President Trump’s Salute to Patients Promises Welcome Changes, But Special Interests Attack

The week before President Trump’s Independence Day “Salute to America” he gave a welcome Salute to Patients when he signed Executive Order 13877, “Improving Price and Quality Transparency in American Healthcare To Put Patients First.”

As free market champion Dr. Keith Smith of the Surgery Center of Oklahoma puts it, the “healthcare industry price gougers wore out their welcome” and were “kicked to the curb by President Trump.”

What does the order do? Its first priority is to end “opaque pricing structures,” that “benefit powerful special interest groups, such as large hospital systems and insurance companies,” but, “generally leave patients and taxpayers worse off than would a more transparent system.”

But there’s more: the order also aims to “enhance patients’ control over their own healthcare resources” by removing failed policies that impede patients from choosing to enroll in affordable Direct Primary Care practices or alternatives to big insurance like Health Care Sharing Ministries.

The bottom line is increasing patient freedom and choice is the centerpiece of President Trump’s order. However, make no mistake, it is also put a target squarely on the middlemen who have for too long taken advantage of backroom deals made with government cronies. And the middlemen are already fighting back with a vengeance and working to undermine the order.

Underestimating the special interests’ power to stop the good changes is not an option. Just last week the Pharmacy Benefits Manager (PBM) cartel killed a White House proposal that would begin to unwind corrupt kickbacks that result in out of control price hikes for life saving drugs through disingenuous propaganda that lower prices would somehow raise premiums.

And the fake news campaigns about the Transparency Order are already underway.

Thankfully physicians like Chad Savage, MD are debunking the industry lies:

No price transparency will not lead to higher prices. “This is akin to saying the best way to get a good price on a new Sony TV is to have no idea what it costs. If someone said that to you, you would rightly reject any future advice from that individual,” explains Dr. Savage.

Marni Jamison of the Association of Independent Doctors exposes another tactic of those who oppose transparency:

The cronies are “lawyering and lobbying up, busily working to undermine, narrow and water down the order. They are not going to give up the hundreds of billions of excess dollars flowing their way easily,” she writes and shares examples of weasel words insurers and mega health systems will attempt to use to corrupt the outcome.

Middlemen’s fingerprints are already evident on the order itself to some extent. For example the “Health Quality Roadmap” provisions empower the use of failed quality metrics that are already driving up the cost of care with out any benefit to outcomes. “Practitioners who practice according to the needs of their individual patients, not according to some standardized protocol approved by a third party whose only focus may be efficiency and cost-cutting, may be penalized,” warns Twila Brase of the Citizens’ Council for Health Freedom and award-winning author of Big Brother in the Exam Room. AAPS, while overall supportive of the order, flagged provisions as potentially harmful to privacy rights and urged that “patients’ right to consent to use of their data must also be respected.”

Winning these battles for patients and those who care for them will not be easy! But nothing worthwhile ever is. So let’s all Salute President Trump for taking these bold steps by stepping to help him fend off the special interests trying to thwart his welcome orders.

Do You Really Want A Unique Patient ID?

The House just passed a bill that eliminates the prohibition on the use of federal funding to assign all Americans a unique medical identifier. Former Congressman Ron Paul, M.D., got that prohibition enacted in 1998.

            The identifier is supposed to improve “efficiency”—of what? Government surveillance of all Americans? The agenda of government-favored special interests, who might want to silence persons with political views they don’t like? Persons who might see you as a threat to their success in business, academia, or other ventures?

            What might be in your record? A prescription for Valium or other drug prescribed during a distressing life crisis? This could be a psychiatric “red flag” causing denial of your gun rights. A diagnosis of a sexually transmitted disease? An admission that you had a temper tantrum or used an illegal drug at a party? Could this derail a job application or cause you to lose child custody or foreclose a political career?

            Can you be honest with your doctor if anything in the record might someday be used against you?

