With President Bush?s re-election and a solid Republican majority in both houses of Congress, the door seems open for a wide range of GOP-backed healthcare initiatives, ranging from access to care to stem-cell research. Whether any can gain enough popular and legislative support for passage, however, is uncertain.
Here's a look at some of the key issues to watch:
Providers of healthcare and vendors of healthcare information technology, irrespective of their politics, had at least one thing to be happy for with the re-election of President Bush and a continued Republican majority in Congress. At a minimum, they say, the returning political leaders are likely to keep a good thing going.
"I usually wear the optimist hat, but not changing horses right now is a plus for IT," says Blackford Middleton, chairman of the Center for Information Technology Leadership in Wellesley, Mass., an affiliate of Partners HealthCare System, Boston. "I think my belief is that the continuation of the Bush administration will allow us to continue the work (on IT) they began in the last (term)."
And that work was significant in 2004, according to Middleton and other IT experts. It began with Bush's mention of healthcare IT in his January State of the Union address and had snowballed by April when Bush called for most Americans to have an electronic medical record within a decade.
With that, Bush "put a stake in the ground," Middleton says. Bush followed up by creating the Office of the National Coordinator for Health Information Technology and appointed David Brailer, the former chief executive officer of an IT company, CareScience, to the top job.
Brailer declined a request to be interviewed for this story, saying through a spokesperson only that some new healthcare IT policy initiatives are coming soon.
The big challenge in IT, of course, is money. Survey after survey of healthcare leaders have said lack of funds is the No. 1 barrier to healthcare IT adoption.
"The main question will be how much appropriation can we get out of Congress to do the further research and IT grants, and No. 2, what will we see from CMS on payments, particularly higher reimbursements for physicians who adopt IT systems," Middleton says. "We hope CMS does both. Particularly for outpatient healthcare, the need is crucial. Without the capital and the reimbursements to maintain it, IT is just not going to get started."
Don't hold your breath, says Kenneth Kizer, president and CEO of the not-for-profit National Quality Forum, and the former undersecretary of health at the Veterans Affairs Department, where he oversaw $20 billion budgets. "With the deficits being the way they are, with the war in Iraq, for healthcare to look to the government for some financing scheme is probably not realistic," he says. "As a catalyst, (government) can be effective, but as a deep pocket I don't think it will be available."
Kizer knows financial help is needed from somewhere, and not just for small physician medical practices. "When you get into the 200-bed hospital or lower, very few of them have these systems in place," he says.
Not surprisingly, a Democrat would argue that what might have been would have been better than what will be.
Michael Zamore is a policy adviser to Rep. Patrick Kennedy (D-R.I.), one of a growing number of lawmakers who are bullish on healthcare IT.
"I don't think that the election is all that likely to change the momentum," Zamore says. "In the short run, (Kerry's election) probably would have slowed down the momentum a little bit just because the change of administrations is a bulky process. It might have taken a couple of months to get organized."
Veteran Washington watcher David Main is chairman of the healthcare practice at the Washington law firm of Shaw Pittman and is the founder of the Healthcare Technology Network of Greater Washington, a group of national healthcare IT leaders who meet monthly to discuss policy. In addition to budget deficits, Main says the Bush administration is ideologically constrained from aggressively leading the IT charge.
"The government is wary about pushing this on the public and healthcare providers," Main says. "They don't want the public to feel there is a database somewhere under a mountain. They want it to be perceived as a private-sector effort. It's very Republican type of thinking."
Still, Main adds, despite the budget deficit, incremental changes in Medicare payments for IT might happen.
"One thing David Brailer is looking into is the reimbursement systems to help move this forward," Main says. While the government won't require providers to implement IT, it could use higher Medicare payments to encourage providers to buy and use the systems, Main says. "That's a very important initiative."
The new catchphrase for insurance coverage--at least for the next four years--is consumer-driven healthcare.
Health savings accounts and other consumer-driven coverage options are likely to become far more common in coming years. HSAs--along with legislation to create association health plans--remain a cornerstone of the Bush administration's agenda to control insurance costs and help the uninsured gain access to coverage.
"President Bush wants to make HSAs a part of his legacy as president," says Frank McArdle, a consultant with Hewitt Associates. With his second term, "The climate for HSAs will become a lot more favorable."
HSAs, created in December 2003 as part of the Bush-backed Medicare reform law, let consumers set up tax-free savings accounts to cover out-of-pocket medical expenses. When the accounts are paired with a high-deductible insurance policy, employers and employees can make annual tax-deductible deposits of up to $5,150 for families. Unused balances roll over to the next year, and employees get to keep the money when they change jobs or retire.
The idea is to give consumers a stronger incentive to seek the most cost-effective care. Today, most patients accept their doctor's treatment suggestions without question, including which drugs to take or specialists to see. But when their own money is at stake, the theory goes, patients will be more likely to shop around for the best price for a routine office visit or to forgo a costly brand-name drug when a cheaper generic may be just as good.
