AzAFP E-News- May 1, 2020
AZ Government Relations Update:
Peters, Cannata & Moody plc
It’s the start of a new month, and the end of the 16
week of the 2020 legislative session. This was the date that legislative leaders hoped to adjourn the session, which has been suspended since March 23 due to the COVID-19 pandemic. A coalition of Republicans overrode that idea, however, and continue to work behind the scenes to obtain the votes they need to force the House and Senate to resume work. They have different ideas of what should be included in the scope of work for the rest of the session – some legislators want to have the chance to hold committee hearings and votes on their top policy priorities, while others believe the legislature should only focus on proposals that have broad consensus. Some want the legislature to enact new laws related to aid or relief for those who have been impacted by the COVID-19 economic disruption; others think the state should wait for a special legislative session later this year to address any policy changes that arise as Arizona ramps up its economic activity.
The legislature has waived rules that set a 100-day limit to the session so there is no deadline for a decision, but House and Senate leaders face growing political pressure to chart a path forward. It is impossible to please every legislator who has strong views on what should happen next; the divisions about when – and how – to resume the session reflect the divisive dynamics that will continue through the and into the 2020 election cycle.
Governor Doug Ducey has not publicly expressed his thoughts on what the legislature should do, except to suggest that legislators
until this summer to make any decisions about the projected budget shortfall.
This month will be a turning point for the 2020 legislative session. If legislators choose to adjourn the session, they will stop consideration of more than 600 proposals that were advancing through the legislative process before COVID-19. If they choose to reconvene and consider legislation, they will return to an unprecedented situation at the Capitol that requires physical distancing and fuels political divides.
Governor Extends, Modifies “Stay at Home” Order
On Wednesday, Governor Doug Ducey issued a
new executive order
that extends the “stay home, stay healthy, stay connected” order until May 15, and outlined the next steps into a “temporary normal” as Arizona prepares to gradually lift the stay-at-home practices that shaped the month of April.
Stores that sell
have remained open, but next week the state will authorize retail shops that sell non-essential goods to open – first for curbside sales (on May 4) and then for limited in-person shopping (on May 8). Stores that open must do so under public health guidelines, providing physical distancing and safety precautions to prevent the spread of COVID-19.
The Governor is working with the Arizona Restaurant Association on a plan for restaurants to open for in-person dining as early as May 12, but warned that bars, gyms, salons, and other businesses that cannot implement physical distancing precautions will remain closed for now.
“We know we’ve asked a lot of the people of Arizona,” the Governor said, and expressed his gratitude to everyone who had sacrificed to stop the spread of COVID-19. Governor Ducey said he felt “a sense of urgency” about re-opening all economic activity, but would make all decisions based on what he believed to be best for public health. “We’re closer,” he pledged. “Please stick with it.”
House Republicans Seek End to COVID-19 Emergency Declaration
The Governor’s extension of the stay-at-home order drew strong opposition from the coalition of House Republicans that are working to fully re-start the legislative session. This week, they announced a plan to introduce legislation that would end the state’s
declaration of emergency
for COVID-19, which the Governor implemented on March 11. Ending the emergency would override the Governor’s authority to issue an extended stay-at-home order, achieving the House Republican coalition’s goal of completely re-opening Arizona’s economy.
Senate President Karen Fann (R-Prescott) warned, however, that overturning the state of emergency could have unintended consequences. An end to the declaration of emergency could also end other executive orders and actions related to COVID-19 – like a temporary halt to evictions, a suspension of liquor license fees, and enhanced hospital data collection about COVID-19 cases. Without a declaration of emergency, the state might also lose some federal COVID-19 aid funding.
The Governor has not responded to the effort to overturn his authority over COVID-19. House and Senate Republicans say they will continue to discuss their differing points of view behind the scenes while they attempt to find agreement on how to finalize the 2020 legislative session.
In the News
On the Bright Side…
One-third of the University of Arizona College of Medicine – Phoenix Class of 2020 were granted early graduation, and by mid-April, many of the 30 students joined Arizona health care professionals in answering questions from providers and the public about the coronavirus on a statewide hotline. “Our students and college want to do everything we can to serve our community in this time of unprecedented need,” said Dean
Guy Reed, MD, MS
READ MORE HERE.
FDA Issues Emergency Use Authorization for Potential COVID-19 Treatment
Today, the U.S. Food and Drug Administration
issued an emergency use authorization
for the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. While there is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19, the investigational drug was shown in a clinical trial to shorten the time to recovery in some patients.
“FDA’s emergency authorization of remdesivir, two days after the National Institutes of Health’s clinical trial showed promising results, is a significant step forward in battling COVID-19 and another example of the Trump Administration moving as quickly as possible to use science to save lives,” said HHS Secretary Alex Azar. “NIH, FDA, and scientists across America and around the world have worked tirelessly with patients to get us this new potential treatment for COVID-19. The seamless cooperation between government and private industry under the President’s all-of-America approach to COVID-19 is getting treatment options to patients in record time.”
The emergency use authorization allows for remdesivir to be distributed in the U.S. and administered intravenously by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. Severe disease is defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator.