            “Make no mistake. The [patient identifier] would be the end of privacy and the foundation of a national health data system,” warns Twila Brase, president of the Citizens’ Council for Health Freedom and author of Big Brother in the Exam Room.

            The damaging information in the record might not even be yours. A hurried data-entry person might have clicked the wrong item on a drop-down menu or even cut-and-pasted something from another patient’s electronic health record.

            The prohibition on funding for the unique identifier needs to be restored, states the Association of American Physicians and Surgeons (AAPS).

Further information:

       

Faux Fight in DC Against the Financial Foolery in Healthcare

TO THE READER: In the bold, black font below, you see parts of a paper provided by Rep. Frank Pallone, Jr. (D-NJ, 3rd District), in anticipation of hearings held on May 9, 2019, by the Committee on Energy & Commerce of the U. S. House of Representatives. Rep. Pallone chairs the committee. The subject of the hearing? “Lowering Prescription Drug Prices: Deconstructing the Drug Supply Chain.”

In the bold, green font (with blue embedded links to sources), you see our comments on elements of the paper, and most particularly on points of fact that were omitted. Those omissions are telling. They reveal not only how politicians are beholden to very powerful lobbying interests inside the drug supply chain, but also the politicians’ lack of seriousness in fighting to reduce America’s disgraceful annual wastage of dollars spent on healthcare.  CLICK HERE FOR PDF FILE OF DOCUMENT WITH COMMENTS.

There are fighters, and then there are the faux fighters. The latter will choose the photo op and optics over substance every time. It’s what they do. It’s who they are.

Here is the lineup for the panels in the hearings of May 9 as found in the paper provided by Rep. Pallone.

Panel I

Justin McCarthy, Senior Vice President, Patient & Health Impact Group (Pfizer)
Kave Niksefat, Vice President, Value and Access (Amgen)
Jeffrey Hessekiel, Executive Vice President & General Counsel (Exelixis)
Amy Bricker, Senior Vice President, Supply Chain (Express Scripts)
Brent Eberle, Chief Pharmacy Officer (Navitus Health Solutions)

Panel II

Estay Greene, Vice President of Pharmacy Services (Blue Cross Blue Shield of North Carolina)
Lynn Eshenbacher, Chief Pharmacy Officer (Ascension)
Jack Resneck, M.D., Chair, Board of Trustees (American Medical Association)
Richard Ashworth, President of Pharmacy (Walgreens)
Leigh Purvis, Director of Health Services Research (AARP)


I. THE DRUG SUPPLY CHAIN

A. Pharmaceutical Manufacturers

Pharmaceutical manufacturers research, develop, and produce drugs. Once the Food and Drug Administration (FDA) approves a drug for purposes of marketing, the pharmaceutical manufacturer establishes a list price (also known as the wholesale acquisition cost). The list price could be determined by a number of factors such as research and development costs, demand, market competition, and manufacturing and marketing costs. Notwithstanding these factors, manufacturers may set any price they choose.

Manufacturers earn revenue when pharmacies, hospitals, and other health care entities purchase their drugs. For 2017, drug manufacturers earned about $324 billion in net revenues.

COMMENTS:

In his first sentence above, Rep. Pallone has identified who really does the serious work in the drug supply chain. All of the rest are middlemen, third-party payers, prescribers, dispensers, or consumers, none of whom are involved in research, development, or production.

The figure for total net revenues in the industry averages out to $1.7 billion for the over 190  pharmaceutical companies in the United States, which are responsible for 4.8 million American jobs, jobs that have been among the best in the country for years, attracting high achievers from the schools of the relevant sciences.

The U.S. is the preeminent manufacturer in the worldwide pharmaceutical market by a wide margin over its nearest competitor. We are also the largest market for pharmaceutical products. In short, the American pharmaceutical industry is indispensable. It’s where the most-serious work in the drug supply chain is done.

