Results from Scientific Studies Are Not Synomymous With Actual Value In Healthcare Practices

 

Results from scientific inquiry do not necessarily create value in health care practices. Read this article to understand why and what we should be doing differently to build population health and economic value.

Scientific studies and clinical trials do not necessarily equate to actual value in clinical practices for patients and health systems. Scientific inquiry is of course necessary, as are clinical trials, but even if these avenues of inquiry demonstrate statistical significance and adequate patient safety, there are other factors that must be considered to create value for population health and for each practice and unique patient. The most important thing in research to improve our health is to ask the right questions. Currently, in scientific inquiry, once an investigation question is identified, it is called the hypothesis, and methods are chosen for controls, measures, and reporting of the data. A randomized control trial is held to the highest standard for this inquiry process, with excellent controls, attempts to eliminate bias, and recognized quality standards. Following this process, if the science finds merit to conduct a clinical trial on patients, this is the next step. This all sounds good, except scientific studies and clinical trials do not reflect real world variables in medical care. There is a field of study, called Real World Effectiveness (RWE) which has been under research for several decades, and there are now improved methods to assess actual effectiveness before a health system adopts a new intervention in health care and it has nothing to do with profits.  Briefly, here are the reasons the current study methods do not provide the information patients and health systems need to optimize efficacy of treatment. (Porzsolt, 2024) (Franz Porzsolt M. W., 2024) Efficacy means the efficiency and the treatment or evidentiary value of an intervention.

1.  Scientific findings of statistical significance are not synonymous with value in the real-world practice of medicine.

2.  Scientific studies do not necessarily include patient populations which are similar in a medical practice, because patients may have multiple co-morbidities, which may exclude them from study participation.

3. Clinical trials attempt to show actual treatment effectiveness, but there is also bias in the patient selection for clinical trials, because the drug company or medical device manufacturer want to show their product works. Thus, clinical trials cherry-pick patients who will conform to the methodology restrictions, and not include a lot of other issues such as health comorbidities.

4. Real world medical practices have many more variables than clinical trials. This is primarily due to the intimate relationship the clinician has with the patient and the customized approach he or she may use to meet the best treatment paradigm for her patients. This phenomenon makes it nearly impossible to make uniform strategies for all the risk profiles.

Thankfully, there is a method for identifying real world impacts of treatments, which would allow health systems and most importantly, the patient, to identify whether a drug, medical device, or procedure is worth it. Just like anything else which informs a decision, the individual weighs risks, potential benefits, proven reliability, and the cost. Unfortunately, unless you work in medical research, are a clinician, or some policy expert, you will not have this information to inform your treatment process.  In many healthcare systems today, the person has more information up front on the vehicle they purchase, then a health care intervention. This practice needs to change and I outline how RWE works and can be applied in real clinical settings here.

The Cochrane strategy, which is the international standard for the highest degree of efficacy in research includes these three questions: (Franz Porzsolt, 2024) The first question is called the principle of proof (POP)and means, can the intervention work. The second question is does the intervention work and what is the real-world effectiveness (RWE) through pragmatic (clinical trial) or observational study (used where clinical trial is not an appropriate study method). Further study will either demonstrate effectiveness or not. But the third question that needs to be asked is does this intervention demonstrate enough value given other treatments currently available. All too often this is swept aside so that the new drug or treatment will supplant existing more economical ones, because of monetary incentives. The third question needs to be applied to any patient health intervention so that the best use of resources for each patient is considered. Currently, in the United States this comes into play based on the type of insurance a person has, because everything is driven by reimbursement, and volume of care. Providing more expensive care to people who can afford it does not mean their outcomes are necessarily better, especially from a population health standpoint. Benefiting a few outliers does not mean large populations would necessarily benefit. The solution is to observe the actual outcomes of care in a medical practice, which is somewhat like the Centers of Medicare and Medicaid Innovation Grant Programs. Unfortunately, there is often a rush to bring a drug or medical device, or practice into approval and adoption before the actual patient effectiveness has been vetted. This results in wasted money and patient harm in many instances, because organizations feel pressured to show their idea works and to receive recognition and of course financial remuneration.

Finally, why do we care about further refinement of experimental results and treatments, because we can treat more people optimally for less money if we include the question, Is it worth it, in our final decision model before adoption of the treatment. This requires decisions to be made at a systemic level, in clinical practice, and as an informed patient.  Only by including the last question and comparing results will we learn what is actually the best treatment for various patient groups. People are not a one-size-fits-all and we should not be using science to justify treatments for some as appropriate for all.

And this is the healthpolicymaven signing off, encouraging you not to sign blanket release forms when you have medical procedures, do stipulate that for which you agree and for which you decline. Also, it is a good idea to get a POLST document in place with your health system, which states your wishes for interventional treatment to extend your life. And this is not the same as a medical power of attorney, whom you have chosen, but it alerts EMT's and others in the care continuum.

Roberta Winter is a freelance journalist who accepts no money from health care entities for this column. Opinions expressed here are her own. Her guidebook to the U.S. healthcare system was published by Rowman & Littlefield in 2013. https://rowman.com/ISBN/9781442222977/Unraveling-U.S.-Health-Care-A-Personal-Guide

References

Franz Porzsolt, M. P. (2024). The Front-End Processor Developed By Engineers-A Useful Tool for Describing the Quality and Quantity of Progress in Healthcare. Qeois-Open Peer Review, 1-19.

