COVID-19 Immunization Availability and Coverage

TRINIDAD NAVARRO COMMISSIONER STATE OF DELAWARE DEPARTMENT OF INSURANCE ## DOMESTIC AND FOREIGN INSURERS BULLETIN NO. 123 PRODUCERS AND ADJUSTERS BULLETIN NO. 35 TO: INSURANCE COMPANIES AND LICENSED INSURANCE PRODUCERS AUTHORIZED TO TRANSACT HEALTH INSURANCE COVERAGE IN DELAWARE RE: COVID-19 IMMUNIZATION AVAILABILITY AND COVERAGE DATED: DECEMBER 21, 2020 This Bulletin informs health insurance carriers and producers of the availability and coverage requirements concerning vaccines for Coronavirus Disease 2019 (COVID-19). The Department encourages carriers and producers to be proactive in planning for COVID-19 vaccination claims handling to ensure that claims and payments are handled promptly and efficiently. With first doses arriving before the end of 2020, planning and preparing for a COVID-19 vaccination reimbursement program is a critical component of the success of the vaccine program. ## Background COVID-19 is a disease that is caused by a respiratory virus, first identified in Wuhan, China, named SARS-CoV-2. It has the potential to cause severe illness and pneumonia in some people and can result in death. COVID-19 spreads through the air by coughing and sneezing, close personal contact such as touching or shaking hands, and touching an object or surface with the virus on it and then touching one's mouth, nose, or eyes. ## Vaccine availability As of December 17, 2020, one vaccine is available that is expected to significantly reduce the risk of infection from COVID-19, and a second is likely to see approval within the week. Most COVID-19 vaccines require two doses, administered three weeks apart. Delaware's vaccine planning effort is led by the Delaware Department of Health and Social Services (DHSS), Division of Public Health (DPH) in partnership with the state's COVID Vaccine Task Force (Task Force). The Department of Insurance is a member of NOTE: This Bulletin is intended solely for informational purposes. It is not intended to set forth legal rights, duties, or privileges, nor is it intended to provide legal advice. Readers should consult applicable statutes and rules and contact the Delaware Department of Insurance if additional information is needed. ♦INSURANCE.DELAWARE.GOV♦ 1351 W. NORTH ST., SUITE 101, DOVER, DELAWARE 19904-2465 (302) 674-7300 DOVER♦ (302) 259-7554 GEORGETOWN♦ (302) 577-5280 WILMINGTON the Task Force. **Vaccine Distribution:** As of the date of this bulletin, Delaware has received 8,776 doses of the Pfizer vaccine. Additional shipments are expected weekly. According to the Delaware Interim COVID-19 Vaccination Playbook (the Playbook)¹ prepared by the Task Force, DPH will serve as the point agency for ordering vaccine doses. All vaccines will be ordered through the U.S. Centers for Disease Control and Prevention (CDC). Vaccine providers will receive vaccines from CDC’s centralized distributor or directly from a vaccine manufacturer.² DPH has established Closed Point of Dispensing (POD) Agreements with hospitals and Emergency Medical Service (EMS) agencies to activate and operate vaccination sites for their staff and dependent upon staffing, identified critical work force members. Vaccine doses will be shipped directly to the PODs. **Vaccine providers:** Providers who wish to administer the vaccine as a POD must register with the statewide Immunization Program through the Immunization Information System, known as DelVAX. At first, when the vaccine is available only to targeted groups, hospital systems and EMS agencies will be responsible for vaccinating staff. When the vaccine is more widely available to the public, the vaccine will be available from primary care providers, pharmacies, Federally Qualified Health Centers, and from DPH. A web-based locator called Vaccine Finder: https://vaccinefinder.org/find-vaccine will list locations as soon as they are available. **Vaccine administration – a phased roll-out:** DPH’s State Health Operations Center (SHOC) will implement a phased roll-out of the vaccine. Initially, access to the vaccine in Delaware is expected to be limited to health care personnel and first responders, and residents and workers at long term care facilities. Eventually, the vaccine is expected to become more widely available to the general public, possibly by the Spring of 2021. According to the Playbook: During Phase 1 and 2, Delaware intends to consider and adopt the priority groups as recommended by CDC and other subject matter experts. Our Crisis Standards of Care Concept of Operations (CSC CONOPs) together with the recommendations from the Delaware Public Health and Medical Ethics Advisory Group will be employed to guide the ethical allocation of vaccine when supplies are not adequate to treat the entire population. During Phase 3, activation of our Point of Dispensing Annex Open PODs will serve the public at large. As Delaware reaches the phase of vaccinating individuals who may qualify as “high risk” for ¹ https://coronavirus.delaware.gov/wp-content/uploads/sites/177/2020/11/COVID-19-Vaccination-Playbook-DE-V7-102620-102920_webready.pdf ² https://www.cdc.gov/coronavirus/2019-ncov/vaccines/faq.html 2 severe COVID-19 illness, DPH advises that these individuals will be asked to have their provider verify whether they are “high risk.” The provider will then be able to either administer the vaccine, or, if they are not enrolled to do so, prescribe one for vaccination at an alternate location. The Department of Insurance encourages carriers to support health care providers in utilizing telemedicine for screening to help ensure that these persons may more easily navigate this process. The choice of which vaccine to administer will rest with healthcare providers, and health care providers will be asked to promote the CDC’s V-Safe app for surveys and health checks. Participating providers must administer COVID-19 vaccine regardless of the vaccine recipient’s ability to pay COVID-19 vaccine administration fees or coverage status. Pfizer’s vaccine is only authorized for ages 16 and older. Pregnant and breastfeeding women are asked to consult their doctor before getting the vaccine. Clinical trials continue to expand those recruited to participate and recommendations allowing use for these groups will likely be soon updated. ## Coverage for COVID-19 Vaccines Vaccine doses purchased with U.S. taxpayer dollars will be provided at no cost.