Special Edition: May 15, 2020
Issue SpotlightAMA cautions physicians, public about limitations of antibody testing for SARS‑CoV‑2
With a growing number of tests claiming to identify people who have been exposed to SARS-CoV-2 and potentially immune to COVID-19, the AMA announced guidance to help ensure physicians and the general public are aware of the limitations and potential uses of serological testing, also known as antibody testing. Through the new guidance, the AMA cautions physicians and the general public about using these tests to determine individual immunity and warns that the discontinuation of physical distancing should not be made on the basis of antibody test results.
"Given that we do not yet have scientific evidence showing if, when and for how long individuals might become immune to COVID-19, physicians and the general public should not use antibody testing to consider anyone immune to the disease—doing so may lead individuals to falsely assume they can stop physical distancing and further the spread of illness," said AMA President Patrice A. Harris, MD, MA. "Although many are using these tests to determine whether an individual had COVID-19, we encourage physicians to only use antibody tests authorized by the Food and Drug Administration (FDA) and only for the purposes of population-level studies, evaluating recovered individuals for convalescent plasma donations, or along with other clinical information as part of a well-defined testing plan for groups or individuals."
The AMA's new guidance provides physicians and the general public with an overview of the current state of antibody testing for SARS-CoV-2, including their limitations, potential uses, and how they are and are not regulated. This guidance can be found online as part of the AMA's COVID-19 Resource Center.
While antibody tests may play an important role in determining the overall prevalence of COVID-19 in the U.S. population, including asymptomatic infection, inherent limitations exist in using them to identify prior infection in individuals. Many of the antibody tests currently on the market may return a significant number of false positive results, as well as show cross-reactivity—meaning the tests also identify antibodies for other coronaviruses, such as those causing the common cold. Given these limitations, the AMA recommends that currently available antibody tests not be used as the sole basis of diagnosing COVID-19, and not be offered to individuals as a method of determining immune status, and not be used to inform decisions such as returning to work, discontinuing physical distancing, or as the basis for "immunity certificates."
Additionally, concerns continue to mount about the performance and fraudulent labeling of many of the SARS-CoV-2 antibody tests currently available. The vast majority of more than 120 tests on the market have not been authorized by the FDA, despite marketing claims to the contrary. The AMA urges physicians to pay close attention to the regulatory status of all available SARS-CoV-2 antibody tests. A list of all antibody tests authorized by FDA for SARS-CoV-2 can be found on FDA's website.
The AMA continues to recommend physical distancing to reduce the spread of COVID-19. However, there are marginalized and minoritized patient-communities disproportionately impacted by COVID-19 and their housing or employment status may make it difficult to adhere to physical distancing recommendations. The new guidance calls for providing messaging to medically underserved communities that explicitly takes into consideration the cultural and social features affecting their ability to make long-term choices on physical distancing and other COVID-19 precautions.
The AMA will continue to provide resources to physicians and physicians-in-training to help prepare them to care for patients as the pandemic evolves and protect themselves and their patients from illness. These resources are available on the AMA COVID-19 Resource Center.
House democrats released their version of the COVID 4.0 relief package. Known as H.R. 6800, the Health and Economic Recovery Omnibus Emergency Solutions Act, "HEROES Act," the 1,800-page bill includes many provisions advocated for by the AMA. The following are some of the key provisions of the bill:
- Provides $100 billion more for the HHS provider relief fund, with clear guidance to ensure that funds are distributed in the most equitable and efficient way on a quarterly basis.
- Improves the Accelerated and Advance Payment Program, including an extension of the repayment period, lower interest rate (1%), and lower per claim recoupment.
- Provides $75 billion in grants to state, local, tribal, and territorial health departments for testing and contact tracing, including provisions to ensure equitable access and culturally competent testing, tracing, and public awareness efforts.
- Increases the Federal Matching Assistance Percentage (FMAP) for Medicaid by 14 percentage points through June 2021, delays implementation of the Medicaid Financial Accountability rule, and allows early Medicaid enrollment for individuals soon to be released from prison.
