My recommendations to a  Bipartisan Congressional Health care Committee

The most important priority is the formation of one cloud-based personal medical record that provides essential information (including genome sequencing to provide truly individualized diagnosis and treatment plans) on each individual in the country in real time using their medical record number (10-digit Health Security Number 0000-00-0000 with use of unique transaction ID numbers and blockchain technology for security). It needs to be set up properly so that anyone with proper authorization will be able to access such information. Seamless links and integration to all EMR’s, databases and the latest AI and computer systems will be needed. The federal government would oversee the cybersecurity of this medical record system and severely criminally  prosecute any unauthorized individuals or organizations who illegally obtain or use the information. It is very difficult to identify and prosecute ( especially internationally) those who illegally  obtain health care information. Let us learn from the government  with regards to enforcement of laws regarding the use of illegally obtained health care information as they do for users of  underage pornography.

Each individual will own and control their own personal medical record. The basic record will  contain current and historical information  that is essential for diagnosis and  treatment. There will be hyperlinks to any additional personal information a patient desires, such as any other medical records. Any health care provider and hospital, emergency response team, lab/x-ray or imaging company, and other health care entities including health insurance companies  will be able to with proper authorization link directly to this record to provide a comprehensive health care chart. In other words, only the necessary basics would be available directly, and all other information would be accessible through hyperlinks. Expansion of the system with time would incorporate an increasing number of integrated health care information. This medical record system would provide researchers with the needed (non-identifying) epidemiological data and data analytics they need for future research and discoveries. Initially intended for use in the United States, this system’s expansion worldwide would be easy. The United States should be the leader in this effort, or someone else will. To minimize legal challenges and maintain personal choice, an individual will be allowed to opt out of the medical record system, but they should also respect a provider opting out of taking care of them in non-emergency cases as a result. They would also need to forgo the governmental benefits that may come with this new system, such as any subsidy to an HSA, lifesaving care contract, catastrophic care coverage and elective care policy.  Any unpaid medical bills would severely affect their credit rating and likely limit their options for non-emergency medical care.

The following will help with the implementation of the HHO system: 

• Allow pretax HSAs to cover all medically indicated care and be funded by any source. Federal government funds HSA accounts for those in need.
• Allow hospitals and health care systems (including networks) to contract directly with payers, specifically individuals, employers, and the government, for lifesaving care.
• Allow the government to modify Medicare to cover catastrophic care for those under age 65.
• Allow health insurance companies to cross state lines and provide various standardized policies (without changing the policy in each state for varying regulations) for elective care. 

 The following will need the prompt help of the government:

• A bipartisan congressional health care committee (federal health board/task force) is needed to provide ongoing guidance and recommend legislation.
• The National Institute of Health (NIH) is to establish a Health Security Number (HSN) for each individual and develop one nationalized medical record for each patient that includes essential (including genome sequencing) health care information. NIH will serve as a biobank for all health care information.
• Regulate AI for health care for contracted AI services  to integrate with the one medical record. This AI woud provide  medical advice to providers that is reliable, vetted and monitored information and inclusive of  no sponsorships, advertising or manipulation of data.
• Enable patients to use HealthCare.gov based on their Zip code to determine available providers, hospitals, health care facilities, and health insurance options, as well as a vetted referral source for virtually all health care-related topics.
• The government must ban medical and pharmaceutical advertising (if unable with 1^st amendment challenge, any direct pharmaceutical/device company-to-patient ads would be followed with direct patient-to-pharmaceutical company payments). In the meantime, include list price prominently in the ad and pass legislation to illegalize reimbursing copays, coinsurance or deductibles. When listing complications  use  the same volume and verbal speed as the rest of the ad and no distracting joyful video. Ideally consider requiring a background of “skull and crossbones” if a complication has a significant complication of death.
• The government must allow personal and institutional vetted overseas purchases of medications that are on the drug shortage list and those that are unfavorably contracted for.
• We must allow providers to be easily licensed ( reciprocity) in all 50 states to help with telemedicine and close state borders. 

 The following are also a priority:

• We must establish and enforce site-neutral (pay the same wherever or however a procedure is done) payments based on clinical guidelines  which  determine where a procedure is to be done and whether procedures are to be carried out under local anesthesia, IV sedation, or general anesthesia.
• We must ban new health care taxes from being introduced and eliminate current “provider” taxes that are “hidden” and expensive cost shifting.
• The government must eliminate the ability to use incentives that directly or indirectly increase health care payer costs. New aggressive STARK rules are to apply not only to providers, but all involved with health care including Big Pharma, health insurance companies and private equity groups. We must eliminate kickbacks, perks, vouchers, rebates, coupons, copays, reimbursements, “free meds,” and sweetheart deals. If such eliminations would risk a legal challenge, then the government must at least limit these whenever governmental funds are involved.
• There must be the ability for aggressive contracting (when present contracts expire and not years down the line) for all components (including pharmaceuticals) of the health care system.
• Allow direct negotiation with and prohibit any ban on bargaining or nondisclosure clauses when dealing with a pharmaceutical company, PBM or other health care entity.
• We must reevaluate antitrust laws and enforce the ones we have.
• The government must bring about significant tort reform on a national level to decrease not only malpractice premiums but also the significant costs of defensive medicine.
• The government must require all to pay the same ( e.g., Medicare / Medicaid) to prevent selectivity by a provider or health care system. Charges can be different to promote competition. The long-term plan is not to increase governmental spending with equalization of payments but  decrease the cost to supply those services to all.