Franz Porzsolt, M. W. (2024). Applying the Rule of Designers and Architects "Form Follows Function (FFF) Can Reduce Misinterpretations and Methodical Shortcomings in Healthcare. Trends in General Medicine, 2(1), 1-7. Retrieved September 2024, 2024

Porzsolt, F. (2024). An Evidence-based Hypothesis: Doctors Do Not Make Decisions Randomly but Based on Individual Patient's Risk Profiles. Private Research Insitute of Economics (PRICE), Ulm, Germany, 1-11.

 

 

Overturn Of the Chevron Doctrine And The Impact on Health Care

 

The overturn of the Chevron Doctrine is the worst Supreme Court decision yet, making effective administration impossible for federal agencies which are charged with regulating public safety laws for air pollution, water quality, food, and healthcare safety. The Chevron Doctrine gave administrative power to federal regulators to make rulings to run their agencies. The Chevron Ruling is cited in 17,000 lower court and 70 previous Supreme Court Decisions (Nielsen, 2024). This includes scientists who decide how to assess pollution damages, water quality, air quality, and other environmental protections to keep the public safe. This also includes medical research and other experts who decide which drugs are safe and should receive Food and Drug Administration (FDA) approval. Further the FDA, oversees health standards for food, and those will become subject to myriad lawsuits, and incompetent rulings in smaller courts by nonexperts. Even worse than that, medical devices, cardiac implants, various surgical treatments will proliferate and be brought to the public based on specious science due to diminished oversite. We all know there is enormous fraud in healthcare, anti-trust activity in big agriculture, and serious conflicts of interest with the oil and gas industry. These industries will now have an outsized influence on the air you breath, the water you drink, whether the soil is contaminated where you live, the safety of the food you eat, and the validity of new drug and medical devices. Huge corporations in pharmaceuticals, oil and gas, and agriculture will now be able to power their way through local, state, and federal courts to create wealth at the expense of public health and safety. And thanks to the Citizens United Decision, corporations are treated as voters.

Ramifications for Health Care

 For the purposes of this analysis, I will focus just on the healthcare ramifications of the overturn of Chevron. Briefly, here are major programs whose existence will be threatened under the new wild west environment with the high court:

  Government’s Ability to Promote Innovation Will Be Hindered-Centers for Medicare and Medicaid demonstration projects, which are incentivized voluntary clinical efforts to improve health care will be hindered and possibly stop.

 Millions of working-class people may lose their health care-Eligibility standards for Medicaid may be changed for the Affordable Care Act expansion, of which all but eight states have adopted, which provides millions of people with subsidized medical insurance.

 Patient Safety is At Risk-If there is limited federal regulation then states can decide how far they wish to go in minimizing staffing ratios at nursing homes and other health care facilities thus endangering patient health. 

Ability to Assure Acceptable Health Care Standards is At Risk-Government payments from Medicare and Medicaid must currently meet standards of care including; staffing ratios, accreditation, and quality of care and the enforcement of these critical provisions are now in question.

Fraud Prevention-The Justice Department has its own division for health care fraud which reviews government billings and prosecutes fraud. In 2023, it charged 193 clinicians with 2.75 billion of fraudulent claims. (United States Department of Justice Press Release, 2024) The federal Department of Justice is the only authority powerful enough to go after abuses by pharmaceutical corporations, insurance companies, medical device manufacturers, mega hospital groups, and third-party administrators like pharmaceutical benefit managers. Who will look out for the American people if their ability to regulate and bring fraud charges is muted?

 Children’s Health Insurance Coverage-Families receive insurance subsidies based on their income according to a federal formula and this will be challenged.

 Increased Cost of Public Program Administration-Slower approval process and more court actions for any government regulation which will make administration by public agencies more expensive not less.

Government agencies are created to serve the people and none could be closer than Health & Human Services (HHS). Briefly these are things HHS does for us:

 1. Finances much of the medical research in the United States through the National Institutes of Health, awarding nearly two trillion dollars in grants 

 2. Creates health care quality standards through the Agency for Healthcare Research and Quality (AHRQ)

 3. Oversees vaccine production and supply as well as pandemic controls for public safety

4.  Is the repository for the National Library of Medicine, essential for medical research and policymaking

5,  Establishes health care treatment and reimbursement standards through the Centers for Medicare and Medicaid

6. Targets specific health interventions like treatment for opioid addiction and suicide prevention efforts

 Health and Human Services used its authority for public health during the Covid-19 pandemic when it was able to rapidly coordinate with the pharmaceutical industry to create effective vaccines to avert more loss of lives. The Centers for Medicare & Medicaid (CMS) deployed its authority for public good when the agency refused to approve reimbursement for aducanumab, an unproven treatment for Alzheimer’s. The approval for this drug application was later repealed by the Food and Drug Administration (FDA), because of a public outcry led by the Right Care Alliance and the scientific community. (Winter, 2022) This is an example of effective administration which saved the public millions from an unproven and specious drug application. The independent decision-making authority of this agency, separate from the FDA is essential for public health and safety. All these actions are for the health and welfare of the people of the United States.

 Given the spate of bad news in 2024, the sweeping aside of the Chevron doctrine will do the most lasting damage for hundreds of years. We are basically watching the collapse of this once great nation, Putin and Xi Jinping must be laughing their buts off.

