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AIDS activists call for urgent meeting with UnitedHealthcare over denial of PrEP

Cited “high risk homosexual sexual behavior”

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(Graphic by Troy Masters)

UPDATE AUGUST 5, 2017: The reaction to United Healthcare’s barriers to access for PrEP prompted a swift apology and retraction:
In a statement, UHC National Communications Director Lynne High said, “We apologize for the insensitive language appearing in the letter and regret any difficulty it caused. We have corrected our letters, removed the prior authorization requirement for Truvada and members can fill their prescription at the network pharmacy of their choice. This is effective immediately,” the Windy City Times reported

 

AIDS activists around the country sprang into action after numerous complaints surfaced that at least one insurance carrier—United Healthcare—has been throwing up possibly illegal barriers to accessing the PrEP drug Truvada by people who are HIV positive.

The HIV Healthcare Access Working Group of the Federal AIDS Policy Partnership, which includes APLA Health, sent a letter to United Healthcare Friday, April 4, urging the insurance giant to “reverse the utilization management requirements that took effect July 1, 2017 for Truvada prescribed Pre-Exposure Prophylaxis or PrEP.” This is the story that came to light on Thursday, in which a UHC client was denied his treatment because of his alleged behavior.

“The request for coverage for Truvada is denied. This decision is based on health plan criteria for Truvada. The information sent in shows you are using this medicine for engaging in High risk homosexual behavior,” reads the letter to the HIV patient on Unitedhealthcare letterhead posted on a Facebook site frequented by people impacted by HIV/AIDS. “This determination is considered to be a determination that the requested coverage is not medically necessary under New York State Law for the purposes of your appeal rights.”

“Specifically,” the letter from the advocates for people with HIV/AIDS continues, “we believe requiring detailed documentation to request prior authorization every three months for Truvada prescribed for PrEP and requiring all members to use UHC’s mail-order pharmacy, BriovaRx, violates the Affordable Care Act (ACA)’s non-discrimination protections and federal and state laws barring mandatory mail order policies.”

The HIV policy advocates want to meet with UHC since a number of people have run out of their medications and the hoops UHC now makes patients jump through can take up to two weeks or more.

Lest the insurance carrier misunderstand what harm this policy change can and is doing, the advocates spelled it out for them:

“PrEP is a critical advancement in HIV prevention that, when taken as prescribed, can provide nearly 100% protection from acquiring HIV infection. Stigma and discrimination are major barriers that have impeded uptake of this highly effective prevention intervention. In addition to violating multiple laws, the new policies have been implemented in such a way as to insult and disrespect UHC members. We have been shocked and appalled by the language in the coverage denial letters that are being sent to patients taking Truvada for PrEP and to patients living with HIV taking Truvada as part of a treatment regimen. The denials are contradictory and contain the type of inflammatory and judgmental language that contributes to the stigma that lesbian, gay, bisexual and transgender individuals and others face. In addition to written communications, UHC members have been subject to inappropriate and invasive questioning about their sexual orientation, HIV status and drug use by customer service representatives.”

There have been some scattered reports that UHC has apologized—but it is not posted on their website or their Twitter account. The issue is not simply with the offensive tone of the denial letter but with the July accessibility change in the first place.

“UHC’s Policy Requiring Prior Authorization for PrEP Violates Non-discrimination Protections,” they write. “The federal Medicaid Act and Section 1557 of the ACA prohibit discrimination on the basis of race, color, national origin, disability, age, and sex. Section §1557 prohibits insurance companies that participate in the state exchanges from discrimination based on these characteristics. The sex protections within the ACA have been interpreted to include gender identity, and sex stereotyping which many courts and federal agencies have implemented to also include sexual orientation. These protections extend to discriminatory drug benefit designs, including unjustified prior authorization processes. With specific regard to HIV medications, the court has ruled that placing arbitrary barriers on HIV medications constitutes discriminatory plan design. This applies to PrEP, which is primarily prescribed to gay, bisexual, or same-gender-loving men; black women; or transgender women.”

