THE VIOLATION OF A NATION

Prior to the issuance of the Affordable Care Act (ACA) in 2010, healthcare policy was devised to improve the health outcome of individuals based on individualized medical needs, regimen and treatment. In contrast, the goal of public health has been to improve the health status of the population through steps such as public health promotional activities and disease prevention measures. Sections of the ACA and subsequent actions from HHS and related agencies have created research guidelines and policies, however, that attempt to combine individual health needs and societal needs into one single silo.

“Living Well with Chronic Illness” was released around the time of the ACA’s adoption, when the government began considering healthcare outcomes (even those relevant to individual health) in the context of how they would impact society, rather than considering the health outcome/benefit to the individual. Further, as the U.S. health system under the Affordable Care Act transformed from a from fee-for-service model to that of an accountable care organization,(8) what was best for individual patients was not always what was best for keeping costs down.

The government understood that the less a population got sick, the less the costs to a government-funded healthcare program like the ACA. But what was to happen to patients with chronic illness? If they could “get better” by implementing the lifestyle changes recommended in the government’s reports, costs could be cut dramatically. Nevermind the fact that the nature of “chronic” illness/pain is that it does not “get better,” but must instead be medically managed for the comfort and health goals of the individual patient.

At the same time the government was considering how to cut healthcare costs with the rollout of the ACA, the CDC released a Public Health Action Plan (2011) on mental health promotion and chronic disease prevention, which contained 8 strategies to integrate mental health and public health programs to address chronic disease. The committee recommended combining what it considered “related” illnesses as “public health” (or as we have seen, individual health) challenges to overcome, in order to “avoid the trap of pitting one disease against another in competing for resources and attention. It [the CDC plan] conceptualizes the commonalities across diseases with the intent of developing strategies that benefit all affected by the vast array of chronic diseases.”

HHS too has recommended combining “related” illnesses (such as substance abuse and chronic illness, or anxiety and chronic pain), and it appears it has in-fact strategized to combine the public health response to the “opioid crisis” with the goals outlined in “Living Well with Chronic Illness.” Along with the CDC, HHS has conflated the two into a single public health campaign addressing (and erroneously connecting) both substance use disorder and chronic pain/use of prescribed pain prescriptions as a similar “challenge” to overcome. Finally, a number of subsequent documents released from

Institute of Medicine and CDC have also made explicit recommendations for changes in healthcare policy delivery that involve the integration of mental and physical health.

Unfortunately, we’ve seen the result of these misguided definitions/policies. Chronic pain patients who use opioid pain medications responsibly have been lumped in with those who misuse opioids (prescription and/or illicit). Some ill-informed politicians and members of the media have even deemed the use of opioids for pain and illness a lesser form of substance use disorder. In the media and at the legislative level, both in states and federally, the response to the opioid crisis is taking precedence over any response to the untreated pain crisis that’s now occurring, with many policymakers stating that once the opioid abuse crisis is “reigned in,” those needing opioids for pain will finally be the subject of their attention via more funding for research, for better pain treatments, etc. Patients in pain are also being told, increasingly, that their pain is all in their “minds.” Stress reduction techniques, mental health services and the rest are being offered for serious pain and illness, while appropriate pain medication is being withheld. Unfortunately, without effective, alternative pain medication, patients in pain are killing themselves.

Perhaps not surprisingly, The committee members anticipated public resistance to the proposed messaging/study, specifically noting how Americans value personal choice, freedom and privacy: “For this reason, it is critical to integrate healthcare policy with public health policy and reframe them both to be consistent with other societal values.”

Below is a list of additional reports/actions the federal government issued/took to assist with the implementation of Healthy People and other related chronic illness healthcare cost-cutting initiatives it rolled out around the time of the ACA

– The Public Health Action Plan to Integrate Mental Health Promotion and Mental Illness Prevention with Chronic Disease Prevention (CDC, 2011c) (9), which stated healthcare providers should “stress the importance of mental health in…preventing or reducing disability and death from chronic disease.” The plan suggested the federal government “define the impact of coping, depression, and other emotional responses to [chronic physical illnesses such as] arthritis.” It also emphasized “surveillance” as a way for various agencies to measure progress towards meeting Healthy People initiative goals.

