AAPS Remarks to Pain Management Best Practices Inter-Agency Task Force on Final Recommendations and Dissemination by Kris Held, MD 5/10/19 “All For The Patient!”

May 10, 2019

Thank you, Dr. Singh and Members of the Best Practices Pain Management Task Force, for your work,

An opioid crisis is plaguing the U.S., and heroic measures are in place to end it. Sadly, patients and the physicians caring for them have been unfairly targeted in the war on opioids. The result? Patients in need of treatment for pain too often cannot access the care they require. Physicians striving to care for these patients not only put their careers on the line but also put themselves at some risk of prosecution and even prison.

This is why the Association of American Physicians and Surgeons (AAPS) would like to express appreciation, on behalf of our members caring for patients across the United States in the face of these challenges, for the work the Task Force has undertaken to put forward solutions. Your work is comprehensive, compassionate, and commendable.

Most importantly, we thank the Task Force for its continued emphasis that patients should come first. We are encouraged that the very first word in the final draft of the report is now, in fact, “Patients.”The emphasis on individualized patient-centered care is paramount. The report makes it clear that a complete history and physical examination are essential to best practice pain management, and “Compassionate, empathetic care centered on a patient-clinician relationship is necessary.” The Best Practices of Pain Management include an individualized, multimodal, multidisciplinary team approach.

 

You point out potential flaws of public health initiatives such as patients in the 1990’s reporting pain scores as a “Fifth Vital Sign” and, in response, physicians increasing their opioid prescribing to improve their pain scores. This warning must be heeded today by regulators who establish Merit-based Incentive Payment System (MIPS) quality measures, such as patient reported Quality ID #461: Average Change in Leg Pain Following Lumbar Discectomy and/or Laminotomy. We must learn from our mistakes, not repeat them.

 

You meaningfully recognize the danger in granting too much power to guidelines that brush aside patients’ individual circumstances. Caution is given to rigid application of guidelines such as the 2016 CDC Guidelines for prescribing opioids for chronic pain. Most doctors are so leery of the ramifications of these guidelines that they shun chronic pain patients. Misinterpretation and misapplication of government guidelines can result in patient harm, patient abandonment, and even patients turning to illicit drugs, because they cannot access the drugs they depend on to relieve their pain.

The moving, heart-felt patient testimonials included in this final draft help and presented in person at this meeting drive this point home, as do the troubling statistics revealing the crisis of suicide among pain patients.  Some patients can live a fairly normal life on opioids, but are otherwise completely disabled, even driven to despair.Pain patients lament they have been stigmatized. Sacrificing the needs of individual patients to “population health” is perhaps one of the most under-appreciated factors precipitating the current crisis.

 

In this day of medical education driven by self study and standardized testing that require robotic memorization of guidelines, a tsunami of guideline dysfunction can spiral out of control. Some states have gone so far as to enact policy based on morphed guidelines. Physicians are afraid to prescribe, and those who do have been stigmatized or worse. Pharmacists have taken it upon themselves to refuse to fill patients’ prescriptions beyond a few pills for a few days in some cases. Insurance companies, likewise, have used the guidelines as a reason to deny coverage of patients medications beyond a certain dosage or duration.

 

You shined the light on three waves of the opioid crisis to which physicians and patients are responding. Legal opioid prescriptions are now down, but overdose deaths from opioids are skyrocketing up. Why- because deadly, illicit opioids are entering the US across our borders, through points of entry, around them, and even through the US postal service; this is where resources must be emergently directed.

 

Your recommendations astutely identify third party participants in healthcare as sources of pain management interference. First, many of the drugs, opioid and non-opioid, necessary to best pain management plans are not available on hospital or insurance provider formularies. Doctors and patients should dictate the list of medications to which they need access, not Group Purchasing Organizations (GPO’s), Pharmaceutical Benefits Managers (PBMs), or other third party businesses. Further, patients must have access to each of the many modalities helpful in the best practices of pain treatment. Insurers’ delays, denials, and lack of coverage altogether must be addressed.

 

Finally, you repeatedly maintain that scientific research must be done before policies and guidelines are established. Policies must be evidence-based certainties that help patients not subjective speculations that turn out to be nothing more than failed experiments that harm patients.

 

So, how can the Association of American Physician and Surgeons help disseminate this important report to the American people?

 

AAPS was founded in 1943 to protect the sanctity of the patient-physician relationship, uphold ethical patient-centered medicine, and defend the constitutional rights of patients and physicians. Our motto “Omnia pro aegroto” means “All for the patient.”  Our members come from all states across the nation in all specialties in all forms of practice. Additionally, we have membership categories for free for patients, non-physician medical professionals, and medical students. We have active chapters in states as well. We are active with state and county medical societies and specialty societies too. We work to educate elected representatives and policy makers in DC as well as state legislators about protecting patients’ and physicians’ rights. We read the bills, rules, and laws, and provide comments and testimony. We support real solutions that restore freedom to patients and their physicians. We work to alert patients and physicians about breaking news impacting medical freedom and how they can fight back.

 

We have well-established infrastructure.

 

Our website had almost a million page views in just the last 2 months alone. It is easy to use for patients and physicians alike. A library of videos can be accessed from our YouTube channel and important information is posted daily. We have weekly media releases going to thousands of media outlets across the United States, a monthly newsletter, and a quarterly peer reviewed journal. We will disseminate this report through all these modalities. We will begin writing and publishing on the report today.

 

This year our annual meeting entitled The Heart, Soul, and Survival of American Medicinewill feature a module- “Healing the Heart and Soul of Patients in Pain and the Physicians who Care For Them”- led by Dr. Vanila Singh, Pain Management Task Force Chair, joined by Task Force member Dr. Molly Rutherford, primary care physician and addiction treatment specialist. The task force report will be presented. We will disseminate the report at our interim meetings and workshops as well.

 

We are extremely active on social media with wide reach:

 

We have 126,000 followers on Facebook, which has been a powerful tool for connecting with both doctors and especially patients. We reach many thousands more through Twitter and email.

 

We produce and disseminate pocket guides, fliers, and one-pagers.

 

We are well suited to disseminate this important information to physicians, patients, and policymakers from across the country, all specialties, and all walks of life.

 

Importantly, in addition to getting this information to patients, physicians, and medical students, we must get this information to the academic centers, hospital administrators and staffs at our hospitals, Emergency Departments, and Ambulatory Surgical Centers, Insurers, GPOs, and PBMs. We must take control of our formularies. We must disseminate this report to our pharmacists, our politicians and policy makers, our pastors and our teachers.

 

We will stand behind and defend physicians when they are mistakenly accused of wrongdoing- especially when they are doing what is best for their individual patients or if they fear retaliation from a hospital, employer, insurer, state, or federal agency.

 

AAPS brings to the table a uniquely trusted connection with grassroots advocates for patient-centered medicine that other larger groups are lacking. For instance, our email alerts are received, read, and redistributed by some of the top leaders and influencers in the physician, policy, and patient grassroots advocacy communities. We will strategically grow our pool of influencers.

 

Our media efforts get wide pickup in the heart of America, while others may focus their efforts on DC and other major metro areas and miss reaching those in “fly over states.”

We look forward to sharing this final report with those who can implement its recommendations that put patients first: our members and other medical professionals who are on the front lines of patient care. We are grateful to Dr. Singh and the Task Force for undertaking this challenging work. We look forward to future discussions about improving on and implementing solutions that align with our motto: “All for the Patient.”

Comments delivered by Kristin Story Held, M.D., President-Elect, Association of American Physicians and Surgeons, May 10, 2019, to the Pain Management Best Practices Inter-Agency Task Force in response to its Final Report during the “Roundtable Discussion on Dissemination Activities with External Stakeholders” in The Great Hall, Hubert H. Humphrey Building, 200 Independence Avenue, S. W. Washington, D.C. 20201A

Drain the Pharmaceutical Benefit Managers’ Swamp Before it Drains Us Dry

A recent patient has severe, debilitating dry eyes, but she is perfectly treated using Restasis eye drops (on the market since 2003) two times each day. Her new insurance company denied her prescription refill pending prior authorization. Her pharmacy informed her the average wholesale price for a three-month supply of the drops is $2007.72 ($8,030.88 yearly or $5.50 per drop), and she is a “covered” patient. If that doesn’t make you tear up, nothing will. Imprimus, a California pharmaceutical company, can compound these drops and mail them to her house for less than $50.00 per month (41 cents per drop). It is better for her NOT to use her insurance and pharmacy “benefits.” This nonsense must end.

