As hospital emergency rooms and intensive care units swell with patients infected with the COVID-19 virus, political leaders coordinating responses in “hot spots” are asking doctors and other medical professionals in parts of the country less impacted by the pandemic to come to the rescue. New York Governor Andrew Cuomo issued such a plea the other day. Governors are issuing executive orders that relax occupational licensing restrictions on the free movement of health care practitioners. Some are also expanding the scope of practice of various licensed health care professionals, permitting them to provide the health care services they are trained to do. Meanwhile, a large pool of doctors trained at excellent institutions outside the borders of the U.S., referred to as International Medical Graduates (IMGs), goes untapped. A cumbersome approval process begun in the 1950s places daunting obstacles in the way of IMGs who want to practice in the U.S. and keeping tight reins on the already short supply of doctors.
The process is overseen by the Educational Commission for Foreign Medical Graduates. The ECFMG is a private non‐profit organization established in 1956 to “evaluate the readiness” of IMGs to enter graduate medical education programs (residencies and fellowships) in this country. (Graduates of Canadian medical schools are not considered IMGs.) The American Medical Association and the American Hospital Association soon recognized the ECFMG as the standard for evaluating IMGs entering the U.S. health care system and serving patients in its hospitals. The ECFMG obtained responsibility for visa sponsorship of Exchange Visitor physicians (J‑1 visas).
Graduates of medical schools outside of the U.S. and Canada must become certified by the ECFMG before they can enter U.S. graduate medical programs. This means they must receive their diplomas from an ECFMG‐approved medical school, pass steps 1 and 2 of the 3‑step U.S. Medical Licensing Examination, complete a graduate medical education program, and then pass Step 3 of the USMLE.
State licensing requirements vary with regard to IMGs. Some require more years of graduate medical education training than they require from graduates of U.S. and Canadian medical schools before they issue them a license. Most issue licenses to graduates of U.S. and Canadian medical schools after applicants have passed step 2 of the USMLE and several don’t require these licensees pass to step 3 in order to maintain their license.
Yet IMGs who received their diplomas a while ago and have been practicing medicine outside the U.S., often for several years, must go through the same process as fresh medical school graduates. This means they must get ECFMG certification—including taking and passing all three steps of the USMLE—and go through a residency training program all over again. Then they must apply for state medical licenses. Many experienced foreign‐trained doctors take positions in ancillary medical fields, such as nursing, lab technician, and radiology technician instead of starting all over again. Some even work as waiters or taxi drivers.
I worked with an Operating Room Technician (the person who passes instruments to the surgeon) from Syria who had impressed me with his knowledge and focus on the operations I perform. He would occasionally offer an excellent suggestion or insight during a technically challenging segment of the operation. I soon learned that he had been a general surgeon who practiced in Syria before coming to the U.S. He decided to divide his time between working as an OR tech and starting up a Middle Eastern restaurant rather than starting all over again.
To be sure, the quality and approach to the practice of medicine varies in different parts of the world. In some parts of the world doctors deal with a different constellation of health problems than exist in the U.S. and some may have less exposure to the technological advances that abound in the U.S. health care system. There may also be cultural differences that affect their understanding and communication with American patients. For this reason, certification organizations like the ECFMG, specialty boards (e.g., American Board of Surgery, American Board of Internal Medicine), as well as rating and evaluation services, play an important role in providing critical information to consumers of health care.
In Canada the provinces have domain over medical licensing. Some provinces grant licenses to experienced immigrant primary care physicians from certain countries to practice without having to repeat the residency program. Some also welcome medical specialists who are trained and experienced in certain other countries without having to start over.
To address the current public health emergency, several states are granting reciprocity to health care practitioners licensed in other states. Three states—Arizona, Pennsylvania, and Montana—reformed their occupational licensing laws to grant reciprocity well before the advent of COVID-19 pandemic. As I have said before, these reforms should apply to all the occupations and should be permanent—not just temporary responses to the public health emergency.
