February 2 RxAdvocate February, 2022 — Newsletter
February Stories:
- COVID-19 Update
- PrEP Treatment Guidelines
- Hemophilia A – Roctavian Trial Results
- Generic Revlimid Capsules Receive FDA Approval
- RxConnection Organizational Announcements
COVID-19 Update
On February 4, 2022, the Departments issued additional guidance on direct access requirements. The Departments clarified plans and issuers have flexibility in how they provide access to OTC tests with no up-front costs. Generally, direct access will be adequate where OTC tests are made available through at least one direct-to-consumer shipping process and at least one in-person channel. Specifically, direct access may be through online or phone orders, a pharmacy network, non-pharmacy retailers, and OTC test distribution sites established by, or on behalf of, the plan or issuer. Plans and issuers must communicate key information on how to access OTC tests to members. A plan or issuer will not fail in providing direct access due to supply shortages out of their control and may continue to limit indirect reimbursement to $12 per test. The Departments also clarified an individual cannot double-dip OTC test reimbursement in a health FSA or HRA where the test has already been reimbursed by a plan or issuer.
Setting up direct access with a head-spinning turnaround time, empty shelves, soaring OTC test prices, and record-high demand for testing in a raging pandemic is a staggering order. In the race to comply with the OTC Coverage Mandate and increased costs ahead, it’s important to remember the other rules that still apply.
Plans cannot limit coverage of OTC testing based on symptoms or exposure.
Relying on the Families First Coronavirus Response Act (FFCRA, enacted March 18, 2020) and Coronavirus Aid, Relief, and Economic Security Act (CARES Act, enacted March 27, 2020), the OTC Coverage Mandate confirms plans must cover OTC COVID-19 tests without any “medical management requirements” including imposing medical screening criteria. In plain terms, this means plans cannot require the presence of symptoms or recent exposure as a prerequisite for OTC test coverage. However, plans are only required to provide testing for individualized personal use, not for general workplace health and safety or public health surveillance.
Plans cannot exclude unvaccinated participants from coverage of OTC testing.
HIPAA’s nondiscrimination rules prohibit excluding employees from eligibility for group health plan coverage based on a health status-related factor. Vaccination is a health status-related factor. Exclusions for COVID-related claims (e.g., OTC testing) for unvaccinated or vaccinated employees are also prohibited. Imposing a premium surcharge implemented through a compliant wellness program is the exception to this rule.
Plans can impose premium surcharges on unvaccinated participants.
HIPAA limits wellness program incentives to 30% of the total cost of the medical plan coverage (50% for programs that include a tobacco-cessation incentive). The total of all wellness program incentives must be below the applicable limit. In FAQ guidance issued on October 4, 2021, the Departments confirmed that employers can incentivize employees towards vaccination with discounts on health insurance premiums (i.e without the surcharge) for those vaccinated. The wellness program must:
- Be reasonably designed to promote health or prevent disease (the surcharge FAQs suggest setting up a toll-free hotline to schedule vaccination appointments);
- Provide a reasonable alternative standard to qualify for the premium discount where the individual can verify COVID-19 vaccination is medically inadvisable (the surcharge FAQs suggest mandating compliance with the CDC’s mask guidelines); and
- Give individuals the opportunity to qualify at least once per year.
Applicable large employers considering surcharges need to confirm the plan still meets ACA affordability standards if employees forego the vaccine and have to pay a higher premium. Incentives under a wellness program that reduce the amount employees must pay for employer-sponsored coverage are not treated as reducing the employee’s required contribution for affordability calculation purposes. That is, calculated without regard to the wellness program’s reduction.
There is no need to reinvent the wheel for reimbursing claims.
Plans are encouraged, but not required, to provide participants information on OTC testing quality, direct access from designated sellers, and claim reimbursement. The Departments’ OTC Coverage Mandate guidance states out-of-pocket reimbursement for OTC tests should be handled under the plan’s normal internal claims procedures. As an initial step, plans should evaluate current reimbursement processes to determine whether streamlining for OTC tests would be beneficial and communicate the process with participants. Plans may also develop oversight of medical and pharmacy claims to prevent reimbursement double-dipping.
Healthcare insurance fraud is illegal.
Plans may act to prevent, detect, and address fraud and abuse. This can include requiring participants sign a brief document with standard healthcare fraud warnings attesting that the OTC test:
- Was purchased by the participant for their own or other plan beneficiary’s personal use;
- Was not purchased for employment purposes;
- Has not been (and will not be) reimbursed by another source; and
- Has not been (and will not be) resold.
Plans may also require documentation of an allowed test’s proof of purchase, such as UPC code and/or receipt showing date of purchase and price. Still, access remains paramount. Any measure to prevent fraud that delays access to tests is not permitted.
Look to state and local laws for whether an employer must pay for COVID-19 tests required under any workplace safety policy.
