The Centers for Medicare & Medicaid Services has published a proposed rule in the Aug. 15 Federal Register that would require long-term care (LTC) facilities to vaccinate all residents against influenza and pneumococcal disease as a condition of participation in Medicare and Medicaid.

The agency's goal is for 90% of LTC facility residents to receive one lifetime dose of pneumococcal conjugate vaccine and an annual influenza vaccine. According to CMS, in 1999 only 38% of nursing home residents had ever been vaccinated against pneumococcal disease and only 65% had received the annual flu vaccine.

The proposed rule requires LTC facilities to offer influenza vaccine to all residents each year between Oct. 1 and March 31. Residents who have never been vaccinated against pneumococcal disease would be offered the pneumococcal conjugate vaccine at the same time. Seniors who received a dose of pneumococcal vaccine before their 65th birthday could be offered the vaccine again at the recommendation of their healthcare provider.

CMS will not require LTC facilities to develop specific protocols or documentation procedures for implementing the vaccination requirements. However, the agency stated that it expects the facilities to incorporate a vaccination history for each resident into whatever process is developed to meet the proposed requirements.

According to the rule, patients or their legal representatives may refuse either or both vaccines, but the refusal must be documented in the patient's medical record. The record must include documentation that the patient or the patient's legal representative "received appropriate education and consultation" about the vaccines' benefits.

If CDC announces that influenza vaccine is in short supply, the rule states that the agency could direct state survey agencies not to cite LTC facilities for noncompliance if they are unable to obtain the vaccine.

In January CMS raised the average reimbursement rate for administering each vaccine to $18 per dose, more than twice the previous payment level. This incentive is in addition to the reimbursement for the vaccines, currently $10.10 per dose of influenza vaccine and $23.28 for each dose of pneumococcal conjugate vaccine.

CMS' proposal drew a positive reaction from Tom Clark, director of policy and advocacy, American Society of Consultant Pharmacists. "There are several states that already have such requirements," he said. "This rule would make it universal across the country. We're supportive of it particularly because in many cases influenza vaccine tends to get administered, but pneumococcal vaccine often gets neglected or overlooked. This would focus more attention on immunization issues and help ensure that residents get those types of immunizations."

While most pharmacists won't oppose the requirement because it is generally beneficial for patients, compliance with the rule may be a challenge for R.Ph.s if the flu vaccine is in short supply as it was last year. "CMS did say that in the event of shortages, surveyors would be empowered to waive the requirements for facilities that can't get the vaccine, which may be a problem again this year," said Clark. "We don't know for sure yet how much vaccine is going to be available."

Another challenge for pharmacists may be that their facilities don't have adequate time to gear up to meet the requirements. "Almost every facility does some type of influenza immunization, but the ones that aren't doing pneumococcal may need some time to learn about it and develop forms and procedures for tracking it," said Clark. "There are forms available, but facilities will need to evaluate options and figure out how they are going to meet the requirement and keep track of it."

Clark said that yet another issue related to the proposal has to do with CMS adding Section W to the Minimum Data Set (MDS), a comprehensive assessment tool that every nursing home is required to fill out electronically for each resident. Section W will track the immunization status of the residents. "In the past, a big problem in LTC has been the lack of a reliable source of data on immunization status of nursing home residents," he said. "The MDS will give us a way to track immunizations in LTC facilities, which will make it easier for state surveyors, consumers, and various entities to track immunization status."