In the same spirit, states should consider granting reciprocity to health care practitioners licensed in certain other countries with reputations for quality medical education. Meanwhile, certifying organizations should include applicants’ active clinical experience in other countries as a factor in certification criteria. Finally, these changes need to be accompanied by liberalizing immigration rules for medical professionals and their families now—waiting for overall immigration reform to happen will not address the problem fast enough.
On March 23, Arizona Governor Doug Ducey sent a letter to Seema Verma, Administrator of the Centers for Medicare and Medicaid Services, informing her the state was opting out of Medicare regulations that require Certified Registered Nurse Anesthetists to be supervised by a physician. This is aimed at expanding the scope of the health care workforce during the COVID-19 public health emergency.
The following day, the governor issued an executive order to that effect, causing Arizona to join 17 other states that allow CRNAs to practice independently. This was made possible by a 2001 Bush Administration rule that made the supervision requirement optional, deferring to the judgment of the states and their state licensing boards.
As the governor of a state, Ducey exercised his best judgment, based upon the knowledge available to him as well as the specific needs and characteristics of his particular state, to determine the risks and benefits of the action. And yet health care practitioners lack the same ability, based upon their knowledge and their patients’ circumstances, to use their best judgment when treating pain.
The 2016 guidelines for the treatment of acute and chronic pain issued by the Centers for Disease Control and Prevention, like Medicare’s CRNA regulation, were always meant to be optional. In fact, in its opening section, the guidelines state:
Clinical decision making should be based on a relationship between the clinician and patient, and an understanding of the patient’s clinical situation, functioning, and life context. The recommendations in the guideline are voluntary, rather than prescriptive standards. They are based on emerging evidence, including observational studies or randomized clinical trials with notable limitations. Clinicians should consider the circumstances and unique needs of each patient when providing care (emphasis added).
That didn’t stop governors and state legislatures from enacting strict restrictions on opioid prescribing by health care practitioners. The majority of states have statutory limits on the dosage and quantity of opioids a provider can prescribe to a patient in pain. Some states direct or authorize state entities to set these limits instead of spelling them out in the law.
In late 2018, then‐Commissioner Scott Gottlieb of the Food and Drug Administration announced plans to consult the National Academy of Science, Engineering and Medicine to develop evidence‐based guidelines for the treatment of pain. In April 2019, the CDC issued a clarification of the 2016 guidelines, claiming these guidelines were misinterpreted and misapplied, and two of the guidelines’ authors wrote in the New England Journal of Medicine:
We need better evidence in order to evaluate the benefits and harms of clinical decisions regarding opioid prescribing, including when and how to reduce high‐dose opioids in patients receiving them long term. The CDC developed the guideline on the basis of the best available evidence, with input from a multidisciplinary group that included experts in pain management as well as representatives of patients and the public. In situations for which the evidence is limited, it is particularly important not to extend implementation beyond the guideline’s statements and intent. And yet in some cases, the guideline has been misimplemented in this way.
In May 2019, the Department of Health and Human Services released a report from its Pain Management Best Practices Inter‐Agency Task Force. The report stated in its Executive Summary:
The Task Force recognizes the utility of the 2016 Guideline for Prescribing Opioids for Chronic Pain released by the CDC and its contribution to mitigating unnecessary opioid exposure and the adverse outcomes associated with opioids. It also recognizes unintended consequences that have resulted following the release of the guidelines in 2016, which are due in part to misapplication or misinterpretation of the guideline, including forced tapers and patient abandonment.
Among its conclusions:
An emphasis on an individualized, patient‐centered approach for diagnosis and treatment of pain is essential to establishing a therapeutic alliance between patient and clinician… The choice of medication should be based on the pain diagnosis, the mechanisms of pain, and related co‐morbidities following a thorough history, physical exam, other relevant diagnostic procedures and a risk‐benefit assessment that demonstrates that the benefits of a medication outweigh the risks (emphasis in the original).