The OTC Coverage Mandate does not require health plans to cover COVID-19 testing for employment purposes. Whether an employer needs to pay for COVID-19 testing required under a workplace policy varies by state. For example, in California, employers are required to pay for COVID-19 testing and travel expenses, but in Massachusetts, employers must pay only when testing is directed at a certain time and location. It’s important to review the latest state and local laws where you operate your business before implementing a COVID-19 testing employment policy. Only a few states have issued clear guidance on this and requirements are quickly changing. Employers may also consider directing employees to free testing sites if available in their area. But testing lines are long these days. If an employer directs an employee to obtain free testing as necessary to perform their job safely during the pandemic, under the federal Fair Labor Standards Act, they need to pay for the time spent getting that testing.
SCOTUS’s OSHA ETS decision has no effect on the requirement to cover OTC COVID-19 tests.
The U.S. Supreme Court’s January 13, 2022 decision to stay OSHA’s Emergency Temporary Standard has no effect on the Departments’ OTC Coverage Mandate. The OTC Coverage Mandate is not an employer mandate. Rather, it applies to health plans and is intended to expand COVID-19 testing access to plan participants.
Next Steps for Employers
Group health plans, including fully insured, self-funded, grandfathered, and non-grandfathered plans, should confirm with their TPAs and insurers that OTC COVID-19 testing will be covered without cost-sharing in accordance with the Departments’ OTC Coverage Mandate.
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PrEP Treatment Guidelines
Pre-exposure prophylaxis (PrEP) treatment for HIV has experienced recent updates to guidelines and products available for patient use. In 2019, the U.S. federal government announced the aim to end the HIV epidemic by 2030. There are currently 1.1 million Americans living with HIV, with 38,000 new infections each year. Prevention of HIV infection in targeted populations at the highest risk for disease is one of the primary means to achieve this eradication goal.
There are currently three products approved for PrEP use in the U.S. The most affordable option is Truvada, as it is the only product that has a generic equivalent available and is taken orally once daily. Descovy is the second orally available product and was approved in 2019 for PrEP treatment. Descovy has advantages for certain at-risk populations, as well as patients that require a product that has less kidney or bone density impact.
Approved for use in 2021, Apretude is the first injectable product indicated for PrEP. The dosing for this new medication is initially once monthly, then every two months thereafter, into the muscle. This delivery system offers a significant advantage over once-daily oral medications, especially for patients that have difficulty taking a prescription on a regular basis. Products in the pipeline for PrEP continue to target patients interested in treatment options with a longer duration of action or alternate delivery methods.
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Hemophilia A – Roctavian Trial Results
Hemophilia A – Roctavian Trial Results
Hemophilia A is a bleeding disorder caused by mutations in the gene responsible for making the clotting protein factor VIII (FVIII). Roctavian, an investigational gene therapy, aims to allow the body to produce its own functional FVIII by delivering a working copy of this gene to liver cells. “More than 80% of the men with severe hemophilia A treated with Roctavian (valoctocogene roxaparvovec) in the Phase 3 GENEr8-1 trial remained bleed-free two years later, and nearly all were off standard preventive therapies.” Prior applications, based on early six-month data from GENEr8-1, were rejected both in the EU and the U.S., with authorities requesting longer-term data. BioMarin, the makers of Roctavian plan to resubmit the U.S application in Q2-2022, once submitted the U.S Food and Drug Administration will take up to 6 months to review. Click here to read more.
Generic Revlimid Capsules Receive FDA Approval
A therapeutic generic equivalent of Revlimid, lenalidomide received FDA approval for the 2.5 mg and 20 mg dosage strengths and tentative approval for the 5 mg, 10 mg, 15 mg, and 25 mg strengths in October 2021. Volume-limited amounts of generic lenalidomide capsules are slated to be available in the U.S. after March 2022. Lenalidomide is indicated for the treatment of adult patients with multiple myeloma in combination with dexamethasone who already have had prior therapy and transfusion-dependent anemia due to myelodysplastic syndromes. Click here to read more.
RxConnection Organizational Announcements
RxConnection Organizational Announcements
Welcome, Ray!
Ray joins our team as the Audit Manager for our Analytics Department. Ray has over 10 years of experience within the healthcare industry, working in a variety of different roles. Prior to joining the RxConnection team, he was a co-managing PBM data auditor/analyst at Aon where he worked on gap analyses, claims data analysis, and process improvements.
Ray earned his Bachelor of Science degree from the University of Phoenix.
Welcome, Cannon!
Cannon Clifton (he/him) joins our team as an Rx Audit Analyst, responsible for developing client reports, analyzing and interpreting pharmacy data, and conducting pricing audits. He brings to this role a wealth of knowledge and experience from his time as a Pharmacy and Benefits Pricing Auditor at Aon, Inc. and his work with Care Navigation Services as a Business Support Coordinator, handling financial reporting and quality-of-care analytics. Cannon holds a Bachelor of Arts degree from the University of Wisconsin – Madison.
Welcome, Elena!
Elena brings over 10 year’s experience in the healthcare industry to RxConnection. She previously worked for nationally recognized, full-service PBMs and has experience in formulary design, validation, coding, and configuration in multiple lines of business including Medicaid, Medicare Part D, employer groups, and health plans. Elena has a Business Management degree from the University of Phoenix and is a licensed Pharmacy Technician.
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