Watch 03: July 2022

 

The HIV/HCV Co-Infection Watch is a project of the Community Access National Network (CANN) designed to research, monitor and report on HIV and Hepatitis C (HCV) co-infection in the United States. The July 2022 Watch includes timely updates herein. To read the project disclaimer and/or methodology, CLICK HERE.

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1. FINDINGS

The following is a summary of the key findings for July 2022:

AIDS Drug Assistance Programs:

There are 56 State and Territorial AIDS Drug Assistance Programs (ADAPs) in the United States, 48 of which offer some form of coverage for Hepatitis C (HCV) treatment. Of those programs, 46 have expanded their HCV coverage to include the Direct-Acting Antiviral (DAA) regimens that serve as the current Standard of Care (SOC) for Hepatitis C treatment. Two (2) programs offer only Basic Coverage and 8 programs offer No Coverage. Two (2) programs cover only a single Direct-Acting Antiviral. Three (3) territories – American Samoa, Marshall Islands, and Northern Mariana Islands – are not accounted for in this data. A state-by-state Drug Formulary breakdown of coverage is included in the July 2022 Updates, with accompanying drug-specific maps in Figures 1 – 10.

Medicaid Programs:

There are 59 State and Territorial Medicaid programs in the United States, and data is represented for all fifty (50) states and the District of Columbia. As of October 01, 2016, all 50 states and the District of Columbia offer Expanded Coverage. A state-by-state PDL breakdown of coverage is included in the July 2022 Updates, with accompanying drug-specific maps in Figures 11 – 20.

Harm Reduction Programs:

Every State and Territory in the United States currently provides funding for low-income people living with substance abuse issues to enter state-funded rehabilitation services (National Center for Biotechnology Information, n.d.). Forty-four (44) States, the District of Columbia and three (3) Territories currently have Syringe Services Programs (SSPs) in place, regardless of the legality. Fifty (50) States and the District of Columbia have expanded access to Naloxone to avert opioid drug overdoses. Fifty (50) States and the District of Columbia have Good Samaritan laws or statutes that provide some level of protection for those rendering emergency services during drug overdoses. Forty-seven (47) States, the District of Columbia, and Guam make reporting to Prescription Drug Monitoring Programs (PDMPs) mandatory, requiring physicians and/or pharmacists to report prescriptions written or filled to a state agency for monitoring. Fifty (50) States and the District of Columbia have Opioid-Specific Doctor Shopping Laws preventing patients from attempting to receive multiple prescriptions from numerous physicians, and/or from withholding information in order to receive prescriptions. Forty-five (45) states and the District of Columbia mandate a Physical Exam Requirement in order for patients to receive a prescription for opioid drugs. Thirty-Five (35) states have in place an ID Requirement mandating that people filling opioid prescriptions present a state-issued ID prior to receiving their prescription. Forty-five (45) states and the District of Columbia require prescribing physicians to attend mandatory and continuing opioid prescribing education sessions. Forty-seven (47) states and the District of Columbia have Medicaid doctor/pharmacy Lock-In programs that require patients to receive prescriptions from a single physician and/or fill prescriptions from a single pharmacy. A state-by-state program breakdown is included in the July 2022 Updates, with accompanying drug-specific maps in Figures 21-29.

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2. AIDS DRUG ASSISTANCE PROGRAMS (ADAPs) & HCV THERAPIES

Of the 56 respective State and Territorial ADAPs, only 8 (KS, KY, OH, UT, VT, GU, PW, VI) do not offer any coverage for HCV drug therapies. States whose formularies are not available on the state-run website have been checked against the most recent National Alliance of State and Territorial AIDS Directors (NASTAD) formulary database (last updated January 1, 2022). The data presented are current as of July 20, 2022.

July 2022 Updates:

Basic Coverage

  • States with Basic HCV Medications Coverage: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, IL, IN, IA, LA, ME, MD, MA, MI, MN, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OK, OR, PA, RI, SC, SD, TN, VA, WA, WV, WI, WY, D.C.