Nevertheless, state‐based restrictions remain in place, straitjacketing health care practitioners who want to relieve their patients’ pain.
The COVID-19 pandemic provides many lessons for policymakers. Many lessons reveal how complicated, inflexible, one‐size‐fits‐all regulations stifle swift and effective responses to changing circumstances. As the federal government temporarily relaxes numerous regulations in response to the public health crisis, state and local policymakers are using their newfound freedom to make risk/benefit decisions that fit their specific needs.
Hopefully this experience will cause state leaders to free clinicians to exercise their best judgment in treating their patients in pain once again.
On March 24 Arizona Governor Doug Ducey issued an executive order allowing CRNA’s (Certified Registered Nurse Anesthetists) to practice independently of physicians or surgeons, thus adding needed personnel to the health care work force during this public health emergency. Guidelines issued by the Centers for Medicare and Medicaid Services state that nurse anesthetists should be “supervised” by a physician, thus preventing these well‐trained specialized nurses from providing anesthesia independently while freeing up physician anesthesiologists so more patients can receive care. Because these CMS guidelines are listed as “optional,” the Governor decided that Arizona will opt out. The press release from the Governor’s office stated:
“Arizona’s hospitals and medical professionals need all the help and resources they can get right now,” said Governor Ducey. “I am confident that this exemption will enhance access to high quality care, provide additional options to our rural hospitals, and is in the best interest of the citizens of Arizona.”
Arizona joined 17 other states that have already opted out of these federal guidelines.
As we are seeing so frequently as the COVID-19 pandemic unfolds, regulations on the state and federal level stand in the way of needed care, equipment, drugs, and tests. In our federal system states have power over occupational licensing and determining the scope of work in which a licensee may engage. In the matter of the licensed health care professions, this is referred to as “scope of practice.”
For decades state legislators have witnessed turf battles among the various health care professions. Nurse practitioners and physicians’ assistants, for example, seek to practice independently of physicians and to expand their scope of practice to meet their level of training. This is usually met with resistance from medical doctors who argue NPs and PAs lack the necessary training to safely provide care beyond a narrowly‐defined scope. The degree to which the scope of practice of NPs and PAs has been widened varies from state to state. Broadening their scope would help address the current health care crisis. But once the crisis passes, maintaining the broadened scope would give people more health care options and access, particularly in underserved rural areas.
Similarly, state capitals witness battles between optometrists, who seek to expand their scope to include prescriptive authority and simple surgical authority, and ophthalmologists who believe such expansions are dangerous.
In most states doctorate‐level clinical psychologists are not allowed to prescribe psychiatric medications to their patients, even if their graduate degree program included extensive training in psychopharmacology. Therefore, patients who need medication to assist in their psychotherapy must go through the added expense in time and money to see a physician—usually a psychiatrist—for a prescription while continuing to see their psychologist. Guam was the first U.S. territory to permit psychologists with psychopharmacology training to prescribe to their patients. Currently five states—Idaho, Illinois, Iowa, New Mexico, and Louisiana—also allow appropriately trained psychologists to prescribe.
Pharmacists are another health care profession seeing its scope gradually expanded. All 50 states currently allow pharmacists to vaccinate patients, with states differing on age limitations and types of vaccinations allowed. Rhode Island and Oregon allow pharmacy technicians to perform vaccinations. Several states now allow pharmacists to prescribe oral contraceptives, and last fall California became the first state to allow pharmacists to prescribe HIV pre‐exposure prophylaxis (PreP) and post‐exposure prophylaxis (PEP). Pharmacists’ scope of practice can be expanded to include a host of services, including tuberculosis skin testing and interpretation; testing and administering prescription meds for patients with influenza and other viral illnesses or common bacterial infections like strep throat; non‐sedating or low‐sedating antihistamines, corticosteroids, and decongestants; and extending routine non‐controlled chronic medication prescriptions for an additional 30–60 days.