Additionally, “The mail order requirement is in violation of the 2014 Settlement Agreement arising from John 3 Does I-V v. United Healthcare Insurance Company. The U.S. District Court of the Central District of California ordered United Healthcare to allow their customers taking HIV medications to opt-out of a mail order pharmacy requirement due to concerns about safety and privacy. The plaintiff class was concerned that their HIV status and sexual orientation would be inadvertently disclosed during delivery of their medications. UHC customers taking PrEP share those concerns,” they write.

“Home delivery of medications to individuals in shared living situations or without secure mail receptacles puts UHC members living with stigmatized conditions or at risk for stigmatized conditions at unnecessary risk for stigma and discrimination. Truvada also is prescribed to treat HIV and discovery of the medication and other HIV medications threatens UHC members’ safety and privacy, potentially leaving them at risk for violence and discrimination.”

Read the entire letter below:

August 4, 2017

Stephen J. Hemsley
Chief Executive Officer
David S. Wichmann
Office of the Chief Executive President
UnitedHealth Group

P.O. Box 1459
Minneapolis, MN 55440-1459

Dear Mr. Hemsley and Mr. Wichmann:

We, the undersigned organizations, urge United Healthcare (UHC) to reverse the utilization management requirements that took effect July 1, 2017 for Truvada prescribed for Pre-Exposure Prophylaxis or PrEP.

Specifically, we believe requiring detailed documentation to request prior authorization every three months for Truvada prescribed for PrEP and requiring all members to use UHC’s mail- order pharmacy, BriovaRx, violates the Affordable Care Act (ACA)’s non-discrimination protections and federal and state laws barring mandatory mail order policies. We respectfully request a meeting to discuss the impact of these new policies on UHC customers.

PrEP is a critical advancement in HIV prevention that, when taken as prescribed, can provide nearly 100% protection from acquiring HIV infection. Stigma and discrimination are major barriers that have impeded uptake of this highly effective prevention intervention. In addition to violating multiple laws, the new policies have been implemented in such a way as to insult and disrespect UHC members. We have been shocked and appalled by the language in the coverage denial letters that are being sent to patients taking Truvada for PrEP and to patients living with HIV taking Truvada as part of a treatment regimen. The denials are contradictory and contain the type of inflammatory and judgmental language that contributes to the stigma that lesbian, gay, bisexual and transgender individuals and others face. In addition to written communications, UHC members have been subject to inappropriate and invasive questioning about their sexual orientation, HIV status and drug use by customer service representatives.
Excerpt from an OptumRx Denial letter:

“Your request for coverage for Truvada is denied. This decision is based on health plan criteria for Truvada. The information you sent in shows you are taking this medication for High risk homosexual sexual behavior. This medication is only covered if you have HIV Infection, Post exposure prophylaxis (PEP) to reduce the risk of acquisition from either an occupational or non- occupational known or suspected possible exposure to HIV, Pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults at high risk or Hepatitis B and meet indications specific criteria. You do not meet any of these criteria.” Read full denial letter here.

We urge you to consider the points outlined below and immediately reverse the prior authorization restrictions implemented in July 2017.

UHC’s Policy Requiring Prior Authorization for PrEP Violates Non-discrimination Protections
The federal Medicaid Act and Section 1557 of the ACA prohibit discrimination on the basis of race, color, national origin, disability, age, and sex. Section §1557 prohibits insurance companies that participate in the state exchanges from discrimination based on these characteristics. The sex protections within the ACA have been interpreted to include gender identity, and sex stereotyping which many courts and federal agencies have implemented to also include sexual orientation. These protections extend to discriminatory drug benefit designs, including unjustified prior authorization processes. With specific regard to HIV medications, the court has ruled that placing arbitrary barriers on HIV medications constitutes discriminatory plan design. This applies to PrEP, which is primarily prescribed to gay, bisexual, or same-gender-loving men; black women; or transgender women.1

UHC’s Prior Authorization Policy Is Restricting Access without Justification
We strongly object to the stringent and overly complex prior authorization documentation that is now required to request coverage of Truvada for PrEP. The medical providers prescribing PrEP are better positioned to determine the clinical appropriateness of PrEP for patients as evidenced by the communications that have occurred regarding this issue and the inappropriate denial letters UHC members have received. If prior authorization is maintained, we urge for the process to be significantly simplified and streamlined and for best practices to be followed. In particular, the approval period should be for 12 months, as is standard practice for medications that are prescribed for an extended period. The three-month cycle puts patients at risk of delays and medication interruptions and creates unnecessary burden to providers and anxiety for UHC members.

