ACA Repeal: It Takes a Village of Congressional Committees

WASHINGTON — The takedown of Obamacare is at the top of the GOP-led Congress’ agenda, and health policy experts gave MedPage Today an account of how that process could play out.

In addition to dismantling the Affordable Care Act (ACA), legislators must also make key decision on bills that will impact healthcare programs for children and veterans, as well as the future of pharma regulation.

‘Process-Oriented’

When it comes to ACA “repeal and replace,” “procedurally it all starts with the budget committee,” said G. William “Bill” Hoagland, senior vice president of the Bipartisan Policy Center here.

But there’s no way to put forward the promised repeal bill until Congress passes a budget resolution, Hoagland told MedPage Today, and it has yet to pass a spending bill for the 2017 fiscal year.

So much of the action will be “process-oriented” rather than “substance-oriented,” and the House appears to be more aligned on that process than the Senate, he noted.

In addition, the House Ways and Means Committee will focus on the tax-related aspects of repeal, while the Energy and Commerce Committee will focus on Medicaid reform, potentially moving from expansion to a block grant or per capita system, said Tom Miller, JD, a resident fellow at the American Enterprise Institute here.

Both committees will play a part in budget reconciliation, Miller told MedPage Today. Meanwhile, in the Senate, much of the action will happen in the Finance Committee, he added.

In 2015, the Senate passed a partial repeal that reversed key pillars of the ACA, including the individual mandate, the employer mandate, and Medicaid expansion after a 2-year transition period, through that exact budgetary process. The bill was later vetoed by President Obama.

But given a similar bill, President-elect Trump is expected to sign.

If the ACA is repealed, it’s the private insurance market that really becomes important, Kavita Patel, MD, a nonresident fellow in economic studies at the Brookings Institution and a primary care internist at Johns Hopkins Medicine in Baltimore, told MedPage Today.

The Senate Health Education Labor and Pensions (HELP) Committee has jurisdiction there. That makes Sen. Lamar Alexander (R-Tenn.) and Sen. Patty Murray (D-Wash.), the chair and ranking member, respectively, of the HELP committee, the two “most important people everyone else has to work with,” she said.

Unlike the House, the Senate, which has only a slim Republican majority, needs bipartisan support in order to pass an ACA replacement. (On Tuesday, the American College of Physicians and the American Medical Association urged Congress to go slow with repeal.)

Hoagland noted some tension in the Senate — Alexander has spoken about “replace and repeal” rather than “repeal and replace” stressing that Congress should know what they are giving people before rolling back healthcare insurance coverage, he said.

Sen. Susan Collins (R-Maine) and Sen. Lisa Murkowski (R-Alaska) have expressed similar concerns, Hoagland added.

Key Positions

Congress is expected to name committee and subcommittee chairs in early to mid-January, and a few of these positions will have a major influence on important aspects of the anticipated repeal-replace agenda.

Currently, Rep. Tom Price (R-Ga.) chairs the House Budget Committee, but in December, President-elect Trump picked Price to serve as secretary of the Department of Health and Human Services (HHS). Price will likely continue in his current position until he’s confirmed as HHS secretary, Miller noted.

If Price is confirmed, Rep. Todd Rokita (R-Ind.), the current vice chair of the budget committee, would be the “logical person” to become chair, said Hoagland, adding that “He would reflect the same principals and position that chairman Price has had.”

Sen. Mike Enzi (R-Wyo.), who leads the Senate Budget Committee, is expected to continue in that role.

Recently, Rep. Greg Walden (R-Ore.) was chosen as chair of the House Energy and Commerce committee, which will help to draft a potential alternative to the ACA. The decision was made by the House Republican Steering Committee and due mainly to Walden’s efforts in helping Republican incumbents get re-elected, reported Politico.

Walden will play an important role in setting the political tone and presenting a unified front, Miller explained, but he doesn’t have a strong healthcare background, so he’s likely to delegate ACA-related issues to the chair of the subcommittee on health, said John O’Shea, MD, a senior fellow at the Heritage Foundation, a conservative think tank.