Modern technology lets pharmacist provide many of these services remotely using vending machines in kiosks. In some states, regulations stunt the growth of this option.
Most states now allow direct‐to‐consumer lab testing, saving patients the time and inconvenience of a doctor visit and promoting self‐care and health awareness. Unfortunately, New York, New Jersey, Massachusetts, Rhode Island, and Maryland prohibit or restrict such activity.
On the dentistry side, dental therapists are an emerging profession analogous to physician’s assistants or nurse practitioners. These trained professionals serve underserved communities today in Alaska, Minnesota, Washington State, Arizona, Maine, Vermont and others. Unsurprisingly, lawmakers considering dental therapy legislation receive pushback from the dental profession, which claims to be concerned about patient safety.
In every one of the examples above—and the list is not exhaustive—resistance to reform usually comes from incumbent professions that would lose market share when health care consumers are given more choices. Every example also provides greater health care choice and access to patients. And the added competition that results should help drive down prices.
This unfortunate pandemic provides us with many lessons on how to streamline and improve the provision of goods and services to the public, and how regulations stand in the way. Many regulatory obstacles are being temporarily set aside on all levels of government. When this crisis passes, policymakers should not rush to put those obstacles back in place, only to wait until the next crisis to remove them again. Rather, they should use these lessons as a springboard to regulatory reform.
In order to facilitate social distancing among people in treatment for opioid use disorder, the Drug Enforcement Administration and the Substance Abuse and Mental Health Services Administration relaxed some onerous regulations surrounding the use of buprenorphine or methadone in Medication Assisted Treatment.
For health care providers to prescribe buprenorphine in an ambulatory setting to patients with addiction, they must apply for an “X waiver” on the narcotics prescribing license they get from the DEA. This is an onerous process that has resulted in a paltry number of practitioners with the waiver. Many addiction experts have called for the DEA to remove the requirements and last summer legislation to that effect was being discussed in Congress.
The DEA requires all patients to be seen in person before they may be prescribed a controlled substance. With medical clinics engaging in social distancing by seeing patients for only urgent matters, thinning staff, reducing hours, and minimizing the number of patients in their waiting rooms, patients on buprenorphine treatment face understandable challenges. Last week the DEA temporarily suspended the requirement that MAT patients see their prescriber in person, allowing for the use of telemedicine. This should ease the burden. Removing the X waiver requirement so that all licensed narcotics prescribers can prescribe buprenorphine to the patients with addiction, as recommended by the National Academy of Science, Engineering, and Medicine, would ease it further.
While patients on buprenorphine face challenges during the COVID-19 epidemic, patients receiving methadone treatment have it even worse. Among the many onerous requirements placed on operators of methadone clinics is the one requiring patients to take the methadone each day in front of a clinic staff member. This makes it difficult to participate in the program even under ordinary circumstances, especially if the nearest clinic is miles away. And the long queues of patients that form waiting to get inside the clinics each day are not examples of social distancing. NASEM recommends reforming methadone regulations to allow community health care practitioners to prescribe several days of methadone to patients they see and follow in their offices, as doctors in the U.K., Canada, and Australia have been doing for decades. Clinical researchers at Boston University reported on the success of a government‐approved pilot project in the primary care setting in 2018.
In response to the pandemic, SAMHSA informed states that methadone clinics may dispense up to 28 days of Take‐Home methadone to their “stable” patients and up to 14 days of take‐home methadone to patients who are “less stable” but the program believes “can safely handle this level of Take‐Home medication.”
All of these moves are moves in the right direction. They clearly foster addiction treatment compliance. When this crisis passes, making the measures permanent should be a no‐brainer. But reform should not stop there. These temporary measures should serve as catalysts for repeal of the “X waiver” and a complete revision of the DEA’s antiquated, stigmatizing approach to methadone treatment programs
At a Coronavirus Task Force briefing last week, President Trump incorrectly told the press that the antimalarial drug chloroquine had already gone through the Food and Drug Administration’s approval process for the treatment of COVID-19 infection: “They’ve gone through the approval process, it’s been approved and they did it, they took it down from many, many months to immediate.” He was later corrected by the FDA Commissioner, who said the approval process had not and will not be completed until controlled clinical trials have convinced the agency.
