Four Executive Orders Regarding Drug Pricing: Two are Needed and Two Should be Rescinded!

https://pharmacistactivist.com/2020/August15_2020.shtml

Two are Needed and Two Should be Rescinded!

The cost of many drugs is far too high!

Pharmaceutical companies, pharmacy benefit “managers” (PBMs), and health insurance companies have been engaged in a “blame game” for many years in faulting the others for the high cost of drugs. While they do this, drug costs continue to increase! These companies will not identify an equitable strategy and solution that will serve society well.

Elected officials and government agencies are engaged in partisan politics to such an extent that they have failed to effectively address the issue of excessive drug costs. This political impasse is not likely to be resolved anytime soon. The victims of these failures are patients and society, and the prescribers, pharmacists, and other health professionals who have the responsibility for assuring the most appropriate and effective use of medications with the least risk possible.

President Trump has issued four executive orders (EOs) regarding drug prices. I give him credit for recognizing the importance of taking action and his boldness in acting at a time when others who should be effectively addressing these matters have failed to do so. We can’t expect anyone who does not have expertise in the areas of health care and medication use and costs to be in a position to identify the best strategies and actions. Indeed, many of the “experts” in health care, including health professionals do not agree on a course of needed action. However, the added challenges for the President are that many of those who have the greatest access to him and the opportunity to contribute to and influence decisions, have vested interests and/or political agendas. The consequence is actions that include some that are flawed. Let’s consider the EOs on an individual basis.

Access to affordable life-saving medications

This EO is applicable to insulin and epinephrine (e.g., EpiPen) products. Federally qualified health centers (FQHCs) and hospitals that serve eligible patients (e.g., those with low income who do not have health insurance) participate in the 340B program and are able to obtain medications at large discounts from pharmaceutical companies. The EO directs FQHCs to pass along discounts for insulins and epinephrine (“life-saving” drugs) to patients.

This is a needed and important action BUT, it must be viewed as a small first step in eliminating the widespread abuses in the 340B program. The EO is only applicable to FQHCs and not the hospitals and PBMs involved in the program, it only includes the drugs considered life-saving, and the policies for implementation and monitoring compliance with the order have not yet been identified.

Increasing drug importation to lower prices for American patients

This is a seriously flawed concept and order, and should be rescinded! This EO would permit individual states to develop programs that would enable safe importation of certain drugs, and would enable personal importation waivers at authorized pharmacies. Such a system would be a great disservice for patients and place them at increased risk of drug-related problems. It would enable even more fragmentation of health care and drug therapy for patients, create additional questions about the quality and potency of imported medications, have a disruptive impact on the supplies of drugs in the countries from which they are imported, have a harmful economic impact on many pharmacies and other healthcare entities in the U.S., and require inefficient and costly regulations and procedures that would erode much of the anticipated cost savings.

The problem of excessive prices for many drugs has occurred and been enabled and exploited in the U.S., and must be resolved within this country!

Lowering prices for patients by eliminating kickbacks to middlemen

This EO is needed and extremely important BUT, it must be viewed as an essential first step in restoring the integrity of drug prices and the drug distribution system. Although there are some relatively small PBM middlemen who are committed to providing transparent and financially responsible services, the marketplace is dominated by three huge PBMs – CVS Caremark, Express Scripts, and Optum – that engage in secretive, deceptive, and highly profitable (for themselves) practices. If government officials and the public were specifically aware of the high percentage (often well above 50%) of the price of some drugs that is extracted as kickbacks/rebates by PBMs, there would be outrage and refusal to tolerate the continuation of these self-serving practices that are at the expense of patients, society, and health professionals. The terms of their secret deals are so fiercely hidden and protected that even government officials are not able to obtain the details of the financial arrangements. Government regulators in Ohio, West Virginia, Pennsylvania, and some other states have made progress in identifying the deception and fraud in certain government-funded programs, but even they are stonewalled and mislead by these PBMs.

Eliminating kickbacks from pharmaceutical companies to PBMs is a positive first step. However, this action must be accompanied by strong regulation of PBM practices in both government-funded and other prescription benefit programs, prohibiting direct and indirect remuneration (DIR) clawback fees from pharmacies, very close regulatory monitoring of their operations, and strong criminal and/or civil actions when harm from and fraud in their operations and programs are identified. Even if rebates from companies to PBMs are eliminated, if these other reforms and actions are not also taken, these PBMs will identify other secretive strategies to recoup their losses and continue their costly programs to the great disadvantage of patients, health professionals, and the healthcare system. More whistleblowers who are current or former employees of these PBMs are needed!

Restricting prices of the most costly Medicare Part B drugs to no more than the amounts charged in other economically comparable countries

This is the second seriously flawed concept and EO that should be rescinded! Suffice it to say that, if government regulators are not able to completely and accurately identify the amounts of kickbacks/rebates and other financial parameters of drug pricing in this country, there is no way of obtaining specific and accurate drug pricing information in other countries beyond knowing that their drug prices are lower.

Recommendations

Pharmaceutical companies, PBMs, and health insurance companies will continue their current drug pricing strategies and programs, and further increase drug prices, unless firm actions are taken to prevent them from doing so. The President, other elected officials, and appropriate government agencies must learn from and act on the counsel and recommendations of patients, pharmacists, and other health professionals who are victims of the destructive present healthcare system. They must give the highest priority to eliminating kickbacks from pharmaceutical companies to PBMs, and to eliminating the unnecessary and costly involvement of PBMs, or rigidly controlling their policies, operations, and programs. Organizations of pharmacists and other health professionals must work together with a united voice and strategy to lower drug prices and attain reforms in the health care system.

Daniel A. Hussar
danandsue3@verizon.net

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