On the Precipice

Our 20th century has been marked by major breakthroughs in science and public health — none more so than childhood immunizations. The number of vaccines recommended for children has grown from four in the 1950s (polio, pertussis, diphtheria, and tetanus) to thirteen distinct vaccines (if we include the recent FDA approval of rotavirus vaccine), with multiple vaccines in the pipeline (human pappilomavirus, herpes, RSV, streptococcus, and parainfluenza). The cost to fully immunize a child has more than doubled since 1999 and 2002, without even counting the newer mandates of rotavirus, meningococcal, and hepatitis A vaccines.

Disease morbidity and mortality have decreased tremendously for mumps, measles, rubella, polio, diphtheria, pertussis, hemophilus influenza, and pneumococcus. For every one-dollar expenditure in childhood vaccines, it is estimated by the CDC that our healthcare infrastructure saves 10–14 dollars. Medical residents in training today rarely see diseases like bacterial meningitis, epiglottis, and paralytic polio.

Despite a recent surge in the public’s concern over vaccine safety, pressures on vaccine supply and delivery (due to the current regulatory environment and inherent commercial concerns over product liability), and limited returns on investment with vaccine production (beyond the scope of this editorial), the healthcare community has by and large managed to raise the immunization rates of two year olds to between 75 and 80 percent, a remarkable achievement. However, there are major clouds looming over the future success in immunizing our childhood population.

The delivery of vaccines is a fragmented patchwork of public and private systems, with just over 50 percent financed in the United States by private insurance, 35 percent eligible for public programs, i.e., Medicaid and the uninsured (VFC), and the remainder represent “underinsured” children whose private insurance doesn’t cover vaccinations.

In the private sector, we are faced with strenuous efforts to ascertain the patient’s insurance status, insurance coverage for various “newer” vaccines, health plan co-pays and deductibles, signed consent forms accompanied by vaccine information sheets, and face-to-face counseling of the vaccine efficacy and side effects — all prior to the actual administration of the vaccines! We are also responsible for maintaining appropriate ordering of multiple vaccine antigens, various storage requirements, and keeping ourselves and our staff up to date with the ever changing ACIP/AAP vaccine schedule and various ever-changing state mandates for school entry.

Finally, we are allowed the privilege of billing the third-party payor, who may or may not reimburse us much more than a few dollars (if we are lucky) over the acquisition costs of the vaccine, with a token additional payment for the vaccine administration. Many instances we have found payments denied as vaccines approved by the FDA and confirmed by ACIP/AAP CDC subcommittee months and months earlier have yet to be programmed into the behemoth third-party payors computers!

Very little empathy is given to the enormous carrying costs of these vaccines, nor to the logistical hurdles we face every day in practice. The health plans know that primary care providers realize that childhood immunizations are a cornerstone of the medical home, and we providers will sacrifice elsewhere before we diminish our vaccine delivery systems, even while we bear most of the financial burden.

Well, the storm clouds brewing are private sector providers who are no longer willing to bear the financial strains of third-party mandates for newer and improved childhood vaccines and who are pushing back. Some are referring a portion of their patients (either by health plan reimbursement or by a particular under-reimbursed vaccine) to public clinics. Others are having patients sign financial waivers and “balance-billing” the patient, even though in many instances this is prohibited in their signed contracts with third-party payors. So, an already fragmented system, with the addition of several new vaccine mandates, has the possibility of being enveloped in complete chaos for the 50 percent of the population dependent on the private sector!

While the larger public health issues of a dependable vaccine supply, and adequate system of checks and balances concerning vaccine safety are of paramount importance and will require public debate, there are several immediate solutions to the cherished U.S. system of private sector delivery of vaccines:

• Mandate, through federal legislation (unlike the IOM proposal that is ‘voluntary’), that all private health plans provide first-dollar coverage for all recommended childhood vaccines.
• Consider federal incentives, either through a subsidy or through generous tax provisions, to private health plans, as the de-facto vaccine purchasers, as long as they maintain high immunization rates. They would be prohibited from reimbursing their providers at average sales price (ASP) and would have to pay at either ASP plus a CDC-determined surcharge or at a CDC ASP that would appropriately incentivize private sector providers.
• Bring harsh penalties to third-party payors who bundle immunization administration codes.
• Require third-party payors to program new vaccine CPT codes as soon as approved by ACIP/AAP or face large monetary penalties.
• Require all private health plans to recognize periodicity schedules that allow for appropriate “catch-up” immunizations, outside the prescribed schedule, so that no provider is denied reimbursement for catch-up immunizations, as long as they are medically appropriate as defined by ACIP/AAP.
• Create an advisory panel to ACIP/AAP with real-world private practice physicians who would have input into ongoing vaccine delivery and reimbursement problems so that no health plan would be able to “gain the system.” Encourage dialogue with third-party payors.
• If all else fails, consider financing mechanisms by third-party payors to a vaccine pool whereby states do a universal purchase program of vaccines, with distribution to private sector for vaccine delivery — as is done in Massachusetts and in other states.

In conclusion, we providers must take a “call to action” to prevent the demise of our private sector vaccine delivery system. By advocating for needed legislative and regulatory relief, the system will be getting a much-needed “shot in the arm” to allow it to be sustainable for the rest of the 21st century!