Many people might therefore conclude that doctors are not legally permitted to prescribe chloroquine, or its analog hydroxychloroquine, to treat COVID-19 infections. In fact, doctors around the globe, including the U.S., are using these and other drugs to treat their patients, and reporting on their findings in the peer‐reviewed medical literature.
French medical researchers reported on the chloroquine’s potential based upon their experience with a small group of patients in the March issue of the International Journal of Antimicrobial Agents. Chinese medical researchers reported similar encouraging results in early February. Researchers at the University of Washington in Seattle are using chloroquine to treat their COVID-19 patients, with one of its research associates calling the results thus far “very promising.” And a report in today’s Wall Street Journal by a practicing physician and the director of the Division of Infectious Disease at the University of Kansas Medical Center also touts the drug’s potential.
Prior to 1962, drug makers were required to convince the FDA their product was safe to consume and met the FDA’s criteria for providing product information, use, and dosage on their labels. But the 1962 Kefauver‐Harris Amendments to the Food Drug and Cosmetic Act of 1938 added the additional burden of proving the drug’s efficacy in treating the condition for which it was developed.
Efficacy requirements add years to the approval process. Ironically, once a drug is thus approved for the treatment of the condition for which it was initially intended, the FDA has no restrictions on using the drug in any other setting. Using it to treat a condition for which it was not initially approved is called “off‐label,” because the label is only allowed to state the condition for which its use was FDA‐approved.
It is reasonable to wonder why, after doctors wait several years to get permission from the FDA to treat their patients with a drug for condition “A,” the FDA in principle trusts doctors to use their clinical judgment, based on their knowledge and experience, to treat conditions “B thru Z.” Why not skip the efficacy component of the approval process and speed things up? Alas, a great many patients suffer or even die waiting for the chance to see if a drug that may be helping patients in other countries can be used by them—a problem called “drug lag.”
Clinicians use drugs “off label” very frequently. In fact, according to the Agency for Healthcare Research and Quality, “one in five prescriptions written today are for off‐label use.” An example of off‐label use in my specialty of general surgery that immediately comes to mind is the antibiotic erythromycin to treat paralyzed intrinsic muscles of the stomach, a condition called gastric atony.
Many years often pass before clinical trials convince the FDA to update its approved use of a drug to include what had been an off‐label use. Aspirin had been used off‐label to prevent recurrent stroke or heart attack for many years before the FDA approved it for that use.
Most of what clinicians read in medical journals or observe at scientific conferences deal with the efficacy and comparative effectiveness of various medications or procedures in the treatment of health conditions.
It may indeed turn out that the FDA eventually approves chloroquine, hydroxychloroquine, and other drugs currently used off‐label for the treatment of coronavirus and other viral infections. That could still be quite a while off. In the meantime, it is important for people to know that clinicians are not prohibited from using these drugs now. If a life‐threatening situation develops, they can discuss using one or more of them with their health care provider.
The American economy is closing down rapidly from both voluntary and mandatory business closings. It is not just restaurants, but also manufacturing, construction, recreation, travel, and many other industries that are shuttering operations.
If this continues, there will be a massive plunge in incomes, and tens of millions of people will not be able to meet basic expenses such as rent and food. Policymakers are acting quickly to slow the virus spread, but I fear they are shuttering too much of the economy because we face a months‐long health crisis, not a weeks‐long crisis. The government does not have enough money to keep the economy afloat until a vaccine arrives, maybe a year from now.
To get a sense of the massive economic shrinkage possible, the data below from BLS shows U.S. employment data in private‐sector industries. I left out the nation’s 23 million government workers because they will likely continue to be paid.
