Vaccine Registries Ever More Engorged; Clinical Directives in 0.2 Seconds

The Centers for Disease Control and Prevention will cough up $29.6 million in the coming fiscal year for 112 grants nationwide for programs geared towards improving state vaccine registries’ capacity for “identifying under-vaccinated populations,” as well as, among other technical capacities, “conducting surveillance [and] collaborating with preparedness….”

The money will go towards demonstration projects that improve registries’ ability to capture kids’ vaccine status and promote higher vaccination rates. Should a program work in one jurisdiction, it’s obviously transferable down the road. (CDC ignored questions on whether almost $30 million represents a typical annual expenditure, but private consultants said it does spend millions yearly on programming for Immunization Information Systems (IIS) upgrades.)

Money’s being made hand over fist while the vaccine decision and consent process becomes ever more automated and digitally streamlined. With Beltway Bandits nationwide hoovering up federal and state funds, it’s a process that yields, if not entirely automatic and uninformed consent, at least a real lessening of parental control. And Oregon has been among the nation’s leaders in it all for years.

In Maryland, for instance, a nonprofit of “immunization stakeholders” worked with funding from the Association of Immunization Managers (AIM) to develop a mobile app for school-located flu shots that “electronically collects parental consent,” bills insurers, and then uploads the child’s vax-status data. This is after printed material has already been sent home with the student.

While happy of the award, Tiffany Tate, Executive Director of the Maryland Partnership for Prevention, says there’s nothing particularly earth-shaking about her group’s app, which she termed similar to the digital records employed in doctors’ offices.

Still, there’s something off-putting about the power-point description that reads, “Contraindications? Yes? App asks additional screening questions. Contraindication Remain?” Only after the app ‘asks’ is the child then referred to a provider. MPP reported that of parents offered the remote-consent app, more than a third total, and more than half of the higher-income parents, employed it.

By signing the consent form – and, again, Tate stressed that something similar is in wide use – parents declare that they have read the Vaccine Information Statement or had it read to them. (At about 1300 words, most VIS would take some 10 minutes to read aloud.) By scrawling an illegible signature with their finger on the screen, parents declare from far away and with bifurcated attention at work, perhaps, that they understand the risks and benefits of a given vaccine. And, what’s more, that they’ve had their questions answered.

Though Tate’s school-located program currently only administers flu and Tdap shots, the model consent form reads: “Please select all the vaccines you would like your child to have. The school nurse will make sure your child receives only the vaccine needed.” Abrogating parental responsibility, deferring it to the slender shoulders of an overworked school nurse, kids lining up behind yours eager to get outside for recess – that’s asking a lot of the nurse.

Notably, there are three vaccines listed on MPP’s model consent form (page 26, here): Tdap, which it already administers to some students, the human papillomavirus (HPV) vaccine and the meningococcal MCV4 vaccine.

AIM (itself partially funded by vaccine manufacturers) provided a grant to MPP to get the project off the ground. Its Executive Director, Claire Hannan, said that MPP is looking to offer school-located HPV and meningococcal MCV4 vaccines sometime down the road.

Hannan added that Tate and MPP are currently in discussion with three states about replicating the electronic billing and consent app in those states. She didn’t know which states are involved.

Tate herself declined comment on when her program might start offering HPV and/or meningococcal MCV4; she also would not identify the states she’s in discussions with. Right — stand up proud.

Called ReadiConsent, the app stands ready for adoption by other jurisdictions. It’s one example of how this is all playing out.

No Wriggle Room

The CDC has issued what it terms Functional Standards for Immunization Information Systems which comment on the utility of this Maryland partnership app. One goal the feds promulgate is that, “The IIS has an automated function that determines vaccines due, past due, or coming due (“vaccine forecast”) in a manner consistent with current [CDC] recommendations. Any deficiency is visible to the clinical user each time an individual’s record is viewed.”

Not a lot of wriggle room for that nurse to make any actual decisions; perhaps not much more for a fancy-pants, private MD.

It’s also worth noting that federal law mandates that doctors administering publicly funded vaccines have no leeway. They must “comply with vaccine schedule with regard to periodicity, dosage and contraindications.” In Oregon, some approximately 26 percent of children are covered by the state’s Medicaid program, the Oregon Health Plan.