However, Rep. Joe Pitts (R-Pa.), chair of that healthcare subcommittee, is slated to retire. As a result, the post could fall to the current vice chair, Rep. Brett Guthrie (R-Ky.). Rep. Tim Murphy, PhD, (R-Pa.) and Rep. Mike Burgess, MD, (R-Texas), a psychologist and a physician, respectively, are also possible candidates, Miller said, and both are aligned with the GOP Doctor Caucus.

If Murphy takes the chair, it’s likely that the subcommittee could see more activity on mental health reform and substance use disorders — agenda items Murphy lobbied successfully to include in the 21st Century Cures Act.

Even if Burgess is not chosen for the spot, he will continue to be heavily engaged in repeal and replace activities, and physician payment rules, said Gail Wilensky, PhD, an economist and senior fellow at Project HOPE.

Regarding the House Committee on Ways and Means, both Rep. Kevin Brady (R-Texas) , the committee chairman, and the Rep. Pat Tiberi (R-Ohio), the current health subcommittee chairman, are expected to retain their positions, Miller noted.

While many key leadership positions are still “in flux,” Hoagland said ultimately those decisions are unlikely to alter Speaker Paul Ryan (R-Wis.) and Senate Majority Leader Mitch McConnell’s (R-Ky.) plans regarding the ACA.

Must-Do Legislation

In addition to changes to the ACA, Congress must also decide whether to preserve a handful of programs and bills before they expire including:

States start planning their budgets in the summer which means that the reauthorization of CHIP, a program managed by states and the federal government that provides healthcare for low-income children whose families aren’t eligible for Medicaid, must happen early in the session.

“Congress has to do something or those funds will not be available,” Patel cautioned.

The last time CHIP was reauthorized, the debate focused on whether the program was really needed because the ACA provided coverage to many of the same individuals. However, if the ACA is repealed and a replacement is not passed quickly, Congress will likely have to extend the program, Wilensky noted.

Meanwhile, two FDA reauthorizations — PDUFA and MDUFMA — are Congress’ “only shot” at curbing drug prices, Patel said.

However, Miller pointed out that a California ballot measure that required states pay no more for medication than the Department of Veterans Affairs failed to pass, possibly signaling a weaker resolve for taking on “Big Pharma.”

Hoagland noted that the passage of the 21st Century Cures Act was an example of bipartisan agreement on safety, efficacy, and innovation.

But the hard-line stance Sen. Chuck Schumer (D-N.Y.) has taken on repeal-replace could “stir the water early” and have ripple effects on other bills, he warned.

The Veterans Choice act allows veterans who live a certain distance from government health centers to seek care in private facilities, and this issue will be high on Congress’ radar as President-elect Trump made veterans’ healthcare a campaign issue, O’Shea said. Trump has spoken of at least partially privatizing veterans’ healthcare, although many veteran groups oppose the idea.

“They’re called vets; they’re not patients [at VA facilities] … they identify with the part of their life they’re most proud of,” he said.

Finally, Rep. Jeff Miller (R-Fla.), chair of the House Committee on Veterans’ Affairs, retired from Congress in 2016. He is one of several people being considered to run the Department of Veterans Affairs, which he’s criticized in the past.

What Else is in the 21st Century Cures Act?

WASHINGTON — When most people think about the 21st Century Cures Act, they think about curing cancer and Alzheimer’s disease, and curbing the nation’s opioid epidemic. But the nearly 1,000-page healthcare spending bill, which President Obama signed in mid-December, also aims to reform the nation’s fragmented mental health system, improve access to electronic health data, and ensure that underrepresented individuals are included in important health research.

Mental Health

Approximately 13 million people in the U.S. have a serious mental illness or substance use disorder, according to the American Psychiatric Association (APA), which applauded the 21st Century Cures Act, calling its reforms to mental health a “huge step forward.”

The Cures Act included efforts to promote evidence-based treatments, strengthen mental health parity, and bolster the mental health workforce. The bill also established a grant program focused on early intervention for those showing warning signs of a potentially serious mental illness.