Recent actions addressing escalating drug costs spark optimism. Senate Finance Committee chair Senator Chuck Grassley (R-IA) held a hearing on drug pricing in America. House Oversight Committee chair Congressman Elijah Cummings (D- MD) held a hearing on drug company price increases. Both committees, from two separate chambers of Congress led by chairmen from two separate political parties simultaneously met to address the same problems: sky-rocketing drug costs and dangerous drug shortages. Senator John Cornyn (R-TX) asked the most significant question of the panel of expert witnesses on drug pricing in America: “Can anybody on the panel explain to me why we have a general prohibition against kickbacks, call them ‘rebates,’ under the Social Security Act, but we nevertheless allow it for prescription drug pricing? What’s the sound public policy reason for excluding prescription drug pricing from the anti-kickback rule under federal law?”

That same heartening day, an op-ed by Health and Human Services (HHS) Secretary, “Alex Azar: Why drug prices keep going up- and why they need to come down,” https://t.co/UtoLS3zQtv appeared in STAT News showing he is committed to addressing the root cause of the problem not perpetuating a farce. February 6, the Office of the Inspector General of HHS published a proposed rule in the Federal Register that would amend the Anti-Kickback Statute that currently excludes GPOs and thus PBMs from having to comply with Anti-Kickback law.

https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&cad=rja&uact=8&ved=2ahUKEwjLjP7lk77gAhUK64MKHWE2CeoQFjAAegQIBBAB&url=https%3A%2F%2Fwww.federalregister.gov%2Fdocuments%2F2019%2F02%2F06%2F2019-01026%2Ffraud-and-abuse-removal-of-safe-harbor-protection-for-rebates-involving-prescription-pharmaceuticals&usg=AOvVaw0Hegs-7WfqDGBf0pBbSeHu  

This is encouraging, because both chambers of Congress and Executive Branch appear focused on the issue that adds 30-50% to drug costs, causes drug shortages, and enables PBMs to create drug formularies for insurers based not on what drugs doctors and patients deem best but on a complex, secret pay-to-play system of rebates (kickbacks), administrative fees, sole-source contracts, and perks. Drug makers must play to earn a preferred tier for their medications or to even get on a formulary at all.

In spite of appalling hyper-partisanship, divisiveness, and derangement on Capitol Hill, perhaps one single, one-page, bipartisan bill can be passed in Congress and signed by the President. Anyone who does not support a bill making GPOs and PBMs comply with Anti-Kickback law like everyone else is either a member of the GPO/PBM industry, uninformed, misinformed, confused, bought off, or afraid for their political, financial or physical well-being. Who sponsors the bill will be supremely telling. Who votes for the bill will be illuminating and instructive. We cannot fix healthcare unless we fix this law.

The law is the Medicare Anti-Kickback Statute (Section 1128B(b) of the Social Security Act (42 U.S.C. 1320a-7b(b)), previously codified at sections 1877 and 1909 of the Act) that provides criminal penalties for individuals or entities that knowingly and willfully offer, pay, solicit or receive remuneration in order to induce business reimbursed under the Medicare or State health care programs. A regulation went into effect July 29, 1991 that excluded Group Purchasing Organizations (GPOs) from the anti-kickback statute. Translation: government created an uneven playing field. Government created law then selectively enforced it. This is a license to steal. I read the final rule https://t.co/yJVI3Ift82 including government responses to comments from the proposed rule to understand how this happened. The final rule “implements section 14 of Public Law 100-93, the Medicare and Medicaid Patient and Program Protection Act of 1987, by specifying various payment practices which, although potentially capable of inducing referrals of business under Medicare or a State health care program, will be protected from criminal prosecution or civil sanctions under the anti-kickback provisions of the statute.” This is a “get out of jail free card” granted to GPOs and then extended to PBMs via another act of rule and regulation shenanigans. Ironically, no financial analysis was done. HHS determined that a regulatory analysis was not required, because they certified the final rule would not have a significant impact. They did not think the rule would result in an annual effect on the economy of $100M or more, or a major increase in costs or prices for consumers, individuals, industries, Federal, State, or local government agencies, or adverse effects on competition, employment, investment, productivity, innovation, and so on. They were wrong. Of significance is a requirement that written agreements exist for HHS Secretary to inspect upon request if GPO/PBM fees exceed 3%, the customary fee in 1991 when the regulation excluding GPOs from anti-kickback law was signed. Ensuing unintended consequences of flawed law result now in nearly a quarter trillion dollars racketeered annually through this faulty, perverse drug supply chain. The Secretary of HHS, DOJ, and OIG must look into these secret contracts. I bet they have.

If the GPO exemption goes, so does the PBM’s. Three major PBMs, UnitedHealth Group, CVS Caremark, and Express Scripts, control over 80% of the PBM market and more than 70% of all prescriptions dispensed in the U.S. These three reported net revenue of $303.7 billion in 2016 alone. CVS Caremark, the largest PBM, is in process of buying Aetna, the nation’s largest health insurer. To protect $250B annual profits, net revenue, GPO/PBM supporters obfuscate and use tricky financial maneuvers in a money laundering operation, disguised as a supply chain. They do deals then change language to disguise what is actually happening. For example, a drug manufacturer offers the PBM a 40% rebate to land a good spot on the formulary of the company represented by the PBM. Don’t let them fool you when they say the rebates go 100% back to employers. What really happens in this version of legalized organized crime goes something like this: the PBM agrees to accept the drug manufacturer’s 40% rebate to put them on a formulary, but half of it (20% overall) shall be renamed “administrative fee.” While they can technically say 100% of the rebate went back to the large employer sponsor, in reality, 100% of 20% went back, while the PBM pocketed 20% that was renamed “administrative fee.” Drug makers must play or go out of business. To afford paying off PBMs, they must in turn raise drug costs in a vicious cycle that increasingly harms patients and taxpayers.

I call on both chambers of Congress and Executive Branch to act now. This is a bipartisan issue of epic proportion. Who can honestly defend this? Sadly, with $250 billion yearly at bay, many stakeholders will not only defend these practices, but they will lie insisting PBMs save money, discredit whistleblowers, work against politicians who want to fix the law, and will fund their political opponents. $250 Billion goes a long way in this regard, especially when those of us fighting them have nothing but our moral compass, knowledge of the law and its effects, and love of our patients and country.

I call on Senate Finance Committee members, Senators Grassley and Cornyn, Wyden and Warner. I call on Senior House Oversight Committee members, Elijah Cummings and Jim Jordan, to come alongside freshman members, Alexandria Octavio Cortez and Chip Roy, expose and end this now. A one-page bill is all it takes. Legislative language exists for both House and Senate.  Introduce legislation now. If you will not, then tell the American people why not.

Congress and HHS must stop pulling weeds and address the root problem. We do not want a partial fix that saves a few billion dollars that looks good on the surface but retains hundreds of billions underground for the continued organized crime spree and its players.

GPOs and PBMs: shame on you for intentionally deceiving and exploiting the American patient and fleecing the US economy.

Big insurance companies that are being acquired by, acquiring, or starting your own PBMs- you are worst of all. You take government subsidies, the people’s money, and money directly from people and their employers. Instead of working for the good of the people by refusing to play the game and exposing the cartel, you join in, taking kickbacks and individual perks.

This must end. Drug costs will plummet and drug shortages will disappear in short order. Wake up America! Save the patients and the people not the PBMs and their dysfunctional “healthcare system” that are draining us dry.

Drain the PBM Swamp Before It Drains Us Dry

A recent patient has severe, debilitating dry eyes, but she is perfectly treated using Restasis eye drops, that have been on the market since 2003, two times each day. Her new insurance company denied her prescription refill pending prior authorization, and her pharmacy informed her the average wholesale price for a three-month supply of the drops is $2007.72 ($8,030.88 yearly or $5.50 per drop), and she is a “covered” patient. If that doesn’t make you cry, I don’t know what will. Imprimus, a California pharmaceutical company, can compound these drops and mail them to her house for less than $50.00 per month (41 cents per drop). It is better for her NOT to use her insurance and pharmacy “benefits.” Something must be done to stop this insanity.

Recent actions addressing escalating drug costs spark optimism. Senate Finance Committee chair Senator Chuck Grassley (R-IA) held a hearing on drug pricing in America. House Oversight Committee chair Congressman Elijah Cummings (D- MD) held a hearing on drug company price increases. Both committees, from two separate chambers of Congress led by chairmen from two separate political parties simultaneously met to address the same problems: sky-rocketing drug costs and dangerous drug shortages. Senator John Cornyn (R-TX) asked the most significant question of the panel of expert witnesses on drug pricing in America: “Can anybody on the panel explain to me why we have a general prohibition against kickbacks, call them ‘rebates,’ under the Social Security Act, but we nevertheless allow it for prescription drug pricing? What’s the sound public policy reason for excluding prescription drug pricing from the anti-kickback rule under federal law?”

