The Impact of Healthcare Legislation on Infection Control

The Impact of Healthcare Legislation on Infection Control
Separating the Wheat from the Chaff

By Kathy Dix

2002 was a banner year for healthcare legislation. Fallout from the September 11th attacks in particular led to a rash of bioterrorism-related bills. But which of these laws -- or proposed laws -- will have an effect on infection control practitioners (ICPs)?

The near-hysteria concerning the attempted anthrax outbreak in 2001 spawned an older, wiser public. As Americans have become more aware of the dangers of infectious diseases -- not just anthrax, but also smallpox and even Ebola -- Congress has responded by crafting legislation to counter fears.

The past few years have been an awakening; books like Richard Preston's The Hot Zone and his newly released The Demon in the Freezer along with movies like Outbreak have engendered a complete bouleversement in the public attitude toward infection control. Antibacterial soaps are staples in the kitchen as well as in the hospital now -- this is not necessarily a good thing, but it speaks volumes about the growing awareness of germs.

Once the red-headed stepchild of medicine, infection control has moved to the forefront of the American consciousness. That perception -- previously considered mere paranoia -- has been proved or shown all too reasonable in light of the anthrax scare.

And anthrax isn't the only disease to fear. In November, vacationers on a pleasure cruise rubbed elbows instead of shaking hands for fear of contracting the Norwalk-like virus that had already sickened hundreds on their ship.

Recent healthcare legislation has focused on many issues of prime concern to ICPs. Restrictions and labeling requirements related to the reprocessing of single-use devices were signed into law in October; the Bioterrorism Preparedness Act of 2001 became law in June. And the cornucopia of bills that are not yet law may have just as great an impact.


Nearly every healthcare-related law passed in 2002 affects ICPs in some way. One of the most obvious items of legislation includes the Bioterrorism Preparedness Act. Public Law 107-188 took six months to transition from introduction (by Congressman W.J. Tauzin (R-Iowa) in December of 2001) to passage June 12 -- a lightning-fast approval process, considering that some bills from January 2001 are still languishing on House or Senate desks.1

Bioterrorism preparedness has been of major interest to the Association for Professionals in Infection Control and Epidemiology (APIC). "This year, our big push has been for adequate funding for bioterrorism preparedness at the local (hospital) level," says Jennifer Thomas, APIC's director of governmental affairs. "We sent a request to HHS (Department of Health and Human Services) back in September, outlining key areas that need attention. HHS was formulating its five-year strategic plan and had not adequately addressed the issue of bioterrorism."

But the Act passed in 2002 should go a long way toward readiness. Among other requirements, the Act provides for "enhancing the readiness of hospitals and other health care facilities to respond effectively to such emergencies." It also allows for protecting the national food and water supply, for developing and producing new drug treatments and vaccines, and for addressing staffing shortages for certain health professionals.

The Nurse Reinvestment Act may also affect infection control departments. Increased staffing means increased infection control education. New employees will have to undergo the orientation process -- which includes infection control education -- as well as continuing education throughout the employee's time at the facility.

The single-use device reprocessing legislation -- signed into law in October -- was another huge issue in the infection control industry. Although the ramifications of the law aren't yet predictable, it is possible -- but unlikely -- that the "user fee" now associated with the submission of an application may be passed on to the consumer. It is doubtful that ICPs will see much effect from this law, other than being able to identify an instrument that has been reprocessed by its new labeling as such.

Another issue, albeit an indirect one, is that of adjusted Medicare reimbursement. If hospitals begin seeing increased revenue based on higher reimbursement (reimbursement was cut for 2002), more capital might be available to spend on the infection control department. This issue was left unresolved when Congress adjourned in November. The American Medical Association, along with many other healthcare organizations, is lobbying hard for this issue to be resolved early in the 2003 session.