– The “National Action Plan to Improve Health Literacy” (2010) (10), which further worked to coordinate care between various “professionals, policymakers, communities, individuals, and families” to track the success of the Healthy People initiative.

– The Institute of Medicine (IOM’s) 2011 “Public Health: Revitalizing Law and Policy to Meet the New Challenges”(11). This document described these policies and made detailed recommendations about the need to review and revise various public health policies and laws in order to improve population health.- The ACA of 2010 required the Secretary of Health & Human Services to contract with IOM, which subsequently issued “Relieving Pain in America”(12) (June 2011).

– HHS appointed the Interagency Pain Research Coordinating Committee (13) (IPRCC) to coordinate all pain research efforts with HHS and across the other Federal Agencies.

– October 2012: Assistance Secretary of HHS asked IPRCC to oversee the creation of the comprehensive population health level strategy (a population Study which was requested by the Arthritis Foundation and, in the opinion of CIAAG, constitutes a pragmatic clinical trial, which by law requires the informed consent of those being study but which was performed on its “subjects” without their knowledge or consent.) (14)

A population-wide, non-consensual clinical trial is born

After initiating the aforementioned non-consensual arthritis study, the IPRCC and National Institutes of Health partnered to establish a framework for developing a National Pain Strategy in consultation with the chair and vice chair of IOM committee. IPRCC selected an expert working group to address 6 key areas that would comprise the National Pain Strategy:

1. Population Research

2. Prevention & Care

3. Disparities

4. Service Delivery & Payment

5. Professional Education & Training

6. Public Education & Communication

The first objective of the National Pain Strategy was to confirm the # of high impact chronic pain sufferers (defined as those experiencing chronic pain that frequently limited life or work activities) (15) and the categories of the conditions the study would be tracking as part of its “population research.” The second objective defined the collaborators to be used, including:

o The Patient-Centered Outcomes Research Institute, or PCORI (16), an NGO that was created as part of a modification to the Social Security Act by Clauses in the ACA.

o Stanford University
o Other Federal Agencies:

• ▪  Centers of Disease Control

• ▪  Agency for Healthcare Research & Quality

• ▪  Centers for Medicare & Medicaid Services

• ▪  Food & Drug Administration

• ▪  Office of the National Coordinator

• ▪  National Institute of Health

• ▪  Public & Private Health Insurers

• ▪  Professional Organizations

  Through a systematic review of the various agencies and organizations involved, our research team identified a number of stakeholders participating in the creation, implementation and dissemination of information for the National Pain Strategy’s unethical and likely illegal population-based study of chronic pain patients.

● The CDC contracted with the government affairs/technical assistance and implementation firm Abt Associates, allegedly to help roll out their guidelines to

support safe prescribing and reduce the adverse consequences of opioid use. SeeCDC developed a prescribing guidelines(17), March 15, 2016. In reality, the guidelines were used to reduce or eliminate chronic pain patient access to needed opioid pain medication.

o Abt synthesized, researched and assembled evidence tables and provided editorial support for the guideline’s draft clinical recommendations on opioid “ceilings” for pain patients. Abt “conducted rapid literature reviews on the harms associated with the use of opioids for chronic and acute pain; the harms of combining opioids with alcohol, other prescription drugs and illicit drugs; the effectiveness of non-opioid treatments for pain; patient and provider values and preferences specific to opioids; the cost- effectiveness of opioid therapy for chronic pain; and the impact of prescription drug monitoring programs on prescribing behavior and patient outcomes.” Abt and the CDC’s rapid and reckless introduction of poorly researched guidelines directly led to the untreated pain epidemic and pain patient suicides we are seeing today.

o The CDC hired Abt Associates to develop a coordinated care plan (CCP) for “safe” opioid prescribing. This plan included dosing thresholds. This plan was communicated to the medical community nationally.