What is glaringly omitted from the “factors” that Rep. Pallone identifies as influencing a drug’s list price? The kickbacks (euphemized as “rebates”) that middlemen in the supply chain—the Pharmacy Benefit Managers (PBMs) and Group Purchasing Organizations (GPOs)—are allowed to accept without fear of prosecution.

The type of drug affects the manufacturer’s costs, as well as the revenue a company earns. Generally, small molecule drugs and their bioequivalent competitors, generic drugs, are cheaper to develop and have a lower list price than biologics. Biologics are made from living organisms and are used to treat serious diseases such as cancer, rheumatoid arthritis, and multiple sclerosis. Biologics often launch at very high prices, with annual list prices reaching tens of thousands of dollars. In addition, unlike the small molecule drug market, many biologics still do not face competition from biosimilar or interchangeable biological products. In 2017, biologics represented two percent of all U.S. prescriptions, but 37 percent of net drug spending. Generic drugs represent nearly 90 percent of all U.S. prescriptions, but only 23 percent of net drug spending.

In 2017, total retail drug spending was $333.4 billion, 6 which was a 0.4 percent year over-year increase from 2016. The key drivers of the slower growth in spending were a continued shift to lower-cost generic drugs and slower sales volume growth in some high-cost drugs.

COMMENTS:

Biologics received extended patent protection as part of a deal to grease Congress’s passage of the Affordable Care Act (detailed on pages 99-102 and 132-133 in America’s Bitter Pill, by Stephen Brill, an outcome for which Amgen alone spent $38 million on lobbying. NOTE: Amgen is represented in the panel testifying on May 9 before the House’s Committee on Energy & Commerce). And, yes, the makers of biologics enjoy large profits; the politicians who extended the period of patent protection to gain support for the ACA saw to that. There’s more than a little irony on display when we see politicians who supported the ACA vigorously (did they have to pass it to find out what was in it?) now pointing at BIG PHARMA as a notable culprit in the search for excessive cost in the drug supply chain. The top biologic, Humira, pulled in over $18 billion in revenues in 2017.

B. Pharmacy Benefits Managers (PBMs)

Pharmacy Benefit Managers (PBMs) are third-party firms hired by insurers, federal health programs, and plan sponsors to manage and administer the prescription drug benefits of health insurance coverage. This includes negotiating the prices of drugs to create formularies, as well as deciding which pharmacies are included in a plan’s network. Formularies developed by PBMs play a role in determining the cost of a prescription drug. The formulary is used to negotiate rebates and discounts with manufacturers, but it is also used to manage prescription drug use and spending by plan members. For example, cost-sharing, drug coverage, prior authorization, and member cost are all determined through a formulary. PBMs also negotiate fees and services with pharmacies, fees that may be based on each filled prescription.

PBMs mostly earn revenue by charging fees to the plans, pharmacies, and drug manufacturers, as well as by keeping a portion of the rebate they negotiate with the drug manufacturers. Increasingly, the large PBMs also earn revenue through the ownership of other parts of the supply chain including insurers and specialty pharmacies. Three companies cover about 70 percent of all prescription claims in the United States: CVS Health, Express Scripts, and UnitedHealth Group. According to one study, the PBM industry had an estimated gross profit of $23 billion in 2016.

COMMENTS:

The top PBMs have annual revenues in excess of $100 billion. This is astonishing. As of 2003, by grant of the Health and Human Services secretary at the time, these middlemen were granted a “safe harbor” from prosecution for receiving money (again, kickbacks) from drug manufacturers. In turn, the middlemen then identify the drugs that go into the formularies of the insurance companies. This is the very definition of a pay-to-play arrangement.

The arithmetic is breathtaking—the middlemen have revenues nearly 100 times as large as the companies that actually do the research and make the drugs.

When it comes to deconstructing the drug supply chain and figuring out where high and unreasonable costs are being injected into the chain, wouldn’t it make sense to mention this obvious fact when passing out white hats and black hats?