Earlier this year, Congress took aim at the Substance Abuse and Mental Health Services Administration (SAMHSA), saying that the agency had failed patients with serious mental health problems.

One almost immediate change the bill makes is to establish a new assistant secretary for Mental Health and Substance Abuse to oversee SAMHSA, explained Andrew Sperling, director of legislative advocacy for the National Alliance on Mental Illness.

Speaking in a phone interview with MedPage Today that included a public relations official, Sperling said he anticipates that Rep. Tom Price (R- Ga. ), the newly appointed Secretary of Health and Human Services, will have “a great deal of influence” in selecting that individual.

Better Integration, Better Care

The 21st Century Cures Act also designates a new Interdepartmental Serious Mental Illness Coordinating Committee, charged with summarizing advances in diagnosing and treating serious mental illness in a written report to congress. The committee — which includes members from SAMHSA, the Department of Defense, the Health Resources and Services Administration (HRSA), and other federal health agencies — will also be required to evaluate the impact of federal programs on important public health outcomes (i.e., rates of suicide, preventable emergency room visits, and homelessness).

Other key mental health-related provisions of the bill include the following:

  • Authorizing a grant program for assertive community treatment for adults with serious mental illness;
  • Authorizing a grant program to enable local governments to improve crisis intervention among emergency responders, clinicians, and law enforcement and funding to build registries of available inpatient psychiatric beds;
  • Establishing policies to create new residency programs to train future primary care doctors and psychiatrists about integrating mental and physical health;
  • Designating a nationwide hotline and online tool for improving access to mental health and substance use providers; and
  • Enhancing grant programs that offer behavioral health services for homeless and justice-involved individuals.

Also, the Cures Act, while not amending the Health Insurance Portability and Accountability Act (HIPAA), does outline the circumstances by which clinicians can share information with family members when a loved one is in crisis. “We hope this will ease the chilling environment around disclosure of information to family members,” by providing clinicians with greater clarity regarding when they can disclose, Sperling said.

With regard to mental health parity — equal access and coverage from insurers for mental health issues compared with physical concerns — most states have not been aggressively auditing insurers, an APA representative told MedPage Today.

However, the Cures Act calls for a standardized approach to auditing, and, on a federal level, requires the Department of Labor to periodically publish reports to showcase the volume of cases the agency has pursued.

Efforts to ensure more consistency and transparency could produce a “sentinel effect,” said the APA official. The more that insurers believe they risk being audited, the more likely they are to take internal compliance seriously.

Electronic Health Records

The Cures Act also strengthens efforts to improve and enforce health information interoperability.

Beginning in January 2018, vendors’ relative interoperability will be evaluated, and by 2019, those not in compliance will lose certification, explained Mandy Long, chair of the Electronic Health Records Association (EHRA) Clinician Experience Workgroup for the Healthcare Information and Management Systems Society (HIMSS), speaking in a phone interview with MedPage Today during which a public relations official was present.

“There are real teeth to [the language in the bill], and [the penalties] grow over the course of a couple of years,” said Long, who is also vice president of product management at Modernizing Medicine, an EHR and practice management software company in Boca Raton, Fla.

She noted that vendors who engage in data blocking can be fined up to $1 million per violation.

Long, whose daughter has Turner syndrome, also spoke as the parent of an ill child about the challenge of keeping specialists in different hospitals current with her daughter’s health status and tests. “We call it the ‘patient’s Bible’ — that binder that patients create for themselves, or their parents create [of various medical records] — we lug it from visit to visit or, God forbid, if we end up in an emergency situation; it’s awful and frequently out of date.”

Long said she believes the bill’s requirements to promote a scalable integration structure will have benefits for patients as well as industry.

The College of Healthcare Information Management Executives (CHIME) offers more specifics on the health IT provisions of the bill related to information blocking, interoperability standards, and hardship exemptions for decertified EHRs.

Superbugs, Vaccinations, and Equity in Research

Other elements of the bill include provisions to fight superbug infections, such as allowing the FDA to require manufacturers or reusable medical devices to share their cleaning instructions and verify that such methods work. The Cures Act also creates new requirements for the National Institutes of Health to encourage scientists studying similar topics to collaborate, with the goal of increasing the volume of data on underrepresented populations (i.e., women, children, and minorities).