  • States without Basic HCV Medications Coverage: ID, KS, KY, MS, OH, TX, UT, VT

  • Territories with Basic HCV Medications Coverage: P.R.

Figure 1. July 2022 ADAP Coverage - Basic HCV Medications

Map Key: Yellow = Basic HCV Medication Coverage; Red = No Basic HCV Medication Coverage/No Information regarding Basic HCV Medication Coverage

Sovaldi

  • States with Sovaldi Coverage: AZ, CA, CO, GA, HI, IL, IN, IA, LA, ME, MD, MA, MN, NE, NV, NH, NJ, NM, ND, OK, OR, PA, SD, VA, WA, WI, WY, D.C.

  • States without Sovaldi Coverage: AL, AK, AR, CT, DE, FL, ID, KS, KY, MI, MS, MO, MT, NY, NC, OH, RI, SC, TN, TX, UT, VT, WV

  • Territories with Sovaldi Coverage: P.R.

Figure 2. July 2022 ADAP Coverage - Sovaldi

Map Key: Yellow = Sovaldi Coverage; Red = No Sovaldi Coverage/No Information regarding Sovaldi Coverage

Harvoni

  • States with Harvoni Coverage: AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NM, NC, ND, OK, OR, PA, SD, TN, VA, WA, WI, WY, D.C.

  • States without Harvoni Coverage: AL, AK, KS, KY, MO, MT, NY, OH, RI, SC, TX, UT, VT, WV

  • Territories with Harvoni Coverage: P.R.

Figure 3. July 2022 ADAP Coverage - Harvoni

Map Key: Yellow = Harvoni Coverage; Red = No Harvoni Coverage/No Information regarding Harvoni Coverage

Zepatier

  • States with Zepatier Coverage: AL, AZ, AR, CA, CO, FL, GA, HI, IL, IA, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NM, NY, NC, ND, OR, PA, SD, VA, WA, WV, WI, WY, D.C.

  • States without Zepatier Coverage: AK, CT, DE, ID, IN, KS, KY, MO, MT, OH, OK, RI, SC, TN, TX, UT, VT

  • Territories with Zepatier Coverage: P.R.

Figure 4. July 2022 ADAP Coverage - Zepatier

Map Key: Yellow = Zepatier Coverage; Red = No Zepatier Coverage/No Information regarding Zepatier Coverage

Epclusa

  • States with Epclusa Coverage: AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, LA, ME, MD, MA, MI, MN, MS, MO, NE, NY, NV, NH, NJ, NM, ND, OR, PA, SD, TN, TX, VA, WA, WI, WY

  • States without Epclusa Coverage: AL, AK, DE, KS, KY, MT, NC, OH, OK, RI, SC, UT, VT, WV, D.C.

  • Territories with Epclusa Coverage: P.R.

Figure 5. July 2022 ADAP Coverage - Epclusa

Map Key: Yellow = Epclusa Coverage; Red = No Epclusa Coverage/No Information regarding Epclusa Coverage

Vosevi

  • States with Vosevi Coverage: CA, CT, FL, HI, ID, IL, IN, IA, LA, MD, MA, MN, NE, NV, NH, NJ, NM, ND, OR, SD, TN, WA, WY

  • States without Vosevi Coverage: AL, AK, AZ, AR, CO, DE, GA, KS, KY, ME, MI, MS, MO, MT, NY, NC, OH, OK, PA, RI, SC, TX, UT, VT, VA, WV, WI, D.C.

  • Territories with Vosevi Coverage: P.R.

Figure 6. July 2022 ADAP Coverage - Vosevi

Map Key: Yellow = Vosevi Coverage; Red = No Vosevi Coverage/No Information regarding Vosevi Coverage

Mavyret

  • States with Mavyret Coverage: AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OR, PA, SD, TN, VA, WA, WV, WI, WY, D.C.