Noam H. Arzt, Ph.D., owner of HLN Consulting, LLC, wrote of his company’s Immunization Calculation Engine (ICE), which tells a doctor or nurse which vaccine comes next. Cool – an engine. The algorithms that HLN and others use “provide clinical decision support at the point of care and also help public health agencies understand and manage the immunization status of whole populations.”

Arzt noted that his company recently tested ICE on two Amazon “Compute Optimized cloud servers…. Each server demonstrated a sustained throughput of 75 requests per second with an average response time of 0.2 seconds per request, including the roundtrip time for the requests/responses to travel over the Internet to a remote client.”

That melds well with the CDC’s goal of IIS being able to generate reports on “immunization coverage, vaccine usage, and other important indicators by … provider, or provider groups for authorized users without assistance from IIS personnel.” In other words, insurance companies among those authorized users here in Oregon, they will be able to pressure doctors and practice groups they deem delinquent without involving the state at all. Just a quiet little hammer on bone.

And that meshes neatly with Oregon’s proposed tracking of clinicians, whether a MD, a ND or a RN, who write medical exemptions, should HB 3063 become law. As discussed in my article below (Oregon’s Pending Vax Bill: Does Anyone Know How It Will Ultimately Work?) there will be three levels of oversight of providers potentially writing exemptions: by their state licensing boards, by OHA and then by a committee of the legislature yet to be designated.

Health Insurers – Do Not Raise Thy Heads

Here in Oregon, Democratic lawmakers push a stringent mandatory vaccination bill for, yup, 11 different diseases, not just the measles that’s engendered the current ‘crisis.’ HB 3063 just passed the Oregon House of Representatives despite the fact, as the articles below on Forbes Fulminates prove, the bill has a very murky – no, currently unknown – route to implementation after August 2020.

Oregon’s vax-status registry, its “tracking” system, is called the ALERT IIS. Cooking with gas, the Oregon Health Authority at the stove, its number of “total data exchange transactions per month” has grown from approximately 300,000 per month when the current servers came online in mid 2013, to about 1.7 million monthly data transactions in late 2016. The number has undoubtedly not lessened since.

A main route to Oregonians’ understanding of ALERT IIS is its “Common Questions” page here. It says, “By law, only authorized users are allowed to access immunization information in ALERT IIS.” OHA then lists them: “Authorized users include health care providers, parents, county health departments, schools, and child care facilities.”

Oddly – or not, who’s kidding? – OHA omits mention of one category of authorized users that some Oregonians might find of particular and problematic interest: health insurers.

Oregon Revised Statute 433.090 states that, “‘Authorized user’ means a person or entity authorized to provide information to or to receive information from an immunization registry or tracking and recall system.” And right there, sandwiched in between health care institutions and state health plans, we find as authorized users: “Insurance carriers.” Nice old fashioned word: carrier.

There’s also this under ORS 433.094: “Allow[s] an immunization record of a client who is under the care of an authorized user or enrolled in an authorized user’s program to be released to the authorized user.” This record release occurs “without the consent of the client or the parent or guardian of the client.” [Emphasis added.]

First fed mumbo-jumbo, after I cited these laws in emailed queries to OHA staffers, including Immunization Program Manager, Aaron Dunn, the agency replied: “OHA confirms the vaccination status of clients that insurers cover….” It does so, the sentence continues, “by checking the client file they send to us (i.e. they already have the vaccination status of their clients, so we just confirm it is correct).”

Despite a couple of specific requests on my part in regard to its listing of who gets access to immunization data, OHA did not indicate why health insurers – as a category of authorized users – were omitted, plain not mentioned, from its frequently asked question page. The FAQ page says “Authorized users include” X, Y & Z. [My emphasis.] A nicely utilitarian word: include; it does not mean: limited to.

OHA buffaloed past my questions without answering. I suppose, depending on your naivety, using include means they just, you know, by happenstance, failed to list health insurers among the entities with vax-data access on the portal to many Oregonians’ understanding of the state registry.

Calls to Internalize Costs

People get squirrely about health insurers knowing too much about them. One reason may be the calls by prominent academics to raise health insurance premiums for clients deemed not fully compliant with the government’s vaccine schedule.