In order to protect against HIV acquisition, a patient must have consistent access to PrEP without interruption. Delays caused by UHC’s prior authorization approval put individuals at greater risk for acquiring HIV infection.

From a UHC Member:
“I have been on PrEP for three years and with UHC for the past year. I called in a refill of my Truvada to my local Walgreens on Saturday, July 1, with two pills left from my (1 See. 42 U.S.C § 18116; see also 42 C.F.R § 92.101(b)(2)(i), 45 C.F.R. § 84 (b)(4) (stating that a recipient of federal funding may not use criteria or methods of administration that have the effect of discriminating on the basis of disability. Cases interpreting the Americans with Disability act and Section 504 of Rehabilitation Act of 1973 (as well as implementing regulations) have consistently recognized HIV/AIDS as a qualifying disability) previous month’s prescription. I went to the Walgreens to pick up my prescription where I was told by the pharmacist that United Healthcare was requiring a prior authorization for my Truvada.

I called United Healthcare and they confirmed that a prior authorization was now required for Truvada and that a prior authorization request had already been sent to my doctor. I called the doctor’s office to find out if the prior authorization was approved. The office told me that the authorization was denied and I needed to call UHC to find out why. I then called UHC and asked if I could appeal the denial and I was told that I should call my doctor and have them call United Healthcare to start the appeal.

I called my doctor’s office and told them that I wanted to appeal the denial. The doctor’s office said that they need to ask me a few questions in order for the doctor to write a letter of appeal. I was asked how many men I have had sex with, was I a receptive anal sex partner, have a slept with HIV positive men, and if I had ever done crystal methamphetamine. I told the doctor’s office that I did not feel comfortable answering these questions.

I called United Healthcare and I asked to speak with a supervisor. The supervisor told me that it would take up to 15 days to do an appeal and five days to do a prior authorization once the HIV test was done. I told the supervisor that I was out of my Truvada prescription and I asked for them to cover a five day supply and they refused. I was also told that I would be required to fill my prescription through United Healthcare’s mail- order pharmacy.

This was an incredibly frustrating experience and I hope that United Healthcare addresses the barriers they created in having patients fill their Truvada prescriptions.”

UHC’s Mail Order Pharmacy Requirement Violates Existing Law
UHC is in violation of the ACA, 45 CFR § 156.122(e). The law requires any health plan required to offer Essential Health Benefits to allow enrollees to access prescription drug benefits at in- network retail pharmacies, unless there are specific safety or handling requirements that would preclude use of a retail pharmacy. Since July 1, UHC has repeatedly failed to provide an opt-out process for customers prescribed PrEP.

In addition to violating federal law, a number of states have statutes that bar mandatory usage of mail order. Georgia Code § 33-64-7-2, effective July 1, 2017, prohibits insurance companies that own pharmacy benefit managers from requiring their customers to use a mail order pharmacy.

New York State’s Anti-Mandatory Mail Order Law similarly prohibits pharmacy benefit managers from requiring that patients purchase prescription drugs from a mail order pharmacy or pay an additional co-payment fee when such purchases are not made from a mail order pharmacy.

The mail order requirement is in violation of the 2014 Settlement Agreement arising from John 3 Does I-V v. United Healthcare Insurance Company. The U.S. District Court of the Central District of California ordered United Healthcare to allow their customers taking HIV medications to opt-out of a mail order pharmacy requirement due to concerns about safety and privacy. The plaintiff class was concerned that their HIV status and sexual orientation would be inadvertently disclosed during delivery of their medications. UHC customers taking PrEP share those concerns.
Home delivery of medications to individuals in shared living situations or without secure mail receptacles puts UHC members living with stigmatized conditions or at risk for stigmatized conditions at unnecessary risk for stigma and discrimination. Truvada also is prescribed to treat HIV and discovery of the medication and other HIV medications threatens UHC members’ safety and privacy, potentially leaving them at risk for violence and discrimination.
From a UHC member:

