Payment parity for phone calls, COVID-19 research on remdesivir, other drugs

CMS announced on April 30 that telephone calls between patients and physicians will be reimbursed at a rate equal to in-office visits, a change ACP had been advocating for since March.

The College praised this move in a statement, saying “More still needs to be done to ensure that physician practices are able to remain operational and care for their patients, but this change in payment policy addresses one of the biggest issues facing physicians as they struggle to make up for lost revenue and provide appropriate care to patients.”

ACP is looking for feedback from members about how they're coping with the COVID-19 public health crisis and the impact on practices. Information collected will help inform ACP's advocacy and practice management support efforts. The survey is online.

In research news, the effectiveness of remdesivir was evaluated in a Chinese trial, published by The Lancet on April 29, that randomized 237 patients hospitalized with COVID-19 to 10 days of remdesivir (n=158) or placebo (n=79) and found no significant difference in time to clinical improvement with the drug (hazard ratio [HR], 1.23; 95% CI, 0.87 to 1.75). The study did not reach its target enrollment because public health measures halted the epidemic. The authors noted that compared to a previous study of compassionate use of remdesivir, their population was less ill and treated earlier, which would have been expected to increase the drug's effect, but the results did not meet this expectation.

An accompanying editorial highlighted the challenge of getting adequate evidence on potential therapies during the pandemic.

A press release from the National Institutes of Health offered preliminary, non-peer-reviewed results from the first U.S. trial of remdesivir, which randomized 1,063 patients and reported a median time to recovery of 11 days for patients treated with remdesivir versus 15 days for those on placebo (P<0.001), with mortality rates of 8.0% versus 11.6% (P=0.059). Based on these results, the FDA on May 1 issued an emergency use authorization for remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in patients hospitalized with severe disease. Remdesivir's manufacturer also reported data that have not yet been peer-reviewed.

The cardiac risks of hydroxychloroquine and azithromycin were described in two studies published May 1 by JAMA Cardiology. The first, a brief report, included 90 patients hospitalized with COVID-19 in Boston. All were given hydroxychloroquine, and 53 received concomitant azithromycin. The overall median baseline corrected QT (QTc) was 455 ms (473 ms with hydroxychloroquine only vs. 442 ms with hydroxychloroquine and azithromycin; P<0.001). The median change in QT interval was 23 ms in patients on both drugs and 5.5 ms in those on hydroxychloroquine alone (P=0.03). Prolonged QTc of 500 ms or more occurred in 19% of hydroxychloroquine patients and 21% of those on both drugs, and changes of 60 ms or more occurred in 3% and 13%, respectively. Hydroxychloroquine was discontinued early in 10 patients for potential adverse drug events, including one case of torsades de pointes. The authors noted that they could not exclude COVID-19-associated stress cardiomyopathy or myocarditis as a cause of the findings and could not definitively conclude that hydroxychloroquine and azithromycin increased cardiotoxic risk.

The second study, published as a research letter, included 40 French patients, 18 treated with hydroxychloroquine with azithromycin and 22 taking hydroxychloroquine alone. Half of the patients also received other treatments associated with QT prolongation in the ICU. In total, 93% showed an increase in QTc after treatment. Prolonged QTc occurred in 36%, and 6 of 18 on both drugs (33%) versus 1 of 22 (5%) in the hydroxychloroquine-alone group developed an increase in QTc of 500 ms or greater (P=0.03). Treatment was halted in 17.5% for electrocardiogram abnormalities and in 25% for acute renal failure.

An accompanying editorial noted that it's not clear whether the findings of these studies can be generalized to other settings but said they underscore the risk of widespread use of these drugs for COVID-19 without QTc monitoring.

Reassurance about hypertension drugs and COVID-19 was provided by three studies published by the New England Journal of Medicine on May 1. First, a population-based case-control study matched 6,272 patients with severe COVID-19 to 30,759 similar controls in Italy and found that the use of angiotensin-receptor blockers (ARBs) and angiotensin-converting enzyme (ACE) inhibitors was more common among case-patients than among controls but that the difference could be attributed to higher prevalence of cardiovascular disease. Neither drug class showed an association with COVID-19 infection or death. The second study looked at previous treatment with ACE inhibitors, ARBs, beta-blockers, calcium-channel blockers, or thiazide diuretics in 12,594 New York patients tested for COVID-19 and did not find any substantial increase in the likelihood of having a positive test or severe case with use of the drugs. The third study used an observational database from 169 hospitals in Asia, Europe, and North America to analyze 8,910 patients with COVID-19, 5.8% of whom died in the hospital, and found that use of ACE inhibitors or ARBs was not associated with increased mortality. “All are observational studies with the looming possibility of confounding, but each has unique strengths, and their message is consistent—none of the three studies showed evidence of harm with continued use of ACE inhibitors and ARBs,” said an accompanying editorial.

Regarding COVID-19-associated disparities, a research letter published by JAMA on April 29 compared COVID-19 tests, cases, and deaths across New York City and found that the Bronx was hit much harder than Manhattan, with variation by borough in the number of COVID-19 tests performed per 100,000 population: 4,599 in the Bronx; 2,970 in Brooklyn, 2,844 in Manhattan, 3,800 in Queens, and 5,603 in Staten Island. Both hospitalizations and deaths per 100,000 were highest in the Bronx and lowest in Manhattan. The authors noted that the differences may be due to underlying comorbid illnesses, occupational exposures, socioeconomic determinants, or race-based structural inequities.

An Ideas and Opinions article published by Annals of Internal Medicine on April 28 called for swift action in response to the disparities in infection and death rates, and research published by Annals the same day noted how these disparities apply to front-line health care workers, reporting that 11.5% of nursing home staff and 14.9% of home care workers in the U.S. lack insurance, and meanwhile, 26.6% of health care workers are at risk for poor COVID-19 outcomes because of age or chronic conditions.

ACP recently called on the federal government to immediately collect and publicly release data on the race, ethnicity, and preferred language of patients related to COVID-19 testing, hospitalizations, and deaths to better understand and address the problem of disparities. More details about ACP's continuing advocacy related to the COVID-19 pandemic are online.