Dorit Rubenstein Reiss, a professor at UC Hastings College of Law, is one such commentator who looms large in immunizations circles. She and her co-authors wrote a paper entitled, “Funding the Costs of Disease Outbreaks Caused by Non-vaccination.” They argue that the Affordable Care Act permits “health coverage premiums to be rated” on the grounds of “age, geography, smoking status and, sometimes, participation in wellness programs.” So, Reiss and her co-authors contend that vaccination “could be considered evidence of participation in a wellness program.”

And in their view, a vaccine program would “meet the requirements for ACA recognized wellness programs. Those who do not get recommended immunizations without a medically valid reason, though, would be subject to higher monthly insurance premiums and would be forced to internalize at least a part of the costs of the failure to vaccinate.”

One of the biggest of immunization bigwigs, Arthur L. Caplan, Ph.D., the Drs. William F. and Virginia Connolly Mitty Professor of Bioethics at New York University, made essentially the same point in a paper on what he and his co-authors termed promising remedies to rising rates of vaccine exemptions.

Caplan and crew “outline arguments for more persuasive and – to a certain extent – coercive approaches that include … increasing the financial liabilities of exemptors.” They add, “Policymakers might consider not only allowing, but mandating differential insurance costs or rewards on the basis of vaccination status. With the rise of state-run health coverage under the ACA, this may become increasingly feasible.”

Neither Caplan nor any of the other some half-dozen experts I interviewed were aware of any health insurers currently imposing fines on noncompliant policyholders in the form of higher premiums for coverage. But Caplan said by phone that, “I favor a 5 to 10 percent premium differential.” He added, “I would treat nonvaccination as like a pre-existing condition. We have to be tough with this.”

Referring to the ban on the unvaccinated appearing in public settings in Rockland County, N.Y. that was judicially barred, Caplan said, “The only way to enforce that ban was after the fact – by sharing information with insurers. That’s good public health.”

Research published in 2012 studied IIS’s “Exchange with Payers.” Payers refers to health insurers and large companies who self-insure their employees’ medical costs. The paper was published by an organization serving the medical directors of “Employers, Health Plans and Provider Systems.”

A scholarly effort, it evaluated six large cities and all fifty states and determined that more than half have “payer exchange provisions.” And of those, 20 “allow direct access [to immunization records] by payers for quality assurance, reimbursement, or evaluation purposes.”

Quality assurance and evaluation purposes. In the realm of health insurance, those are loaded terms.

The IIS software vendor mentioned above, Noam Arzt, confirmed the tendency. He said that health insurers often can reach an agreement with a health department whereby the insurer provides the name and demographic information for a panel of patients, and the department will return vax-status data on individual kids.

And the “Exchange with Payers” authors found that in the time frame covered, Oregon was all in: “Oregon’s IIS statute allows for exchange among authorized users, including payers” such as health insurers or large, self-insured employers. Additionally, Oregon’s “IIS rule authorizes exchange among authorized users and payer access to their member information.”

They also write that payers “can potentially benefit from IIS participation in terms of cost savings and improved quality service provision.” So these health insurers and big companies “may want to collaborate” with officials and lawmakers to “improve allowable access and exchange.”

It’s for Life!

One journal article referred to the “ongoing expansion of IIS to life-span systems.” It offered the promise that, “As more IISs incorporate vaccine administration data for adults, either through enrolling vaccination providers that serve adults or as individuals already enrolled in the IIS age into adulthood, the capabilities of IIS will become more universally applicable to individuals of all ages.”

It’s a promise not solely in the offing. Noting the wide variety among various state registries, Richard Hughes IV, a principal with the consultants, Avalere Health, put it somewhat obliquely: “Less than half the states have 50 percent of adults captured in their registry.”

It’s all part of that chimera on yon horizon: a truly national, cradle-to-grave system. Once these pesky kids are squared away, the focus may shift to adult vaccination. When all state registries are able to communicate fairly seamlessly, that’s known as interoperability. But, state registries’ code tending towards deep bowls of spaghetti, interoperability is still some ways off. That’s where IIS program funding like the CDC’s $29.6 million comes in.

