Does health insurance cover PrEP? this is a question that has been asnwered several times but you need to have more light shed on this.

On July 19th, 2021, The Departments of Health and Human Services, Labor, and Treasury released new guidelines that clarifies the scope of PrEP (PrEP) as preventive care in the Affordable Care Act (ACA). PrEP is an antiretroviral medicine that aids in preventing people at high risk of developing HIV and can be an essential preventative tool that can help to end the HIV epidemic.

Therefore, all private health plans that were not grandfathered-in, which includes small group, large group, and self-insured plans, were required to cover PrEP, with no cost-sharing starting in the year 2021 of the plan year under the 2019 policy recommendation of the U.S. Preventive Services Task Force (USPSTF).

Proper use of PrEP involves more than just the medication. That includes regular visits with a doctor as well as screening to detect HIV and STIs and monitoring of renal function and many more. Unfortunately, the cost of these support and ancillary services are often an obstacle to patients (even if the medication is covered with no costs sharing).

It realizes this, the insurance regulators of certain states, such as California, Colorado as well as New York–had already issued guidance to either require or advocate for the coverage of support and ancillary services with no cost sharing.

This new federal guidelines confirms that the cost-sharing benefits extend to ancillary and supporting services required for the effective use of PrEP. It means private health insurance plans must provide these services and PrEP medications without cost sharing. This will help reduce expenses out of pocket and improve the availability of PrEP for those at high risk. As the battle against HIV requires a multi-faceted approach, and this is a significant step towards improving access to lifesaving drugs and removing a hurdle for HIV prevention.

Since not all plans and insurers may comply with the law, The Departments provide an enforcement grace period of 60 days. In this period, the Departments won’t take enforcement actions against a plan or an insurer that fails to offer coverage for these services. Federal officials urge states to adopt an identical approach to enforce.

What Is PrEP?

As mentioned above, PrEP is a medication used for daily use that can help prevent people at high risk from contracting HIV. Each day PrEP usage reduces the chance of contracting HIV via sexual activity (by 100%) and from injectable drugs (by 74%). PrEP is, however, been under-utilized.

Out of those 1.1 million Americans who would use PrEP, only 10 percent of the eligible users are taking the medication. There are significant discriminations based on race and ethnicity concerning PrEP usage. In the group with PrEP being used, 44 % are Black, and 25% are Hispanic.

But just 11 and 13 percent of the people who took PrEP between 2014 and 2016 were Black or Hispanic and Hispanic, respectively. Also, there are gender gaps in the number of women who comprised only 4.7 percent of those who took PrEP prescriptions in 2016.

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Although there are several reasons that PrEP is not being used, high costs even for those who have insurance have proved to be an significant obstacle. Although insurance policies are far from being the only option that can be used to combat PrEP gaps and combat HIV the costs of PrEP and associated services are not accessible to patients who need the medication.

Coverage Of Preventive Services

Section 2713 in the Affordable Care Acta (ACA) mandates that all private health plans to provide certain preventive services without cost-sharing. This obligation applies to non-grandfathered group health plans as well as health insurers which offer group or individual coverage. The only plans not covered by the requirement are grandfathered health plans and plans that are not comprehensive (such as plans for short-term use).

In establishing preventive standards for adult patients, Section 2713 uses clinically-validated services that carry ratings either “A” or “B” according to the current USPSTF guidelines. It was the PrEP recommendation was released in June 2019. According to federal regulations, a policy or insurance company must provide an updated or new recommended preventive program beginning the plan year, which commences on or following precisely one year from the date of issue date.

With the number of policies Section 2713 applies to, millions of Americans, including those with employment-based insurance, have benefited from this portion of ACA. A 2015 estimate indicates the existence of a minimum number of 137 million were covered by plans offering first-dollar protection of preventive services offered under the ACA. Section 2713 is among the most popular provisions in the ACA. most well-known provisions..

Challenges With Coverage Of Preventive Services

In the implementation process of Section 2713 has not, however, been without a few hiccups. In certain situations, individuals may be subject to cost-sharing, but it is not waived under certain conditions. A person enrolled in the program may still be required to pay for cost-sharing if, for example, they get treatment due to the recommendation of a preventive procedure or if the reason for a visit to the doctor was not for preventative reasons.

Insurers can also use “reasonable medical management” techniques to determine the frequency, the method of treatment, or the setting for preventive services, even if the requirements aren’t stated in the policy.

Medical management strategies are usually employed to reduce expenses, which means they could contain barriers to treatment. Therefore, if a recommendation cannot determine, for example, how many smoking cessation programs must be paid for, an insurance company can set the parameters themselves, provided they’re “reasonable.”

The implementation challenges are the reason federal regulators publish a variety of “frequently asked questions” regarding recommended preventive services. So far, federal regulators have dealt with concerns regarding the treatment of colorectal cancer screening and aspirin to reduce the risk of cardiovascular diseases and to breastfeeding, well-woman-visits as well as breast cancer treatment, smoking cessation, and contraceptives, in addition to other things. A large portion of the guidance is described in this document.

