Health care issues are certain to be at the top of president-elect Donald Trump’s agenda when he takes office January 20. But how he handles the controversies sure to erupt around repealing and replacing Obamacare, efforts to turn Medicare into a voucher program, and the nomination of conservative Rep. Tom Price to head the Health and Human Services Department are still to play out over the next few months.

Trump and congressional Republicans have made no secret of their united desire to repeal and replace President Obama’s signature health care law. But now that Republicans are to be in charge of the White House and the Congress, specific details on what to replace Obamacare with, must be answered. At the same time, questions of how to protect the millions of people who have pre-conditions or are covered up to age 26 by their parents’ policies without imposing an individual mandate (as Obama chose), will help determine Trump’s effectiveness as a new president.

Already, House Republicans have raised another issue to the top of their agenda, one that Trump has said he disagrees with. House Speaker Paul Ryan, R-Wis., is pushing hard to turn Medicare into a privatized voucher-style program. Trump, during the presidential campaign, regularly pledged not to cut Medicare benefits or Social Security funds for seniors. But Ryan insists it is at the top of his priority list, regardless of Trump’s campaign position.

At the same time, Trump has nominated a steadfast Ryan ally, Rep. Tom Price, R-Ga., as Health and Human Services Secretary. Price, a surgeon by training, who chairs the House Budget Committee, has been Ryan’s top advocate of the Speaker’s plan to transform Medicare from a program that supplies a defined set of benefits into a “premium support” model that would, similar to Obamacare, offer subsidies to participants to purchase health care directly from insurance companies. Price also wants the Medicare eligibility age raised to 67.

Any changes to Medicare won’t be determined until after Trump takes office in January and gets his entire team in place. An early sign of how things will go could be found in the details of what the Trump administration submits to Congress in its fiscal year 2018 budget, which is due no later than Feb. 6, 2017 –just 17 days after Trump is inaugurated. But no real action is expected until the spring as the administration will have other battles it needs to settle and personnel it needs to get into place.

21st Century Cures Act Passed and Signed

But while those issues are left up in the air, lawmakers in the December lame-duck session of Congress, joined in a rare bipartisan effort to approve the 21st Century Cures Act, a sweeping medical innovation bill that will streamline faster approval of new drugs from the Food and Drug Administration.

The bill is one of the most significant pieces of legislation passed by this Congress, with bipartisan support – from both the outgoing Democratic White House and GOP leaders in Congress. It makes sweeping policy changes and funding increases for mental health care programs, money to fight the national opioid epidemic and additional money for Alzheimer’s disease research and cancer research. Supporters of the bill called it a “game-changer” that would touch almost every American in some way or another.

The measure, sponsored in the House by Rep. Fred Upton, R-Mich. and Rep. Diana DeGette, D-Colo., was approved in the House 344-77, over the objections of some conservatives who said it was too expensive and some liberals, who argued it was a giveaway to the drug industry. The Senate approved the bill 94-5 and President Obama signed the bill in early December. Here’s an overview:

• The bill provides nearly $4.8 billion over the next decade to the National Institutes of Health for cutting-edge research on hard-to-treat diseases including $1.8 billion to support Vice  President Joe Biden’s “Cancer Moonshot” initiative, designed to accelerate research into new cancer therapies and expand prevention and early detection. That effort is spearheaded by Biden, whose son Beau Biden, died last year of brain cancer.
• Provides $1 billion in new funding over the next two years for opioid addiction prevention and treatment in the form of grants given to states with the highest rates of opioid addiction and overdoses. From 2000 to 2015 more than half a million people died from drug overdoses. 91 Americans die every day from an opioid overdose, according to the Centers for Disease Control.

Nearly 12 million Medicare beneficiaries received at least one prescription for an opioid painkiller last year at a cost of $4.1 billion, according to a federal report that shows how common the addictive drugs are in many older Americans’ medicine cabinets.

With the overdose epidemic worsening, nearly one-third of Medicare beneficiaries received at least one prescription for commonly abused opioids such as OxyContin and Fentanyl in 2015. Those who did received an average of five such prescriptions or refills, according to a recent Health and Human Services Inspector General’s report.

