Why drug prescriptions should include diagnoses

The Covid-19 pandemic is teaching us many tragic lessons along with some instructive ones, like the importance of adding patients’ diagnoses to their prescriptions. An example from 2020 shows why.

In the spring and summer of 2020, there was a dramatic increase in the number of prescriptions written for hydroxychloroquine, a proven therapy for malaria, lupus, and rheumatoid arthritis that was being hyped as a treatment for Covid-19. But it is difficult to determine the reason for the spike in prescribing because the data shed no light on why the drug was prescribed. That’s because doctors are not required to include this critical information on prescriptions.

On March 28, 2020, the Food and Drug Administration (FDA) granted an emergency use authorization for hydroxychloroquine for adults and teens hospitalized with Covid-19 who weighed more than 50 kilos and could not participate in a clinical trial. The emergency use authorization did not apply to outpatient uses. The FDA also cautioned that the drug could cause heart rhythm problems and other safety issues. Then, on June 15, 2020, the FDA revoked that authorization based on new data, including results from a large, randomized clinical trial in hospitalized Covid-19 patients which found that hydroxychloroquine did not speed recovery or prevent death.

A preliminary internal data analysis by the Department of Health and Human Services Office of Inspector General, for which we work, looking at Medicare claims data showed that from March 2020 to July 2020, Medicare paid for hydroxychloroquine prescriptions for 28% more beneficiaries than during those months in 2019. There were more than 27,000 new prescribers — one urologist, who had not previously prescribed hydroxychloroquine, prescribed it for 42 Medicare beneficiaries in April 2020.

The uptick was especially striking in nursing homes, possibly because nearly 40% of Covid-19 deaths in the U.S. were among nursing home residents in the early months of the pandemic. Prescribers may have followed hope more than evidence, and patients may have taken unproven drugs without knowing why.

According to our agency’s early analysis of Medicare claims data, nearly 30 times as many nursing home residents received a new hydroxychloroquine prescription in the spring and summer of 2020 as they had the year before, with one facility giving 82% of Medicare patients a new prescription.

But since neither prescriptions nor Medicare claims include diagnoses — the reason why a drug was prescribed — we cannot definitively explain this trend.

Medicare is supposed to cover only drugs for FDA-approved uses or well-supported off-label uses, such as those listed in authoritative compendia. Medicare does not cover unsupported off-label uses. For risky drugs — like hydroxychloroquine — with side effects including cardiotoxicity and unproven benefits, patients and payers should know why the drug was prescribed.

A 2011 Office of Inspector General study found that Medicare inappropriately paid $116 million in a one-year period for risky antipsychotic drugs for patients with diagnoses that should have made the prescriptions ineligible for Medicare coverage.

Medicare claims for outpatient prescription drugs require 37 data elements, such as the patient’s gender and the health insurance claims number. Diagnosis is not one of those data elements.

Our 2011 report recommended adding diagnosis information to claims data, but the Centers for Medicare and Medicaid Services declined to do that because putting that into practice would entail adding diagnoses to prescriptions, which is not general practice and would need to be implemented state by state.

A key Medicare coverage requirement hinges on a drug being prescribed for an FDA-approved use or a well-supported off-label use. Omitting diagnosis information renders that requirement difficult to implement.

That prescriptions routinely omit diagnoses may come as a surprise to many. When a physician prescribes a medication — whether it’s handwritten on a prescription pad, done electronically, or telephoned to a pharmacy — he or she provides extensive information about the patient, drug, formulation, administration, dose, and quantity. But nothing about why the patient needs the medication.

As Medicare’s expenditure on outpatient prescription drugs approaches $100 billion a year, saving taxpayer dollars justifies including diagnoses. But improving the quality of care, patient safety, and public health are even more compelling.

Helping loved ones organize medications requires patience. Sorting through a shoe box of pill bottles, it’s not uncommon to hear, “I take these twice a day for my blood pressure, and I take that big one once a day, but I don’t know what it’s for.” As medical care becomes more team based, physicians, pharmacists, patients, and caregivers need better information to collaborate to achieve better health outcomes.

Taking medications as prescribed — which many people don’t — would help them do this. Granted, diagnosis information would not mitigate barriers to adherence, like high costs or unpleasant side effects. But diagnoses on prescriptions would make patients more informed and hopefully more motivated to fill their prescriptions and take them as prescribed.

Diagnosis information on prescriptions could help pharmacists identify safety issues. For handwritten prescriptions, it could prevent rare dispensing errors where illegibility causes a pharmacist to confuse one drug with another.

As electronic prescribing supplants illegible prescriptions, more information allows pharmacists to apply their expertise. Sometimes, pharmacists know what medications a patient actually takes better than the prescribing physicians.

Improving the appropriate access to and use of electronic health information by pharmacists supports beneficial care coordination. Some may worry that adding diagnoses to prescriptions could pose a privacy issue. But pharmacists, as part of the care team, are already bound by HIPAA, the Health Insurance Portability and Accountability Act. Diagnoses on prescriptions is one more way to improve how patients and providers can use this information consistent with existing privacy and security laws. If needed, additional safeguards could always be added for individuals concerned about sensitive diagnoses.

Not surprisingly, when the Office of Inspector General proposed requiring diagnoses for Medicare drug claims in our 2011 report, the American Pharmacists Association endorsed the proposal to help their members better serve patients.

Public health researchers may also value outpatient prescription drug data enriched with diagnosis information. Had that been available during the early days of Covid-19, researchers could have readily seen not only that providers had changed prescribing patterns for hydroxychloroquine, but why and to what effect. Enriched data could inform safety and effectiveness of approved drugs. It could also offer targeted educational opportunities for physicians whose prescribing deviates from professional norms.

The Covid-19 pandemic challenges hardworking medical professionals. In asking several physicians about including diagnoses on prescriptions, we heard “excellent idea, but only if it doesn’t add to my paperwork.”

Minimizing administrative burden is compelling. Physicians who handwrite or call in prescriptions already know why they are ordering the medicine, so saying why should be easy enough. Recently updated standards for electronic prescribing functions in an electronic health record require the technology be able to receive and transmit the reason for the prescription. Successful implementation of this standard by electronic health record companies could minimize burden for health care professionals, designing the digital platforms to integrate diagnosis information without much additional user input.

Given the significant potential benefit and minimal burden, prescriptions for outpatient drugs should include diagnoses, and this information should be captured in claims data.

Christi A. Grimm is the Principal Deputy Inspector General performing the duties of the Inspector General for the U.S. Department of Health and Human Services. Julie K. Taitsman is the Chief Medical Officer for the Office of the Inspector General.