Patient-Centered Healthcare Quality and Accountability Act
Agnes T.
Director, Worldwide Clinical Operations (Oncology)
Clinical Research Management since 1994
PREAMBLE: In 2016, Johns Hopkins University conducted an in-depth review of death certificates and electronic medical files from a representative subset of medical centers. Their findings revealed that more than 250,000 Americans had died from medical mistakes in 2013, establishing medical mistakes as the third leading cause of death in the United States. This analysis demonstrates that outcome data is readily accessible, provided hospitals are required to submit it. With the widespread use of Electronic Medical Records (EMR) systems such as Epic and the like, the data infrastructure for tracking healthcare outcomes is already in place.
Data from the CIA World Factbook highlights a stark disparity in health outcomes in industrialized countries: a woman born in Monaco or South of France lives on average 10 years more than a woman born in the United States. This glaring gap underscores the consequences of systemic issues in the U.S. healthcare system, particularly concerning access to quality care and the standards governing it.
Given their financial interest in limiting access to care to maximize profits, Healthcare Insurance Companies (HICs) should not be allowed to determine the minimum coverage standards. While they should be permitted to enhance these standards, they must never be allowed to set them below a nationally mandated baseline. The Department of Health and Human Services (HHS), provided it operates independently from industry ties, should be responsible for establishing these standards. This model aligns with practices in countries with superior health quality Key Performance Indicators (KPIs) than the U.S., currently ranked 49th globally.
POLICY RECOMMENDATIONS:
1. Mandatory Reporting and Transparency for Medical Centers and Insurers :
Require all hospitals, and healthcare providers to report comprehensive outcome data, including readmission rates and medical errors, to an independent oversight body (Healthcare Quality Improvement Task Force Described in #6).
Additionally, hospitals and insurance companies must be required to specifically flag incidents where delays in care, directly imputable to their decisions, policies or delay in pre-authorization process or repeated erroneous denials, result in patient harm or death regardless of age or potential pre-existing condition. These incidents will be tracked in a national database managed by the Healthcare Quality Improvement Task Force, with public access to promote transparency and accountability.
All Hospice or palliative care Healthcare providers should be able to report any delay in authorization for pain management coverage through a hotline
The entirety of those data points should be publicly accessible to drive transparency and accountability.
2. Outcome-Based Financial Incentives :
Adopt a system used in some countries with better health outcomes and life expectancy, where standardized reimbursement rates for specific procedures apply. To further enhance quality of care, link reimbursement rates to performance and patient outcomes. Hospitals achieving superior outcomes (e.g., lower readmission rates, fewer complications, better recovery times) would receive higher reimbursements for the same procedures in the following fiscal year.
Example: An appendectomy might reimburse $30,000 for a hospital with poor outcomes but $32,000 for a hospital with excellent outcomes based on the previous year’s performance metrics.
* Outcome Metrics : Key metrics should include at minima:
* Survival rates for major diseases and conditions (e.g., cancer, heart disease, strokes, diabetes) at immediate, 1-year, 2-year, & 5-year intervals time points.
* Surgery outcomes, including complication and recovery rates.
* Maternal mortality and infant mortality rates.
* Rates of nosocomial infections (e.g., hospital-acquired infections).
* Readmission rates and overall patient satisfaction scores.
* Mental health outcomes (e.g., post-discharge suicide rates)
3. Accountability for Avoidable Readmissions :
Hold hospitals accountable for avoidable readmissions related to the same procedure or disease, except in cases deemed unavoidable or outside the hospital’s control (e.g., a patient falling at home and reopening a wound) by requesting a CAPA (Corrective and Preventive Action) plan for the hospitals where a quality incidents trend is identified. This would incentivize hospitals to provide thorough post-procedure care, patient education, and follow-up.
4. Continuing Education Requirements : Hospitals would be required to demonstrate a commitment to ongoing staff education as part of their quality improvement efforts. This could include implementing structured programs for continuing medical education (CME), certifications, and training sessions aligned with industry standards and the latest medical guidelines.
5. National Minimum Coverage Standards :
Prohibit Healthcare Insurance Companies (HICs) from denying coverage for treatments that have been approved by the FDA. These decisions should instead be made by the Department of Health and Human Services (HHS), ensuring a standardized, evidence-based approach to coverage policies.
This policy shift would prevent private entities from making profit-only-driven decisions that could compromise patient access to necessary treatments and care.