 The following will also be helpful:

• Individuals, providers, states and all other participants in all components of the HHO system would be voluntary, however if anyone declines it would also be expected they do not receive  benefits from the HHO plan.
• Any government payment adjustment for health risk should be made on a group’s estimated health care costs and not on an individual’s risk score.
• Health system employees who currently offer no direct health care benefit must be given the opportunity to retrain to become health care employees.
• Limit lobbying and eliminate political donations for all involved in health care decisions.
• Eliminate governmental cost shifting, unfunded mandates, monopolies, and safe harbors.
• Set up safeguards to detect and minimize healthcare abuse and prosecute those convicted of fraud.
• The government must pass legislation that, if needed, allows the components of the HHO system to work rather than the entire system to bypass traditional political gridlock.
• Federal and state dollars will be needed to pay for an individual’s health care directly rather than support programs to increase access to a broken health care system.
• The proposed enormous nationalized medical records database will allow researchers to use this information for clinical research with the stipulation that any financial gain will be limited, and public investment will be compensated with public gain. Federal dollars from the NIH will fund not only individual researchers’ proposals but also generalized research projects such as was done with the Human Genome Project funded mainly by the NIH and U.S. Department of Energy (DOE).
• To help with staff and resource shortages we must encourage and promote vetted low-cost venues such as internet and self-help groups (e.g., AA and NA).
• The NIH is to fund studies that determine the best cost-effective care (including no care) and not just the most advanced care.
• The NIH is to fund studies that determine the best use of medical care, such as proper antibiotic usage to decrease drug resistance. It must not only fund research for new antibiotics to treat drug resistance.
• The NIH is to fund research on lifestyle changes that may have a greater effect on longevity than the latest, most expensive medications.
• FDA regulations must be based on unbiased scientific studies and not pharmaceutical company influence.
• Restrict with enforceable non-compete clauses  the hiring of employees back and forth between Big Pharma, Health Insurance companies and regulatory bodies such as the FDA, Centers for Disease Control and Prevention (CDC). If unable with legal challenge, then limit or exclude those companies from government contracts.
• Eliminate excessive  fees paid by the drug  companies submitting their applications for new medications.
• The FDA is to learn from the unfortunate withdrawal of silicone breast implants in 1992 and subsequent reapproval in 2006, as well as the failure to promptly recognize the opioid (oxycontin; patented in 1996) epidemic in a timely manner.
• Consolidate health care programs. Historically, each president, along with Congress, has left its mark, oftentimes reacting to the current emotional and physical needs of a specific group.
• Let us learn from the United Kingdom’s National Institute for Health and Care (NICE) program that provides guidance and advice for the provision of covered health care. We can use not only the idea of an advisory panel but also their recommendations for treatment as a starting template for our own program.

 My vision for the future is as follows: 

• Payers— (individuals, employers, and the government)—Pay for what they want or are willing to pay for.
• Individuals—Provide essential care for all and elective care for most, with everyone to pay the same for the same service so everyone gets the same care.
• Employers—Finance health care as needed to employ/keep employees.
• Government—Finance health care for those in need, pay for catastrophic care, and support health care in communities that cannot support a health care system.
• Providers—Have fair compensation and control over clinical care of patients.
• Hospitals—Provide emergency and lifesaving care.
• Health insurance—Provide various risk-based insurance contracts for elective care. Allow health insurance companies to cross state lines and provide various standardized policies (without changing the policy in each state for varying regulations) for elective care.
• Pharmacy benefit managers—Unneeded; contracting for medications, pharmaceutical metrics, and drug formularies to be done by health care systems and pharmaceutical companies (may use pharmaceutical distributors paid for by reasonable mark up in price but not PBM that use control and hidden rebates and are controlled or owned by health insurance companies).
• Pharmaceutical companies/device manufactures—Oversee research and development of new drugs/devices. Fair pricing reflects resources used in product development. Realizing the chance of a drug making it through the entire process is limited.
• Pharmacies—Operate in neighborhoods/mail-order systems.
• Health care advertising—Heed direct or indirect patient advertising bans. However, promotion through Healthgov.com, website as well as limited promotional advertising for the benefit of providers allowed.
• Tertiary care centers—Offer very specialized expertise (subspecialists) in virtually all areas of medicine like Mayo and Cleveland Clinics and the ability to share that information by telemedicine, including via provider peer-to peer  and provider to patient  as well as patient to provider consultations, so the most rural communities can have access to the latest and most specialized care. These centers  should ideally be nonprofit and benevolent.
• Telemedicine—Benefit both patients and providers.
• International medical care—Expand well-known U.S. health care systems to other countries through the private sector. Medical mission trips are not enough. Collaborative work will help share medical advances with other countries’ health care systems such as England’s NHS. Most countries that need help with their socialized health care systems also have private health care available to varying degrees.
• Health care system—Transition from the very expensive fragmented and patchwork health care system we have now to one where everyone has affordable essential care.