Finally, the bill aims to raise maternal vaccination rates through efforts to prevent vaccine shortages and by incentivizing drugmakers to develop new vaccines for pregnant women. In addition, the act encourages pediatric drug development by allowing products given a “rare pediatric disease designation” from the FDA before 2020 the chance to be considered for a voucher until 2022.

Senate Passes 21st Century Cures Act

WASHINGTON — The Senate passed the 21st Century Cures Act, sweeping legislation that aims to bring treatments more quickly from the lab bench to patients’ bedsides on Wednesday afternoon in a vote of 94-5.

“As a result of a lot of strong bipartisan work, we are sending a bill now to the president’s desk that will invest in tackling our hardest to treat diseases, put real dollars behind the fight against the opioid epidemic and make badly needed changes to mental health care in our country,” said Sen. Patty Murray (D- Wash.), Ranking Member of the Senate Health, Education, Labor and Pensions (HELP) Committee, just before the vote.

“I’ve heard often from those whose loved ones are suffering from Alzheimer’s, addiction, and other debilitating diseases,” wrote President Obama in a press release shortly after the vote, citing Vice President Joe Biden’s own tragic loss of his son Beau Biden.

“Their heartbreak is real, and so we have a responsibility to respond with real solutions,” Obama wrote, adding that he looked forward to signing Cures as soon as it reaches his desk.

The “Cures” bill authorizes a total of $6.3 billion for funding basic science, streamlining the FDA’s review process, and addressing the opioids epidemic. The bill also incorporates a handful of mental health reforms, aimed at improving care coordination, strengthening mental health parity laws, and promoting evidence-based treatments and therapies.

Murray thanked HELP Committee Chairman Lamar Alexander (R-Tenn.), who offered his own appreciation to his colleague and to those on both sides of the aisle.

Earlier this week Alexander called the bill’s provisions to invest in regenerative medicines “a game-changer” for stroke patients, those with heart disease or retinal disease and dubbed the entire package “another Christmas miracle” — referencing President Obama’s nickname for the 2015 rewrite of the “No Child Left Behind” education bill.

But not everyone was cheering: Public Citizen called the bill an early Christmas present for the pharmaceutical industry.

But the watchdog group didn’t sound only sour notes: in a prepared statement Michael Carome, MD, director of the group’s health research arm, claimed credit for helping to eliminate “provisions that would have 1) opened a gaping hole in the Physician Payments Sunshine Act for educational gifts made by industry to physicians; 2) increased medication prices and cost taxpayers an estimated $12 billion over 10 years; 3) encouraged hospitals to overuse the newest antibiotics, thereby contributing to the harmful spread of antibiotic resistance; and 4) allowed medical device manufacturers to make changes to high-risk medical devices without U.S. Food and Drug Administration oversight.”

Battling Opioids

Several Senators focused on the bill’s response to the opioids epidemic, emphasizing the current lack of resources and the slim capacity of many treatment facilities.

“When people with substance use disorder are turned away this means they remain on the streets, desperate, often committing crimes to support their addiction and at constant risk of a lethal overdose … Make no mistake this legislation will save lives,” said Sen. Jeanne Shaheen (D- N.H.) speaking from the floor on Tuesday.

Her colleague, Sen. Harry Reid (D- Nev.) said that the bill was “weak” in parts and “we could have done better,” but was also excited to see dollars for opioids.

“There should be far more, and it should be given a different way than we have it here, but it’s money,” he said. “And we have people … dying as a result of this scourge that’s sweeping America … So, that part of [the bill] is excellent.”

But the harshest critics of “Cures,”as the bill has been dubbed were unmoved by this sentiment.