That same heartening day, an op-ed by Health and Human Services (HHS) Secretary, “Alex Azar: Why drug prices keep going up- and why they need to come down,” https://t.co/UtoLS3zQtv appeared in STAT News showing he is committed to addressing the root cause of the problem not perpetuating a farce. On February 6, 2019, the Office of the Inspector General of HHS published a proposed rule in the Federal Register that would amend the Anti-Kickback Statute that currently excludes GPOs and thus PBMs from having to comply with Anti-Kickback law. https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&cad=rja&uact=8&ved=2ahUKEwjLjP7lk77gAhUK64MKHWE2CeoQFjAAegQIBBAB&url=https%3A%2F%2Fwww.federalregister.gov%2Fdocuments%2F2019%2F02%2F06%2F2019-01026%2Ffraud-and-abuse-removal-of-safe-harbor-protection-for-rebates-involving-prescription-pharmaceuticals&usg=AOvVaw0Hegs-7WfqDGBf0pBbSeHu

This is encouraging, because both chambers of Congress and the Executive Branch appear focused on the issue that adds 30-50% to drug costs, creates drug shortages, and allows PBMs to create drug formularies for insurers and employers based not on what drugs doctors and patients deem best but based on a complex, secret pay-to-play system of rebates (kickbacks), administrative fees, sole-source contracts, and perks drug makers must engage in to buy their medications a preferred tier or to get on a formulary at all.

In spite of appalling hyper-partisanship, divisiveness, and derangement on Capitol Hill, perhaps one single, one-page, bipartisan bill can be passed in Congress and signed by the President. Anyone who does not support a bill making GPOs and PBMs comply with Anti-Kickback law like everyone else is either a member of the GPO/PBM industry, uninformed, misinformed, confused, bought off, or afraid for their political, financial or physical well-being. Who sponsors the bill will be supremely telling. Who votes for the bill will be illuminating and instructive. We cannot fix healthcare unless we fix this law.

The law is the Medicare Anti-Kickback Statute (Section 1128B(b) of the Social Security Act (42 U.S.C. 1320a-7b(b)), previously codified at sections 1877 and 1909 of the Act) that provides criminal penalties for individuals or entities that knowingly and willfully offer, pay, solicit or receive remuneration in order to induce business reimbursed under the Medicare or State health care programs. A regulation went into effect July 29, 1991 that excluded Group Purchasing Organizations (GPOs) from the anti-kickback statute. Translation: government created an uneven playing field. Government created law then selectively enforced it. This is a license to steal. I read the entire final rule https://t.co/yJVI3Ift82 including all comments and government responses from the proposed rule to understand how this came to be. The final rule “implements section 14 of Public Law 100-93, the Medicare and Medicaid Patient and Program Protection Act of 1987, by specifying various payment practices which, although potentially capable of inducing referrals of business under Medicare or a State health care program, will be protected from criminal prosecution or civil sanctions under the anti-kickback provisions of the statute.” This is a “get out of jail free card” granted to GPOs and then expanded to PBMs via another act of rule and regulation shenanigans. Ironically, no financial analysis was done. HHS determined that a regulatory analysis was not required, because they certified that the final rule would not have a significant impact. They did not think the rule would result in an annual effect on the economy of $100M or more, or a major increase in costs or prices for consumers, individuals, industries, Federal, State, or local government agencies, or adverse effects on competition, employment, investment, productivity, innovation, and so on. The Secretary of HHS, DOJ, and OIG can, however, look into these secret contracts upon request. They must. I bet they have.

If the GPO exemption goes, so does the PBM’s. The three major PBMs, UnitedHealth Group, CVS Caremark, and Express Scripts, alone control over 80% of the PBM market and more than 70% of all prescriptions dispensed in the U.S. These three reported net revenue of $303.7 billion in 2016 alone. CVS Caremark, the largest PBM, is in process of buying Aetna, the nation’s largest health insurer. To protect $250B annual profits, net revenue, GPO/PBM supporters obfuscate and use tricky financial maneuvers in a money laundering operation, disguised as a supply chain. They do deals then change language to disguise what is actually happening. For example, a drug manufacturer offers the PBM a 40% rebate to land a good spot on the formulary of the company represented by the PBM. Don’t let them fool you when they say the rebates go 100% back to employers. What really happens in this version of legalized organized crime goes something like this: the PBM agrees to accept the drug manufacturer’s 40% rebate to put them on a formulary, but half of it (20% overall) shall be renamed “administrative fee.” While they can technically say 100% of the rebate went back to the large employer sponsor, in reality, 100% of 20% went back, while the PBM pocketed 20% that was renamed “administrative fee.” Drug makers must play or go out of business. To afford paying off the PBMs, they must in turn raise drug costs in a vicious cycle that increasingly harms patients and taxpayers.

Of importance is a requirement that written agreements exist for HHS Secretary inspection if GPO/PBM fees exceed 3%, the customary fee in 1991 when the regulation excluding GPOs from anti-kickback law was signed. Ensuing unintended consequences of flawed law result now in nearly a quarter trillion dollars racketeered annually through this faulty, perverse drug supply chain.

I call on both chambers of Congress and the Executive Brach to act now. This is a bipartisan issue of epic proportion. Who can honestly defend this? Sadly, with $250 billion yearly at bay, many stakeholders will not only defend these practices, but they will lie insisting PBMs save money, discredit whistleblowers, work against politicians who want to fix the law, and will fund their political opponents. $250 Billion goes a long way in this regard, especially when those of us fighting them have nothing in our arsenal but our moral compass, knowledge of the law and its effects, and love of our patients and country.

I call on Senate Finance Committee members, Senators Grassley and Cornyn, Wyden and Warner. I call on senior House Oversight Committee members, Elijah Cummings and Jim Jordan, to come alongside freshman members Alexandria Octavio Cortez and Chip Roy, join hands, expose, and end this now. A one-page bill is all it takes. Legislative language exists for both House and Senate.  Introduce legislation now. If you will not, then tell the American people why not.

Congress and HHS must stop pulling weeds and address the root problem. We do not want a partial fix that saves a few billion dollars that looks good on the surface but retains hundreds of billions underground for the continued organized crime spree and its players.

GPOs and PBMs: shame on you, for intentionally deceiving and exploiting the American patient and fleecing the US economy.

Big insurance companies that are being acquired by, acquiring, or starting your own PBMs: you are worst of all. You take government subsidies, the people’s money, and money directly from people and their employers. Instead of working for the good of the people by refusing to play the game and exposing the cartel, you join in, taking kickbacks and individual perks.

This must end. Drug costs will plummet and drug shortages will disappear in short order. Wake up America! Save the patients and the people not the PBMs and their dysfunctional “healthcare system” that are draining us dry.

Do Not Be Deceived! Medicare For All is Socialized Medicine, and the Democrats’ Socialist Bill has 123 Cosponsors- Americans must identify and vote against Medicare For All supporters.

Deceptively, pollsters report that “Medicare For All” is popular with Americans, as the media proclaims healthcare a top concern on voters’ minds a mere two weeks before the midterm election.  While many candidates are indeed running on a “Medicare For All” platform, few Americans realize that a Medicare for All bill actually exists and that it already has 123 Democrat cosponsors to boot. H.R.676, “The Expanded and Improved Medicare For All Act,” was introduced January 24, 2017, by former Representative John Conyers, Jr. (D-MI). Representative Keith Ellison (D-MN) assumed sponsorship when Conyers resigned after 52 years in Congress, amidst multiple allegations of sexual harassment. If Americans actually knew what was in this bill, pollsters would find rare few supporting it.

The following is a dissection of H.R.676, The Expanded & Improved Medicare For All Act, including much of the exact language as written, because it is so Orwellian socialist, that it sounds fake. But, I don’t write it; I just read it. So, here we go.

Who is eligible to be registered in the Medicare For All program?

 

  • 3   101. ELIGIBILITY AND REGISTRATION.
  • 4  (a) IN GENERAL.—All individuals residing in the
  • 5  United States (including any territory of the United
  • 6  States) are covered under the Medicare For All Program
  • 7  entitling them to a universal, best quality standard of care.
  • 8  Each such individual shall receive a card with a unique
  • 9  number in the mail. An individual’s Social Security num-
  • 10  ber shall not be used for purposes of registration under
  • 11  this section.

All individuals residing in the US, including any territory of the US, are covered under the Medicare For All program. Notice, the bill covers residents, not just citizens. The HHS Secretary is given the power to define what constitutes residency. Clearly, the political ideology of the party in the White House will impact this definition. Do you become a resident when your caravan crosses the bridge at the U.S. border? Or will there be something more to show, like a water or electricity bill?  And, each individual shall receive a card with a unique number in the mail. Just what we need, a new identifying number in addition to our Social Security number. Who knows what other uses government will devise for this new healthcare number. If the federal government handles our medical data like they do texts and emails of our politicians, the potential for malfeasance is infinite.

