Special Edition: May 1, 2020
Issue SpotlightNext steps the nation must take on COVID-19 testing
A national strategy is needed to provide greater clarity and transparency about existing COVID-19 testing capacity and the supply chain for testing supplies, as well as to help ensure that states have the testing resources they need, the AMA said in a letter to Brett P. Giroir, MD, the Health and Human Services (HHS) assistant secretary for health and an admiral in the Commissioned Corps of the U.S. Public Health Service.
Specifically, the letter told Dr. Giroir about the AMA's concerns regarding the current state of diagnostic testing, access to testing components, and ensuring that laboratories have adequate resources—this includes being prepared for a potential resurgence of COVID-19 this autumn.
The AMA is appreciative of Dr. Giroir's willingness to collaborate on the issue of access to diagnostic testing services, but other concerns were also raised, including issues about the performance of serological tests currently on the market and their use by the public to inform physical distancing decisions.
"As we anticipate the threat of COVID-19 may persist into the fall, the coming months represent a critical time for federal leadership to help ensure states are adequately resourced and prepared with critical strategies to manage what may be increased demand for testing services," AMA CEO and Executive Vice President James L. Madara, MD, wrote in the letter.
To ensure diagnostic testing is available to all who need it and that laboratories can handle the persistent and intense demands placed on them by the pandemic, the AMA made the following recommendations:
- Pursue a national strategy for testing during the COVID-19 pandemic.
- Consult with hospital, academic and community labs.
- Ensure laboratories have adequate resources to meet demand.
- Provide additional guidance and education to physicians and the public regarding serological testing, its performance limitations, and the risk for false positives.
Read the full story here.
The AMA is urging the Centers for Medicare & Medicaid Services (CMS) to reinstate its Accelerated and Advance Payment (AAP) Program and to expand it to cover Medicaid services for the duration of the COVID-19 public health emergency.
The AMA hailed CMS when it expanded the AAP program, which provides physicians with an emergency cash advance—based on historical payments—to compensate for the disruption in claims submission and processing during the COVID-19 pandemic. However, the program was paused for an evaluation on April 26.
"Given the uncertainty facing physician practices as the pandemic is on different surge timelines in communities across the country, we fear physician practices may not resume normal operation in the immediate future and will continue to need access to cash flows to keep their doors open for patients," AMA CEO and Executive Vice President James L. Madara, MD, wrote in a letter to CMS Administrator Seema Verma.
Dr. Madara also spoke directly to Verma by phone on April 27 and urged her to restart the AAP program and to authorize similar advance payments or retainer payments to allow state Medicaid programs to provide critically needed funds to physician practices.
Also, as practice revenue drops while patients remain at home and physicians delay non-urgent services and procedures, more flexibility is needed for the terms of repayment. The AMA urges CMS to use the full extent of its statutory discretion to do the following:
- Extend the repayment period for physicians to at least two years.
- Reduce the recoupment amount to a maximum of 25% of claims to ensure that the recoupment process does not result in a future sudden stoppage of Medicare revenue to practices.
- Waive the interest rate that applies to advance payment balances after the initial repayment period.
Many pediatric, ob-gyn and safety-net practices have not been able to receive AAP payments and are in critical financial condition.
Read the full story here.
HHS has started distribution of the next $20 billion in financial relief for physician practices, groups and other health care delivery organizations that is part of the Coronavirus Aid, Relief and Economic Security (CARES) Act.
The relief comes under the Public Health and Social Services Emergency Fund in the CARES Act. The initial $30 billion in CARES Act relief was directed to hospitals and physician practices in direct proportion to their share of Medicare fee-for-service spending.
Payments from this $20 billion are calculated so that a physician practice or group's allocation from the entire $50 billion general distribution is in proportion to its 2018 net patient revenue. As detailed in an HHS fact sheet shared on the AMA website, all physician practices or groups are required to submit revenue information to the provider portal for later verification.
The fact sheet also explains what the payments can be used for, how the payments will be distributed, and what action physician practices, groups and other recipients should take—whether they get paid automatically or not. Those who don't get paid automatically should visit the CARES Provider Relief Fund Payment Portal and follow the instructions on how to claim the second general distribution.
The AMA has provided additional guidance about the financial and tax information physicians will need to have on hand to successfully claim your practice or group's share of the funds.