 And this is the healthpolicymaven signing off, encouraging you not to sign blanket releases when you have medical procedures, do specify that for which you consent and which you decline. This column is published without remuneration from any healthcare entity and the opinions expressed here are those of health policy analyst and journalist, Roberta Winter, whose guidebook to the U.S. healthcare system was published in 2013. https://rowman.com/ISBN/9781442222977/Unraveling-U.S.-Health-Care-A-Personal-Guide 

References

Melissa Quinn, J. R. (2024, 24 22). What is Project 25-What To Know About the Conservative Blueprint For A Second Trump Administration. Retrieved 9 2, 2024, from CBS News: https://www.cbsnews.com/news/what-is-project-2025-trump-conservative-blueprint-heritage-foundation/

Nielsen, M. (2024, July 12). Impact of Supreme Court Decision on Health Policy. Retrieved September 3, 2024, from Milbank blog.org: https://www.milbank.org/2024/07/impact-of-supreme-court-chevron-decision-on-health-policy/#:~:text=In%20addition%20to%20the%20numerous,health)%2C%20and%20patients'%20data

United States Department of Justice Press Release. (2024, June 27). National Health Care Fraud Enforcement Action Results in 193 Defendants Charged and Over $2.75 Billion in False Claims. Retrieved September 3, 2024, from Justice.gov: https://www.justice.gov/opa/pr/national-health-care-fraud-enforcement-action-results-193-defendants-charged-and-over-275-0

Winter, R. E. (2022, January 27). https://healthpolicymaven.blogspot.com/2022/01/high-cost-of-single-unproven-drug.html. Retrieved from Straight Talk On Healthcare. healthpolicymaven.blogspot.com: https://healthpolicymaven.blogspot.com/2022/01/high-cost-of-single-unproven-drug.html

 

 

 

 

Common Anxiety Shown To Reduce Life Expectancy By 8 Years

 Excising our internal anxieties is an essential aspect of wellness. Relief from internal strife and stress is a key component for health. In The Lancet’s published study on all-cause-loss-of-years-of-life attributable to mental illness, men were found to have lost fifteen years and women, thirteen. To arrive at these conclusions, the researchers analyzed 35,865 studies and found 109 which were similar for inclusion in their meta-analysis of 12,171,909 patients with mental disorders. (Joe Kwun Nam Chan, 2023) This is a type of statistical analysis called meta-analysis, where high quality studies which are similar in hypothesis and population, are analyzed to find a pattern and to draw conclusions on the study findings from a much larger population sample. Conclusions from meta-analysis studies are very valuable for health policy planning and funding for interventions in public health. Statistically when the studies are of high quality, with confidence intervals in the 90^th percentile and represent a larger population, the findings are more reliable than smaller studies for informing systemic changes in healthcare. A confidence interval is a statistical measure to determine the likelihood of the same result being generated using similar data. It is a validator for the quality of the study methods and analysis. What makes the conclusions so urgent is even a benign diagnosis of anxiety or neurosis showed a reduction in life expectancy of eight years. It was no surprise the study found those suffering from substance abuse disorders had a reduction in life expectancy of twenty years. People with eating disorders were found to have a loss of sixteen years in life expectancy. Intriguingly those suffering from schizophrenia showed fewer years of lost life than the eating disorder group. Please note this study was only for patients seeking treatment, when untreated mental illness is a global problem and some would say crisis.

 Youth Suicide

The United States has one of the highest youth suicide rates in the industrialized world with 11.5 deaths per 100,00 persons between the ages of 19 and 24, second only to Australia and tailed by Canada. (Cristopher Doran, 2020) The National Institutes of Health study on global youth suicides found that for youths between nineteen and fifteen years, the mean suicide rate was 7.4 deaths per 100,000. In other words, the rate of youth suicide in the U.S. is 35% higher than the rate elsewhere in the world. Males showed much higher suicide rates at 10.5 to females of 4.1 per 100,000 of their peers. This study reviewed data from ninety countries and alarmingly found the suicide rate for females was increasing and the overall suicide rate for men and women was also increasing, except in Europe. Information was drawn from the World Health Organization Mortality database. (DANUTA WASSERMAN, 2005) Young people killing themselves is a public health crisis of immense proportions and is indicative of poor primary care, the limited availability of qualified mental health clinicians, and the lack of funding for adequate treatment.

 The point is what you spend your time thinking about and how that impacts your nervous, circulatory, and immune systems are indelibly linked. Thankfully, there are many more tools today to help people redirect their thoughts and make changes in negative practices. Virtual therapy allows those in rural areas to access high quality therapy, as well as busy working parents to be able to do it from their home or office. The advent of smart phones means many more people in the world have access to the internet and this is empowerment. Health and Human Services has invested thirty-five million dollars in expanding community mental health services and suicide prevention. (Substance Abuse and Mental Health Services Administration, 2022) The total mandatory spending for healthcare in the United States Budget for 2024, which was approved on March 23^rd, designated 4.2 trillion in mandatory allocations and 1.9 trillion for discretionary programs like this. As you can see, the amount mental health services are receiving in the federal budget allocation is tiny compared to the overall investment.

US Government Investment in Targeted Mental Health Services-2024 Budget

 Currently, there are three federal government initiatives to increase access to care for mental health services: shared Savings Programs through the Accountable Care Organizations (Health & Human Services, Centers for Medicare and Medicaid, 2012), targeted funds for health care in rural America, and the expansion of state Medicaid programs which decrease the likelihood of rural hospitals closing by half. (United States Department of Health and Human Services, 20232) The Accountable Care Act was created in 2010, along with the Accountable Care Organization Shared Savings Program and has been instrumental in creating financial rewards for health care organizations to target key health outcome criteria, based on evidence-based planning and medical research. Though the expansion of Medicaid under the Affordable Care Act was good for increasing the number of people whom can obtain affordable medical insurance, it did little to increase access to the availability of mental health services, as most mental health practitioners do not accept the Medicaid reimbursement level. Under the Accountable Care Act, which is administered by the Centers for Medicare and Medicaid, as of January 2024 there is additional funding allocated for rural hospitals to help them obtain advance payments to fund mental health workers. The Biden-Harris Administration allocated twenty-eight million in direct funding for health care for rural entities and another sixteen million for technical support in the 2024 budget. (United States Department of Health and Human Services, 20232) The goal is to expand the rural health care workforce and increase access to care for the sixty million people who live in rural areas. However, the implementation of these programs will be determined after the 2024 presidential election.  We can only hope this is supported by both parties.

