By Ed Coghlan.

The testimony submitted to the FDA by Terri A. Lewis PhD NCC for the July 9 public meeting for Patient-Focused Drug Development on Chronic Pain might also be viewed as the “voice of the chronic pain patient.”

That’s because her testimony was driven by the results of a survey that Dr. Lewis prepared and distributed in cooperation with the National Pain Report.

Nearly 1700 persons – patients, care partners and providers – representing all 50 states opined that much is wrong in how chronic pain is being treated in this country. For a summary of the barriers to care, read part one of this report.

In her testimony, the long-time clinical educator in the field of Rehabilitation and Mental Health who is also a care partner for a family member, outlined some solutions.

Here is what she recommended to the FDA.

Recommendation 1. Evidence based care and treatment protocols that are consistently employable across care continuum locations, based on medical necessity criteria and outcome evaluation.

As states implement regulations forcing people into pain clinics and away from their primary care and specialty care providers (who may have provided long term care), this forces individuals with multiple chronic morbidities into a care model that for many is inappropriate and which may result in harms. Few board-certified anesthesiologists have experience with rare and complex disease progression and few have interacted effectively with palliative care. These are also unfamiliar with patient histories and are often consumed with fitting them into an interventional pain or surgical model whether or not it is appropriate. Further, the adoption of CDC guidelines (March 2016), and the poorly understood opioid street drug crisis expressed in overdoses and suicides (now becoming clearly an illicit drug problem) has created a problem of ‘one-upsmanship’ by states that have adopted treatment criteria based on very flawed and harmful logic applied to everyone as an opiate naïve user and without regard for the range of individual needs. This has removed judgment from physicians and tied the hands of clinicians to make effective clinical decisions. It is now the case that physicians are forced to treat to the regulation as opposed to treat to appropriate levels of health care needs. I have personally stated over and over this many months that the need to treat the person has become lost in treating labels which have little ability to inform care. This forces out harmful care based on stereotypes, stigma, and flawed data that has negative harms attached and we are observing this injured effort to flow through the entire system.

Recommendation 2. Create cross cutting regulatory approaches to reduce barriers to access, reduce paperwork, increase communication between providers.

It is very difficult to receive care across state lines, across systems, between care systems, and across the progressive slide toward disability in this fractured system. The handoff from short term disability, workman’s compensation and the like is fraught with difficulty for the chronic care population and traps them into shortfalls of care based not on a disease model but a return to work model. The imposition of Medicaid work rules is likely to increase problems of handoff for a complex population that employers often want to avoid. States are under capacitated to ascertain how people with chronic illness will fit into this emerging paradigm.

Recommendation 3. One set of overarching insurance regulations – Medicare, Medicaid, VA, Workman’s compensation, state pain regulations to reduce duplication, gaps, waste and harms.

Definitions between programs are inconsistent, create gaps, and have differing expectations for eligibility. They need to be aligned to create a seamless set of criteria focused on a lifespan model of care rather than an acute medical model of care delivery. The onset of disease is no respecter of state borders. Part D prescription formularies should be uniform and consistently applied across disease progression and flow through all contracted insurers consistently. At this time, it is difficult to ferret out effective indicators when input variables create enormous confounds in our understanding of results, outcomes, and impact. Drug development cannot effectively proceed in this contaminated environment.

Recommendation 4. Create unfettered pharmacy access across state PDMP agreements that allocates medications to be dispensed based on medical necessity criteria.

For instance, Lupus is Lupus everywhere one goes. Multiple Sclerosis has a course that is known and it includes lesions on the nerve sheath that generate extreme pain. Neurofibromatosis generates tumors on the nerve tracks. A person who has had a spinal fusion with subsequent onset of Arachnoiditis will always experience intractable pain. Whether one lives in West Virginia or Nevada, one should have the same expectations for care that is consistently supported across insurance plans and state regulations. State regulators, insurance companies and pharmacies should not be free to dictate who will receive proven evidence-based medication supports and nor should this be left to pharmacy clerks in corporation pharmacies to parse out who will be lucky enough to get their prescription filled. The same is true for any number of the chronic diseases reported here. This requires federal policy directives to assure a seamless system.

Recommendation 5. Monitor for effective insurance implementations, provider capacity, and training which are often mistaken as red flags by a fractured system of a care.

Currently red flags are raised by simply being chronically ill and requiring the use of complex medications. This needs to be remedied. It should not be a crime to be gravely ill and policies that reinforce stigma based on consumer characteristics or payment sources pose unnecessary barriers as they rely on individual judgment applied by persons who have little knowledge on many levels.

Recommendation 6. Nondiscrimination in coordination of care, minimum access requirements within state regulations as part of Federal state plan requirements for public health.

No provider with a Medicare number should be allowed to discriminate in care. Abandonment of patients should be closely examined by the federal and state governments. The federal government should create an indicator for federal state public agreements that track this as a function of the public health system. This tracking should include the functioning of Medicare A, B, C and Part D plans. Capitation by Advantage plans is a particularly grievous issue for persons with complex care needs and dual-eligibles in Medicaid.

Recommendation 7. Support for physician training and flexible implementations across treatment locations – community, hospital, assisted living, nursing home.

Physicians should have the ability to reconfigure their care provision to meet individuals where they are. Serving persons who need palliative care within the acute care model or forcing them into higher expense models for care delivery is absurd. It is well understood that palliative care is a model that leads to better quality of life at lesser cost for affected individuals. Supporting palliative care with adjunctive supports that widen the insurance payer system reduces reliance on higher cost prescriptions and health care utilization while improving community function for many. Insurers should be required to contract with physicians who can serve persons with chronic care needs through a continuum of integrated medical home models – community located, in home, palliative care, assisted living, nursing home, hospice, hospital.

Recommendation 8. Move to ICD-11 as quickly as possible to correct logical flaws in ICD-10 that negatively impact data collection about the impact of healthcare practices visited upon persons with multiple chronic comorbid conditions.

I will spend some weeks yet on analysis in this area. It is my goal to correlate reported comorbidities with ICD-10 body system criteria and self-reported interventions. However, based on a preliminary evaluation, there is enough data to raise this question – does the logic in the ICD-10 and electronic health record implementation actually contribute to errors of care and duplicative costs? Comparing ICD-10 to ICD-11 is important because it clears up some of the diagnostic difficulties associated with chronic disease and related symptoms that include pain.

To register for Public Meeting on Patient-Focused Drug Development for Chronic Pain, click here.

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