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The preamble to a recent interim COVID-19 final rule specifically clarified that plans and insurance companies must pay for, without cost sharing, the items, and services that are essential in the provision of a recommended preventive services. This applies regardless of whether a service or item is separately billed. Examples include covering without the cost of sharing or removal of polyps during a colonoscopy to prevent screening or collection of specimens from preventing screenings for diabetics or STIs.

USPSTF Recommendation For PrEP

In June in June 2019, the USPSTF suggested that healthcare professionals provide PrEP and effective antiretroviral treatment to patients who have a higher chance of contracting HIV. The USPSTF has also issued the Final Recommendation Statement as well as an Evidence report.

PrEP usage received the “A” rating from the USPSTF, which means that PrEP is highly likely to provide significant benefits to preventative medicine for the reduction of risks of HIV infection.

In its statement of recommendation in its recommendation statement, the USPSTF determines people at risk of contracting HIV as active sexually gay or bisexual as well as heterosexual women or men as well as sex workers and transgender persons.

The identities of these groups aren’t considered to be high-risk. Instead, the person must have a behavior risk aspect (such as being in an intimate relationship with someone living with HIV or a lack of condom use). This recommendation also applies to those who inject drugs with another risk aspect (such as sharing equipment for injecting drugs). PrEP is only accessible to people who don’t currently have HIV.

As mentioned above, insurers and plans were required to provide PrEP as per recommendations of the USPSTF recommendation for policy years or strategy years that began within one year of when the recommendations were issued. Since this USPSTF recommendation was released in June 2019, the policy took force for policy or plan years that started on or after June 30th, 2020. In this regard, all grandfathered and private health plans that aren’t grandfathered in should cover PrEP without cost sharing for those with high risk.

New Federal Guidance

The July 19th advice issued by Departments of Health and Human Services Departments clarifies the scope of PrEP and will to increase access for those at risk covered by private insurance. Its guidance 1) clarifies that ancillary and support services should be paid for, with no cost-sharing, in conjunction with PrEP as a whole; and 2)) clarifies that insurance plans and insurers cannot apply reasonable medical management methods to restrict access to these services.

The Departments insist on referring at their reference to the last recommendation document by the USPSTF and not just the single sentence recommendation. The complete recommendation statement references PrEP recommendations that are provided by the Centers for Disease Control and Prevention (CDC) and declare the fact that PrEP itself is a “comprehensive intervention” that includes the medication as well as vital support services (like the adherence counseling and risk reduction strategies and mental health counseling etc.) to make sure that PrEP is used safely and efficiently.

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In this case, the Departments refer to their final statement about the need for advanced HIV screening as well as kidney function testing, screening for hepatitis and STIs, as well as pregnancy tests before initiating PrEP and frequently following.

Therefore Departments have confirmed that insurers and plans must cover the cost of the support services. In particular, insurers and plans cannot impose cost-sharing for items recommended by the USPSTF and services required before PrEP beginning and continuous surveillance that is essential to the effectiveness of PrEP as a whole.

These services and items include HIV screening; hepatitis B and C tests; creatinine tests, kidney function testing, pregnancy tests; STI tests, counseling, and adherence counseling to ensure that Prep is taken in the manner prescribed. These are usually required before the beginning of PrEP and then periodically after that, according to CDC Guidelines (e.g., HIV testing is required every three months when taking PrEP).

Insurance companies and plans cannot employ reasonable medical management methods to limit the duration of these services if the frequency is stated within the PrEP recommendation. For example, the USPSTF’s final statement on PrEP says that HIV testing is recommended every three months when taking PrEP.

So, insurance plans and plans are not able to restrict access to this degree of HIV testing or require costs for frequently-used tests (or visits, as explained below). This is the case even if there is an specific USPSTF suggestion regarding HIV testing which differs from the requirements of those who are on PrEP.

The Departments further state that office visits associated with these preventive services for PrEP must be covered with cost-sharing if it is a prophylactic procedure (i.e., PrEP or any of the ancillary or support services mentioned previously) and is not charged separately in connection with the office visit.

In other words, if the visitor’s primary goal is to provide preventive care and it’s not billed independently, then the visit must be covered with no cost sharing. Insurance companies and plans also can keep the number of times individuals can begin PrEP.

In addition, lastly, the Departments recognize that plans and insurance companies can make use of reasonable medical management practices concerning PrEP coverage under certain conditions. For example, plans and insurers may choose to only cover PrEP in its generic form PrEP with no cost share while having cost-sharing requirements for brand versions (e.g., Truvada, for instance).

This could encourage the use of generic drugs instead of costly branded medications. However, insurance companies and plans offering this option must provide an accommodation process that allows for the elimination of charges when a person cannot take the generic drug due to medical reasons. In addition, insurance companies and plans must offer a readily accessible, clear, efficient, and transparent procedure for patients or providers to request a different medication.

In the case of PrEP, this procedure must permit patients to access PrEP medication within the same day the patient is given a positive HIV screening or opts to take PrEP.

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