³ However, vaccine providers will be able to charge an administration fee for administering the vaccine, which can be reimbursed as follows: - Patients with either private or public insurance: by the patient’s private insurance carrier, or public insurer such as Medicare and Medicaid. - Uninsured patients: by the Health Resources and Services Administration’s Provider Relief Fund. Stated differently, vaccine providers may seek appropriate reimbursement from a program or plan that covers COVID-19 vaccine administration fees for the vaccine recipient. In fact, according to an October 28, 2020 interim final rule with comment period (IFR) issued by the Centers for Medicare & Medicaid Services (CMS), carriers are required to provide coverage for all office visit fees and administrative costs within 15 business days after the date on which the United States Preventive Services Task Force or the Advisory Committee on Immunization Practices (ACIP) of the CDC makes an applicable recommendation relating to a qualifying coronavirus preventive service. The Department urges carriers to begin this coverage as soon as the vaccine is approved without waiting 15 business days. Carriers are reminded that 18 Del. C. §§ 3363 and 3558 require carriers to cover certain immunizations for children and adults. These provisions also prohibit carriers from imposing cost-sharing requirements with respect to an office visit if the immunization is not billed separately or is not tracked as individual encounter data separately from the office visit, and the primary purpose of the visit is the delivery of the immunization. Immunizations are also preventive services that must be covered under individual and small group comprehensive ³ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/8-things.html 3 health insurance policies and contracts as an essential health benefit. See 18 Del. C. §§ 3571M and 3610. Additionally, carriers are reminded that 18 Del. C. §§ 3348 and 3564 provide that if medically necessary covered services are not available through network providers, or network providers are not available within a reasonable period of time, the carrier must provide access to an out-of-network provider, and the carrier shall reimburse the out-of-network provider at a previously agreed-upon or negotiated rate. Carriers are directed to monitor their provider networks to identify those providers who have registered as a POD provider through DelVAX. COVID-19 vaccination may present unique questions concerning limitations of in-network providers, such that patients may need to be referred out-of-network. Examples include but are not limited to: - A lack of equipment that would prevent the healthcare provider from being able to keep the vaccine at required refrigeration levels; - Situations in which a person's local in-network provider may be out of vaccine, another in-network provider is not available, and therefore the person may need to be referred out of network; and - Situations in which a person's local in-network provider may not be registered with DelVAX to administer the vaccine, no other registered in-network provider is available, and therefore the person may need to be referred out of network. Regarding the allowed administration fees, absent a negotiated rate, carriers must reimburse providers for such service in an amount that is reasonable. Since the health care provider may be the entity responsible for verifying whether a patient is "high-risk" and should therefore be vaccinated in early phases of vaccine rollout, carriers are encouraged to waive preauthorization requirements, if any, that may apply to this "high-risk" screening, in an effort to ensure that as many people are vaccinated as quickly as possible. ## Other steps that carriers can take Communication with insureds will be a critical component to successful vaccine outcomes and misinformation about the vaccine may dissuade people from getting vaccinated. Carriers can help insureds understand that: - The vaccine must be administered in two doses – a primer and booster shot – and the booster shot must be from the same vaccine manufacturer as the primer (inter-manufacturer mixing is not permitted). - They should be sure to get the booster, even if they experienced side effects from the primer. - Some people may experience side effects, but the side effects do not mean the patient has contracted the virus; it is the body's immune system response to the vaccine. 4 Questions concerning this Bulletin should be directed to the Department of Insurance's Consumer Services Bureau at consumer@delaware.gov. This Bulletin shall be effective immediately and shall remain in effect unless withdrawn or superseded by subsequent law, regulation or bulletin. Trinidad Navarro Trinidad Navarro Delaware Insurance Commissioner 5