What entitlements will Medicare For All provide to all residents of the US and US territories (potentially everyone in the world)? The answer is seen below directly from the text of the bill. Everyone will be entitled to everything from inpatient care, outpatient care, and prescription drugs to nutritional therapy, long term care, and, of course, palliative care. Again, the presiding political philosophy will play a huge role in determining what care will be provided and for which patients (remember Ezekiel Emanuel’s Complete Lives System). The prevailing political ideology will effect the right of conscience for physicians and other clinicians.  Various levels of tolerance for various levels of procedures, as extreme as abortion and euthanasia, will swing in and out of vogue as the pendulum of societal mores, political correctness, and Godliness or Godlessness permeates the halls of Congress, White House, and Supreme Courthouse. See for yourself.

SEC. 102. BENEFITS AND PORTABILITY.
(a) In General.—The health care benefits under this Act cover all medically necessary services, including at least the following:

 

  • (1) Primary care and prevention
  • (2) Approved dietary and nutritional therapies.
  • (3) Inpatient care.
  • (4) Outpatient care.
  • (5) Emergency care.
  • (6) Prescription drugs.
  • (7) Durable medical equipment.
  • (8) Long-term care.
  • (9) Palliative care.
  • (10) Mental health services.
  • 11) The full scope of dental services, services, including periodontics, oral surgery, and endodontics, but not including cosmetic dentistry.
  • (12) Substance abuse treatment services.
  • (13) Chiropractic services, not including electrical stimulation.
  • (14) Basic vision care and vision correction (other than laser vision correction for cosmetic purposes).
  • (15) Hearing services, including coverage of hearing aids.
  • (16) Podiatric care.

 

Who will provide all the care? The defintition of “legally qualified” is unspecified and remains of concern. The government regulatory strings attached to legal qualification and licensure could be long, expensive, coercive, and destructive to physician and patient autonomy.

 

  • (b) Portability.—Such benefits are available through any licensed health care clinician anywhere in the United States that is legally qualified to provide the benefits.

 

What will each beneficiary pay? Reportedly nothing; however I could find no specific mention of premiums in the 18 pages of the bill. Currently, Medicare beneficiaries pay premiums, which are means tested. I suspect means tested premiums will eventually become part of this as socialists implement additional layers of compounded redistribution when they have to reckon with the reality that this Utopian scheme must be paid for.

 

 

  • (c) No Cost-Sharing.—No deductibles, copayments, coinsurance, or other cost-sharing shall be imposed with respect to covered benefits.

 

 

Section 104 is huge and astounding. This section makes it illegal for health insurers to sell insurance that duplicates benefits of Medicare For All. That’s it! Government completes the takeover of the entire health insurance industry in one small paragraph. Government becomes the single payer, and the transformation from free-market, patient-centered medicine to socialized medicine that serves the common good of the state is complete.

 

SEC. 104. PROHIBITION AGAINST DUPLICATING COVERAGE.

  • (a) In General.—It is unlawful for a private health insurer to sell health insurance coverage that duplicates the benefits provided under this Act.
  • (b) Construction.—Nothing in this Act shall be construed as prohibiting the sale of health insurance coverage for any additional benefits not covered by this Act, such as for cosmetic surgery or other services and items that are not medically necessary.

 

How on earth will all the elements of this monstrosity be funded? The federal government will dole out monthly lump sums to regions to cover all operating expenses. This is capitation on an unprecedented, mammoth, untested scale. Most of the government’s experience with capitation thus far has been a huge fail.

 

  • 202. PAYMENT OF PROVIDERS AND HEALTH CARE CLINICIANS.
  • (a) Establishing Global Budgets; Monthly Lump Sum.—
  • (1) IN GENERAL.—The Medicare For All Program, through its regional offices, shall pay each institutional provider of care, including hospitals, nursing homes, community or migrant health centers, home care agencies, or other institutional providers or pre-paid group practices, a monthly lump sum to cover all operating expenses under a global budget.

 

Who will be conscripted to provide all the free care to all “residents” of the U.S. and U.S. territories? Medicare For All commandeers all “Healthcare” Professionals.

 

  • (1) IN GENERAL.—The Program shall pay physicians, dentists, doctors of osteopathy, pharmacists, psychologists, chiropractors, doctors of optometry, nurse practitioners, nurse midwives, physicians’ assistants, and other advanced practice clinicians as licensed and regulated by the States by the following payment methods:
  • (A) Fee for service payment under paragraph (2).
  • (B) Salaried positions in institutions receiving global budgets under paragraph (3).
  • (C) Salaried positions within group practices or non-profit health maintenance organizations receiving capitation payments under paragraph (4).

Remember the MACRA/MIPS scoring system. This perverse system will apply here.

 

Who will decide what medications are available to you? The government will establish the drug formulary. In other words, the government will decide the list of medications from which clinicians will be able to prescribe. These may not be the best, most effective, most innovative, safest, or even cost-effective drugs, but they will no doubt be the drugs that special interests have paid-off politicians or other players in order to gain favored status. Hundreds of billions of dollars will be squandered and laundered here annually, just like is happening now with the Pharmaceutical Benefits Managers (PBMs) and Group Purchasing Organizations (GPOs) via their racketeering scheme that siphons over $200 billion annually from patients and taxpayers, inflates drug prices by 30-50%, and creates drug shortages. The government negotiations will continue to be influenced by countless special interest groups that pay to play. Conversely, if politicians refuse to play, the special interests may fund opposition candidates. The level of corruption in the swamp will skyrocket. What is best for patients will be nothing but an annoying afterthought.

 

  • 205. PAYMENT FOR PRESCRIPTION MEDICATIONS, MEDICAL SUPPLIES, AND MEDICALLY NECESSARY ASSISTIVE EQUIPMENT.
  • (a) Negotiated Prices.—The prices to be paid each year under this Act for covered pharmaceuticals, medical supplies, and medically necessary assistive equipment shall be negotiated annually by the Program.
  • (b) Prescription Drug Formulary.—
  • (1) IN GENERAL.—The Program shall establish a prescription drug formulary system, which shall encourage best-practices in prescribing and discourage the use of ineffective, dangerous, or excessively costly medications when better alternatives are available.

 

Where will the money to pay for this impracticable behemoth come from? There is not enough money for Medicare to cover its 60 million beneficiaries now. How will over 300 million more U.S. residents be covered? This part is shocking and maddening. The money does not exist, so the Medicare For All bill magically creates a new Medicare For All Trust Fund. It confiscates all money that previously went to Medicare, Medicaid, CHIP, and any other healthcare allocation and transfers it into the Trust Fund. It creates a multitude of new taxes on the American taxpayers and increases existing taxes. It then grants itself a blank check and empowers the HHS Secretary to estimate what might have been spent on all healthcare, take that amount from the US treasury, and deposit it in the Medicare For All Trust Fund.

 

 

Subtitle B—Funding

  • 211. OVERVIEW: FUNDING THE MEDICARE FOR ALL PROGRAM.
  • (a) In General.—The Medicare For All Program is to be funded as provided in subsection (c)(1).
  • (b) Medicare For All Trust Fund.—There shall be established a Medicare For All Trust Fund in which funds provided under this section are deposited and from which expenditures under this Act are made.
  • (1) IN GENERAL.—There are appropriated to the Medicare For All Trust Fund amounts sufficient to carry out this Act from the following sources:
  • (A) Existing sources of Federal Government revenues for health care.
  • (B) Increasing personal income taxes on the top 5 percent income earners.
  • (C) Instituting a modest and progressive excise tax on payroll and self-employment income.
  • (D) Instituting a modest tax on unearned income.
  • (E) Instituting a small tax on stock and bond transactions.

We must especially beware of this government blank check included in the bill. The HHS Secretary can literally estimate how much he or she thinks would have been spent on healthcare and can transfer that amount (such sums as may be necessary) directly out of the Treasury into the Medicare For All Trust Fund. No limit on this money is established. This is flagrant theft from US taxpayers.

 

  • (3) ADDITIONAL ANNUAL APPROPRIATIONS TO MEDICARE FOR ALL PROGRAM.—Additional sums are authorized to be appropriated annually as needed to maintain maximum quality, efficiency, and access under the Program.
  • 212. APPROPRIATIONS FOR EXISTING PROGRAMS.
  • Notwithstanding any other provision of law, there are hereby transferred and appropriated to carry out this Act, amounts from the Treasury equivalent to the amounts the Secretary estimates would have been appropriated and expended for Federal public health care programs, including funds that would have been appropriated under the Medicare program under title XVIII of the Social Security Act, under the Medicaid program under title XIX of such Act, and under the Children’s Health Insurance Program under title XXI of such Act.

 

If that doesn’t seem frightening enough, the scariest part is this: the Medicare For All Bill establishes the National Board of Universal Quality and Access, and not even one actual physician is guaranteed to be on it.