Read the full story here.
The AMA, alongside 31 other groups, sent a letter to Congressional leadership urging them to take immediate action to support employers and workers by protecting and expanding high quality, affordable health care coverage.
More than 26 million Americans have lost their jobs during the COVID-19 pandemic and since a majority of Americans receive health insurance through their employer, immediate action needs to be taken to support employers and workers by protecting affordable health care coverage. The AMA is calling on Congress to increase coverage options for the uninsured by:
- Providing employers with temporary subsidies to preserve health benefits
- Covering the cost of coverage through the Consolidated Omnibus Budget Reconciliation Act (COBRA)
- Expanding use of health savings accounts (HSA)
- Opening a special enrollment period for health insurance marketplaces
- Increasing eligibility for federal subsidies for the health insurance marketplaces
Taking these actions would be a great help to stabilizing businesses and strengthening health care coverage and the economy.
On April 30, CMS announced a broad range of regulatory waivers and rule changes to help expand care to seniors and provide more flexibility to the healthcare system. While the changes are broad and still under review, they included a change that the AMA and many Federation groups have been requesting.
Retroactive to March 1, 2020, Medicare will pay for audio-only telephone visits between beneficiaries and their physicians and other clinicians, including many behavioral health and patient education services. The agency is also increasing payment for these telephone visits to match those for similar office and outpatient visits. This would increase payments for these services from a range of about $14-$41 to about $46-$110.
The AMA is supporting bipartisan House legislation that would ensure telehealth coverage for care, including mental health and substance-use disorder treatment, for as long as the COVID-19 public health emergency continues.
The bill—the Health Care at Home Act, H.R. 6644—was introduced by Washington Democrat Kim Schrier, MD, and Tennessee Republican Phil Roe, MD. Among other things, the legislation would:
- Ensure all medically necessary benefits in Employee Retirement Income Security Act (ERISA) plans are covered via telehealth for the duration of the COVID-19 public health emergency.
- Establish parity between telehealth and face-to-face visits, including audio-only visits.
- Bar restrictions on which conditions can be managed remotely.
- Ensure that all cost-sharing for COVID-19 related treatment can be waived.
CMS has taken important steps to ease regulatory barriers to telehealth and also enforce pay parity for telehealth visits during the pandemic. But private payers, including employer-provided ERISA health plans, have not necessarily followed suit. This legislation would change that, enabling greater access to telehealth for patients to get the care they need while doing their best to stay home and save lives.
Read the full story here.
The U.S. Food and Drug Administration (FDA) has cautioned against the use of some medicines FDA-approved to treat or prevent malaria and being used for the treatment or prevention of COVID-19. The FDA has warned that hydroxychloroquine and chloroquine should only be used in hospitals or clinical trials because they have been linked to a risk of heart rhythm problems, especially when paired with the antibiotic azithromycin.
There have been reports of serious, potentially life-threatening, heart rhythm problems in patients with COVID-19 who are treated with hydroxychloroquine or chloroquine and used in combination with azithromycin and other QT prolonging medicines.
"We are also aware of increased use of these medicines through outpatient prescriptions. Therefore, we would like to remind health care professionals and patients of the known risks associated with both hydroxychloroquine and chloroquine," says the FDA drug safety communication.
There is no evidence to show that hydroxychloroquine and chloroquine—prescribed for years to treat lupus and arthritis—are safe and effective for treating or preventing COVID-19. These medicines are currently being studied in clinical trials for COVID-19 treatment and prophylaxis. However, in late March the FDA issued an emergency use authorization (EUA) to supply chloroquine and hydroxychloroquine from the Strategic National Stockpile to treat certain patients who are hospitalized with COVID-19 and for whom clinical trials are not available, or participation is not feasible. Learn more about lessons learned from COVID-19, including how treatment is unclear at this time.
Read the full story here.
The AMA sent a letter to the Drug Enforcement Administration (DEA) commending its proposal to reduce the administrative burden for narcotic treatment programs (NTP) that operate mobile components. Under this new proposal, NTP registrants that operate mobile components will be able to dispense controlled substances without obtaining a separate DEA registration for the mobile component. The wider scale operation of mobile components by registered NTPs has the potential to significantly alleviate the disparities in access to opioid use disorder (OUD) treatment that are being exacerbated by the COVID-19 health crisis. By increasing access to methadone maintenance therapy, which has a strong evidence base, mobile components will help reduce stigma as more patients initiate therapy, stay in treatment and demonstrate positive treatment outcomes. The AMA is urging the DEA to quickly finalize the proposed regulatory changes for NTPs that operate mobile components.