C. Insurers

Health plans assume the financial risk for the cost of drugs their customers receive as part of offering a prescription drug benefit. Insurers such as Medicare, Medicaid, private insurance companies, and self-insured large employers reimburse pharmacies, hospitals, and other healthcare entities for the amount paid to purchase the drug and related fees. The actual amount paid by the healthcare entities is confidential; therefore, insurers generally can only estimate the reimbursement amount.

Plans manage the prescription drug benefit by contracting with an external PBM, operating their own PBMs, or by purchasing drugs directly from manufacturers and dispensing the medication to consumers at their own pharmacies.

Plans earn revenue when the premiums they charge exceed the health care claims they pay. Plans use a range of strategies to hold down their drug costs, including through:

  • Formulary tiers (varying cost-sharing to encourage preferred or low-cost generic drugs);
  • Prior authorization (a physician must obtain approval from the insurer prior to prescribing a particular medication);
  • Step-therapy (a physician must begin treatment using the most cost-effective drug therapy before moving to more costly therapies if necessary); and
  • Cost-sharing and copayments (when a patient must pay a portion of health care costs not covered by the health insurance plan).

D. Hospitals and Physicians

Hospitals and physicians will often purchase large volumes of drugs from manufacturers or wholesalers through Group Purchasing Organizations (GPOs). GPOs help hospitals and physicians aggregate purchasing volume to negotiate discounts with manufacturers and distributors. If the physician or a hospital administers a drug to a patient, then the physician or hospital will use a buy-and-bill model, meaning that they will purchase the drug from a manufacturer first (sometimes with the help of a GPO), and then bill for it after it is administered.

Physicians and hospitals earn revenue if they are reimbursed at a higher rate than what it costs them to purchase and administer the drug.

COMMENTS:

The reader may have noticed that one type of middleman, the GPO, has been omitted from the drug supply chain. Did Chairman Pallone think that no one would spot that detail?

Professor Martin Makary, M.D. and Professor of Surgery at Johns Hopkins, has written in the Journal of the AMA, about the kickbacks that GPOs receive as the root cause of the over 150 FDA-documented drug and solution shortages that jeopardize the lives of Americas who are most in need of these medicines. Those shortages drive skyrocketing costs to patients, and increase costs to hospitals as both physicians and bedside nurses “MacGyver” their way around the shortages. We sure hope that the AMA board chair on the panel acknowledges the GPO role in juicing up the cost to the patient and gives Dr. Makary credit for speaking an uncomfortable truth. Dr. Resnick should also reveal what the AMA knows about the kickbacks and when they knew it.

Even pharmaceutical companies who make injectable drugs and solutions make it clear that their access to the market and attainment of market share hangs on their relationships with GPOs. This quote comes from the website of Amphastar Pharmaceuticals: “We currently produce approximately 15 injectable products while we continue to develop a portfolio of generic and branded products that target large markets with high technical barriers to entry. Amphastar’s long-standing relationship with the major group purchasing organizations and drug wholesalers in the U.S. enables it to establish significant market share upon the introduction of its new products.” Amphistar makes injectable Narcan (naloxone), which has recently been unavailable due to shortage.

To name just a very few, the following are among the drugs/solutions in short supply: epinephrine, saline solution, Pitocin, chemotherapy drugs, and insulin.

Philip Zweig has written about this very subject in the Wall Street Journal.

Multiple governmental panels have pointed to kickback to the GPOs as the root cause of these shortages and the related upward pressure on costs.

In a classic instance of the fox-in-the-henhouse paradox, Todd Ebert, the head of the GPOs’ lobbyist, the Healthcare Supply Chain Association, was a panelist on a FDA/Duke Margolis Center event to get to the bottom of the shortages. At the end of the hearings, Mr. Ebert declared that HHS can ask at any time to review the contracts between the GPOs and manufacturers of drugs that are or have been in shortage. During the symposium on shortages, attendees heard again and again that to get to the bottom of the shortages, transparency was key, and that the shortages were driven by economics.