The nation’s 130 million private‐sector workers would have generated $16 trillion of income this year (Table 6.1D). With massive business closings, how much of that will be lost? The health part of the largest sector, health care and education, will of course remain open during the crisis. But other large sectors—such as leisure and hospitality, retail, manufacturing, and construction—are mainly closing down.
Consider a scenario where half of private‐sector workers are idled for three months. That would lose the economy $2 trillion of income. Some closed businesses may continue to pay workers for a while, but when cashflows are vanishing that may not last for long.
In a Washington Post piece, a small‐business owner with 75 employees expressed her fear at the impossible situation she is in. Cathy Merrill argues that even a two‐month closure would be a death sentence to businesses such as hers. As she points out, she might be able to borrow to keep paying rent and labor costs, but borrowing would be risky because she doesn’t know when revenues may come back since this is an open‐ended crisis. I think she’s right that small‐business layoffs and bankruptcies will soar if shutdowns extend very long.
The logic of virus‐fighting suggests strong measures to flatten the curve of infection in coming months. But as Merrill says, “who is going to quantify the number of deaths from unemployment stress, food insecurity, depression or lost health insurance — plus the spike in suicide rates and heart angina from the stress of being laid off or furloughed?”
Merrill suggests that officials don’t appreciate the financial vulnerability of America’s 30 million small businesses when they are ordering all‐encompassing shutdowns. California has ordered a general economic shutdown except for essential services. Pennsylvania has ordered “all non‐life‐sustaining” businesses in the state to close. All mining, construction, most manufacturing, most retail trade, and many other industries must close based on a government central plan. These sorts of actions are very heavy handed. Governments are offering emergency businesses loans, but that won’t compensate for the massive income loss imposed if this extends for more than a few weeks.
Policymakers face tough decisions in the days ahead, but I fear that they are swinging too far toward virus control at all costs. We should be putting more weight on the economic and health damage that will be risked by extended business shutdowns.
I and others have attributed much of the initially flat‐footed response of public health officials to the coronavirus pandemic to cumbersome, inflexible, and outdated regulations controlling the development and distribution of drugs and tests.
As I pointed out in an article earlier this week, while the cumbersome Food and Drug Administration’s approval process delayed the development and distribution of coronavirus tests in the U.S. in the early days of the current pandemic, South Korea, having learned from its horrible encounter with the Middle East Respiratory Syndrome (MERS) outbreak of 2015, enacted regulatory reforms that allowed the government to give almost immediate approval of testing systems developed during a public health emergency.
In recent days the FDA has relaxed its regulatory process in order to get tests out to the public more rapidly. On March 13 Roche labs received expedited approval to distribute a test it developed that yields results ten times faster than the CDC‐developed test. On March 16, perhaps in an attempt to replicate the South Korean model, the FDA exercised its regulatory authority to effectively outsource the approval process to the states. The FDA delegated to states the authority to oversee and approve tests developed within their borders. It also announced that, under certain circumstances, manufacturers may distribute newly developed tests before the FDA grants emergency use authorization, and labs will be permitted to use them.
As a result of these measures, Indiana‐based pharmaceutical manufacturer Eli Lilly and Co. announced on March 18 it will be performing tests on samples taken in health care facilities within the state of Indiana–including nursing homes and emergency rooms–free of charge to patients, insurers, hospitals, and government agencies. A company spokesman said it could be performing 1,000 tests per day within a week and hopes to ramp the number up to 2,000 per week by using a drive‐thru clinic. Tests results should be back the same day. Indiana State Health Commissioner Kris Box praised this “public‐private partnership.”
The speed with which the private sector is responding to the demand for coronavirus testing once the regulatory ankle weights have been temporarily removed is a spectacle that should not go unnoticed by politicians and policymakers. It is unfortunate that it took a calamitous epidemic to provide this lesson in deregulation. Let’s hope the lesson is taken to heart and leads to permanent regulatory reform when the crisis passes.