The AMA has assembled a new web page as a central location for all its state-based advocacy resources to help medical societies and other stakeholders address the COVID-19 pandemic. Topics addressed include telemedicine, liability protections for physicians, Medicaid, opioid use disorder, chronic pain, elective procedures, prior authorization and more.
The page will be updated as new resources are created. If there are topics and tools that you feel should be included or developed, please let us know by contacting ARC@ama-assn.org.
For patients who are bed-ridden or in the final days of their life, it may be next to impossible for a hospice and palliative care physician to conduct an in-person evaluation to satisfy state and federal rules for prescribing controlled substances. While the authors of a new commentary in Health Affairs acknowledge that the DEA has helped ease the burdens for patients with chronic pain, hospice and palliative care patients remain an extremely vulnerable population with distinct needs.
The challenge is not only the ability to prescribe to patients who are bedbound or approaching the end of their lives, according to the authors, but any patient with symptoms and needs for whom a prescription of a controlled substance is indicated. For example, if a patient is living with metastatic cancer and requires opioid analgesics for the pain, unless the physician has previously seen the patient, even with DEA's new flexibility, the physician will not be able to prescribe it for the patient, including if the patient goes into a hospice program.
"If this waiver is granted, we will be able to provide the full range of palliative care treatment needed to reduce hospitalizations, decrease exposure to COVID-19, significantly reduce suffering, and save lives," write Patrice Villars, MS, GNP-BC, Eric Widera, MD, and Chad Kollas, MD.
Currently, for the duration of the pandemic, the DEA has allowed audio-visual evaluations of patients to be able to prescribe controlled substances. Audio-only can be used for existing patients. The AMA has called on the nation's governors to adopt the DEA guidance in full, but the hospice and palliative care physicians argue that more is needed.
"When I'm called to provide an e-consult to a patient just beginning hospice, there is no guarantee that the patient or her family will have FaceTime, Skype or Zoom," said Dr. Kollas, the physician representative from the American Academy of Hospice and Palliative Medicine to the AMA Opioid Task Force. "This is happening with increasingly regularity, and it leaves me and the patient in a tremendous quandary because under federal law, I can't prescribe necessary medication to these 'new' patients for whom I've not conducted an in-person evaluation."
In an interview, the authors also acknowledged that even if the DEA changes its rules, it is incumbent upon governors to adopt those rules.
"Even if the DEA provides further flexibility for hospice patients, there are too many states where current laws, payer and pharmacy policies would prevent us from helping our patients," said Dr. Kollas. "This is why it's essential for governors to follow the DEA."
A new AMA resource, "Making tough decisions: Managing the practice's employee costs," outlines key options for physician practices to consider to control labor costs, including redeployment, outside activities, compensation changes, workforce reduction, benefit modifications, legal compliance and stimulus relief considerations.
Designed off of existing CMS guidance, the AMA has created guidance and new resources to ensure physician practices are ready to reopen during COVID-19. The Physician Guide to Reopening details how to comply with government guidance, make strategic plans and institute safety measures for patients, clinicians and staff. The resource also offers a pre-visit screening script template to determine which patients can safely receive care from the practice.
May 8: Health care providers are invited to participate in a weekly call series from CMS, "Lessons from the front lines," which are a joint effort between CMS Administrator Seema Verma, Food and Drug Administration Commissioner Stephen Hahn, MD and the White House Coronavirus Task Force. These calls allow physicians and other clinicians to share their experience, ideas, strategies and insights related to their COVID-19 response. The next call will take place on May 8 from 12:30 to 2 p.m. Eastern time.
And every Tuesday and Thursday, CMS hosts Q&A calls for health care providers. Get answers to your COVID-19 questions directly from CMS in this open forum. Read answers to questions from previous calls in this FAQ document or sign up to receive information on future calls.
For more information visit Coronavirus.gov and the CMS Current Emergencies page.
May 20: Given the ongoing stress that COVID-19 has placed on individuals seeking care for opioid use disorder (OUD), Get Waivered, ACEP 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.