“From day one, the FDA has been committed to expediting the development and availability of potential COVID-19 treatments. Today’s action is an important step in our efforts to collaborate with innovators and researchers to provide sick patients timely access to new therapies where appropriate, while at the same time supporting research to further evaluate whether they are safe and effective,” said FDA Commissioner Stephen M. Hahn, M.D. “There’s tremendous interest among all parties to identify and arm ourselves with medicines to combat COVID-19, and through our
Coronavirus Treatment Acceleration Program
, the FDA is working around-the-clock and using every tool at our disposal to speed these efforts.”
Based on evaluation of the emergency use authorization criteria and the scientific evidence available, it was determined that it is reasonable to believe that remdesivir may be effective in treating COVID-19, and that, given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug’s use.
The EUA also requires that fact sheets that provide important information about using remdesivir in treating COVID-19 be made available to
health care providers
, including dosing instructions, potential side effects and drug interactions. Possible side effects of remdesivir include: increased levels of liver enzymes, which may be a sign of inflammation or damage to cells in the liver; and infusion-related reactions, which may include low blood pressure, nausea, vomiting, sweating, and shivering.
Following the declaration by the Secretary of HHS that circumstances exist justifying the emergency use of unapproved products, the FDA may issue an emergency use authorization to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by chemical, biological, radiological and nuclear threats when there are no adequate, approved, and available alternatives.
The issuance of an EUA is different than FDA approval. In determining whether to issue an EUA, the FDA evaluates the available evidence and carefully balances any known or potential risks of any unproven products with any known or potential benefits of making them available during the emergency.
The EUA was issued to Gilead Sciences Inc. The FDA previously allowed for study of the investigational drug under clinical trials, as well as expanded access use for individual patients and through a multi-patient expanded access program coordinated by Gilead.
The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated and may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance.
Family physicians are a critical part of our nation's response to COVID-19, yet the virus has exposed critical shortcomings in the U.S. primary care safety net. The AAFP has called on congressional leaders to prioritize the needs of the primary care workforce and patients and take bold steps to address this pandemic. The
April 13 letter
urged Congress to stabilize the primary care system and increase patient protections. Join us in telling Congress that relief to family physicians is essential to a comprehensive COVID-19 action plan.
Speak out now
AAFP Cohosts Hill Briefing on COVID-19 Impact on Primary Care Access
The AAFP joined the Pacific Business Group on Health and the Partnership to Empower Physician Led Care to offer an online briefing to legislative staff on April 30. National policy experts and physicians on the front lines of the pandemic outlined its impact on primary care practices and patient access and made specific policy recommendations to prevent the collapse of the primary care system. Watch a recording of the briefing
Senate Committee to Discuss COVID-19 Tests
On May 7, the Senate Health, Education, Labor, and Pensions Committee will hold a
on COVID-19 tests and testing innovations. Officials from the National Institutes of Health and the Biomedical Advanced Research and Development Authority will testify.
House Cures 2.0 Concept Paper Released
On April 28, Reps. Diana DeGette, D-Colo., and Fred Upton, R-Mich., announced their Cures 2.0 concept
on health care. The paper identified public and pandemic preparedness, FDA modernization, and CMS modernization within its six priority areas.
Medicare Increases Payment for Audio-only Telehealth Visits
On April 30, CMS
interim final rule
making additional policy changes in response to COVID-19. Among several changes, and reflecting
, CMS is increasing reimbursement for the telephonic E/M visits (CPT codes 99441-99443) to the same rate as regular, in-office E/M visits (99212-99214). This would increase payments for these services from a range of approximately $14-$41 to about $46-$110. The payments are retroactive to March 1, 2020. This will enable physicians to better care for their patients, especially elderly patients with chronic conditions and patients in rural communities who may not have access to audio-visual technology or high-speed internet.
HHS Urged to Provide Financial Relief
On April 28, the AAFP, the AAP, and ACOG sent a
to HHS regarding financial relief for obstetrician-gynecologists, pediatricians, and family physicians. The letter noted that distributed funds to date have favored physicians who care primarily for patients with Medicare coverage, leaving behind physicians with few to no Medicare-enrolled patients.
COGME Hears from AAFP on Importance of Rural Physician Training
The Council on Graduate Medical Education met on
to hear from experts and develop recommendations on the physician workforce in the COVID-19 pandemic. Atul Grover, M.D., Ph.D., FACP, FCCP, of the Association of American Medical Colleges, brushed off training physicians for rural practice. AAFP Medical Education Division Director Karen Mitchell M.D., FAAFP, however, urged COGME to promote GME training in rural areas to address significant health disparities. She said: "GME training in rural areas is of utmost importance" as "physicians provide significant adaptability to provide inpatient, outpatient, telehealth ... not just this pandemic but for future health care needs." COGME's
includes several family physicians.
House Subcommittee to Convene a Hearing on Federal COVID-19 Response
On May 6, the House Labor, Health and Human Services, and Education Appropriations Subcommittee will hold an in-person
on the federal government's response to the coronavirus pandemic.