 

  • 305. NATIONAL BOARD OF UNIVERSAL QUALITY AND ACCESS.
  • (a) Establishment.—
  • (1) IN GENERAL.—There is established a National Board of Universal Quality and Access (in this section referred to as the “Board”) consisting of 15 members appointed by the President, by and with the advice and consent of the Senate.
  • (2) QUALIFICATIONS.—The appointed members of the Board shall include at least one of each of the following:
  • (A) Health care professionals.
  • (B) Representatives of institutional providers of health care.
  • (C) Representatives of health care advocacy groups.
  • (D) Representatives of labor unions.
  • (E) Citizen patient advocates.
  • (3) TERMS.—Each member shall be appointed for a term of 6 years, except that the President shall stagger the terms of members initially appointed so that the term of no more than 3 members expires in any year.

 

Imagine, the Board- consisting of a dietician, a long term care facility administrator, the head of Planned Parenthood, a labor union representative, and a patient advocate, plus a few others as picked by the President- making all our healthcare decisions for us. The party of Pelosi, Warren, and Waters could potentially appoint an ANTIFA member to fill the citizen patient advocate requirement. These 15 appointees will function as the arbiters of our very lives.

These unelected, government appointees, like politicized Senators and Judges wrapped into one, will decide everything from what equipment can be bought to how much a nurse will be paid and how many hours everyone can work. We just saw how well the “advice and consent of the Senate” part of the appointment process went with Judge Kavanaugh. Imagine when we are picking members of the “Life Panel.” Six year terms, with no mention of term limits, might as well be life terms. The potential for foul play and the weaponization of medicine is breathtaking.

 

  • (b) Duties.—
  • (1) IN GENERAL.—The Board shall meet at least twice per year and shall advise the Secretary and the Director on a regular basis to ensure quality, access, and affordability.
  • (2) SPECIFIC ISSUES.—The Board shall specifically address the following issues:
  • (A) Access to care.
  • (B) Quality improvement.
  • (C) Efficiency of administration.
  • (D) Adequacy of budget and funding.
  • (E) Appropriateness of reimbursement levels of physicians and other providers.
  • (F) Capital expenditure needs.
  • (G) Long-term care.
  • (H) Mental health and substance abuse services.
  • (I) Staffing levels and working conditions in health care delivery facilities.

The scope of power of these 15 government Appointed Arbiters of Americans’ lives is astounding. They literally have the power to make every single healthcare decision for every us. And when there is no money left in the US Treasury to do anything but offer “healthcare,” these 15 will allocate the scarce medical resources as they see fit. In ultimate irony, our seniors, the very Americans Medicare was created to help, will likely be the first group to de denied care- other than palliative that is.

(3) ESTABLISHMENT OF UNIVERSAL, BEST QUALITY STANDARD OF CARE.—The Board shall specifically establish a universal, best quality of standard of care with respect to—

  • (A) appropriate staffing levels;
  • (B) appropriate medical technology;
  • (C) design and scope of work in the health workplace;
  • (D) best practices; and
  • (E) salary level and working conditions of physicians, clinicians, nurses, other medical professionals, and appropriate support staff.

 

Take a moment to regroup and reckon with the possibility that Medicare For All is coming for all soon with a pricetag that will destroy the U.S. economy. In 10 years, the VA will be taken in, and the Indian Health Service Program will be taken over in just five.

 

  • TITLE IV—ADDITIONAL PROVISIONS
  • 401. TREATMENT OF VA AND IHS HEALTH PROGRAMS.
  • (a) VA Health Programs.—This Act provides for health programs of the Department of Veterans’ Affairs to initially remain independent for the 10-year period that begins on the date of the establishment of the Medicare For All Program. After such 10-year period, the Congress shall reevaluate whether such programs shall remain independent or be integrated into the Medicare For All Program.
  • (b) Indian Health Service Programs.—This Act provides for health programs of the Indian Health Service to initially remain independent for the 5-year period that begins on the date of the establishment of the Medicare For All Program, after which such programs shall be integrated into the Medicare For All Program.

 

The estimated cost of Medicare For All is $40 TRILLION over 10 years but can be reduced to $32.6 trillion if all providers’ pay is cut 40%. We will lose our highly trained medical workforce. This financial undertaking more than doubles current annual healthcare costs from inception, and we know from history that this will become exponentially more expensive as time goes on.

When will this insanity take effect? If Democrats win the House and Senate in 2 weeks, this bill could theoretically become law and take effect one year thereafter. With the Democrats’ fixation on impeachment and overt hatred of our duly elected President of the United States, the possibility is not all that far-fetched.

 

  • TITLE V—EFFECTIVE DATE
  • 501. EFFECTIVE DATE.
  • Except as otherwise specifically provided, this Act shall take effect on the first day of the first year that begins more than 1 year after the date of the enactment of this Act, and shall apply to items and services furnished on or after such date.

 

American voters must not be deceived. Medicare for All is not compassionate or good in any rational, sustainable way. Medicare For All will not solve all the problems that Medicare For Some created; it will make things tremendously worse. This Bill is an affront to the American people. No one can in good conscience cast a vote for a candidate that is running on such incompetency. Anyone running on this bill either has not read it or is a devout socialist intent on completing the fundamental transformation of the United States of America, destroying the U.S. economy, and shredding our Constitution once and for all. If we are to secure our blessings of liberty, we must identify and vote against any candidate that supports this Medicare For All bill.

 

Incompetent or Immoral- Which is it, United Healthcare?

The obstacle courses that patients and physicians must successfully navigate for physicians’ prescriptions to result in patients’ actually obtaining needed medications are becoming increasingly aggravating and dangerous. While obstacle courses are well established as part of military training for soldiers to prepare for combat and part of pop culture for contestants to compete for prizes on reality television series, the obstacle courses set up by health insurance companies serve no good purpose other than to enrich those very multi-billion dollar companies themselves and increasingly rich and powerful middlemen known as Group Purchasing Organizations (GPOs) on the inpatient side and Pharmaceutical Benefits Managers (PBMs) on the out-patient side. A misguided law with serious unintended consequences (a 1987 Medicare Anti-Kickback Safe Harbor statute that exempts these middlemen from criminal penalties for taking rebates/kickbacks from suppliers that went into effect in 1991 for GPOs) gave rise to an unimaginably corrupt pay-to-play system to let a given medication or medical device gain access to the healthcare marketplace. Translation, a medication is available at a hospital or on an insurance company’s formulary not because it is the best drug chosen by our nation’s expert physicians as having the best results and least side effects for most patients, but because the supplier of that drug has paid the most administrative fees, marketing fees, advances, conversion fees, prebates, rebates, and “sharebacks” to the GPO or PBM to pay-to-play. The drug manufacturer must then raise prices to offset the costs of the “pay-to-play.” Repeal of this flawed law would reduce cost of drugs by 30%, if not 50%, and save Medicare and Medicaid $75 billion annually. We cannot fix the healthcare mess until we shed light on the $200 billion that these middlemen take for themselves and repeal this law of unintended consequences.

 

The PBM industry is highly concentrated with just three huge companies controlling over 80% of the PBM market and more than 70% of all prescriptions dispensed in the United States. These three, UnitedHealthGroup, CVS Caremark, and Express Scripts reported aggregate net revenue of $303.7 billion in 2016 alone. The Pharmaceutical Benefits Manager for the United Healthcare, United Optum, is the largest. In 2003, PBMs petitioned the HHS OIG to extend the 1987 law covering GPOs, to cover the PBM industry. According to the Bipartisan Policy Center, from 2003 to 2013, Andy Slavitt worked at United Health Group, eventually serving as the Executive Vice President for Optum, United’s PBM middleman, which he grew to a $40 billion health services enterprise. In 2013, President Obama tapped him to repair healthcare.gov, and he then served as Acting Administrator for the Center for Medicare and Medicaid Services (CMS) from 2015-2017, executing many new programs including the significant shift to “pay-for-value” models, MACRA, and the ACA. This illustrates the incestuous nature of the PBM industry’s relationship with the federal government and explains why the middlemen are left alone with their booty as lawmakers, who rely on lobbyists’ money to get themselves reelected, turn a blind eye to anticompetitive, self-dealing business practices such as secret, sole source contracts that manipulate pricing and cause drug shortages. If just 10% of the $200 billion these middlemen bilk from our healthcare dollars through this loophole is spent lobbying, that’s a cool $20 billion they use to influence and buy favor. While politicians get re-elected and middlemen get rich, patients get gouged financially, get sicker, and needlessly die- as reported in the recent case of a young diabetic who died because he could not afford his insulin. The PBMs are to blame for a recent 300% increase in the cost of insulin. The enormous frustration I experience as a physician, is exceeded only by that I experience as a patient.