HSAs hold both promise and peril for the nation's healthcare system, experts say. If consumers truly become more frugal healthcare shoppers, everyone--from doctors and hospitals to drugmakers and medical-equipment companies--would be forced to rein in prices to compete for business. Yet if the market forces that HSAs are designed to unleash don't curb prices, employees could end up shouldering far higher medical costs, and those with chronic conditions would bear the brunt as they burn through their savings accounts year after year.
For now, payers, desperate for a new solution to rising healthcare costs, are embracing the concept. According to a survey released in April by Mercer Human Resource Consulting, 73% of employers are at least somewhat likely to offer an HSA by 2006 (Sept. 6, p. 28). And with Bush remaining in office, "Employers may be even more inclined to offer HSAs," says Arnold Milstein, a healthcare consultant with Mercer.
In response, most major insurers have rushed to offer HSAs. According to a new survey by the Blue Cross and Blue Shield Association, 39 of its 41 affiliated plans intend to offer HSAs by 2006, with products available in every state but Rhode Island. Even Kaiser Permanente, a staff-model HMO that has long relied on its physicians to direct care and hold down costs, has announced plans to roll out its own HSA next year.
Bush has made it clear that he plans to expand the HSA law during his second term. He has already proposed giving small businesses a tax credit for contributions to their employees' HSAs. And he wants to help lower-income individuals without job-based coverage by directly depositing $1,000 into their HSAs and giving them a $2,000 tax credit to buy a high-deductible policy. But such a plan, which would cost about $250 billion over 10 years, could bump up against budget concerns, experts say.
Separately, the Bush administration is expected to continue its push for legislation creating association health plans, which would allow small businesses to band together across state lines to collectively buy insurance at lower rates. Administration-backed proposals have cleared the House several times but have died in the Senate.
The legislation is endorsed by a number of employer groups, including the National Federation of Independent Business, which touts AHPs as a way to combat skyrocketing premiums for small employers and reduce the number of uninsured workers. But the plans are opposed by state insurance commissioners and commercial health insurers, which fear AHPs would destabilize the market (Jan. 26, p. 8).
AHP bills may stand a better chance of passing now, in part because of the retirement of an influential Senate opponent, Budget Committee Chairman Don Nickles (R-Okla.). Nickles will be replaced in the Senate by obstetrician Tom Coburn (R-Okla.), who supports AHPs. In addition, Senate Minority Leader Tom Daschle (D-S.D.), who also opposed the creation of such plans, was defeated by former Rep. John Thune (R-S.D.), an AHP supporter.
But AHP supporters still face an uphill battle, says Jamie Amaral, national director of healthcare research and development for the federation, adding that the legislation currently has just 39 of the 60 Senate votes needed to survive a filibuster. "With the election results, the possibility of passing AHP legislation is better than ever before," Amaral says. "We expect to pick up additional votes in the 109th Congress, but whether they will be enough remains to be seen."
While President Bush's re-election is unlikely to spell major changes in healthcare antitrust policy, a recent change in chairmen at the Federal Trade Commission portends a different philosophy, according to healthcare antitrust attorney David Balto, a former FTC policy director.
Earlier this year, Deborah Majoras, the former No. 2 figure under Charles James, the former assistant attorney general in the U.S. Justice Department's Antitrust Division, was named to succeed departing FTC Chairman Timothy Muris, who returned to academia. Balto says Muris revived the FTC's healthcare mission in the past three years by escalating investigations into physician price-fixing arrangements and renewing the agency's interest in hospital mergers. With its "lookback review" into previously consummated hospital mergers and its challenge of the 2000 merger between Highland Park (Ill.) Hospital and Evanston (Ill.) Northwestern Healthcare, the FTC returned to a sector it had neglected since 1998.
Balto, now with the Washington office of the law firm Robins, Kaplan, Miller & Ciresi, says the change in FTC chairmen makes a difference. He says Muris' departure suggests a more cautious approach in hospital mergers under a Majoras administration.
"She is highly unlikely to point the commission in an area in which it's previously lost cases," he says. James and Muris signed a merger clearance agreement in 2001 in which the Justice Department effectively ceded most healthcare-sector mergers to the FTC, a deal that was nixed because of opposition from Sen. Fritz Hollings (D-S.C.), who feared a diminution of enforcement activity. The deal became a de facto policy, however, as the Justice Department's healthcare enforcement profile has diminished while the FTC's has risen.
Balto says the biggest political development in healthcare antitrust enforcement could be Hollings' retirement from the Senate. "It's unlikely that they'll revive the clearance agreement," Balto says. "But probably one of the best things they could do for the enforcement of antitrust laws would be to consolidate healthcare within a single agency. And that should be at the FTC because it has an institutional advantage with its administrative law process."
Hospitals and medical professionals say the gaping U.S. budget deficit stands to significantly affect healthcare spending in coming years, including appropriations for the Nurse Reinvestment Act and nurse education efforts, which received $142 million in 2004.