“Since December 2015 I have picked up Truvada at a local retail pharmacy by opting-out of the mail-order requirement and having UHC grant an exception to deliver my meds to this specific pharmacy. Now due to the changes that went into effect 1 July 2017 (which I am still unsure what those changes are), the customer service representatives at UHC tell me that I can no longer opt-out. I repeatedly told them that I have major privacy and security concerns over receiving my PrEP through the mail, and they just now seem to be interested in looking to grant me another exception. I am out of PrEP as of tomorrow, and UHC will be responsible for this outrageous and unacceptable lapse in coverage. I am in school to become a physician and this process is mind-bendingly confusing even for me – I cannot fathom how someone without my level of health literacy could navigate these added barriers. This is an attempt to confuse and intimidate a vulnerable population into forgoing the lifesaving preventive services we deserve.”

Conclusion
In response to these concerns, we urge UHC to:

  • Remove the prior authorization requirement for Truvada for PrEP. If a prior authorization process is maintained, it should be significantly streamlined, invasive personal information should be removed, and be approved for a 12-month period.
  • Remove the mail-order pharmacy requirement and allow customers to opt-out.
  • PrEP is an effective prevention intervention that can help to stop HIV in its tracks. UHC members should not be denied access to this highly effective HIV prevention tool.
UHC’s prior authorization process is discriminatory and unnecessarily complicated, and the mail order requirement is illegal. For the reasons stated above we believe these actions are discriminatory in nature and reserve the right to pursue this matter further by filing a complaint with the U.S. Department of Health and Human Services Office for Civil Rights, charging unlawful discrimination under the
  • Affordable Care Act’s non-discrimination protections.

We reiterate our request to meet with you immediately to discuss the UHC prior authorization policy for PrEP. We look forward to your response within 10 business days.

To schedule a meeting or to resolve questions regarding this letter, please contact:
Ramon Gardenhire, AIDS Foundation of Chicago, (312) 334-0928 or [email protected]
Benjamin Brooks, Health HIV, (202) 507-4737 or [email protected]
Respectfully,
AIDS Foundation of Chicago
AIDS United
APLA Health
Association of Nurses in AIDS Care
Health HIV
Human Rights Campaign
HIV Medicine Association
National Coalition for LGBT Health
National Alliance of State and Territorial AIDS Directors
New York City’s Lesbian, Gay, Bisexual & Transgender Community Center
Project Inform
The AIDS Institute
San Francisco AIDS Foundation
Treatment Action Group

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AIDS and HIV

Federal blood donation study recruiting gay, bi men

The study is aimed at assessing the individual risk of a gay or bisexual man transmitting HIV if they donate blood

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FDA headquarters in Silver Spring, Maryland (Photo Credit: FDA/GSA)

SILVER SPRING, Md. – Washington D.C.’s Whitman-Walker Institute and the Los Angeles LGBT Center are among LGBTQ supportive organizations in eight U.S. cities working with the nation’s three largest blood donation centers on a study to find a way to significantly ease blood donation eligibility for men who have sex with men or MSM.

The study, which is funded by the U.S. Food and Drug Administration, calls for recruiting a total of 2,000 gay and bisexual men in eight U.S. cities selected for the study to test the reliability of a detailed donor history questionnaire aimed at assessing the individual risk of a gay or bisexual man transmitting HIV if they donate blood.

A statement released by the study organizers says the questionnaire, which could be given to a gay or bisexual person showing up at a blood donation site, could be a replacement for the FDA’s current policy of banning men who have had sex with another man within the previous three months from donating blood.

In the early years of the AIDS epidemic in the 1980s, the FDA put in place a permanent ban on blood donations by men who have sex with men. In 2015, with advanced HIV testing and screening techniques readily available, the FDA lifted its permanent ban on MSM blood donations and replaced it with a 12-month restriction for sexual activity between MSM.

The FDA further reduced the time of sexual abstinence for MSM to three months in 2020.

