The Impact of Healthcare Legislation on Infection Control

January 1, 2003

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. Falloutfrom the September 11th attacks in particular led to a rash of bioterrorism-relatedbills. But which of these laws -- or proposed laws -- will have an effect oninfection control practitioners (ICPs)?

The near-hysteria concerning the attempted anthrax outbreak in 2001 spawnedan older, wiser public. As Americans have become more aware of the dangers ofinfectious 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 TheHot Zone and his newly released The Demon in the Freezer along with movies likeOutbreak have engendered a complete bouleversement in the public attitude towardinfection control. Antibacterial soaps are staples in the kitchen as well as inthe hospital now -- this is not necessarily a good thing, but it speaks volumesabout the growing awareness of germs.

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

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

Recent healthcare legislation has focused on many issues of prime concern toICPs. Restrictions and labeling requirements related to the reprocessing ofsingle-use devices were signed into law in October; the BioterrorismPreparedness Act of 2001 became law in June. And the cornucopia of bills thatare 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 BioterrorismPreparedness Act. Public Law 107-188 took six months to transition fromintroduction (by Congressman W.J. Tauzin (R-Iowa) in December of 2001) topassage June 12 -- a lightning-fast approval process, considering that somebills from January 2001 are still languishing on House or Senate desks.1

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

But the Act passed in 2002 should go a long way toward readiness. Among otherrequirements, the Act provides for "enhancing the readiness of hospitalsand other health care facilities to respond effectively to suchemergencies." It also allows for protecting the national food and watersupply, for developing and producing new drug treatments and vaccines, and foraddressing staffing shortages for certain health professionals.

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

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

Another issue, albeit an indirect one, is that of adjusted Medicarereimbursement. If hospitals begin seeing increased revenue based on higherreimbursement (reimbursement was cut for 2002), more capital might be availableto spend on the infection control department. This issue was left unresolvedwhen Congress adjourned in November. The American Medical Association, alongwith many other healthcare organizations, is lobbying hard for this issue to beresolved 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 thepocketbooks enough to significantly decrease the occurrence of nosocomialinfections, to upgrade supplies, or to pay for a few more nurses (thus loweringthe patient mortality rate, according to the highly-touted report in The Journalof the American Medical Association).


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

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


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

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

OSHA's risk assessment had suggested that a positive tuberculin skin test wasevidence of a material impairment of health or functional capacity. Theorganization had also estimated that those with positive skin tests, if leftuntreated 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 regardingTuberculosis in the Workplace, APIC's president Georgia Dash made the followingcomments:

  • "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 internationalcooperative efforts in finding and controlling infectious disease outbreaks,regardless of the outbreaks' cause (intentional or natural), as well asimproving the training of public health officials and epidemiologists, andproviding assistance to developing countries to do the same. Technical andmonetary assistance can be offered by the President to international healthorganizations; the act also allows for appropriations for the fiscal years2003-2004.

Then there is the Patient Safety and Quality Improvement Act. Both the Senateand the House of Representatives drafted legislation by the same name; theSenate's version would provide legal protections for information submittedvoluntarily to patient safety improvement systems. If enacted, the law wouldallow healthcare workers to submit information about medical errors, theircauses, and prevention; it would also provide for voluntary, non-punitivereporting systems. The intent is to protect the safety of patients whilereducing 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 bycaregivers; privacy protections would be established, as would civil monetarypenalties for violations of the protections. The Secretary of HHS would beobligated to "develop voluntary national standards that promote thecomparability of medical information technology systems."

Qualified practitioners would receive grants for establishing electronicprescription programs, and other grants would be available to hospitals andother healthcare facilities for either purchasing or implementing informationtechnologies.

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


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