 And this is the healthpolicymaven signing off encouraging you not to sign blanket releases when you agree to medical procedures, do stipulate that to which you agree and decline.

 This column does not purport to give medical advice and all opinions are those of Roberta Winter, an independent healthcare analyst and journalist who accepted no reimbursement for its contents.

 

References

Cristopher Doran, I. K. (2020, May 19). Economic and epidemiological impact of youth suicide in countries with the highest human development index. PLOS One. PLOS One.org. doi:https://doi.org/10.1371/journal.pone.0232940

DANUTA WASSERMAN, 1. Q.-X. (2005, June 4). Global suicide rates among young people aged 15-19. World Psychiatry(June 4 (2) 114-120). World Health Organization. doi:PMID: 16633527

Health & Human Services, Centers for Medicare and Medicaid. (2012, April 10). First Accountable Care Organizations Under the Medicare Shared Savings Program. CMS.gov. Retrieved June 1, 2024, from https://www.cms.gov/newsroom/fact-sheets/first-accountable-care-organizations-under-medicare-shared-savings-program

Joe Kwun Nam Chan, a. C. (2023, October 31). Life expectancy and years of potential life lost in people with mental disorders: a systematic review and meta-analysis. The Lancet.com, Volume 65. London, England/United Kingdom. doi:https://doi.org/10.1016/j.eclinm.2023.102294

Substance Abuse and Mental Health Services Administration. (2022, May 9). HHS Announces Nearly $35 Million To Strengthen Mental Health Support for Children and Young Adults. SAMSA.gov Press Release. United States. Retrieved May 27, 2024, from https://www.samhsa.gov/newsroom/press-announcements/20220309/hhs-announces-35-million-strengthen-mental-health

United States Department of Health and Human Services. (20232, November 3). The Biden-Harris Administration is taking actions to improve the health of rural communities and help rural health care providers stay open. Health & Human Services News. Washington, District of Columia, United States. Retrieved May 30, 2024, from https://www.hhs.gov/about/news/2023/11/03/department-health-human-services-actions-support-rural-america-rural-health-care-providers.html

Explanation of Healthcare Tax Subsidies in the USA-Medicaid-Insurance Exchanges-Group Insurance Programs-Medicare

 

Health Care is Not Free

In an election year, it is important to discern facts from fiction and this article addresses the subject of free or subsidized health care in the United States. First, there is no free health care, someone is paying for the care. For Medicaid eligible persons or families, the state and federal government do provide health care without an insurance premium to those who qualify. This does not mean there are no copayments for the Medicaid participants, but these are generally modest. Access to health care providers is not guaranteed, because many clinics and clinicians do not treat Medicaid patients or have a limit on the number they will accept. This is because of the low level of reimbursement from the government for providing care.

 Medicaid-Eligibility

Medicaid, also known as Apple Health, Medi-Cal or whatever label each state chooses, is a government run medical insurance program for low-income residents. To be eligible for Medicaid, the individual or family must meet certain criteria, for example, living within the United States for at least five years, having legal residency status, meaning a work permit, student visa, permanent resident status, or citizenship. Citizenship in the USA is based on birthright, taking the oath of citizenship, or marriage. The funding for the Affordable Care Act requires legal residency criteria, to control costs and to avoid adverse selection from potential high-medical-needs immigrants. There are exceptions to this, which are for immigrants who have refugee status for humanitarian reasons (torture), Protected Juvenile Status, Temporary Protected Status and Victims of Trafficking. Here is a complete list of the immigrant standards for qualification for Medicaid or government health care subsidies, like tax credits under the insurance exchange plans for the Affordable Care Act (Obamacare): https://www.healthcare.gov/immigrants/immigration-status/

 Finally, if someone is blind, disabled, pregnant, or caring for a child on public support (foster child) you may be eligible for Medicaid, if you meet the residency status requirements. In other words, people without means who are immigrants do NOT have unlimited access for free or subsidized health care. Wealthy people, including medical tourists with private insurance, who can pay, will be able to have carte blanche access to the US healthcare system.

 State Medicaid Eligibility Varies

Most states have now expanded their Medicaid eligibility to match the 2010 Patient Protection and Affordable Care Act standard of 133% of the federal poverty level (FPL). In 2024, this is $15,060 for a single individual and $31,200 for a family of four. So, the baseline for receiving medical insurance through a state Medicaid program which has chosen the Affordable Care Act standard and receives federal matching funds is: $20,030 for a single individual and $41,496 for a family of four. Some states, where the cost of living is very high, have more generous subsidies, like California, which offers pregnant women with incomes up to 208% of the FPL and children under 18 are covered up to 261% of the FPL.

Federal government handy interactive chart to determine your state’s Medicaid eligibility standards.

https://www.medicaid.gov/state-overviews/state-profiles/index.html

 The federal Children’s Health Insurance Plan or CHIP has been around since 1997 and was reauthorized by both Democrats and Republicans in 2009.This is a positive thing because it is good public health investment to make sure we are creating healthy children, which is after all our future work force. Investing in the health and well-being of our citizens is a public good. This is why we have parks and recreation, air and water quality standards, sanitation systems, and standards for food safety.