  • States without Mavyret Coverage: AK, DE, KS, KY, OH, OK, RI, SC, TX, UT, VT

  • Territories with Mavyret Coverage: P.R.

Figure 7. July 2022 ADAP Coverage - Mavyret

Map Key: Yellow = Mavyret Coverage; Red = No Mavyret Coverage/No Information regarding Mavyret Coverage

Pegasys

  • States with Pegasys Coverage: AL, CA, CO, CT, DE, HI, IL, IA, LA, ME, MD, MA, MI, MN, NE, NV, NH, NJ, NM, NC, ND, OR, PA, RI, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, D.C.

  • States without Pegasys Coverage: AK, AZ, AR, FL, GA, ID, IN, KS, KY, MS, MO, MT, NY, OH, OK, SC, TN, TX, UT, VT, VA

  • Territories with Pegasys Coverage: None/Unknown

Figure 8. July 2022 ADAP Coverage - Pegasys

Map Key: Yellow = Pegasys Coverage; Red = No Pegasys Coverage/No Information regarding Pegasys Coverage

Harvoni (generic)

  • States with Harvoni (generic) Coverage: AZ, AR, CA, CO, CT, FL, IL, IA, ME, MD, MA, MN, MS, NE, NV, NH, NJ, NM, NC, ND, OK, OR, PA, SD, TN, WA, WI, WY, D.C.

  • States without Harvoni (generic)Coverage: AL, AK, DE, GA, HI, ID, IN, KS, KY, LA, MI, MO, MT, NY, OH, RI, SC, TX, UT, VT, VA, WV

  • Territories with Harvoni (generic) Coverage: P.R.

Figure 9. July 2022 ADAP Coverage - Harvoni (Generic)

Map Key: Yellow = Harvoni (Generic) Coverage; Red = No Harvoni (Generic) Coverage/No Information regarding Harvoni (Generic) Coverage

Epclusa (generic)

  • States with Epclusa (generic) Coverage: AZ, AR, CA, CO, CT, FL, IL, IN, IA, ME, MD, MA, MN, MS, MO, NE, NV, NH, NJ, NM, ND, OR, PA, SD, TN, WA, WI, WY, D.C.

  • States without Epclusa (generic) Coverage: AL, AK, DE, GA, HI, ID, KS, KY, LA, MI, MT, NY, NC, OH, OK, RI, SC, TX, UT, VT, VA, WV

  • Territories with Epclusa (generic) Coverage: P.R.

Figure 10. July 2022 ADAP Coverage - Epclusa (generic)

Map Key: Yellow = Epclusa (generic) Coverage; Red = No Epclusa (generic) Coverage/No Information regarding Epclusa (generic) Coverage

July 2022 Notes:

  • States with Open Formularies: IL, IA, MA, MN, NE, NH, NJ, NM, ND, OH, OR, WA, WY

    • N.B. – Although Ohio is listed by NASTAD as having an open formulary, both NASTAD’s ADAP Formulary Database and Ohio’s ADAP website indicates that the state does not offer any treatment for HCV.

    • N.B. – Although North Dakota has adopted an open formulary, they provide only co-pay and deductible assistance for HCV medications.

    • N.B. – Wyoming's ADAP Open Formulary document, the following disclaimer related to HCV is made: Hepatitis C treatment medications (i.e. Harvoni, Sovaldi, Ribavirin, Zepatier, Epclusa) must be prior authorized. To be eligible, clients must have applied for prior authorization from their insurance plan and the WY ADAP Hepatitis C Treatment checklist must be completed and signed by the provider and client.

  • Colorado offers five coverage options – Standard ADAP, HIV Medical Assistance Program (HMAP), Bridging the Gap Colorado (BTGC), HIV Insurance Assistance Program (HIAP), and Supplemental Wrap Around Program (SWAP). ‘Yes’ indications in Figure 1. for Colorado denote that at least one of these programs offers coverage for each respective drug. The Standard ADAP Formulary covers medications only if funds are available to do so.