• Makes big changes to the nation’s mental health system. It strengthens existing laws requiring insurers to cover mental health the same way they cover other diseases and establishes a mental health and substance abuse “policy laboratory” to promote better prevention and treatment of those illnesses.
• Directs $1.6 billion to the BRAIN Initiative, which is developing innovative technologies to treat, cure and prevent brain diseases like Alzheimer’s. The bill also secures an additional $1.5 billion over 10 years for the Precision Medicine initiative, to push biomedical discoveries and provide clinicians with information to help individual patients.
• Gives NIH the authority to finance high-risk, high-reward research using special procurement procedures versus using more conventional grants and contracts. For example, the bill will use the privately-funded X Prizes, which offers millions of dollars for specific technological achievements, like space exploration, as a model for a new “Eureka prize” competition to advance medical research, which could include movement toward an Alzheimer’s cure. Money will be awarded after certain specific well-defined technological goals are met, kind of a reverse engineering of the way traditional research grants are awarded.

Critics Abound But Funding May Not Even Come with New Government Players

While most lawmakers hailed the bill as the most significant changes in decades to how medical treatments are tested and brought to market, the bill had its share of critics. Rep. Rose
DeLauro, D-Conn., said that while the bill contained "noble goals that I share," its relaxation of some standards for federal drug approvals was dangerous and "neglects the very people clinical trials are meant to help, that is the patients."

Consumer advocacy group Public Citizen sharply criticized the legislation as a huge deregulatory giveaway to the pharmaceutical and medical device industries. They argue that the bill abandons the gold standard of medicine, by seriously rolling back numerous Food and Drug Administration regulations and instead puts in place an expedited “middle path” for drugs, medical devices and regenerative therapies that will make it easier for new drugs and medical devices to clear regulatory hurdles. Critics say it’s deregulation in sheep’s clothing and ultimately patients and science will inevitably pay the price.

But, it is important to point out that the actual funding for the programs may never happen. Getting bipartisan agreement on legislation is hard enough, but with the new Trump administration getting its first crack at changing the federal budget and its priorities, and Congress trying to fund many of the proposals Trump and Republicans supported during the campaign, the battle over where to put dollars in Congress’s annual appropriations may face tougher objections than usual. Plus lawmakers need to fund these programs every year.

This legislation has been bouncing around Congress since 2015. But it was only recently when the bill’s authors combined rolling back FDA standards with funding for the National Institutes of Health – which has long been starved of resources – that brought many Democrats on board. But to critics, it may have caused Democrats to overlook the extent to which the bill cuts regulations on drug and medical device makers.

Another strong criticism of the legislation came from Trust for America’s Health, a nonprofit advocacy group, which opposed it because lawmakers raided the Prevention and Public
Health Fund, a vital health-care prevention fund, to offset the cost of the legislation’s huge price tag.

Lawmakers paid for a chunk of the legislation by taking money from the prevention fund, which normally funds all Preventive Health and Human Service Block Grants and about 12 percent of the Centers for Disease Control’s budget, including 317 immunization program, all of which are critical to preparing for and responding to public health emergencies. The prevention fund also provides critical dollars for chronic disease funding, which are responsible for seven out of 10 deaths and $1.3 trillion in treatment costs and lost productivity every year.

Who Won, Who Lost?

The 21st Century Cures Act had some big winners and some big losers. The clear winner of the legislation’s passage were the more than 1,300 lobbyists, most of them working for pharmaceutical companies and medical device manufacturers, according to an analysis report by Stat, a new health publication from the Boston Globe.

One of the losers in the legislation was the elimination of a provision in the bill that would have expanded treatment for stroke victims and people suffering from Alzheimer’s, Parkinson’s and diabetes using stem cell therapies. Several of the most promising cures for these diseases are expected to come from stem cell treatments.

This provision had been included by Sen. Mark Kirk, R-Ill., himself a 2012 stroke victim, and would have permitted the FDA to approve stem cell treatments conditionally, without a large final-stage clinical trial, which is usually required and when many drugs fail.

Lawmakers cut out that provision, but the bill does permit FDA to speed up stem cell and other regenerative medicine products if they can show a path toward ultimate success so, for example, a cancer drug, could be approved if it shrinks a tumor, even if it hasn’t shown yet that it extends someone’s life.

[Also contributing to this column were USA TODAY; Stat; and Wired.]

Alan Schlein runs DeadlineOnline.com, an internet training and consulting firm. He is the author of the bestselling “Find It Online” books.

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