Tax Credits Under Affordable Care Act

All the insurance exchange enrollments require persons applying for medical insurance coverage to disclose their incomes, because the Affordable Care Act provides federal tax credits for the purchase of the insurance. The government is advancing an income tax credit, that you would be expected to receive upon filing your annual tax return. If your income varies from this declaration, the government will refund any unused tax credits or require you to pay back some of the advance credits you received. It is the onus of the insurance exchange participant to notify the agency of any material change while enrolled. The tax credits are not free, but reflect earned income federal taxes. If someone has no earned income and qualifies for some insurance subsidy, this is determined through the process.

 Tax Credits Under Employer Group Insurance Plans

The federal government provides significant tax incentives for employers to provide health insurance, by allowing a tax deduction for the entire expense which are paid by the company. Additionally, employees are often given the opportunity to use pre-tax income to pay for their covered dependents or elective benefits, through a Section 125 plan. These tax credits do not have to be repaid, as long as the programs are administered correctly.

 Medicare Eligibility

For persons reaching age 62, their eligible spouses, and certain disabled people, the federal government provides Medicare, which has components which are fully paid by the government, Part A for hospitalizations and Part B, which is for outpatient care and requires an insurance payment monthly. There is also a prescription drug program which requires an insurance premium, unless the enrollee chooses a Medicaid Advantage Plan with an integrated drug program.  And there are Medicare supplements, which cover the many deductibles and co-payments that Medicare requires.

 Obtaining age 62, 65, or 70 does not automatically mean that person is enrolled in Medicare. The individual must apply for Social Security Benefits first, and that process takes two months. During this time, the Social Security Administration will verify residency status, address, and determine the number of quarters the applicant paid the necessary payroll taxes to qualify. Social Security is NOT FREE, the applicant must have earned wages and paid payroll taxes for Social Security and Medicare for no less than ten years. Some, myself included, think this is too liberal, because what other entity, government or private provides a pension after only a decade? Social Security is financed through a trust fund and current payroll taxes from employees and the self-employed whom are still working.

 In addition to the age qualification, Social Security is eligible to persons who have end-stage renal failure (kidney) and are on dialysis and for those who are blind. It is possible for other individuals with disabilities to qualify for benefits, but this is not easy and is not guaranteed.

 Conclusion

The United States does not offer FREE HEALTH CARE, rather it provides various targeted programs for enrollment, based on eligibility. These standards require individual tax contributions at all levels, based on the Internal Revenue Service Code. Only billionaires and a few hedge funders seem to manage tax exemptions. If you earn wages in the U.S.A. you will pay into the Social Security and Medicare programs. Residents in the country may be eligible for Medicaid or Insurance Exchange subsidies based on the duration of their residency and their immigration status. Americans are raised with the ethos that we work and earn that which we acquire and utilize. Though our tax code is arcane, it does provide incentives for programs the nation is trying to encourage and those it discourages. Universal healthcare is a myth, for even in countries with national health systems (France, Germany), there are populations whom are not covered under the safety net, primarily based on residency status.  Where the US goes off the rails is in the affordability of health care, ranked as the most expensive health care in the world. And of course, there are more persons without medical insurance and access to care in the US than in other nations with national healthcare systems. That said, this bellicose nation does not appear ready to move away from its current system in the near future.

 And this is the healthpolicymaven signing off, encouraging you not to sign blanket releases when you agree on a surgical procedure or a hospitalization, do specify that for which you agree and decline. It is best to do this with an Advanced Medical Directive or a POLST agreement. Make sure your emergency contact is aware of this document and be prepared to present to healthcare administrators.

 Roberta Winter is an independent healthcare analyst and journalist who receives no money from any sector of US healthcare. She is the author of Unraveling US Healthcare-A Personal Guide, published by Rowman & Littlefield in 2013. She has been a speaker at international and national healthcare events.

https://www.amazon.com/Unraveling-U-S-Health-Care-Personal/dp/1442222972

Hospitals Across the Country Forced to Return Millions for Overcharging Patients

Behemoth Providence Health Care abandoned their defense for avoidance of providing charitable care to eligible patients and settled with Washington State’s Attorney General only weeks prior to trial, because they knew they would lose. Attorney General, Bob Ferguson (gubernatorial candidate) and his team, compelled Providence to refund 20 million dollars and forgive medical debt of 137 million, all owed to low-income patients. The suit impacts over 100,000 state residents. (Washington Attorney General, 2024)

Providence operates 14 hospitals in Washington State under that moniker as well as Swedish and Kadlec hospitals. Washington State was able to achieve this result for the people of the state because of the strength of its charitable care laws. For more information on Providence’s reach in other states, including Oregon, California, and New Mexico, read my former post from September 25, 2022.

https://healthpolicymaven.blogspot.com/2022/09/opportunistic-practices-based-on.html