 

One month ago, a young physician mom in the last month of her residency was admitted to deliver her first baby boy. Suddenly, she sustained a complete placental abruption requiring emergency C-section and blood transfusion. Thanks to the quick, brilliant actions of the OB/Gyn, general surgeon, anesthesiologist, and labor and delivery team, both mother and baby survived this potentially fatal event. During the baby’s 16 day stay in the Neonatal Intensive Care Unit (NICU) , the astute neonatologist consulted a pediatric cardiologist, who fortunately happened to be one of 150 pediatric electrophysiologists in the country. He clinically diagnosed Congenital Long Q-T syndrome, a diagnosis that can only be confirmed by genetic testing. The hospital and insurance company balked at the physician’s order for genetic testing, which was delayed until sufficient administrative third party hurdles had been jumped. You see, physicians’ orders, including prescriptions for medications and medical devices, are now largely regarded as requests by the all-powerful hospital and insurance industries. The insurance company would not approve anything until the newborn had been entered into their system and informed the parents (who had already notified their employer, through which they got their insurance, of the birth) this could take 5-7 working days or longer. Until then, (even though in reality the baby was living in the NICU surrounded by the best doctors and nurses in Texas), the baby did not exist to the insurer, and they could make no determinations as to whether they would cover anything. The delay in diagnosis could prove fatal for the baby, who is at increased risk for sudden cardiac arrest if treated with inappropriate medications or denied protective drugs and devices. The decision was made to presumptively start the baby on protective medications and send him home with breathing monitors and an AED in case his heart stopped, pending the results of his genetic testing. The insurance company refused to cover the $1400.00 defibrillator, but fortunately, the baby’s mom was able to charge it to her credit card- knowing full well that she most likely would never be reimbursed (in spite of her onerous, monthly premiums, high copays, and huge $8500.00 family deductible.) She had spent a significant portion of medical school, internship, and residency working on prior authorizations and other obstacles to patient care thrown up by insurance companies and their PBMs. The fact that our physicians in training are used as pawns of PBMs, insurance companies and hospitals as glorified billing agents in this deadly game of delay and deny care for profit is pathetic in and of itself.

 

The mother was blessed that she and her husband could afford the defibrillator, which the insurance company refused to cover, because following hospital discharge, the results of the genetic test confirmed the diagnosis of Long QT Syndrome. Fortunately, the physicians had fought those “insurers,” who claim they must follow “process,” even if flawed. The insurance company’s business “process” includes delay and denial of care and even the ridiculous notion that the baby, who was in the NICU, did not exist for the arbitrary 5-7 day insurance company window needed to enter the baby’s data into their system. Imagine the expense of keeping the baby in the NICU even longer waiting on insurance nonsense. Imagine if a parent could not afford the defibrillator, and the baby was sent home from the NICU only to die, because the parents couldn’t afford what the doctor ordered but the insurer denied. The parents are less likely to be able to afford the $1400.00 defibrillator, because they have already handed over an exorbitant amount of money to the insurance company in the form of exorbitant monthly premiums (in addition to what the employer pays), co-pays, deductibles, and cost-sharing. We have not even factored in lost productivity for the parents and wasted resources of a neonatologist and pediatric cardiac electrophysiologist groveling for authorization for medical devices and genetic testing that determines appropriate diagnosis and treatment of the patient.

 

Once home the baby thrived but developed a tear duct infection common in infants. This condition responds beautifully to early treatment with antibiotic eye ointment but can require I.V. antibiotics and readmission to the hospital if it progresses. A person with long QT syndrome can be thrown in to sudden cardiac arrest if given improper medications that further prolong the long QT interval. The baby was accordingly prescribed Bacitracin ophthalmic ointment instead of erythromycin ophthalmic ointment, which can prolong the QT causing the heart to speed up and then stop beating. A baby’s skin is very thin and even topical medications can be absorbed into the body.

 

Bacitracin ophthalmic ointment is a drug that has been around for over 20 years and used to be very inexpensive; however, as a result of the medication middlemen and their secretive business dealings, it is now very expensive. It also did not make the cut to be listed on the United Healthcare formulary. The patient’s neighborhood pharmacy told the baby’s mother would cost $101.00 for a tiny 3.5 gram tube, and United Healthcare refused to cover it. Further insanity ensued. The United Healthcare Representative said the baby’s birthday was wrong- which it wasn’t- and that he had not met his deductible- which after 16 days in the NICU for him and 3 hospital admissions and emergency surgery for his mom, he most certainly had. The representative said he could have the erythromycin only, in spite of the pleas from the baby’s mom, a physician, who informed her the erythromycin could put the baby at risk for sudden death. This all required hours of waiting, recording, script reading, template following, transferring, holding, and discussing on the phone. The physician’s staff was simultaneously spending hours on this, as was the pharmacy. (United Optum teams up with CVS and Walgreens to the detriment of other pharmacies, and that’s another story that warrants discussion too.) So, the baby went without treatment for another 24 hours.

 

The baby’s mom tried to get access to the United formulary to see what was listed and would be covered at what tier. The representative told the mom the only way was to enter each potential drug into their website to see if it was covered, and said sending a hard copy or online copy of the formulary was not possible. The insurance was purchased through the baby’s parent’s employer who then became involved as well, as access to a formulary was pursued. The parent’s employer referred them to a MyUHC website. Not easily, the physician’s staff was able to access an online United Healthcare formulary that listed gentamicin ophthalmic ointment as tier 1, so this was then called in to the patient’s chosen pharmacy- only to be called back by the pharmacy that said there is a drug shortage and the gentamicin ophthalmic ointment is back ordered for months. Finally, another UnitedOptum formulary was found that said tobramycin drops were covered, so this was then ordered, even though it is a drop with more toxicity to the eye and not as good as an ointment for an infant in this scenario. The mom therefore decided they had worn her down, broken her, and her baby needed the medication the doctor had ordered- she would just have to go ahead and pay the $101.00 to get the best medication for the baby- and she felt blessed to once again be able to charge it on her credit card. She also grievd for all the other mom’s who could not afford to detour around the insurance obstacle course. Ironically, she could buy the Bacitracin ophthalmic ointment cheaper by not going through her insurance and using a Good Rx coupon, but this would once again require calling the physician’s office to call another prescription in to another pharmacy, and time was ticking by and serious manpower had already been squandered on patient, physician, and pharmacy ends. She could have also gotten it for less at CVS or Walgreens who have deals with United Healthcare and their PBM, OptumRx, as well- but again, more calls and delays. Finally, if point of service dispensing was legal in Texas, as it is in 44 other states, she could buy the exact medication the doctor prescribes in the doctor’s office at cost plus a couple dollars as she checks out at the front desk, administer it to the baby immediately, and forgo the run around altogether. But, is this the intent of the insurance obstacle course in the first place? Make things so difficult, that patients just give up and pay for themselves or doctors supply samples.

 

The United representative informed the baby’s mom, the case is now open, and a team is looking into covering the bacitracin since the erythromycin is contraindicated and the gentamicin is backordered, but that they have 48-72 hours to respond (and of course July 4th is in the window). The mom asked, “Do you not agree that an infection can significantly progress in a baby in 48-72 hour?” (This is a one-month-old baby, mind you.) So, she was placed on hold again, waiting to talk to an “escalation team.” The United representative returned to tell her it will take 5-7 days to get the issue resolved per the “escalation team.” So, the baby’s distraught mother asked “Does a human life matter?” Their solution was for her to pay the $100.00 then submit a claim form to try to get reimbursed retroactively. (LOL-which they will deny-and it is the mom’s responsibility to find the appropriate form and submit it to the appropriate entity.) The exhausted mother, who had just nearly died giving birth to a son she had nearly lost and now was sick in need of meds, inhaled and stated, “ So, you’re asking me to charge $101.00 on my credit card, which is an amount a lot of people can’t afford, because it takes y’all 5-7 days to resolve an issue that we know the solution for.” The representative replied, “Yes,” but you can fill out a medical claim form to try to get reimbursed.” The exasperated mom replied, “I’m a physician, so I know that you’ll deny the claim, because no one will take the time to review our case.” I ask, are you incompetent or immoral, United Healthcare?

 

I contend, the business model employed by the insurance company, its PBM, and favored pharmacies is perverse and immoral-and intentional. I contend the business model is designed to increase profit by delaying and denying care to patients. Prior authorizations, step edits, quantity limits, tiers, restricted formularies, and so on are all perverse business inventions intended to wear us out, physicians and patients, to the point we won’t finish their obstacle course. This is by design. Think about it, while small town physicians like me, my father before me, and two of my four daughters after me, endured 4 years of college, 4 years of medical school, and 4 or more years of internship and residency, sacrificing much to endure a rite of passage required of us in our pursuit of the ability to care for others as their physicians and surgeons, those in big insurance and big government like Andy Slavitt of United Optum and CMS went to Wharton Business School, got MBAs at Harvard, and worked on Wall Street in their pursuit of making money and amassing power through money. And what better commodity for them than patients’ lives?