• ●  March 16, 2016 HHS’ Agency for Healthcare Research and Quality (AHRQ) issued grant # R18HS0237850 / AHRQ for: “Improving Opioid Care” to fund a project called the Six Building Blocks, or “six key work areas you [physicians] need to redesign to improve your clinic’s management of patients who are on long-term opioid therapy.” It is noteworthy that this HHS grant was provided just 1 day after the CDC guidelines were issued publicly.

• ●  Additional funding for the Six Building Blocks project was awarded by the Washington State Department of Health Subcontract HED23124 of Cooperative U17CE002737, funded by the Centers of Disease Control (See appendix A). It’s interesting to note that this grant publication states: “This project is solely the responsibility of the authors and does not represent the views of the AHRQ, CDC, or WA DOH”, particularly since the Six Building Blocks that were funded via this grant were in the sole control of these agencies and are now being used to implement changes into the public health system. It is also important to note that the private insurer Kaiser Permanente was involved in the Six Building Blocks grant study (and that Kaiser, in their materials and in visits with their doctors, is notorious for promoting a “mental” health approach to physical chronic health issues.)

• ●  The AHRQ gave funds to Abt Associates to evaluate and implement the Six Building Blocks (18) . The Six Building Blocks program would go on to provide healthcare providers and programs in the U.S. with the structure needed to implement a new delivery care model that aligns with the goals outlined in “Living Well with Chronic Illness.” This model inappropriately and outrageously encourages self-management for those living with serious chronic pain and illness. It is important to note that the outcome of everything

described in this briefing is that those living with chronic illness and pain now being involuntarily pushed into these cost-cutting (for insurance companies, the ACA) “self-management” programs, which including mental “coping skills” and cognitive behavioral health interventions to address complex physical maladies. Self-management also includes techniques such as “meditation” in lieu of the science-based, clinically appropriate healthcare services and medications formerly provided by to those with chronic illness/pain by their primary care doctors and/or specialists. The result is nothing short of widespread human rights abuses.

● Of note: The AHRQ’s website, which previously stored 20 years of medical best practices, was defunded and shut down on July 16, 2018. The site noted that “summaries of guidelines” were going to be issued in lieu of the previous database that permitted clinicians to view guidelines with supporting clinical research.

o The removal of clinical research/best practices in treating medical conditions allows the AHRQ and other stakeholders charged with developing the chronic illness guidelines the ability to publish their harmful “self-management” recommendations without supporting data and/or necessary clinical trials for safety and efficiency.

• ●  Well Being Trust is a national foundation that describes itself as “dedicated to advancing the mental, social and spiritual health of the nation.” This organization has been charged with overseeing a portion of the Six Building Blocks study and directing government officials to implement changes to the public health policy/laws to align with the goals identified in the study. CIAAG recommends Congress research further what parties are funding and directing the activities of this organization.

• ●  Trust for America’s Health “makes the prevention of illness of illness and injury a national priority.” The organization promotes “cost control” of healthcare in the states, especially as it relates to treating chronic illness and “prevention.” Well Being Trust and Kaiser Permanent are funders. CIAAG recommends Congress research this organization as well.

• ●  Robert Wood Foundation and Providence St. Joseph Health co-funded “Pain in the Nation”(19) and the National “Resilience Strategy”(20) The Resilience Strategy website asks “How do we care for people in pain?” and recommends improving “substance use disorder treatment services” and increasing “medication assisted treatment” for this population, which is not appropriate for those with chronic pain at all, but is to be used for those in recovery from substance use disorder. The “strategy” again conflates people in need of pain medication with those with substance use disorder.

• ●  Brandies Opioid Collaborative (23)

The Opioid Policy Research Collaborative

(OPRC), based in the Institute for Behavioral Health

(21)

(IBH) of the Schneider

Institutes for Health Policy

(22)

at Brandeis University Heller School for Social

Policy and Management

, is advancing scholarship on interventions to address