Example: an individual diagnosed with prediabetes or Type 2 diabetes is limited by their insurance from accessing necessary tests to assess potential underlying causes such as PCOS, hypothyroidism, or hormonal imbalances. Instead, upon basic blood tests, the insurance company might require the physician to prescribe metformin, a cost-effective but limited treatment, without exploring the root causes that will remain untreated and will likely worsen. Additionally, insurance may deny coverage for advanced tools like continuous glucose monitors (CGMs), which have been shown to help patients manage blood sugar more effectively. These limitations prioritize cost savings over comprehensive care, compromising the patient’s ability to manage their condition optimally. Diabetes alone accounts for 178,000 deaths annually in the U.S. yet insurers are limiting access to advanced diagnostic tools and preventative care.
6. Healthcare Quality Improvement Task Force(HQITF) :
Establish an HHS-led Healthcare Quality Improvement Task Force composed of healthcare experts, administrators, and patient advocates. This task force would provide guidance, training, and tailored recommendations to hospitals aiming to improve the quality of care. Participation would be voluntary but incentivized through access to additional resources, such as data analysis tools, best practices, and enhanced financial reimbursements tied to quality improvements.
Hospitals participating in this initiative would become eligible for higher reimbursement rates under the outcome-based financial incentive program starting in the next fiscal year, based on their progress and demonstrated improvements in patient outcomes.
While driving up the quality of care, this approach avoids creating new taxes, as hospitals would finance internal improvements through a higher reimbursement rate and savings generated by reducing unnecessary administrative burdens, such as billing disputes with HICs.
Under this policy, all patient advocates in hospitals should run quarterly public meetings where all patients who were seen in the hospital in the previous FY and ongoing FY are invited to participate and give feedback. These meetings should be widely advertised, with the next meeting date displayed prominently in hospital lobbies, waiting rooms, hospital corridors, and on the hospital’s website. This ensures that hospitals remain accountable to the communities they serve and that patient concerns are addressed transparently.
7. Right to Appeal : Ensure patients have the right to appeal denied claims or poor treatment decisions to the HQITF independently from the insurance company. This could involve mediation or arbitration to resolve disputes between patients and insurers and ensure that the HQITF can adequately limit profit-driven patient-harming decisions.
8. HQITF Hotline to immediately report any major violations, insurance abuse, fraud, delay in maternal care (specifically if the life of the mother is at risk) and delay in palliative care pain medication authorization.
9. Comprehensive Complaint Reporting by Medical State Boards :
Require Medical State Boards to report 100% of complaints filed against healthcare providers, including those that were dismissed.
Public reporting should include:
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The names of providers who were the target of each complaint, regardless of whether the complaint was dismissed or upheld.
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Anonymized data on the patient may include nature of complaints and resolution outcomes.
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Detailed explanations for dismissals, ensuring transparency and accountability in the decision-making process.
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All data should be readily available to the public on the Medical Board’s website
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Measures should be implemented to ensure that reporting protects patient confidentiality and minimizes risks of misuse while enhancing public trust in the oversight process.
This approach addresses concerns about potential corruption within boards by providing a public record of complaints and resolutions, enabling independent scrutiny.
10. Patient-Centered Data Accessibility :
Ensure patients have easy access to their healthcare data, enabling them to make informed choices about providers based on quality metrics and outcomes.
11. Public Awareness Campaigns : Launch campaigns to educate the public about their rights and how to effectively advocate for their care. This could include guides on what to look for in a healthcare provider, how to file a complaint, and what to do if denied necessary treatments.
12. Protect Whistleblowers : Offer anomized hotline and legal protection for whistleblowers—patients, hospital staff, insurance employees or even other healthcare providers—who report substandard care or unethical practices. This could encourage reporting without fear of retaliation.
13. Enforcement:
Consequences for hospitals or insurers failing to comply with reporting requirements or other mandates may include:
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For Non-Compliant Hospitals:
Reduced reimbursement rates.
Public ranking systems to highlight adherence to mandates and accountability.
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For Non-Compliant Insurers:
Higher taxation rates.
A simultaneous freeze on premium increases to prevent insurers from passing on the costs of non-compliance to consumers, which would remain in place for at least one FY after the insurer went back to compliance.
14. No Clinical Research interference. As long as a Clinical Trial is properly registered in FDA/EMA registries (https://clinicaltrials.gov/) no insurance should be allowed to obstruct and dissuade a patient from participating in a clinical trial by any means, nor should they be allowed to put pressure on a patient to force their participation in a Clinical Trial.
Furthermore, when a Clinical Trial in which the patient wishes to enroll is only offered at a facility out of network, the insurer should make all efforts to facilitate the enrollment of the patient in the trial such as (but not limited to) -
Provide coverage for the standard of care procedures that the Sponsor of the clinical Trial does not cover (because it is standard of care), in the facility where the clinical trial is being conducted, without any increase in out-of-pocket expenses for the patient.