ORS 433.100 provides that OHA can charge fees for registry services, “including associated tracking and recall systems maintained by the authority.” If the insurer knows who’s in the recall system, that means it knows – by name, address and date of birth – which of the kids it covers are, as ORS 433.090 puts it, “late in receiving recommended immunizations.”

ORS 433.100 helpfully notes that the authorized users can also make make voluntary contributions. These fees are assessed against HMOs and their ilk, plus, “insurance carriers that are using the information from the registries for quality improvement activities for their privately insured patients.”

Mary Beth Kurilo, currently the Policy and Planning Director for the American Immunization Registry Association, was ALERT IIS’s Director from 2007 to 2014. She said that insurers did make voluntary contributions to Oregon’s registry back in her day, but that they were “nominal amounts,” typically between $5,000 and $20,000.

OHA declined to give ALERT IIS’s current budget. It said, “ALERT doesn’t have a budget per se. We have a maintenance and support contract, and have staff associated with ALERT staff costs.” Maybe. But none of that amounts to any sort of transparency you can slap a “$” in front of. What, it’s an embarrassingly large amount of money to – to use a phrase you encounter in the immunization literature – surveil Oregon’s children?

Sausage?

As Oregon HB 3063 wended its way toward a vote in the House (where it passed, a vote in the Senate expected the week of May 13) several lines of one amendment, A18, were deleted at the last minute. This was announced the morning a joint House-Senate committee voted it on to consideration on the House floor. Whether the late deletion came from simple oversight or, more likely, was the product of legislative sausage-making is unclear. But it was no small beer that got deleted.

The kiboshed provision proposed that the state Department of Education report annually to some unnamed legislative committee “on the immunization status of children who are homeschooled students….”

That would seem to obviate what some parents might view as a minor – emphasize that – but still valid reason for homeschooling in the face of mandatory vaccination: to shed annual government oversight of a child’s vaccine status. There’s a deal of sorts: My tax dollars don’t go to educate my child. And the state of Oregon doesn’t get all up in our business.

Had it survived, the A18 amendment would have changed all that.

But for now, the following still seems to apply: I posed several questions to the state’s Office of the Legislative Counsel, specifically Deputy Legislative Counsel Suzanne C. Trujillo. By email I asked Trujillo:

Say HB 3063B does pass. And a family opts for home schooling their kids. No vaccines for them they’ve decided. Is that family still required to report to the state their children’s vaccine status in any fashion?”

Trujillo replied: “No. A child who is taught at home by a private teacher, parent or guardian (see ORS 339.030 and 339.035) is not required to report immunization status because the child does not attend “school” as defined in ORS 433.235 (7), amended by HB 3063-B.”

In response to additional questions, Trujillo said such a family is not required to report to their local school district, nor to their local health department.

Given the mandatory needles possibly in the offing, maybe reporting your child’s vaccine status does seem relatively insignificant (small beer) for now.

Just know that should any deviance from the established orthodoxies – orthodoxies which may become state law depending on the vote in the Oregon Senate next week – make its way into an IIS, it’s likely for life and available by law to a host of “authorized users.” Know also that there’s a field on a child’s ALERT IIS record in Oregon where clinicians can note vaccine refusal.

How soon before such authorized users might include potential employers? There’s already been calls from folks like Caplan for vax status to be part of the job application process. How soon before digital applications (i.e., all job applications) include a field for vaccine status, a data point to be routinely verified along with employment history and everything else?

A Brave New World indeed soon dawning, $30-million next year from the CDC heralding … what? Pick your term.

Author: danielforbesxyz

Daniel Forbes’s series of 20 articles in The Portland Mercury on toxic emissions from Portland glass factories helped drive state policy change. Won awards from such outfits as Columbia University’s J-School, published in a bunch of national publications such as Rolling Stone and The Nation, etc., and appeared on radio and TV a fair bit. (Cool when they send a big black limo, you exit the house in a suit, and the neighbors think someone's died and send over free food.) Testified before the U.S. House and the Senate at hearings I caused on the Clinton White House’s $24-million, sub rosa propaganda campaign to rewrite TV scripts to sway elections. My novel, Derail this Train Wreck, from Fomite Press, was sparked by a police assault that led to a successful, free-speech federal lawsuit against Lincoln Center and the NYPD.

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