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Connection Newsletter - FDA recalls certain Philips ventilators

This recall is separate and unrelated to the June 2021 Philips Respironics ventilator, BiPAP, and CPAP machine recall.

COVID-19 Arizona update

Over the past 10 weeks, Arizona has seen an increase in COVID-19 cases to the point that health experts are referring to the increase as the third surge. In Valleywise Health’s COVID-19 briefing Wednesday, Chief Clinical Officer Michael White, M.D., shared that over 95% of patients in Valleywise being treated for COVID-19 are not fully vaccinated. According to the Centers for Disease Control and Prevention, 57% of Arizona adults have received 2-doses of the vaccine while another 10% have received 1-dose. Data shows COVID-19 vaccines help prevent those from getting seriously ill. Individuals who are not fully vaccinated may find a vaccination site at

AzHHA issued a statement this week citing the increase in hospitalizations that put Arizona hospitals at, nearing or over capacity. While COVID-19 hospitalizations today are not as high as they were in December and January, the trend is ominous. We ask our communities to help us by doing your part: get the COVID-19 vaccine, wear your mask and help us slow the spread of COVID-19.

FDA recalls certain Philips ventilators

The U.S. Food and Drug Administration (FDA) has issued a number of Class I recalls on certain models of Philips respirators in the past month including the most recent issued August 3 recalling V60 Plus ventilators and all V60 ventilators that provide High Flow Therapy (software version 3.00 and 3.10) due to the risk of patients receiving reduced oxygen. This recall is separate and unrelated to the June 2021 Philips Respironics ventilator, BiPAP, and CPAP machine recall. To view the list of medical device recalls, visit the FDA website.

FDA grants full approval of Pfizer-BioNTech COVID-19 Vaccine

The FDA granted full approval to the Pfizer-BioNTech COVID-19 Vaccine Monday for the prevention of COIVD-19 for individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine, now known as Comirnaty, has been available since December 2020 under emergency use authorization (EUA) in individuals 16 years of age and older. The authorization was later expanded to include those 12-15 years of age. Use of the vaccine for children 12-15 years of age will continue under EUA. In the FDA’s review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19.

CMS expands Medicare payments for at-home COVID-19 vaccinations

While many individuals who are Medicare beneficiaries can receive a COVID-19 vaccine at a retail pharmacy or from a healthcare provider, some have difficulty leaving their homes or cannot easily access vaccination. To better serve this group, Medicare will expand payments for at-home COVID-19 vaccination administration in smaller group homes, assisted living facilities and other group living situations by allowing vaccine providers to receive the increased payment up to five times when fewer than 10 Medicare beneficiaries get the vaccine on the same day in the same home or communal setting. Medicare had previously increased the total payment amount for at-home vaccination from approximately $40 to approximately $75 per vaccine dose, in certain circumstances.

More information on Medicare payment for COVID-19 vaccine administration – including a list of billing codes, payment allowances and effective dates – is available on the Medicare COVID-19 Vaccine Shot Payment webpage.  

AzHHA submits comments on OSHA ETS rule

AzHHA submitted comments on August 19 to the Occupational Safety and Health Administration (OSHA) expressing its concern on the Emergency Temporary Standard (ETS). Key concerns regarding the ETS include the rule being at odds with CDC guidance, the definition of an “exposure” and burdensome screening instead of allowing hospitals flexibility to assess based on the level of community spread and other protective measures taken. Arizona hospitals have focused and will continue to focus on the health and safety of their workforce and patients. AzHHA strongly believes in the effectiveness of the vaccines and programs our members have put in place to protect patients and staff, therefore, urging OSHA to withdraw its ETS rule.

U.S. Departments of Health and Human Services, Labor, and Treasury Release FAQs on Transparency, No Surprises Act Regulations

The U.S. Departments of Health and Human Services, Labor, and Treasury released Frequently Asked Questions (FAQs) on August 20 related to provisions in the No Surprises Act and the Transparency in Coverage final rule. The departments announced they will be deferring enforcement of the good faith estimate requirements for insured patients, as well as the advanced explanation of benefit requirement. They also recognize the significant overlap between several of the No Surprises Act provisions and the transparency in coverage final regulations and plan to streamline requirements where appropriate. Lastly, they identified instances where they do not expect to issue regulations before a provision’s effective date and addressed how they will monitor enforcement in those cases.

FBI Cyber Division issues Flash Alert - Indicators of compromise associated with Hive ransomware

The Federal Bureau of Investigation (FBI), Cyber Division, released a Flash Alert Wednesday notifying of a new strain or ransomware that may be of particular interest to the healthcare industry. Hive ransomware was first detected in June 2021 and likely operates as an affiliate-based ransomware, employs a wide variety of tactics, techniques and procedures (TTPs), creating significant challenges for defense and mitigation. This ransomware uses multiple mechanisms to compromise business networks, including phishing emails with malicious attachments to gain access and Remote Desktop Protocol (RDP) to move laterally once on the network.

After compromising a victim network, the FBI says Hive ransomware actors exfiltrate data and encrypt files on the network. The actors leave a ransom note in each affected directory within a victim’s system, which provides instructions on how to purchase the decryption software. The ransom note also threatens to leak exfiltrated victim data on the Tor site, “HiveLeaks.”

House passes a $3.5 trillion budget resolution

The U.S. House of Representatives approved a $3.5 trillion budget resolution Tuesday, which included reconciliation instructions to provide the majority party with the means to pass a comprehensive reconciliation package with 51 votes in the Senate, rather than the usual 60-votes. As part of an agreement to pass the budget, the House is also expected to act on the Senate-passed bipartisan infrastructure legislation in September. 

The House and Senate majorities can now proceed with the budget reconciliation process. Among the Democrats’ planned expenditures are subsidized childcare, expanded Medicare benefits and paid family and medical leave. The resolution’s assumptions include action on a number of healthcare initiatives including a continuation of expanded Affordable Care Act subsidies; filling the “Medicaid coverage gap”; addressing healthcare provider shortages through action on graduate medical education; an expansion of Medicare to cover hearing, dental and vision benefits; home healthcare benefits for seniors and persons with disabilities; addressing inequities in healthcare; reducing prescription drug costs and certain workforce investments, including the National Health Service Corps, Nurse Corps and Teaching Health Center Graduate Medical Education.



Upcoming Events

October 7, November 11 and December 2 - Introduction to POLST

Interested in learning how to use the Arizona POLST form with your patients? The one-hour Introduction to POLST workshop equips healthcare professionals with knowledge and resources to begin using POLST in Arizona. The objectives are to describe what POLST is at the state and national level, explain why POLST is important, define the population for POLST, when to begin the conversation and who completes POLST, describe the process for completing, reviewing and updating POLST and learn the process of submitting healthcare planning documents to the Arizona Healthcare Directive Registry. To register for a workshop, click on a date below.

October 14 – 2021 Arizona Health Equity Conference

Join the statewide movement to promote resiliency and health equity by attending the 2021 Arizona Health Equity Conference  October 14. Attending the conference is a great opportunity to understand current health equity research, outreach and policies taking place in Arizona and to connect with partners who are working in the field of health equity or interested in reducing health disparities. To view the conference program, click here. Both virtual and limited in-person registration options are available.

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