New CDC Regulations Threaten to Dismantle Vaccines for Children Program

The policy changes would affect how providers store and replenish vaccines and have a severe impact on rural clinicians.

Significant federal policy changes could force many providers to opt out of Oregon’s well-established immunization program, potentially leaving kids around the state unvaccinated and with a higher risk of disease, state health care leaders and providers say.

New policies from the Centers for Disease Control and Prevention (CDC), set to take effect as early as Feb. 1, could dismantle the state’s successful Vaccines for Children (VFC) program, which includes about 600 clinics and serves about 52 percent of the state’s children in the state.

Among the new requirements is the separation of public and private inventory with public stock including VFC and state purchased vaccines. Public stock includes VFC and state-funded Children's Health Insurance Program (CHIP) doses, while the state’s Billable Project provides immunizations to children with private insurance.

“The purpose of this requirement is to assure VFC vaccine is not administered to non-VFC eligible children,” wrote Melinda Wharton, CDC’s deputy director, in a Sept. 5 memo. “This has been identified through various program integrity reviews as a critical risk. For this reason, we must require that VFC vaccine be stored separately in providers’ offices.”

CDC has introduced the policy changes in response to an audit of the federal VFC program by the Office of Inspector General, which found unacceptable accounting and vaccine storage and handling practices in several states around the country.

Oregon was not among those states cited in the audit and has already found a way to work around a portion of the CDC’s policy changes for the Advance Credit Model, which took effect Oct. 1.

Last week, the Oregon Health Authority (OHA) announced it would pay up to $7.5 million in advance for the cost of vaccines for both CHIP and Billable programs. Those costs have been in arrears quarterly by the state under the old model after the CDC had provided the vaccines in advance.

But other parts of the new regulations could prove more onerous and lead to private clinics dropping out of the VFC program, said Mimi Luther, VFC manager with the Oregon Health Authority’s Public Health Division.

“The risk is that we will have kids who don’t have access to vaccines,” she said.

Oregon’s VFC program, which started as part of a federal program in 1995, relies upon a system of provider accountability for waste and a vaccine tracking method that is one of the most established in the country, Luther said.

The new policies, which have been in flux since they were announced in August, would change how providers store and replenish vaccines and ultimately lead to lower vaccination rates and greater vulnerability in an outbreak, Luther said.

Under the current regulations, when providers run out of doses marked for VFC kids, they can borrow from their supply of Billable doses and replenish the supply through reordering. Roughly 43 percent of providers borrow vaccines that are intended for different eligibility groups or from other providers, she said.

That practice would no longer be allowed under the new regulations.

One exception to this rule would occur in times of outbreak, but would require providers to get written permission from the state’s Public Health Officer, who would need written permission from the CDC, Luther said.

“That is just absurd,” she said. “Can you imagine being a pediatrician during an outbreak and saying, ‘sorry, I can’t immunize your kid today? It is crazy.”

Storage guidelines also would change, potentially costing up to thousands of dollars for larger clinics.

Another new requirement is that providers organize and stock their vaccines in separate refrigeration bins for different eligibility classes, including VFC, CHIP, Billables, and Section 317 clients, according to OHA. Many providers would need to purchase new refrigerators and increase their staffing and electricity costs to meet those requirements.

Additionally, the new regulations would dismantle the state’s successful buying program, which requires providers to pay for any doses that are wasted or expired.

“Oregon always has required providers to pay for waste because we think it’s a good stewardship of public dollars,” Luther said.

The system has proven successful with only a 2 percent rate of waste, she said.

But under new CDC regulations, providers would be required to buy replacement doses on the private market.

The costs would increase dramatically in most cases.

Using the state’s bulk buying power, the cost of a single dose of measles, mumps and rubella (MMR) vaccine would cost $19.75 through the state and $56.14 through the private market.

“The state has huge purchasing power and contracts in place,” she said. “What I pay for a vaccine is much less than anybody would pay for on the private market.”

Exemplifying this point, Luther priced Hepatitis A vaccine at $15.25 for a single dose from the state and $30.40 on the private market. Polio vaccine would cost $12.42 and $27.44, respectively.

That is ordering a single dose. Most private insurers sell vaccines in packs of 10, so while an HPV vaccine would cost $107.16 from the state, a provider would end up paying about $1,350 from private insurers for a 10-pack, according to Luther.

“I am hopeful that Oregon is going to find a way to not require the separate inventories,” Luther said. “I am sure in my heart that if we fail at that we are going to lose many providers.”

The new policy guidelines could have the most impact on rural clinicians, who would need to follow a new set of storage and handling guidelines that would increase costs and potentially leave some clinics short of vaccines at critical times.

“They’re trying to fix something that isn’t broken in our state,” said Michael Sheets, a family nurse practitioner and owner of The Merrill Clinic and The Bonanza Clinic in rural Southern Oregon. “Potentially what could happen is that some of the centers may opt not to do immunizations instead of meeting these requirements.”

The value of the VFC program in rural areas cannot be overstated, said Sheets, who drives 23 miles between his two private clinics and spends a half-day at each.

The private clinics fill in a 96-mile stretch between the Public Health Department in Klamath Falls and the next closest public facility in Lakeview.

“Basically, we’re not making any money on this,” Sheets said. “Providers are trying to help the kids because otherwise the working poor couldn’t afford to get their shots.”

At his two clinics, Sheets administers a variety of shots for kids in the VFC and CHIP programs, including influenza, chicken pox, diphtheria and polio.

Since the program began in the mid-1990s, ear, sinus and respiratory infections have dropped dramatically because of the shots, he said.

“The kids that have these shots, don’t end up having those problems,” he said. “The value cannot be overstated in terms of reduced illness. It is a marriage of the public and private sector that works. We should have more of that, not less.”

Vaccines are currently stored and marked according to eligibility classes in a single refrigerator unit close to exam rooms, Sheets said. Under the proposed CDC rules, providers could end up needing additional storage space and temperature monitoring equipment to meet the CDC regulations, he said.

Additional refrigeration unit in each of his clinics would cost $400 to $500. The units would need to be moved further away from the patients due to lack of space, he said.

Clinicians could opt out of the system altogether, forcing rural families to travel further distances to get to the closest clinic, Sheets said. Or patients could potentially be turned away, he said.

“The new regulations are not in the best interests of anyone,” he said. “Somebody who is sitting in Atlanta or D.C. has written the regulations and doesn’t know how clinics work.”

The next steps for Oregon’s medical community include asking CDC for an exemption to the new requirements or a delay in their implementation until December, 2014, OHA’s Luther said.

The state would like the opportunity to problem solve the new regulations with the CDC, she said.

Otherwise, the changes would shift the burden onto already cash-strapped county health departments, said Karen Vian, immunization program manager for Douglas County Public Health.

Vian is one of many members of the health community who have shared their story with the state, and her experiences could help shape national policy, Luther said.

“These policy changes don’t work for the private sector and they don’t work for the public sector,” Vian said. “Public health departments are going to be unable to meet these policy changes.”

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Jeff can be reached at [email protected]

Image for this story by Sanofi Pasteur (CC BY-NC-ND 2.0) via Flickr.

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