In the end, there will probably be less than a dozen major health care systems that can compete to provide the best care from a clinical standpoint. The major systems need to ensure each segment of their systems can stand on their own as far as maintaining cost-control incentives. New and small entities need the ability to integrate with the larger ones from a clinical standpoint. This would not only allow for innovation but also competition. However, government oversight and legislation would be needed to prevent any major system from becoming a monopoly.

I am realistic as far as the health care changes that will be possible with the issues of political gridlock, variable demographics, and financial constraints. The direction of change is unclear, but what is crystal clear is that change is needed—we need generational change on a transformational level. We are all “special interest groups” insofar that we all see the problem and solution differently. This book presents my personal views, and I recognize that they are only some among the various thoughts and perspectives out there. Society needs input from all parties involved to chart the best path forward. The path may or may not include components of my recommendations. However, whether my recommendations are all or even partially included is not important. What is important is that the path we choose as a society includes all, is fair, and is sustainable. Health care needs to evolve just like every other facet of society, from the financial sector to technology. The difference with the health care sector is that we are directly dealing with human lives, and we each only have one. No one is more or less important than us and our loved ones, and we need to protect each life while we still can.

I have proposed that catastrophic care be covered on an individual basis and be paid for by the government. I must add that catastrophic care should be expanded to cover treatments for things every one of us benefits from, like vaccines, and new treatments that would be extremely expensive under our present health care system but should be available to all. These new treatments should initially be paid for with the savings from the redesign of the present system. However, it would be acceptable in the long run to increase taxes to pay for these truly new advances. The government would be in the best bargaining position to keep costs down and quality of care up. Furthermore, the government will play a pivotal role in ensuring that new advancements in care can be accessed by all and not just a privileged few. This is where the government will need to be aggressive in a bipartisan fashion to enforce antitrust laws, “march-in rights,” and new legislation as needed to keep costs down without putting a hold on innovation.

I do feel the HHO plan is important and will be able to deal with the incentives currently playing a negative role in the provision of health care. It was assumed that defunding pharmaceutical companies would decrease the number of new discoveries made. This may have been true in the past, but now we have a very different playing field. This is for two reasons: 1) public funds have often been used to promote extant drugs and increase marketing for profits, and 2) new drugs and therapies are often invented by small research groups and other developers. Big Pharma only steps in when a clinical trial is already underway, or a new development has great promise. They may also invest in, let’s say, a quantum computer that will help narrow down options for research projects.  Nowadays, Big Pharma devotes fewer resources to traditional “bench” research. Instead, it focuses on buying out smaller biotech companies or patents from university research departments. If Big Pharma profits are decreased with aggressive price negotiations, they may not be able to pay as exceedingly high prices for innovation as in the past, but opportunities to develop new products   will  still be available. Currently, there are tens of thousands of people working day and night to secure a piece of the health care pie for themselves. Under the current system that literally allows potential unlimited profits, we have angel investors, graduate students, professors (who may then go into the higher-paying drug industry), universities benefiting from beneficial patent laws, and numerous other parties looking for a financial windfall. (At this point, I must give kudos to those who are truly looking to help others instead of seeking financial gain like Dr. Jonas Salk and so many others.)

The real solution in the long run is how “society,” through government intervention and leadership, will deal with rapidly advancing technologies. Our present system may be able to tolerate a 4.25-million-dollar charge for a single dose of gene therapy that is used to treat an extremely rare genetic defect. However, it cannot deal with such grossly expensive treatments for arthritis, heart disease, or any one of many other common ailments. Consider another example. Let’s say every person had their genomes sequenced and wanted to change each deficient gene. The cost to do so would cripple the health care system as it is now. There are over 10,000 known conditions, and there is no way the health care system can sustain the cost of providing top-of-line cutting-edge treatments for each. This is especially the case if we were to operate on the premise that health care should be equally accessible to all and not only the rich. A waitlist is not a solution.  Therefore, we need the government to either allow or put in place a method of access and payment for these new modalities of care for all. I think we can all agree that change is needed, but where that change will take us is another story. Here, I have offered my proposed solution. 

Do you happen to have a better one? If so, please share it with me—I would be happy to hear it. ehs@hhoplan.org