  • Louisiana’s ADAP (Louisiana Health Access Program – LA HAP) offers two coverage options – Uninsured (Louisiana Drug Assistance Program – L-DAP) and Insured (Health Insurance Program – HIP). HIP pays for the cost of treatment only if the client’s primary insurance covers the drug under its formulary.

  • Georgia’s ADAP notes the following: “Georgia ADAP Hepatitis C Program is currently on HOLD until future funding is available. Please utilize Patient Assistance Programs (PAP’s) for Hepatitis C medications.”

  • Texas ADAP’s coverage of HCV medications is limited to Epclusa (brand).

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3. MEDICAID PROGRAMS & HCV THERAPIES

All 50 states and the District of Columbia continue to offer some form of HCV coverage. All 50 states and the District of Columbia have expanded their Preferred Drug Lists to include at least one HCV Direct Acting Agent (DAA).

July 2022 Updates:

Basic Coverage

  • States with Basic HCV Medications Coverage: AZ, AK, AR, CA, CO, CT, DE, FL, GA, HI, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MS, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OR, PA, RI, SD, TN, TX, UT, VT, WA, WV, WI, D.C.

  • States without Basic HCV Medications Coverage: AL, ID, KS, MO, OK, SC, VA, WY

Figure 11. July 2022 Medicaid Coverage - Basic HCV Medications

Map Key: Blue = Basic HCV Medication Coverage; Yellow = No Basic HCV Medication Coverage/No Information regarding Basic HCV Medication Coverage

Sovaldi

  • States with Sovaldi Coverage: AR, CA, CO, DE, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, ND, OH, OK, PA, RI, SD, TN, TX, UT, VT, WA, WV, WI, WY, D.C.

  • States without Sovaldi Coverage: AL, AK, AZ, CT, FL, NM, OR, SC, VA

Figure 12. July 2022 Medicaid Coverage - Sovaldi

Map Key: Blue = Sovaldi Coverage; Yellow = No Sovaldi Coverage/No Information regarding Sovaldi Coverage

Harvoni

  • States with Harvoni Coverage: AL, AR, CA, CO, DE, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, ND, OH, OK, PA, RI, SD, TN, TX, UT, VT, WA, WV, WI, WY, D.C.

  • States without Harvoni Coverage: AK, AZ, CT, FL, NM, OR, SC, VA

Figure 13. July 2022 Medicaid Coverage - Harvoni

Map Key: Blue = Harvoni Coverage; Yellow = No Harvoni Coverage/No Information regarding Harvoni Coverage

Zepatier

  • States with Zepatier Coverage: AL, AR, CA, CO, DE, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, ND, OH, PA, RI, SD, TN, TX, UT, VT, WA, WV, WI, WY, D.C.

  • States without Zepatier Coverage: AK, AZ, CT, FL, NM, OK, OR, SC, VA

Figure 14. July 2022 Medicaid Coverage - Zepatier

Map Key: Blue = Zepatier Coverage; Yellow = No Zepatier Coverage/No Information regarding Zepatier Coverage

Epclusa

  • States with Epclusa Coverage: AL, AR, CA, CO, GA, HI, IL, IN, IA, KS, KY, LA, MA, ME, MI, MN, MS, MO, MT, NV, NH, NJ, NM, NY, NC, ND, OR, PA, RI, SD, TN, TX, UT, VT, WA, WV, WI, WY, D.C.

  • States without Epclusa Coverage: AK, AZ, CT, DE, FL, ID, MD, NE, OH, OK, SC, VA

Figure 15. July 2022 Medicaid Coverage - Epclusa

Map Key: Blue = Epclusa Coverage; Yellow = No Epclusa Coverage/No Information regarding Epclusa Coverage

Vosevi

  • States with Vosevi Coverage: AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, ND, OH, OR, PA, RI, SC, SD, TN, TX, UT, VT, WA, WV, WI, WY, D.C.