Given that Congress in 1987 provided to the GPOs the “safe harbor” from prosecution for requiring and receiving “rebates” (again, kickbacks), reasonable people may get the impression that the Congress OWES the American people the effort of overseeing the contracts between the GPOs and pharmaceutical companies. They can make a modest gesture toward discharging that duty by calling upon HHS now to demand to see those contracts A few thousand government employees ought to be able to handle the job of reviewing the contracts.

Furthermore, those with financial acumen, but without conflicts of interest, should be present when those contracts are reviewed.

Anything less is staged faux fighting over the financial foolery embedded in the American healthcare system.

E. Pharmacies

Pharmacies dispense prescription drugs to individual patients. There are retail, mail, long-term care, and specialty pharmacies.

Pharmacies negotiate with manufacturers or wholesale distributors and purchase drugs at a confidential price. They will also negotiate with PBMs to be included in a PBM’s network and for reimbursement from the PBM, as well as other types of government and private payers. In addition to reimbursement for the cost of the drug, pharmacies will also receive a dispensing fee, which varies based on the payer. Total prescription dispensing revenues reached $423.7 billion in 2018.

F. Patients

Patients depend on prescription Rx drugs to manage chronic conditions, prevent, treat, or cure diseases, and reduce side effects from diseases or conditions. When patients purchase a drug, the price they pay may depend in part on how much of the cost their health plan covers. Patients are increasingly exposed to the list price of their prescriptions, either through their deductible or through a coinsurance percentage.

If the patient is not enrolled in a health plan, then they typically pay the full list price of a drug. Patients may access patient assistance programs and discount cards from manufacturers to lower the price they pay for a particular drug depending on criteria that is set by either the program or the manufacturer.

A recent poll found that a quarter of people who take prescription drugs say it is difficult for them to afford their medications. People are more likely to have difficulty affording their medications if they have monthly drug costs of $100 or more, are in fair or poor health, have annual incomes of less than $40,000, or take at least four drugs monthly. Three in ten 50-64 year olds report problems affording their drugs.

Comment: The saddest part of what appears to be another faux fight in the battle to help Americans have affordable accessible healthcare, is that Chairman Pallone, D-NJ, puts the patients last and the chosen panel is chock full of financial conflicts of interest. Who is speaking for the patients? We hope committee members ask pointed questions revealing who is making the big money and denying access to healthcare. Americans deserve the real truth and not another staged moment in American politics.

Freedom does not force people off plans but gives more options.

A case-in-point on how the media can mislead you, sent in by Beverly Gossage of http://www.hsabenefitsconsulting.com/

1) CNBC professes to tell you who will lose their insurance if the ACA is repealed. Not might…WILL…they say. :/ Their number is 25 million.

2) They outline 3 groups but fail to mention that most people are in all 3 subsets. So their number is erroneous.

3) Truth: none of these people would be forced off a plan. Of course, there would be a ramp off the ACA and the current plans would be grandfathered as new options would become available subject to state regs not federal. States can amend their regs to tailor them to their state.

4) Freedom does not force people off plans but gives more options.

Fact Checking Sen. Menendez ACA Diatribe

Dear Senator Menendez,

As a N.J. citizen, taxpayer, physician, husband and father, I must offer factual correction on your healthcare policy ACA diatribes.

You tweeted:

Nothing could be further from the truth in your partisan message:

1. Insurance coverage is not healthcare.
2. Forcing citizens into ACA Medicaid at taxpayer expense is foolhardy.
3. ACA through “guaranteed issue(preexisting conditions)” destroyed the risk pools that kept prices stable. Now ALL commercial plans premiums have doubled and tripled.
4. The individual insurance market was decimated by ACA, destroying any semblance of insurance competition.
5. ACA put most private practice independent physicians, that are more efficient and cheaper, out of business and working for hospitals. As you know, hospitals inflated pricing schemes also extorts taxpayer dollars
6. ACA also pushed insurers toward “narrow networks.” eliminated patients long-term relationships with physicians and further limited their choice of physician and facility.
7. ACA and forced government dependence will bankrupt the country and its citizens, as a whole and individually.
8. Remember the three big lies of Obamacare? Keep your doctor. Keep your insurance. Each family will save $2500. All proven false partisan narrative.
9. Attacking the president of the United States is a waste of time, money and energy when he would gladly work with you on these issues.