In the omnibus budget bill, Congress boosted spending for 2005 by $9 million. That's far less than the $60 million increase the American Nurses Association said would be needed to meet demand for nurses.
Efforts to overturn recently changed overtime rules failed in the final days of Congress, but Democratic leaders and labor will continue to push for an overhaul in 2005, said Suzanne Ffolkes, an AFL-CIO spokeswoman. Unions say the regulation strips overtime from 6 million workers, including nurses, and have repeatedly sought to stop enforcement of the rules, which went into effect in August.
The United American Nurses, which represents 100,000 U.S. registered nurses, has ranked federally mandated nurse-to-patient ratios at the top of its legislative agenda. How the GOP hold on the White House and gains in Congress will affect the group's success "remains to be seen," says Suzanne Martin, a spokeswoman for the UAN, an affiliate of the American Nurses Association and the AFL-CIO. "It is certainly an uphill battle."
Canadian drug imports
On the reimportation of prescription drugs from Canada, several winners in Senate races--including Republicans like David Vitter, who is taking over for Sen. John Breaux (D-La.)--support reimportation, increasing the chances of a battle between the Senate and the White House on the issue.
Bush signaled recently that he might be willing to soften his opposition to reimportation if safety concerns can be addressed. Circumstances may soon force his hand since there is strong bipartisan support in Congress, rising demand among seniors and increased backing from state and local governments, according to a report issued by PricewaterhouseCoopers.
An HHS task force looking into whether procedures could be implemented to monitor safety is scheduled to release its report next month.
There will likely continue to be increases in funding for bioterrorism preparedness, but there isn't enough money available to quickly provide the nation's healthcare workers with the necessary resources to deal with a mass bioterror attack, says Laura Segal, a spokeswoman with Trust for America's Health, a nonpartisan disease-prevention advocacy group.
HHS' bioterrorism spending was budgeted at $4.1 billion in fiscal 2005 compared with $305 million in fiscal 2001--and a Centers for Disease Control and Prevention spokesman says he hasn't seen a sign of that waning.
Where those funds go has been the subject of debate.
Segal's organization spoke against a plan that redistributed bioterrorism preparedness funds from the states to 21 cities, but she says that both cities and states need the money. There wasn't much talk on the campaign trail about bioterrorism preparedness, but one public health subject that did grab some headlines was the shortage of flu vaccine. That shortage should bring to light the need for stockpiling vaccines and antidotes to chemical and germ attacks, Segal says.
In July, the president signed a bill funding Project BioShield, a $5.6 billion program that is supposed to make drugs and vaccines available to protect against biochemical and biological weapon attacks.
Bush's re-election dashed any hope that funding for embryonic stem-cell research would be unclogged at the federal level in the immediate future, but the scientific community was buoyed by the success of an ambitious $3 billion bond measure in California that will fund stem-cell research for the next decade. In the end, stem-cell research advocates insist the science will convince even the strongest opponents of its promise.
Harvested from embryos--the crux of the controversy--stem cells represent the best hope of curing devastating conditions such as juvenile diabetes, spinal cord injuries and heart failure, according to many medical and patient advocacy groups. Indeed, patient advocacy groups, particularly juvenile diabetes groups, played key roles in the success of the California measure.
Research on stem cells is a "scientific must," says Arthur Levine, senior vice chancellor for the health sciences at the University of Pittsburgh and dean of the school of medicine. "We already know enough to know that much more is in the offing with respect to greatly illuminating human biology--both normal and abnormal--even if there is no immediate clinical application," he says. There are strong suspicions that some type of stem cell will have therapeutic applications, especially embryonic stem cells that are cloned from a donor who would then become the recipient, eliminating rejection problems often associated with transplants.
Levine predicts the political issue will die rapidly with the first definitive cure using stem cells--no matter where in the world the discovery takes place. "Even the ultra-rightists will capitulate," Levine says. A cure "will trump any electoral result."
With the election over, perhaps politics will step aside and allow rationality to reign again, says Antonio Gotto Jr., dean of Cornell University's Weill Medical College in New York. "I'm hopeful with the election over there might be some greater freedom to develop cell lines beyond those that the president has allowed to be used for study," Gotto says. "Sometimes after elections are over and people are not running on a particular issue, sometimes you can have a more rational discussion than when an issue may decide an election by a few million votes."
The administration is expected to continue its fight to enforce the Partial Birth Abortion Ban Act, which President Bush signed into law in November 2003. Federal judges in California, Nebraska and New York have ruled that the law is unconstitutional, mostly because it doesn't allow the procedure even if the pregnancy endangers the mother's health. A Justice Department spokesman said it has filed appeals in all three cases. Arguments for the appeals have not been heard.
--Cinda Becker, Laura B. Benko, Joseph Conn, Melanie Evans, Joseph Mantone and Mark Taylor contributed to this report.