  • States without Vosevi Coverage: AL, AK, AZ, NM, OK, VA

Figure 16. July 2022 Medicaid Coverage - Vosevi

Map Key: Blue = Vosevi Coverage; Yellow = No Vosevi Coverage/No Information regarding Vosevi Coverage

Mavyret

  • States with Mavyret Coverage: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, D.C.

Figure 17. July 2022 Medicaid Coverage - Mavyret

Map Key: Blue = Mavyret Coverage; Yellow = No Mavyret Coverage/No Information regarding Mavyret Coverage

Pegasys

  • States with Pegasys Coverage: AK, AZ, CA, CT DE, FL, GA, HI, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MS, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OR, PA, RI, SD, TN, TX, VT, WA, WV, WI, D.C.

  • States without Pegasys Coverage: AL, AR, CO, ID, KS, MO, ND, OK, SC, UT, VA, WY

Figure 18. July 2022 Medicaid Coverage - Pegasys

Map Key: Blue = Pegasys Coverage; Yellow = No Pegasys Coverage/No Information regarding Pegasys Coverage

Harvoni (generic)

  • States with Harvoni (generic) Coverage: AL, AR, CA, CO, DE, GA, HI, ID, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, ND, OH, OK, PA, RI, SD, TN, TX, UT, VT, WA, WV, WI, D.C.

  • States without Harvoni (generic) Coverage: AK, AZ, CT, FL, KS, NM, OR, SC, VA, WY

Figure 19. July 2022 Medicaid Coverage - Harvoni (generic)

Map Key: Blue = Harvoni (generic) Coverage; Yellow = No Harvoni (generic) Coverage/No Information regarding Harvoni (generic) Coverage

Epclusa (generic)

  • States with Epclusa (generic) Coverage: AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, D.C.

  • States without Epclusa (generic) Coverage: AK, ID, ME, OK

Figure 20. July 2022 Medicaid Coverage - Epclusa (generic)

Map Key: Blue = Epclusa (generic) Coverage; Yellow = No Epclusa (generic) Coverage/No Information regarding Epclusa (generic) Coverage

July 2022 Notes:

  • The follow states’ Medicaid programs offer multiple coverage plans for their respective Medicaid clients. The plan highlighted in bold typeface represents the most comprehensive plan with the most drugs covered in the respective state:

    • Hawaii – (1.) Advantage Plus; (2.) QUEST Integration

    • New Jersey – (1.) Aetna; (2.) AmeriGroup NJ; (3.) Horizon NJ Health; (4.) UnitedHealthcare of New Jersey; (5.) WellCare

    • New Mexico – (1.) BlueCross BlueShield of New Mexico; (2.) Presbyterian Centennial Care; (3) Western Sky Community Care

    • Kentucky has a Unified Medicaid Formulary

    • Louisiana has a Unified Medicaid Formulary

    • Ohio – Ohio has a Unified Medicaid Formulary that applies to all MCOs

  • Connecticut has added Epclusa (generic) to its Medicaid PDL.

  • Maryland has removed Epclusa (brand) from its Medicaid PDL.

  • Virginia Medicaid has reduced its HCV coverage to only Mavyret and Epclusa (generic).

  • Washington Medicaid has returned basic HCV medications to its formulary.

  • Idaho Medicaid has removed coverage of basic HCV medications.

  • As of July 25th, 2022, Florida’s Medicaid program notes the following “The Preferred Drug List is currently under construction. A new PDL will be posted here soon representing changes from the June 24, 2022 P&T Committee meeting.”

  • No data is has been made available by the Medicaid programs in the U.S. Territories.