I would be glad to work with you and other legislators on competitive free-market plans and assure quality and give patients best choice and restore personal responsibility and freedom.

Sincerely
Craig M. Wax DO
Independent family physician, media host and healthcare policy expert

What is Healthcare? And How to Fund It.

Dear Chairman Alexander,

Thank you very much for asking America’s MD and DO Physicians to weigh in on solutions to improve Americans’ health and launch an efficient and sustainable path for the healthcare ecosystem.

The first critical step is educating your colleagues that there is a difference between medical care and health insurance. My recent article published in Medical Economics may help policymakers understand that the difference matters: https://www.medicaleconomics.com/med-ec-blog/what-healthcare

Solving the current healthcare policy disaster ultimately means less federal intervention and regulation, combined with more freedom and liberty.

Please consider:

1. Expanded universal HSA heath savings accounts for all, independent of insurance, and usable for every healthcare service, medication and device.

2. Remove ACA restrictions on insurance policies and stop multi-billion dollar bailouts of the insurance industry. Insurers have driven up costs. Instead allow a diversity of insurance plans to compete side by side: from catastrophic with high deductible to first dollar HMO-coverage. Unique individuals should be shopping for unique plans to suit their own needs.

3. Repeal the Group Purchasing Organization safe harbor to the Anti Kickback Statute that is also being abused by Pharmacy Benefits Managers. The federal government has permitted kickbacks disguised as “rebates“ for decades and it must stop. Make kickbacks illegal again. GPO and PBM middleman must compete legally and not extort manufacturers.

4. Innovative solutions like Direct Primary Care (DPC), and similar direct payment arrangements between specialists and their patients are must not be subject to over-regulation under insurance rules . These arrangements are not insurance but cut out the third party bureaucracy driving up the cost of care. DPC serves to strengthen patient-physician relationships not interfere in them. This healing relationship is critical for regaining health and health maintenance. It makes both patients and physicians responsible to each other directly, as it should be.

5. Allow physicians and patients to opt out of Medicare, MACRA, and other top-down government programs. They should be voluntary, not compulsory. Direct contracting between patient and physicians will save lives and tax dollars.

6. Consider legislation to protect patient access to physicians of their choice, even if they are not in their plan’s network. Narrow networks serve to trap patients into obtaining care in the most expensive settings instead of from higher quality and less expensive options like independent physicians.

Please feel free to contact me via letter, email, social media, phone, or any other mechanism for short and long-term planning. Together we can harness free market and personal individual responsibility to organically solve America’s healthcare crisis.

My article catalog: https://www.medicaleconomics.com/authors/craig-m-wax-do

Best wishes for good health,

Craig M. Wax, DO
Family Physician
VP Healthcare Policy, Practicing Physicians of America
National Physicians Council on Healthcare Policy member
Independent Physicians for Patient Independence
Host of Your Health Matters
Rowan Radio 89.7 WGLS FM
Twitter @drcraigwax
HealthIsNumberOne.com

Be There! New Jersey Doctor-Patient Alliance Inaugural Summit

You will not want to miss this summit on February 8-9, 2019!

IP4PI’s own Craig M. Wax, D.O. will join an all star lineup as a featured speaker. Dr. Wax will share reform priorities that will help put doctors and patients back in the driver’s seat. It is time to put and end to the shenanigans politicians pull to hand advantages to their crony buddies in the hospital industrial complex. Patients and their physicians must team up to reclaim their rights, increase the availability, and slash the cost of high quality care.