Administrators continually petition the powers-that-be for more funding, which is steadily decreasing each year. Additional resources might open up the pocketbooks enough to significantly decrease the occurrence of nosocomial infections, to upgrade supplies, or to pay for a few more nurses (thus lowering the patient mortality rate, according to the highly-touted report in The Journal of the American Medical Association).


Still-outstanding bills include the Patient Safety and Quality Improvement Act and the Global Pathogen Surveillance Act of 2002. Also on the roster is the aforementioned Medicare Modernization and Prescription Drug Act. Although the House approved H.R. 4954, the Senate delayed taking action on the issue, adjourning without fixing the problem that will emerge when the Continuing Resolution expires January 11. As Congress is scheduled to return to work January 7, only a few short days are available to address the problem.

The difficulty lies with the Medicare payment formula, which was calculated erroneously. Physicians have already taken a 5.4 percent pay cut in Medicare reimbursement; during the next three years, a further 12 percent cut will be instituted unless the Senate approves the legislation to fix the error.


Another issue -- not legislative, but regulatory in nature -- is that of the Occupational Safety and Health Administration (OSHA)'s tuberculosis (TB) guidelines. OSHA had proposed standards that address occupational exposure to tuberculosis, but the proposed rule had generated tremendous opposition from several healthcare associations. APIC has spent six years challenging the rule.

"We oppose that rule and have tried very hard to prevent its issuance," Thomas affirms. "There is some talk around D.C. lately that OSHA may be considering abandoning the standard all together, but until that decision is official, we will continue to fight it."

OSHA's risk assessment had suggested that a positive tuberculin skin test was evidence of a material impairment of health or functional capacity. The organization had also estimated that those with positive skin tests, if left untreated and infected, would have a 10 percent chance of developing active TB; this, APIC says, is an overestimate.

After a report was released by the Institute of Medicine regarding Tuberculosis in the Workplace, APIC's president Georgia Dash made the following comments:

  • "Effectively controlling TB does not require the promulgation of a static regulatory standard on this issue.
  • "The CDC guidelines are working, as evidenced by the steadily declining rate of TB in this country.
  • "The answer is not to impose requirements on an area that is already under control.
  • "We should be funneling these limited resources into community-based screening programs that will identify those individuals at greatest risk -- particularly the foreign-born.
  • "Unless regulatory requirements are based in science and are deemed absolutely necessary, we simply cannot spare the resources required to comply."2

The Global Pathogen Surveillance Act is intended to improve international cooperative efforts in finding and controlling infectious disease outbreaks, regardless of the outbreaks' cause (intentional or natural), as well as improving the training of public health officials and epidemiologists, and providing assistance to developing countries to do the same. Technical and monetary assistance can be offered by the President to international health organizations; the act also allows for appropriations for the fiscal years 2003-2004.

Then there is the Patient Safety and Quality Improvement Act. Both the Senate and the House of Representatives drafted legislation by the same name; the Senate's version would provide legal protections for information submitted voluntarily to patient safety improvement systems. If enacted, the law would allow healthcare workers to submit information about medical errors, their causes, and prevention; it would also provide for voluntary, non-punitive reporting systems. The intent is to protect the safety of patients while reducing medical errors; the anonymity would encourage more frequent reporting.3

The House bill would allow for the creation of patient safety organizations, which would collect patient-safety data that was voluntarily submitted by caregivers; privacy protections would be established, as would civil monetary penalties for violations of the protections. The Secretary of HHS would be obligated to "develop voluntary national standards that promote the comparability of medical information technology systems."

Qualified practitioners would receive grants for establishing electronic prescription programs, and other grants would be available to hospitals and other healthcare facilities for either purchasing or implementing information technologies.

One key point of H.R. 5478 is that it would prevent healthcare providers from "taking certain actions against employees because the employee provided information to patient safety organizations."


So what does this mean for ICPs? They can expect 2003 to be another notable year; pending legislation aims to improve American healthcare across the board. Improvements in technology, Medicare and Medicaid reimbursement and in the quality of patient care can only bode well for ICPs, although their jobs may become busier and more diverse as a result.

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