*Medicaid coverage excludes patients from most drug manufacturer patient assistance programs (PAPs)

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4. VETERANS PROGRAMS & HCV THERAPIES

The Veteran's Administration (VA) currently offers coverage for all HCV drugs. This is according to the most recent VA National Formulary, dated May 2021 (U.S. Dept. of V.A., 2021a). The VA Treatment Considerations and Choice of Regimen for HCV-Mono-Infected and HIV/HCV Co-Infected Patients, dated March 2021 (U.S. Dept. of V.A., 2021b) lists the following therapies as preferred treatments:

Abbreviations:

- CTP – Child-Turcotte-Pugh (score used to assess severity of cirrhosis)
- IU/mL – International Units Per Milliliter
- PEG-IFN/IFN – Peginterferon/Interferon
- RAS – Resistance-associated substitutions

Genotype 1:

  • Treatment-naïve without or with cirrhosis (CTP A):

    • Pangenotypic regimens

      • Mavyret: 3 tablets orally daily with food for 8 weeks; may consider 12 weeks in patients with poor prognostic factors

      • Epclusa: 1 tablet orally daily for 12 weeks

    • Non-pangenotypic regimens:

      • Zepatier: 1 tablet orally daily for 12 weeks if GT1a without baseline NS5A RAS or GT1b

      • Harvoni: 1 tablet orally daily

        • If HCV-noninfected, non-cirrhotic, and HCV RNA baseline <6 million IU/mL: 8 weeks

        • If cirrhotic, baseline HCV RNA ≥6 million IU/mL, HIV/HCV-co-infected, or African American: 12 weeks

        • Consider adding ribavirin in CTP A patients

  • Treatment-naïve with decompensated cirrhosis (CTP B or C):

    • Harvoni: 1 tablet orally daily + ribavirin (600 mg/day and increase by 200 mg/day every 2 weeks only as tolerated) for 12 weeks

    • Epclusa: 1 tablet orally daily + ribavirin (1000 mg/day - <75kg – or 1,200 mg daily - ≥75kg – orally daily in 2 divided doses with food) for 12 weeks; start at lower ribavirin doses as clinically indicated (e.g., baseline Hgb).

  • Treatment-experienced (NS5A- and SOF-naïve [e.g., failed PEG-IFN/RBV ± NS3/4A PI]) without or with cirrhosis (CTP A)

    • Pangenotypic regimens:

      • Mavyret: 3 tablets orally daily with food

        • If PEG-IFN/RBV-experienced: 8 weeks if non-cirrhotic or 12 weeks if cirrhotic

        • If NS3/4A PI + PEG-IFN/RBV-experienced: 12 weeks

      • Vosevi: 1 tablet orally daily for 12 weeks

    • Non-pangenotypic regimens

      • Zepatier: 1 tablet orally daily for 12 weeks if GT1b, or if failed only PEG-IFN/RBV and GT1a without baseline NS5A RAS

      • Harvoni: 1 tablet orally daily for 12 weeks

  • Treatment-experienced (NS5A-naïve and SOF-experienced) without or with cirrhosis (CTP A)

    • Mavyret: 3 tablets orally daily with food

      • If PEG-IFN/RBV + Sovaldi-experienced: 8 weeks if non-cirrhotic or 12 weeks if cirrhotic

      • If Olysio + Sovaldi-experienced: 12 weeks

    • Epclusa: 1 tablet orally daily for 12 weeks if GT1b

    • Vosevi: 1 tablet orally daily with food for 12 weeks if GT1a

  • Treatment-experienced (prior NS5A-containing regimen) without or with cirrhosis (CTP A)

    • Mavyret: 3 tablets orally daily with food for 16 weeks if failed only an NS5A inhibitor without NS3/4A PI (e.g., Harvoni)

    • Vosevi: 1 tablet orally daily with food for 12 weeks

  • Treatment-experienced with decompensated cirrhosis (CTP B or C)

    • Epclusa: 1 tablet orally daily + RBV; start at lower RBV doses as clinically indicated (e.g., baseline Hgb);

      • If NS5A-naïve: 12 weeks

      • If NS5A-experienced: 24 weeks; NOT FDA approved for 24 weeks

Genotype 2:

  • Treatment-naïve or treatment-experienced (PEG-IFN/IFN ± RBV or Sovaldi + RBV ± PEG-IFN) without or with cirrhosis (CTP A)