LGBTQ rights organizations and others advocating for a change in the current FDA restriction point out that at a time when the nation is facing a severe shortage of blood donations due to the COVID pandemic, the three-month donation deferral requirement for MSM is preventing a large number of blood donations from men whose risk of HIV infection is low to nonexistent.

Under the FDA-funded and initiated study, the American Red Cross, Vitalant, and OneBlood — the nation’s three largest blood donation centers — have been conducting the questionnaire testing since the study was launched in March 2021.

“To gather the necessary data, the blood centers will partner with LGBTQ+ Centers in Washington, D.C., San Francisco, Orlando, New Orleans/Baton Rouge, Miami, Memphis, Los Angeles, and Atlanta,” the study organizers say in a statement on a website launched to help recruit volunteers for the study.

“The study will enroll a total of 2,000 gay and bisexual men (250 – 300 from each area) who meet the study eligibility criteria,” the statement says.

Among the criteria for being eligible, the statement says, is the person must be between 18 and 39 years old, have expressed an interest in donating blood, must have had sex with at least one other man in the three months before joining the study, and must agree to an HIV test. A negative test result is also required for acceptance into the study.

The study is officially named ADVANCE, which stands for Assessing Donor Variability And New Concepts in Eligibility.

“The ADVANCE study is a first step in providing data that will help the FDA determine if a donor history questionnaire based on individual risk would be as effective as time-based deferral, in reducing the risk of HIV in the blood supply,” the study organizers statement says.

“If the scientific evidence supports the use of the different questions, it could mean men who have sex with men who present to donate would be assessed based upon their own individual risk for HIV infection and not according to when their last sexual contact with another man occurred,” the statement continues. “The ADVANCE study is groundbreaking because it’s the first time a study is being conducted that could result in individual risk assessment for men who have sex with men to donate blood,” the statement says.

The Whitman-Walker Institute, which is among the community-based organizations involved in helping organize and conduct the study, is an arm of Whitman-Walker Health, the LGBTQ supportive D.C. health center.

Christopher Cannon, director of Research Operations for Whitman-Walker Institute, said that since the D.C.-based part of the study was launched early last year prior to the official announcement of the study on March 20, D.C. has surpassed the original city goal of recruiting 250 participants for the study.

“We are currently at 276 as of last Friday’s report,” Cannon told the Blade in a Jan. 13 interview. “And the current goal is now 300,” he said. “So, we’re hoping to push this over that goal line in the coming days and weeks.

Cannon said that like the community organizations involved in the study in other cities, Whitman-Walker Institute’s role has been focused on recruiting gay and bisexual men to participate in the study and to send them to the American Red Cross headquarters building at 430 17th St., N.W. near the White House. That site, which serves as a blood donation center, is also serving as the site where study participants are screened, interviewed, and presented with a detailed questionnaire.

“We promote the study within ,” Cannon said. “We promote it to our networks. We did social media promotions across the city.’

Although Whitman-Walker doesn’t have the final draft of the questionnaire being presented to study participants, Cannon said he has seen “bits and pieces” of it.  

“They ask very direct questions about the person’s sex life, sexual partners, sex acts, numbers of partners,” Cannon said. “There are questions about condom use, PrEP use, drug use. How recently have you had sex? Lots of related questions,” he said.

“It’s really about trying to figure out effectively which are the best questions,” according to Cannon. “The hope is by analyzing the questions and identifying maybe the best 10 to 12 questions that can be universally used…to get the best answers that identify the individuals that may have the highest risk,” he said. Doing that, he points, out can help determine which men who have sex with men should be eligible to safely donate blood.

A statement released by Whitman-Walker last March calls the study a “monumental research effort” that has the potential to lift the stigma imposed on gay and bisexual men whose ability to donate blood is currently based on their sexual orientation.

“The ADVANCE study is designed to understand if, by asking carefully crafted and research-informed research questions, blood collectors can screen potential blood donors for their individual HIV risk factors rather than applying a ban against sexually active gay and bisexual men,” the statement says.

“The goal is to move away from overly broad questions that exclude potential donors and spread stigmatizing messages about MSM and their HIV risks,” it says.

