatening situations.

The agency didn't recommend testing each machine, old or new, for M. chimaera because of challenges such as long culture time and a high rate of false-negative results.

Medicare Hassles: CMS Has a Plan ... Again

The Centers for Medicare & Medicaid Services said Thursday it is trying to ease administrative hassles for physicians participating in Medicare, and physician groups seemed pleased with the idea.

"The American Medical Association (AMA) welcomes this new initiative to reduce regulatory burdens on physicians," AMA president Andrew Gurman, MD, said in a statement. "Acting Administrator [Andy] Slavitt is leading a timely effort to be responsive to physicians' concerns. We look forward to working with CMS on this initiative so all physicians can spend more time on patient care and less time on paperwork."

If any of this seems familiar, that is because it is: here is a 1991 version.'

New Medicaid 'Education' Group Launches

Leaders of a new Medicaid coalition gathered Thursday to announce their group's formation, and said their immediate goal will be to educate lawmakers and the public about the federal-state program.

A group of 27 organizations held a briefing to introduce the Modern Medicaid Alliance, an organization that will "educate policymakers and the public about the benefits of Medicaid to the American people and highlight how innovative health solutions in Medicaid improve outcomes and lower costs," according to the alliance's press release.

Getting attention for Medicaid can be difficult in the nation's capital, where lawmakers are more focused on the elderly population, said Gary Puckrein, PhD, president and CEO of the National Minority Quality Forum. "Here in Washington there is a great and focused interest on Medicare -- it has 50 million voters in it," he said. "We find just a shadow of the same attention on Medicaid," a program that includes millions of children, who obviously can't vote. "We're going to have to find a way to raise awareness that kids are so vitally covered in this program."

FDA Gets Pushback on Move to Regulate Lab-Developed Tests

Patient advocates, clinicians, entrepreneurs, and FDA's top brass deliberated at a congressional briefing here Thursday over how much regulation is needed for laboratory-developed diagnostic tests (LDTs).

Nobody questions the high standards and thorough review that drugs undergo before reaching the market, said Jeff Shuren, MD, director of the FDA's Center for Devices and Radiological Health. "You care if that drug works, but why wouldn't you care if the test that determines whether or not you're going to get that drug also works?" he asked.

Shuren argued that the reliability of LDTs, which have been largely unregulated, is inconsistent and could put patients at risk. Last year, his office released a report listing 20 LDTs that had produced clinically erroneous and even invalid results.

Next Week

Congress continues its recess.

On Tuesday, the National Coalition on Health Care will host a congressional briefing regarding the 2017 healthcare policy agenda.

On Wednesday, the FDA's Bone, Reproductive and Urologic Drugs Advisory Committee will discuss desmopressin nasal spray for the proposed treatment of adult-onset nocturia.

And Wednesday evening, Fox News will host the final presidential debate of this election.

On Friday, the FDA will hold a public meeting to discuss the reauthorization of the 2012 Generic Drug User Fee Amendments.

And the Alliance for Health Reform will host a congressional briefing on veterans' healthcare.