 Summary of Charitable Care Standards in Other States

State	State Mandates for Charitable Care at Hospitals (Bosco, 2021)
California	Families without medical insurance, those with high medical costs, and people within 400% of the federal poverty rate are eligible for financial assistance.
Colorado	A 2022 law strengthens protections from medical debt and requires all hospitals to provide medical assistance.
Connecticut	Requires all hospitals to screen for financial aid, but only mandates aid consideration for persons not covered on Medicare, Medicaid, or other coverage and whose income is below 250% of the federal poverty rate.
Illinois	Hospitals must offer financial assistance to families within 600% of the poverty rate, free care is mandated for those within 200% of the poverty rate, and hospitals are prohibited from collecting more than 20% of a patient’s income for payment in a twelve-month period.
Massachusetts	Families whose incomes are within 200% of the federal poverty rate are eligible to receive financial assistance.
New Jersey	Specifies families without medical insurance and those with low reimbursement from insurance plans are eligible for charity care. Also stipulates that healthcare providers can only collect a portion of patient income for repayment and the law stipulates what that payment ceiling is based on income.
Oregon	Requires hospitals provide full financial aid for those within 200% of the federal poverty rate and a sliding fee scale for those within 400% of the poverty rate.
Texas	Requires financial aid for those with incomes equal or less than 21% of the federal poverty rate. And individuals must be ineligible for Medicaid.
Washington	Families with incomes below 100% of the federal poverty rate must receive free care; families within 200% of the poverty rate are eligible for financial assistance.

 Lawsuits Against Hospitals Elsewhere

North Carolina

HCA (Health Care of America) is once again charged in North Carolina in a case against Team Health brought by heroic emergency doctors at Mission Hospital. The lawsuit alleged:

HCA-Team Health used unnecessary trauma coding to get more money from insurers, the government, and patients. On average, patients using this trauma facility were overcharged $40,000 through unnecessary specialists, procedures, and drugs through this “upcoding scheme.” Doctors alleged that nonphysicians made these coding decisions in Mission Hospital, as a part of HCA’s business practices to optimize reimbursement. Most of the upcoding and overcharging were done on geriatric patients.

Tennessee

HCA and Team Health are also being sued in Tennessee for overcharging practices for billing practices in Bucumb County. (Jones, 2023)

HCA has the distinction of having the largest (2003) settlement of 631 million with the US government for overcharging Medicare and Medicaid. Interesting factoid, HCA was helmed by android Rick Scott, who went on to become Governor of Florida, and then Senator during the Trump Administration. Unfortunately, being a shyster, does not appear to hurt your chances of doing even greater damage to the American people.

 Widespread Aggressive Collection Practices

Kaiser Family Foundation found in 2022 that thousands of hospitals bring lawsuits against patients to collect unpaid bills, regardless of the patient’s ability to pay. They found at least 5,100 used aggressive collection practices, despite charitable care eligibility and other mitigating factors. Worse yet, 20% of these hospitals deny emergency care to patients who are in collections, which may be illegal under the federal Emergency Medical Treatment Act. And because these hospitals know the public would not approve of their collection practices, they do not make this information available to the public. And many directly flout their own edicts on charitable care, Lourdes, an Ascension Hospital in New York said they no longer practiced this technique in 2019, but New York court records show they were still doing it in 2021. (Levy, 2022)

Here is a nationwide map of the hospitals who have been found to practice aggressive collection:

https://kffhealthnews.org/news/article/medical-debt-hospitals-sue-patients-threaten-credit-khn-investigation/

 By shining a light on egregious and often illegal collection practices of healthcare organizations we can create some reforms.  Through the power of the free press and our collective actions we can make a difference. Remember, you do NOT have to let a collection action or lawsuit go unchallenged and it is highly likely a judge will take a more favorable view towards an individual than a large corporation, but you do need to show up in court. Get a nonprofit legal organization to assist in your action if you cannot afford legal representation. Any Google search will show plenty of law firms which specialize in defense of medical claim actions brought by hospitals.

 And this is the healthpolicymaven encouraging you not to sign blanket releases when you are going to have medical procedures, do stipulate that for which you agree and which you decline. No money was accepted from anyone in the healthcare industry for this article. Roberta Winter is an independent healthcare analyst and journalist.

 References

Jones, B. D. (2023, June 14). Doctors’ lawsuit: HCA Healthcare and TeamHealth overcharged patients. Retrieved from Asheville Watchdog.org: https://avlwatchdog.org/doctors-lawsuit-hca-healthcare-and-teamhealth-overcharged-patients/

Levy, N. M. (2022, December 21). Hundreds of Hospitals Sue Patients or Threaten Their Credit, a KHN Investigation Finds. Does Yours? Retrieved from KFF Health News.org: https://kffhealthnews.org/news/article/medical-debt-hospitals-sue-patients-threaten-credit-khn-investigation/

Washington Attorney General. (2024, February 1). AG Ferguson: Providence must provide $157.8 million in refunds and debt relief for unlawful medical charges to low-income Washingtonians. Retrieved from Washington State Office of the Attorney General: https://www.atg.wa.gov/news/news-releases/ag-ferguson-providence-must-provide-1578-million-refunds-and-debt-relief

 

Drug Shortages in the US-Solutions

 Acute shortages in prescription drugs in the United States are deferring and changing treatment for everything from cancer to antibiotics. Medical centers have succumbed to warehousing supplies for fear of running out. Global manufacturing and distribution centers for drugs have not kept up with demand. Pharmaceutical companies indicate there is not enough money in generic drugs to economically afford to manufacture them. Policymakers also blame the gatekeepers, the pharmacy group purchasing organizations or PBM’s, which exert outsize control over the supply of drugs by depressing the price for large employer groups. Group purchasing organizations are generally located outside the U.S. and are not subject to national regulations. Group purchasing organizations are designed to leverage volume to lower prices. Some pharmacy benefit management groups have created their own group purchasing entities. In general, PBM’s dictate which drugs the insurance plan will cover, hence driving utilization, but not necessarily the public price of drugs, whereas GPOs are all about price reduction. Clinicians and pharmaceutical companies indicate this is restricting the availability of life saving medications.