 

Physicians work to serve our patients; insurers work to serve their stockholders. The government takes patients’ money in the form of taxes and transfers it to the insurance companies in the form of subsidies, premium support, managed are contracts, tax benefits and so on and on top of what patients and employers pay to the insurance companies as well. The insurance companies receive hundreds of billions of dollars from patients directly, from their employers, and from the government; they keep the money by delaying and denying our care. They are the de facto rationers. We are their commodity, an annoying but necessary inconvenience. All they need to do is run their numbers just right to make it look like not too many of us are dying too soon or too uncomfortably. And they must keep us quiet. Their definition of success is to best serve their stockholders. This requires least serving their patients. Keeping our money in their bank accounts even a day longer results in hundreds of millions of dollars in profit from interest alone in the long run. Each extra obstacle, each hour we linger on the phone, each day we wait for their “escalation team” to decide our fate… escalates their bottom line and our blood pressure. Think about it, when we buy our own meds, they win. When we can’t afford to buy our meds and go without, they win. When physicians tide patients over with samples and provide pro bono care, insurers win- but so do we, because that is our definition of success, serving our patients. That’s why the buck stops with us, the patients and physicians of America. The enormous frustration I experience as a physician and patient, is exceeded only by that I experience as a mother and grandmother.

 

I thank God for my amazing physician colleagues who saved the lives of my precious physician daughter and her precious baby boy, my first grandson, and I praise God for my amazing community of faith, replete with the incredible prayer warriors who prayed with us and for us without ceasing as we walked that valley. I thank God, the ultimate healer, that this community includes the most incredible, life loving, patient serving physicians, pastors, and healthcare professionals across the country who are willing to take on this scam.

 

We must shine the light on these perverse insurance business practices and processes. We must shine the light on the corrupt, racketeering PBMs. As physicians we must not be oppressed and live in fear of being fired as employees or kicked off insurance networks. We must do what’s right in our lives of service to our patients. We must become doctors again. Our patients’ lives depend on us. This will take patients and physicians refusing to run the insurance/PBM obstacle course, exposing the insurance tricks and traps, and demanding our elected representatives close the middlemen loophole that allows PBMs and GPOs to bilk us for over $200 billion per year while we experience inflated drug costs, drug shortages, poor access to drugs, and stifled innovation. While we don’t have $20 billion to lobby on Capitol Hill, we have the vote. This is not a partisan issue. This affects every single American. We must unite on this, America, all of us. Will we unite or will we continue on this never-ending immoral obstacle course- which is it America?

 

 

 

 

 

 

 

 

Stop the middlemen’s legalized kickback scheme! Repeal the anti-kickback exclusion for GPOs and PBMs. Save patients, not middlemen.

Please read and understand the following from my two dear physician colleagues Dr. Bob Campbell, Founder of Physicians Against Drug Shortages, and Dr. C.L. Gray Founder of Physicians For Reform and author of The Battle for America’s Soul. America, we must wake up and act! We are being bilked for $200 billion annually by heartless, unethical profiteers who via unintended consequences of a loophole in federal law have legalized a pay-to-play, kickback scheme beyond the wildest imagination. What’s most disturbing is that what they are doing not only results in our prescription drugs and medical devices being exorbitantly expensive, but the drugs and devices available to us on insurance formularies or in the hospital are determined by these unethical business dealings rather than what doctors believe is best for patients. Further, innovation is squelched as is the production of generics and free market competition. These underhanded business deals are also the cause of drug shortages nationwide, and THEY DON’T CARE! They want the $- patients be damned. We must educate our Congressional Representatives and Senators and demand repeal of this loophole.

 

Lowering Healthcare Costs through Safe Harbor Repeal

 

CL Gray, MD

Robert Campbell, MD

January 9, 2018

 

Abstract

 

The 1987 Medicare Anti-Kickback Safe Harbor statute exempted hospital Group Purchasing Organizations (in-patient side) and later, Pharmacy Benefit Managers (out-patient side), from criminal penalties for taking rebates/kickbacks from suppliers. This law unintentionally created a $600+ billion nationwide distribution monopoly of medical supplies and medications.

 

While legal, this misguided “Safe Harbor” statute gave rise to an unimaginably corrupt pay-to-play system. This distribution monopoly collects administrative fees, marketing fees, advances, conversion fees, pre-bates, rebates, and “sharebacks” simply to let a given medication or medical device gain access to the healthcare marketplace. These fees add an estimated $200 billion of unnecessary expense to American healthcare every year. In short, the 1987 “Safe Harbor” statute legalizes contracts and payments that in any other industry would be subject to criminal prosecution.

 

Repeal of the “Safe Harbor” provision would reduce costs of drugs and healthcare supplies by an estimated 30% and save Medicare and Medicaid approximately $75 billion annually. Over time, renewed free market competition would produce additional innovation and further cost reductions.

 

The Players

 

  • Hospital Group Purchasing Organizations (GPOs) control the purchase of over $300 billion annually of drugs, devices and supplies for about 5,000 hospitals and thousands more outpatient clinics and alternative care facilities.

 

The GPO industry is highly concentrated. According to the Government Accountability Office (GAO), four giant GPOs account for over 90% of total annual GPO contracting volume. In size order, they are:

1) Vizient Inc.

2) Premier Inc.

3) HealthTrust

4) Intalere

 

  • In 2003, Pharmacy Benefit Managers (PBMs) quietly asserted control over outpatient drugs and devices after petitioning HHS OIG to extend the “Safe Harbor Law” to cover the PBM industry. Drug manufacturers compete with each other to get their products on PBM formularies by paying ever-larger rebates/ kickbacks. They then raise their prices to offset these excess costs.

 

The PBM industry is highly concentrated as well. Three huge companies control over 80% of the PBM market and more than 70% of all prescriptions dispensed in the United States. In 2016, these three PBMs reported aggregate net revenue of $303.7 billion. In size order, they are:

1) UnitedHealth Group

2) CVS Caremark

3) Express Scripts

 

  • To give a sense of the magnitude and power of this distribution monopoly, in December of 2017, CVS Caremark (the largest PBM) announced its $69 billion purchase of Aetna (the nation’s largest health insurer). This is the market equivalent of a trucking company that delivers soft drinks purchasing Coca-Cola or Pepsi.

 

Background

 

In brief, here is how this system works:

 

  • Long before online ordering and “just-in-time” inventory, the first hospital GPO was founded in New York City in 1910. GPOs were specifically developed to reduce members’ supply costs by buying in bulk. Under that cooperative business model, hospitals paid dues to the GPOs to cover administrative expenses. By design, the “bulk savings” outweighed the “administrative” costs.

 

That system worked well for about 80 years because GPOs served member hospitals. Payments and incentives aligned with consumer interests.

 

  • That business model changed in 1987 when Congress enacted the anti-kickback “Safe Harbor” provision. GPOs were now exempted from criminal prosecution for taking kickbacks from healthcare suppliers. After the Inspector General of the Department of Health and Human Services implemented the “Safe Harbor” rules in 1991, vendors, not hospitals, paid GPO “administrative” expenses.

 

Rather than reducing costs for member hospitals, GPOs could now extract a variety of fees from both suppliers and the medical supply chain for the “privilege” of a given medication or medical device gaining access to the healthcare market. Rather of serving member hospitals by cutting costs, GPOs rapidly became a highly paid middleman.

 

  • While GPO’s service the in-patient side, the PBM industry services the out-patient side. PBMs allocate market share and may confer “Preferred Distributor” status to middle market distributors. (Sometimes these distributors are entirely owned by PBM shell corporations.) PBMs use secret contracts to manipulate pricing. Manufacturers and distributors unwilling or unable to pay the kickbacks are removed from the supply chain.

 

  • Predictably, this gave rise to a pay-to-play system. Suppliers literally buy market share by paying exorbitant fees to the GPOs/PBMs in return for contracts giving their products exclusive access to GPO-member hospitals and PBM preferred distributors.

 

This system created supplier monopolies by slashing the number of suppliers of vital generic drugs, devices, and other medical supplies; it also discouraged potential competitors from entering the marketplace. Most importantly, the GPO/PBM cartel is a powerful Buyers’ Monopoly, or Monopsony. This is the rarest and most harmful type of monopoly.

 

  • Under this perverse system, purchasing agents, not clinicians, typically decide which drugs, medical devices and supplies physicians can use for their patients. These decisions are based largely on how much kickback revenue these products generate for the GPO or PBM, not what is best for patients. Patients and healthcare workers are often denied access to lifesaving, cost-effective goods including drugs, hip implants, pacemakers, pulse oximeters, safety needles and countless other products.

 

  • Under the safe harbor rules, “admin” fees were to be limited to 3% of sales. If they exceeded that amount, the GPOs were supposed to report the fees to their member hospitals. The available evidence indicates that totalkickbacks paid by suppliers to GPOs/PBMs have often exceeded half of the suppliers’ annual revenue for a single drug! Because kickbacks are generated on a percentage of total contract volume (sales), the higher the price of a medication or medical device, the larger the kickback for the GPO/PBM.