- Improves health insurance coverage through COBRA subsidies and special enrollment periods for Medicare and the ACA exchanges.
- Establishes a Public Health Workforce Loan Repayment Program, provides up to $10,000 in debt relief for private student loans, and provides temporary relief for federal student loan borrowers.
- Temporarily eases immigration-related restrictions to allow immigrant physicians and other critical health care workers to assist in fighting COVID-19, including permanent reauthorization of the Conrad 30 program.
- Requires the President to appoint a Medical Supplies Response Coordinator to be responsible for supply chain logistics, including distribution of PPE.
- Provides $130 million for public health data surveillance and infrastructure modernization at CDC, and requires regular reporting on race, ethnicity, age, sex, and gender of individuals diagnosed with COVID-19.
- Provides $7.6 billion for Health Centers to expand the capacity to provide testing, triage, and care for COVID-19 and other health care services at approximately 1,000 existing health centers across the country.
Importantly, this legislation is best viewed as the democrats' broad wish list of items to be addressed in the COVID 4.0 package. Many of its provisions are seen as highly partisan and any final legislation will look much different. AMA is preparing a more detailed summary that will be available in our COVID-19 Resource Center.
With more than 20 million U.S. workers losing their jobs due to the pandemic, they and their family members are at risk of losing their health insurance coverage too. Federal funds are available to pay for uninsured patients' COVID-19 testing and treatment, and the U.S. Department of Health and Human Services (HHS) has put in place a mechanism to channel that money toward the payment of claims.
But Congress can do more to stop individuals and families from losing their coverage in the first place and prevent the newly unemployed to also become newly uninsured.
The matter is urgent. Unemployment exploded by an unprecedented 15.9 million persons in April to reach 23.1 million. This does not count an additional 6.4 million persons who dropped out of the labor force.
The AMA and a coalition of medical and business organizations have outlined steps Congress can take to help companies maintain their employees' insurance during the COVID-19 public health emergency and to bolster the health insurance marketplace.
"COVID-19 shows that our efforts to cover the uninsured in this nation are not complete; more needs to be done," wrote Dr. Harris in a recent Leadership Viewpoints column.
This point was echoed in a letter to Congressional leaders signed by the AMA and more than 30 other medical and business groups, including the U.S. Chamber of Commerce.
"Employers need more support—and workers need to be able to continue their stable, secure coverage," the letter states. "As you consider the next round of legislation to overcome COVID-19, we urge you to prioritize maintaining private health benefits for individuals and families and to increase coverage options for those who are already uninsured."
Specifically, the organizations called on Congress to:
- Provide employers with temporary subsidies to preserve health benefits. Many employers experiencing loss of revenue reluctantly reduce benefits to manage expenses. Congress could help by providing subsidies to offset the cost of preserving health coverage.
- Cover Consolidated Omnibus Budget Reconciliation Act (COBRA) coverage costs. Many may maintain job-based coverage through COBRA but find the costs to be prohibitive—especially when facing a significant loss of income. Congress could subsidize COBRA costs to former employees.
- Expand use of health savings accounts (HSA). Congress could temporarily lift limits on what HSAs can be used for in order to provide access to additional resources to pay insurance costs.
- Open a special enrollment period for health insurance marketplaces. While individuals who recently lost employer-based coverage are eligible to enroll in the marketplaces, Congress could create a one-time marketplace special enrollment period specifically for individuals who are uninsured and not otherwise eligible.
- Increase eligibility for marketplace federal subsidies. Some individuals and families earned too much money to qualify for subsidies but didn't make enough to afford premiums. Congress could increase access to individual market coverage by increasing eligibility for federal subsidies.
Responding to Americans' growing reluctance to share health data and unresolved tension over eroding personal privacy, the AMA issued new privacy principles supporting an individual's right to control, access and delete personal data collected about them. Using the new privacy principles, the AMA will actively engage the administration, Congress and industry stakeholders in discussions on the future direction of regulatory guardrails that are needed to restore public confidence in data privacy protections.