Companies that Control Drug Pricing and Supply in the US

The largest pharmacy benefit managers (PBM’s) are:

 Caremark-CVS

Express Scripts-Cigna

Optum-United Healthcare

According to the Drug Channels web site, the largest drug group purchasing organizations are:

Ascent Health Services-based in Switzerland but licensed as an LLC in Delaware. Cigna, Kroger, and Prime Therapeutics, own stakes in this company. (Adam Fein, 2023)

Emisar Pharma Services is part of United Healthcare’s Optum, headquarter in Ireland and an LLC in Delaware.

Zinc Health Services, owned by CVS is US based

 What Can We Do

Senator Ron Wyden, Chairman of the Senate Finance Committee convened a hearing on drug shortages December 5, 2023. Findings included the recommendation that Congress reform the Medicare Drug Rebate Program which encourages these large drug purchasing entities to capture up to 13% of drug costs in the form of rebates. The rebates which were meant to lower the cost of drugs are not necessarily shared with customers, instead add to corporate profits. Reform ideas include mandating the drug companies repay rebates if they raise prices faster than inflation and exempting some sterile injectables from the rebate program, which could increase supply. (Hunt, 2023) Both federal and state governments are reviewing anti-trust behavior for price collusion for these behemoth drug purchasing entities.

 The Government Accountability Agency, a nonpartisan analyst entity of the federal government convened a group of pharmaceutical company and other industry experts to discuss the dearth of generic drugs and potential causes within the FDA regulation. (Government Accountability Office, 2023)

Findings include:

1. Drug maker reformulations of drugs with minor modifications extend patents, keeping prices higher, and restricting the availability of generic drugs.

2. FDA’s rules regarding labeling also prevent generic drug manufacturers from entering the US market, even though their drugs are safe and used in other markets.

3. Half of the pharmaceutical manufacturers said the FDA needs to take a more active role in tracking generic drug-device combinations, because brand name sponsors are not required to submit information on identifying which patents are related to the device part of a drug-device combination product (example-insulin pump).

4. Half of the stakeholders indicated confusion or unnecessary delays in market entry are due to the overly broad and ambiguous codes for labeling (page 19 of the GAO report) and the FDA agreed with this conclusion.

5. Two of the participants felt that brand name sponsors may delay entry of generic drug device combination products by shifting active ingredients from older products into newer ones with patent extensions, and in some cases, remove their older more affordable products from the marketplace altogether. A literature review found that this practice led to 28 years of extended patent protection on inhalers from 1986 to 2020, which is another form of price gouging.

6. Many of the conference participants expressed concern that the FDA was outgunned by the legal resources of the pharmaceutical companies. There has not been an FDA rule change on drug-device combination products since 2016.

The American Medical Association has recently announced its support for government or a greater role for nonprofits to manufacture drugs. Of course, this would not work for the biologics, which are subject to trademark protection, but it would work for generic drugs. The federal government already provides most of the funding for initial research on drug development through National Institutes of Health grants to universities and health centers. The private market approach to supply and demand is failing at the cost of human lives. It is well known people died during Covid because they could not obtain their infusions or other drugs, but this phenomenon is still ongoing. A recent New York Times article cited severe shortages in chemotherapy even at well-funded medical centers like the Mayo Clinic. (Jewitt, 2023).

 Much of the drug supplies for the US and other nations are manufactured in India, due to consolidation and sheer economics. The Food and Drug Administration does inspect pharmaceutical manufacturing facilities offshore and in February 2023, shortages of supplies in generic drugs were directly related to a surprise FDA inspection that found numerous failures at Intas Pharmaceuticals. (Jewitt, 2023)

 The US successfully created incentives for large pharmaceutical manufacturing companies in the country to create the Covid vaccines, because the national government quickly provided funding for a national emergency. It is time we establish a government run generic drug manufacturing entity to assure supply of essential medicines for our residents. As a nation we must quit running the provision of health care like a lottery, as winner-take-all for the lucky ones and low or no treatment for others. This is no way to run a healthcare system.

 And this is the healthpolicymaven signing off wishing you a healthy new year and remember, don’t sign generic releases when you agree to inpatient medical procedures, do stipulate that for which you agree and that which you decline. Your health is after all, up to you.

This column has been in continuous publication since 2007 and is written by Roberta E. Winter, an independent healthcare analyst and journalist who accepts no money from any sector of US healthcare. Opinions are strictly her own and supported by full citations. She is the author of Unraveling U.S. Healthcare-A Personal Guide, published by Rowman & Littlefield in 2013.

https://www.amazon.com/Unraveling-U-S-Health-Care-Personal/dp/1442222972

References

Adam Fein, P. (2023, May 24). Five (or Maybe Six?) Reasons that the Largest PBMs Operate Group Purchasing Organizations. Retrieved from Drug Channels: https://www.drugchannels.net/2023/05/five-or-maybe-six-reasons-that-largest.html

Government Accountability Office. (2023, March). Generic Drugs-Stakeholder Views on Improving FDA's Information on Patents. doi:GAO 43-105477

Hunt, S. (2023, December 8). WASHINGTON HIGHLIGHTS-Senate Finance Committee Holds Hearing Examning Drug Shortages. Retrieved from AAMC.org: https://www.aamc.org/advocacy-policy/washington-highlights/senate-finance-committee-holds-hearing-examining-drug-shortages

Jewitt, C. (2023). "I'm Scared to Death,"Behind the Shortage Keeping Cancer Patients from Chemo. New York City: The New York Times. Retrieved 12 19, 2023, from https://www.nytimes.com/2023/12/19/health/cancer-drug-shortage.html