Those opposing the bill included Sen. Bernie Sanders (I- Vt.), Sen. Jeff Merkley (D- Ore.), Sen. Ron Wyden (D- Ore.), Sen. Elizabeth Warren (D- Mass.), and Sen. Mike Lee (R- Utah)

The final breakdown for the bill is as follows:

  • $4.8 billion for the National Institutes of Health
  • $1 billion in state grants to help respond to the opioid crisis
  • $500 million in additional support for the FDA

Of the money allocated to the NIH over a 10-year period, the bill earmarks $1.8 billion for Vice President Joe Biden’s “Cancer Moonshot” project, — renamed “The Beau Biden Cancer Moonshot” — $1.6 billion for the BRAIN initiative, and $1.4 billion for President Obama’s Precision Medicine Initiative.

The Beau Biden Cancer Moonshot

The FDA’s funding would be geared towards bolstering research and staff, and like its sister agency, funds would be delivered over a decade, whereas the opioid grants will be administered over 2 years.

As Biden presided over a vote for cloture on Monday night, Congress offered an amendment to rename the Cancer Moonshot Initiative in memory of his son, Joseph “Beau” Biden III, who died from brain cancer in 2015.

“I think it fitting to dedicate this bill’s critical cancer initiatives in honor of someone who’d be so proud of the presiding officer [Biden] today: his son Beau,” said Senate Majority Leader Mitch McConnell (R-Kentucky).

That amendment passed without debate.

Winners and Losers

However, a second proposed amendment brought by Sen. Bernie Sanders (I -Vt.) did, receive pushback.

“I have been fighting the greed of the prescription drug industry for decades and as far as I can tell the pharmaceutical industry always wins. They win but the American people lose,” he said in a floor speech on Tuesday.

His legislation would allow Medicare to negotiate with drug companies and that would enable Americans to import their medications from other countries. Sanders stressed that both provisions had been endorsed by President-elect Trump during his campaign.

“Think about what you can do to pave the way for Mr. Trump coming in,” he said attempting to bait Senate Republicans who did not bite.

Full Speed Ahead

“One way to be sure and not get the work done we’re doing today is to add another topic,” said Sen. Roy Blunt (R- Missouri) who objected to Sanders’s amendment. “If everything’s a priority, nothing’s a priority.”

Sanders also criticized Cures for cutting $1 billion from Medicare and Medicaid programs and another $3.5 billion from the Affordable Care Act’s Prevention and Public Health Fund and for not giving enough funding to the NIH. Sanders said that if the bill passed it would still only grant the agency $7 billion less than it received in 2004, accounting for inflation.

The depletion of the ACA’s controversial fund also irritated the American Academy of Family Physicians, the group sent a letter to House leadership last week highlighting its disappointment, according to a press statement. The AAFP also noted that “the legislation stops well short of appropriately funding the important mental health and addiction provisions that are included.”

Mental Health

Echoing, Murray, Sen. John Cornyn (R-Texas) praised the bill’s mental health provisions noting that many families struggle to help their adult children who have mental health problems.

“Often there’s additional tools that need to be available to family members when they find that their loved one is getting sicker and sicker and not being compliant with their medication and potentially becoming a danger to themselves or to the community at large,” he said speaking from the Senate floor.

Cornyn noted that legislation will improve states and local government’s access to tools to help evaluate the healthcare needs of those in prison, so they can be helped. The bill also encourages the development of crisis intervention teams.

Though she voted for the bill, Sen. Debbie Stabenow (D- Mich.) urged Congress to “complete the job,” by delivering full-funding to community mental health centers.

The American Psychiatric Association applauded Cures saying it would improve the access and quality of care for people with serious mental illness, and those with substance use disorders.

“The bill will toughen enforcement of existing parity laws, helping to ensure that mental health care services are covered just like other health care services,” said Maria Oquendo, MD, PhD, president of the APA in a press release.

While Murray argued that another advantage of passing Cures now is to “lock-in” important investments ahead of the next administration, much of the actual funding in the bill will require Congress to appropriate or unlock dollars from various sources each year, such as sales from the federal Strategic Petroleum Reserve.

Approximately 420 organizations lobbied for the Cures bill, according to the The Center for Responsive Politics, including Blue Cross/Blue Shield, Roche, Amgen, and the Pharmaceutical Research & Manufacturers of America, the industry’s major trade association.