Cannon said that as of last week, study organizers had recruited a total of 879 study participants nationwide out of the goal of 2,000 participants needed to complete the study. He said issues related to the COVID pandemic created delays in the recruitment efforts, but study organizers were hopeful the study could be completed by this summer.

Information about participating in the study or learning more about it can be obtained at advancestudy.org.

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AIDS and HIV

Peacock will premiere HIV documentary on World AIDS Day

Drew, who was diagnosed with HIV in the late 1980’s when he was only 23 years old, was not paid for his participation in the trial

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Right to Try (2021) Peacock/NBCUniversal Television and Streaming

NEW YORK — NBCUniversal’s streaming service Peacock will premiere the documentary short “Right to Try,” which explores one man’s search to cure his HIV, Wednesday on World AIDS Day. 

The film, produced by Oscar-winning actress Octavia Spencer and directed by “The Late Late Show With James Corden” producer Zeberiah Newman, follows HIV survivor and activist Jeffrey Drew’s participation in an experimental vaccine trial. 

“We are thrilled our film ‘Right to Try’ will be seen on Peacock. Though Jeffrey Drew’s heroic journey is singular, his story is universal,” Spencer said in a statement, according to Variety. “This is an important film and with Peacock we have a wonderful partner to bring it to our audience.”

Val Boreland, EVP of content acquisitions at NBCUniversal Television and Streaming, added: “It is an honor to share Drew’s story with Peacock users and raise awareness around the important issue of HIV research. We know the impact of this documentary will be far-reaching.”

The documentary shows the side effects that Drew experienced during the early days of the trial. The coronavirus pandemic interrupted the study, as the doctor spearheading the experimental vaccine started working on the COVID-19 vaccine. 

Drew, who was diagnosed with HIV in the late 1980’s when he was only 23 years old, was not paid for his participation in the trial that a major pharmaceutical company did not fund. 

“There are people who are still getting infected and sick and dying,” he told Variety in a June interview. “I would love to see a generation that doesn’t have to think or worry about this anymore.”
“Right to Try” won the Audience Award for Documentary Short last summer at Outfest, an LGBTQ+ film festival in Los Angeles.

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AIDS and HIV

Los Angeles observes World AIDS Day with star-studded concert

Gay Men’s Chorus of Los Angeles and Juan Pablo di Pace will also be performing at the ceremony

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LOS ANGELES — As World AIDS Day is recognized around the globe, Los Angeles will mark the day with a free concert with a star-studded line-up at The Forum hosted by the AIDS Healthcare Foundation (AFA) and a ceremony at The Wall Las Memorias (TWLA) AIDS Monument in Lincoln Park Wednesday.

In a press release, the AFA said Grammy award winners Jennifer Hudson and Christina Aguilera are set to perform in front of a sold-out crowd. Emmy-nominated comedian Randy Rainbow will host the event, which will take place from 8:00 p.m. to 10:00 p.m.

In addition to the entertainment, the AFA will honor Vermont’s U.S. Sen. Bernie Sanders with a Lifetime Achievement Award and a special video presentation. The award will be accepted by his wife Jane Sanders.

“This year marks two significant milestones in the decades-long fight against HIV and AIDS: first, for the first recognition by the CDC of the virus that led to what is now known as AIDS (40 years ago, in June 1981), and second, the launch of AHF (35 years ago),” the release reads. 

TWLA’s ceremony will reveal an expanded footprint of the surrounding landscape of the country’s only publicly funded AIDS monument. The monument, created in 2004, will also add over 1,000 names of loved ones lost to AIDS to the 360-plus names already etched into it and unveil new artwork. 

TWLM Founder Richard Zaldivar, Los Angeles City Councilman Gil Cedillo and County Board of Supervisors Chair Hilda Solis are all expected to attend the event, which will start at 6:15 p.m. at 3600 N. Mission Road. According to NBC 4 Los Angeles, organizers also hope Los Angeles Mayor Eric Garcetti will be in attendance. 

Gay Men’s Chorus of Los Angeles and Juan Pablo di Pace will also be performing at the ceremony. 

World AIDS Day is observed every December 1 to raise awareness about AIDS and honor the people who have died of the disease. This year’s theme is “End inequities. End AIDS and End Pandemics.”

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