 

 

Virtual Reality Therapy Can Improve Learning For Children With ADHD

 Children with Attention Deficit Hyperactive Disorder have numerous challenges with attention, organization, and impulse control and studies have shown this is because the prefrontal cortex takes longer to mature. The cerebellum is also thought to be smaller, which is the part of the brain that controls motor response inhibition, such as staying seated in class. (Faith Wilkins, 2023) The ability to pay attention is essential for learning and when this is impacted by too much disruption it affects everything in life from social, academic, to employment. Endeavor RX is using Virtual Reality technology to impact brain activity to enhance learning and after scientific study, was given approval by the Food and Drug Administration in June 2020. (Endeavor RX, 2020)

https://play.google.com/store/apps/details?id=com.akiliinteractive.t01a

Apple https://apps.apple.com/us/app/endeavorotc/id6447322997?platform=iphone

 Breakthrough Treatment

According to Adam Gazzaley, the best way to harness the brain’s plasticity and improve attention is through immersive experiences. Adam invented the video game Neuro Racer, to boost attention and impulse control for children and youth with ADHD. After a placebo-controlled trial, Adam’s virtual reality game was approved by the FDA as a medical device, with thirty minutes as a designated dose. (Ross, 2023) An innovative treatment that does not involve drugs is now available through a smartphone app, in which thirty minutes a day of game time is a prescribed treatment for ADHD. FDA approval generally means insurance reimbursement will follow.

 Scientific Review

In 2022, a U.S. study on the use of virtual reality technology to help children and youth with Attention Deficit Hyperactive Disorder was published in Digital Health. (Zangiacomi A, 2022) The same study is referenced in the National Institute of Health, PubMed Central. (An immersive virtual reality-based application for treating ADHD: A remote evaluation of acceptance and usability, 2022) The use of a video game as a tool to help the ADHD brain organize and function better is a new treatment for children and youth.Study participants used the VR game tool virtually due to Covid restrictions, rather than in a controlled environment. Results showed the technology was helpful as a therapy for those with ADHD. Ease of use with the technology was deemed suitable for children aged six years and up.   Twenty clinical experts reviewed the study findings to arrive at these conclusions, which had a high degree of statistical validity. Another benefit of the virtual reality program was improved quantifiability of behavioral testing over traditional measures.

Findings

1.  VR demonstrated clinical value as a tool to improve cognition through increased attention and control of impulsivity

 2. VR can also be useful in identifying attention deficit disorders

3. VR Technology was found to treat some symptoms of ADHD better than Pharmacology

 A concern cited in the study was the lack of device customization by child, since there is so much variability in attention deficit disorder symptoms and severity.

 Global View

A systematic review of scientific studies analyzing Virtual Reality interventions on children with Attention Deficit Hyperactive Disorder from the International Cochrane Library for statistical efficacy was published in January 2021. The meta-analysis reviewed four studies and included 125 participants who were children. Here are the findings: (Romero-Ayuso, 2021)

Findings

VR-based interventions were found:

1. Effective in improving sustained attention

2. Improve vigilance measures and increase the number of correct responses

3. Decrease the number of omissions

4. No improvements were observed in impulsivity responses

 A systematic review and metanalysis of Virtual Reality technology to treat Attention Deficit Hyperactive Disorder was shown to improve memory in children with ADHD, similar or better than pharmacological treatments. However, the VR-intervention does not have the metabolic side affects of ADHD drugs, which include weight loss, ticks, insomnia, depression, and more. Further studies are needed on the long term affects, but this is a breakthrough treatment for this neurodevelopmental disorder! Response by parents should be thunderous applause. Treatment of learning and behavioral problems can happen without drugs. As someone who struggled with medications for my own son’s ADHD, compliance and dosage were always concerns and it would have been wonderful to have something he would have embraced and I daresay, enjoy as a treatment.

 And this is the healthpolicymaven signing off encouraging you not to sign blanket release forms when consenting to inpatient medical procedures, do stipulate that for which you agree and decline. Roberta Winter is an independent healthcare journalist who accepts no money from any healthcare sector to publish this column. She is the 2013 author of a guidebook to the US healthcare system, which is still in print. https://www.amazon.com/Unraveling-U-S-Health-Care-Personal/dp/1442222972

 

References

An immersive virtual reality-based application for treating ADHD: A remote evaluation of acceptance and usability. (2022). National Library of Medicine, 8. doi:PMC9747881

Endeavor RX. (2020, April 16). Denovo Classification Request for Endeavor RX. Retrieved from Food and Drug Administration: chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN200026.pdf

Faith Wilkins, A. N. (2023, May 2). How Is the ADHD Brain Different? Retrieved September 25, 2023, from Child Mind.org: https://childmind.org/article/how-is-the-adhd-brain-different/#full_article

Romero-Ayuso, D. &.-G.-M.-V.-F. (2021). Effectiveness of Virtual Reality-Based Interventions for Children and Adolescents with ADHD: A Systematic Review and Meta-Analysis. Children, 18-70. doi:10.3390/children8020070.

Ross, S. M. (2023). Your Brain on Art How Art Transforms Us. In S. M. Ross, Your Brain on Art How Art Transforms Us (pp. 154-157). New York : Random House.

Zangiacomi A, F. V. (2022). An immersive virtual reality-based application for treating ADHD: A remote evaluation of acceptance and usability. Digital Health, 10. doi: doi:10.1177/20552076221143242, 8.