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Work with the Clinical Trial’s sponsor on an agreement to offer a guarantee that participation in a clinical trial does not and will not penalize the patient financially nor it will interfere with the patient’s standard of care immediately or in the future. This Agreement should include who, from the sponsor or the insurer, covers the costs of treatment if side effects or adverse events should arise during and after the Clinical Trial.
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When the patient completes or leaves a Clinical Trial out of network, the insurer should immediately accept the patient back into their network without any delay, penalty or raise in premium, or out-of-pocket expenses.
15. Organ Procurement
This policy establishes governance, transparency, and anti-corruption measures for Organ Procurement Organizations (OPOs) to ensure ethical decision-making, prevent conflicts of interest, and enhance public trust in the organ procurement and allocation system.
1. Anti Corruption Mandatory Cooling-Off Period for all executives, C-suite and, board Members:
- A strict three-year cooling-off period is required for executives transitioning from healthcare, pharmaceutical, or insurance corporations to leadership positions within OPOs.
- Conversely, OPO executives must observe the same cooling-off period before accepting roles in healthcare corporations, insurance companies, or pharmaceutical firms.
- Applies to all leadership roles, including CEO, CFO, COO, board members, and advisory or consulting positions.
- No exceptions to this policy are permitted, regardless of urgency, qualifications, or other considerations.
- HHS or designee will oversee compliance.
- Violations will incur substantial financial penalties and removal of non-compliant executives.
2. Transparency
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. Public Listing of Organ Availability:
- Each OPO must maintain a publicly accessible, anonymized organ availability list on its website, updated in real-time.
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. Decision-Making Disclosure:
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Publication of Criteria:
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Clearly outline organ allocation policies (e.g., based on urgency, geographical proximity, or compatibility) on the organization’s website.
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Include any exceptions to standard protocols.
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Audit Logs:
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Share anonymized explanations for decisions, particularly when an organ goes to a lower-ranked patient on the compatibility list.
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Example: “Patient A bypassed due to medical instability; organ allocated to Patient B based on proximity and match priority.”
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Ethical Oversight:
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Decisions involving exceptions should be reviewed by an independent ethics board, with summaries made publicly available.
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3. Board Composition Requirements
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. Patient and Patient Advocate Representation:
- At least two board seats reserved for patients who have received transplants, or represent prospective donor families.
- At least one seat reserved for a professional patient advocate with a background in patient rights or transplant advocacy.
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. Nomination Process:
- Candidates must be nominated by the Director of the Department of Health and Human Services (HHS) or designee through an open application process.
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. Eligibility Criteria:
- Nominees must:
- Have no financial or employment ties to pharmaceutical companies, hospitals, or insurance providers (verified via a thorough background check).
- Demonstrate prior engagement in patient advocacy or transplant-related issues (applies to Patient advocate role only)
- Nominees must:
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. Term Limits:
- Representatives serve 3-5 years with the option for one renewal.
4. Transparency and Reporting
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. Annual Reports:
- OPOs must publish annual reports detailing:
- Allocation outcomes.
- Compliance with cooling-off and transparency policies.
- Financial statements, including executive salaries and bonuses.
- OPOs must publish annual reports detailing:
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. Public Audits:
- Independent third-party audits must be conducted annually and made publicly available to ensure transparency and adherence to policies.
5. Anti-Corruption Measures
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. Conflict of Interest Policy:
- All board members and executives must disclose financial ties and affiliations upon appointment and annually thereafter.
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. Training Requirements:
- Mandatory ethics and anti-corruption training for all leadership and board members.
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. Whistleblower Protections:
- Establish an anonymous whistleblower program to report unethical practices, with strict protections against retaliation.
6 . Implementation and Oversight
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. Regulatory Oversight:
- The HHS or a designated federal agency will oversee policy implementation and compliance.
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. Penalties for Non-Compliance:
- Violations of this policy will result in penalties, including:
- Fines proportional to the OPO’s revenue.
- Revocation of OPO certification for egregious violations.
- Violations of this policy will result in penalties, including:
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. Review and Updates:
- This policy will be reviewed every five years to adapt to new challenges and ensure continued alignment with public health goals.
This governance and transparency policy underscores the commitment of OPOs to prioritize ethical practices, enhance public trust, and ensure fair organ allocation for the benefit of all patients.
anyway for sinking time into this and coming up with an excellent plan!
and Votes on this PLEASE!