 

  • The HHS Inspector General was empowered to request data excess GPO/PBM fees. However, it has often chosen not to do so. In fact, a 2012 GAO investigation—requested by three U.S. Senators—found that the HHS OIG had not exercised its oversight authority in years.

 

  • These anti-competitive contracting and pricing practices, self-dealing, conflicts of interest and other abuses have forced many firms to stop making inexpensive generic drugs rather than produce them at a loss. They’ve also crippled the ability of other manufacturers to maintain their plants, equipment, and quality control, resulting in tainted drugs, adverse FDA inspections, and plant closings.

 

  • The deadly 2012 meningitis outbreak, which was caused by contaminated drugs sold by an unregulated compounding pharmacy, was a direct result of this crisis. After two FDA-regulated generic drug makers stopped making a widely-used steroid pain killer because it had become unprofitable, many providers were forced to buy this medication from now-shuttered New England Compounding Center (NECC).

 

  • Years before the drug shortages made headlines, four Senate Antitrust Subcommittee hearings, federal and state investigations, media exposés, antitrust lawsuits and independent academic studies found that GPOs, instead of saving money for hospitals by purchasing in bulk, actually inflatedhealthcare costs.

 

  • Various investigations revealed that many GPO and hospital executives have enriched themselves personally through this system. GPO executives have received stock options in firms they do business with, while hospital officials have gotten “patronage fees” and “sharebacks” from GPOs and lavish perks from suppliers.

 

  • Thanks to aggressive GPO/PBM lobbying and campaign contributions, there is virtually no disclosure, transparency, regulation, or oversight of the powerful, secretive GPO/PBM industry. Few, if any, outsiders know where the billions of dollars are going.

 

Action Item/Recommendations

Physicians for Reform (PFR) is helping assemble and lead a broad network of organizations to reframe the healthcare debate and lay out a free-market, patient centered vision for the future of American healthcare. Repealing the “Safe Harbor” law is the first of twelve separate reforms.

 

Physicians Against Drug Shortages (PADS) is a key member of this network. For the past six years Dr. Robert Campbell, PADS chair and co-founder, and his colleagues have investigated this issue at the highest levels. They have concluded there is no path to affordable, high quality healthcare until free-market competition is restored to the drug/medical supply marketplace. This is possible only if Congress repeals the 1987 Medicare anti-kickback “Safe Harbor” provision.

 

Legislation has already been drafted in both the House and the Senate. However, we must change the politics of the issue through public education before these bills can be successfully brought to the floor. This represents a unique and historic opportunity to save money, save lives, and make American healthcare great again.

 

Please contact us if we can be of further service.

 

Sincerely,

 

 

 

CL Gray, MD

President, Physicians for Reform

 

 

Robert Campbell, MD

Chairman, Physicians Against Drug Shortages

 

Time to stand against obstructionist insurance company nonsense- real life insanity from the trenches

Insanity reigns, and we must dethrone it. Today, a precious new patient sought my care. She is 28 and was perfectly healthy until 10 days ago when she developed a headache and then rather suddenly started to lose vision in her left eye. She was scared and waited a day or so hoping things would get better, but they’re not, they’re worsening. She confided in her mom who brought her in to see me, based on the recommendations of friends. I’m an M.D., a board certified ophthalmologist, having completed 4 years of college, 4 years of medical school, an internship in internal medicine, a three year residency in ophthalmology and ophthalmic surgery, 5 years on faculty as an attending physician at the medical school, and 23 years in private practice.

 

The patient and I engaged in a patient-physician relationship, and I obtained her medical history and examined her. This dear patient needs an immediate work up to make a definitive diagnosis, so that appropriate treatment can be implemented before she loses her vision or worse. She is worried, and so are her mom and I. According to standard practice, I arranged for her to have an immediate MRI scan of her brain. This is where the obstruction to her care began. The obstructionist is Blue Cross Blue Shield (BCBS), her “insurance company.”

 

BCBS will not authorize her MRI, because she is an HMO patient and has not seen her assigned “PCP” (primary care physician). If you have a BCBS HMO plan, you must see your PCP before BCBS will cover anything- even if deemed indicated by a board certified specialist. Your designated PCP is your gatekeeper, and there are no exceptions. She has not seen her PCP since having the BCBS HMO policy, because she is 28 and healthy. Apparently BCBS randomly assigned her a PCP, but the physician listed could not be located today, and no one was “on call” for her. In fact, the number listed seemed to be out of business. It just rang and then disconnected time after time. Sadly, there is a scarcity of PCP’s, and it can take months for a patient to get an appointment. Often, PCPs listed by the insurance companies are not actually “in network”, not accepting new patients, not in town anymore, not even in business, or not even practicing medicine anymore. My staff spent hours today trying to ascertain this PCP’s status and obtain authorization for the MRI, to no avail. I called and spent over an hour on hold and talking to various levels of BCBS employees working my way up the ladder through non medical personnel to finally speak to a nurse (God forbid I should get to speak to an actual physician colleague), who tried to get her manager to approve my patient’s MRI. This was all a massive waste of time as BCBS was unyielding. I was told all the usual things, sorry, this is policy, there’s nothing we can do, and even “maybe next time she won’t get the HMO plan.” I was informed all our conversations were being recorded for quality purposes, and I was glad. No one would believe the irrational nonsense I had to endure at the hand of these non-physician BCBS obstructionists without the recordings to prove it. At the end of the day, in spite of my pleas and appeals for rational behavior and ethical care, BCBS said NO, AKA- patient be damned, and screw you while you’re at it.

 

My patient can go to the emergency room tonight, and get the MRI at thousands upon thousands of dollars extra and hours upon hours of waiting and NOT seeing a specialist, and that will be covered. What a waste of valuable resources and abuse of the patient. The MRI I, a specialist, scheduled for this afternoon will not be covered. Further, BCBS negotiated a fee for the MRI of over $4000.00. The patient’s deductible is high. She will have to pay thousands. Ironically, I am an “out of network” physician. I will not enter into agreements with “insurance companies.” I only enter into agreements directly with my patients. I negotiated directly with a local imaging center a fee for the MRI at a fraction of the cost- $350.00. Much to my surprise, the radiologists’ practice has just been purchased by a 3rd party venture capitalist group, and the fee has increased to $550.00 and growing. Still, $550.00 is much less than the $4000.00 BCBS negotiated. This is all one big hot mess.

 

My patient went home with her mom. She is worried sick and asked me for sedatives to get her through the night. I refused, tried to reassure her, and gave her marching orders. If she suddenly gets worse, she will got to the E.R. BCBS will pay thousands of dollars extra, but the MRI will get done, and she will get actual medical care. It’s all a crapshoot now. God willing, she will make it through the night, and I will literally beg a colleague who is listed as a BCBS “in-network” provider to see her tomorrow to sign off on my (the specialist to whom he would have sent her in the first place) orders for the MRI. We’re hoping it helps that her mom went to high school with him, and I can name drop that to get her in before a few months. Then BCBS will hopefully authorize the MRI. It will most likely cost the patient significantly more money, but will at least “apply to her deductible.” Again, this is all convoluted, irrational, and unethical.

 

I am fed up. I can’t play this game. Patients will be harmed, and no doubt patients will die needlessly, because of insurance “policy.” For the second year in a row, the life expectancy in the USA has gone down- what does that tell you about the corporate practice of medicine? I accused BCBS of malpractice and the unethical obstruction of indicated patient care. I can’t sleep, because I am worried about my patient and angry that the tail is wagging the dog in the name of “universal coverage,” which is a scam, garbage, especially if you bought the HMO plan. And just know this, the ACA, MACRA, and the cascade of failed federal “healthcare” laws, rules, and regulations are all part of a top-down, government scheme for HMO’s on steroids, now called ACO’s (accountable care organizations) or APMs (alternative payment models). It is one giant insane mess. This mess benefits the insurance companies and the central planners. I will continue my fight for this patient in a few short hours. I pray she will get through this ordeal- a medical fiasco, pot stirred and fire stoked by BCBS, and its unethical, rigid, nonsensical, wasteful policies.

 

I call on my physician colleagues to refuse to put up with this anymore. They can’t do it without our consent. I call on my patient colleagues (we are all patients, I have cancer among other things- how about you?) to demand the insurance companies deliver. We are paying these companies thousands upon thousands at the individual and family levels and hundreds of billions at the national level to do what- obstruct, delay, deny, ration our care for their bottom line? Just think of the money from interest alone they make on a month of delays and denials. This insanity must stop. If all physicians would give the few remaining insurance companies a 90 day without cause severance notification tomorrow this would end in short order. Patients must stand up to the insurance companies too. Patients must read the fine print and know what they have signed up for and agreed to. Lawsuits against the obstructionist, rationing insurance companies will be essential. The time is now.