"The AMA privacy principles set a framework for national protections that provide patients with meaningful control and transparency over the access and use of their data," said AMA President Patrice A. Harris, MD, MA. "Preserving patient trust is critical if digital health technologies are to facilitate an era of more accessible, coordinated and personalized care. To restore confidence in data privacy and security, the AMA privacy principles promote individual rights, equity and justice, corporate responsibility to the individual, applicability and federal enforcement."
Recent events have highlighted how critical it is to have clear rules of the road with respect to data use. There is unprecedented reliance on remote care technologies, like telehealth, to help people avoid leaving their homes during the COVID-19 pandemic. But both patients and clinicians are justified in questioning how platforms will secure and protect the information exchanged during the virtual visits.
Similarly, many private and public efforts are underway to collect, use and disseminate public health surveillance data to help inform public health officials and policymakers about the spread of the novel coronavirus. These efforts are critically necessary but must address questions about how best to handle the data both during collection and once the pandemic has subsided.
The AMA believes the primary purpose of boosting guardrails around data use is to build public trust, not inhibit data exchange. The AMA privacy principles seek to promote individuals' confidence in institutions. The more confidence people have in how entities will use and exchange data, the more willing society will be to participate in data donation efforts.
"The delicate balance between privacy and data protection on the one hand, and the protection of public health on the other, presents a number of challenges," said Dr. Harris. "The AMA's privacy principles provide a meaningful framework to guide data collection efforts, privacy legislation, and public health plans to help ensure that steps we take now will not unfairly and disproportionately impact vulnerable populations down the road, but rather will instill trust in the systems we establish to help keep people safe and healthy."
Reports from more than 20 states indicate that the nation's opioid epidemic may be getting worse during the COVID-19 pandemic, according to a new AMA Advocacy Resource Center issue brief.
Despite new policies from the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) and U.S. Drug Enforcement Administration (DEA) that provide increased flexibility for providing buprenorphine and methadone to patients with opioid use disorder, states must take action to implement those policies, including:
- Governors must adopt the new SAMHSA and DEA rules and guidance in-full for the duration of the national emergency—this includes flexibility for evaluation and prescribing requirements using telemedicine.
- States must enact as part of their own Emergency Orders and other actions a complete removal of prior authorization, step therapy and other administrative barriers for medications used to treat opioid use disorder.
- States must remove existing barriers for patients with pain to obtain necessary medications. This includes removing arbitrary dose, quantity and refill restrictions on controlled substances.
- States must enact, implement and support harm reduction strategies, including removing barriers to sterile needle and syringe services programs.
Read the full range of AMA recommendations for states to help patients with opioid use disorder and pain as well as how to further harm reduction efforts.
To reopen practices closed by the COVID-19 pandemic, physicians will need to ensure safety and patient peace of mind. An AMA checklist has been developed for safely reopening practices. It builds upon guidance offered by the Centers for Disease Control and Prevention and offers these tips on getting started. The AMA has also developed a chart detailing state-by-state actions regarding the resumption of postponed medical services and procedures.Back to Top
May 20: Given the ongoing stress that COVID-19 has placed on individuals seeking care for opioid use disorder (OUD), Get Waivered, the American College of Emergency Physicians and ED-Bridge are partnering to provide the first Zoom DEA X waiver training class on May 20 from 10 a.m. to 6 p.m. Eastern time. Elevated levels of anxiety and depression caused by isolation measures are having a particularly severe impact on patients with opioid addiction. Given the realities of isolation and the increased difficulties of accessing care during the COVID-19 pandemic, many patients who struggle with addiction are having a harder time finding the treatment they need. Combined with new guidelines on telemedicine, remote waiver training will allow physicians to manage OUD in an outpatient setting while maintaining required social distancing.
Please register at getwaivered.com/remote.