    • Mavyret: 3 tablets orally daily with food for 8 weeks; 12 weeks if CTP A and treatment-experienced or in patients with poor prognostic factors

    • Epclusa: 1 tablet orally daily for 12 weeks

  • Treatment-experienced (NS5A-experienced) without or with cirrhosis (CTP A)

    • Vosevi: 1 tablet orally daily with food for 12 weeks

  • Treatment-naïve or treatment-experienced patients with decompensated cirrhosis (CTP B or CTP C)

    • Epclusa: 1 tablet orally daily + ribavirin; start at lower ribavirin doses as clinically indicated (e.g., baseline Hgb)

  • If NS5A-naïve: 12 weeks

  • If NS5A-experienced: 24 weeks

Genotype 3:

  • Treatment-naïve without cirrhosis or with cirrhosis (CTP A)

    • Mavyret: 3 tablets orally daily with food for 8 weeks; may consider 12 weeks if cirrhotic or in patients with poor prognostic factors

    • Epclusa: 1 tablet orally daily for 12 weeks

      • If CTP A, test for NS5A RAS

      • Add ribavirin if Y93H RAS present

  • Treatment-experienced (PEG-IFN ± RBV or Sovaldi + RBV ± PEG-IFN) without or with cirrhosis (CTP A)

    • Mavyret: 3 tablets orally daily with food for 16 weeks

  • Treatment-experienced (NS5A-experienced) without or with cirrhosis (CTP A)

    • Vosevi: 1 tablet orally daily with food for 12 weeks

      • If CTP A, consider adding ribavirin (no supporting data)

  • Treatment-naïve or treatment-experienced with decompensated cirrhosis (CTP B or CTP C)

    • Epclusa: 1 tablet orally daily + ribavirin; start at lower ribavirin doses as clinically indicated (e.g., baseline Hgb)

      • If NS5A-naïve: 12 weeks

      • If NS5A-experienced: 24 weeks

Genotype 4:

  • Treatment-naïve without or with cirrhosis (CTP A)

    • Pangenotypic regimens

      • Mavyret: 3 tablets orally daily with food for 8 weeks; may consider 12 weeks in patients with poor prognostic factors

      • Epclusa: 1 tablet orally daily for 12 weeks

    • Non-pangenotypic regimens

      • Zepatier: 1 tablet orally daily for 12 weeks

      • Harvoni: 1 tablet orally daily for 12 weeks

  • Treatment-naïve with decompensated cirrhosis (CTP B or C)

    • Pangenotypic regimen

      • Epclusa: 1 tablet orally daily + RBV for 12 weeks; start at lower ribavirin doses as clinically indicated (e.g., baseline Hgb)

    • Non-pangenotypic regimen:

      • Harvoni: 1 tablet orally daily + ribavirin (600 mg/day and increase by 200 mg/day every 2 weeks only as tolerated) for 12 weeks

  • Treatment-experienced (Sovaldi-experienced and NS5A-naïve) without or with cirrhosis (CTP A)

    • Mavyret: 3 tablets orally daily with food for 8 weeks if NS3/4A PI-naïve without cirrhosis, and 12 weeks if NS3/4A PI-experienced or CTP A

    • Epclusa: 1 tablet orally daily + ribavirin for 12 weeks; start at lower ribavirin doses as clinically indicated (e.g., baseline Hgb)

  • Treatment-experienced (NS5A-experienced) without or with cirrhosis (CTP A)

    • Vosevi: 1 tablet orally daily with food for 12 weeks

  • Treatment-experienced with decompensated cirrhosis (CTP B or CTP C)

    • Epclusa: 1 tablet orally daily + ribavirin; start at lower ribavirin doses as clinically indicated (e.g., baseline Hgb)

      • If NS5A-naïve: 12 weeks

      • If NS5A-experienced: 24 weeks; NOT FDA approved for 24 weeks

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5. PATIENT ASSISTANCE PROGRAMS

The drug manufacturers and various national nonprofit organizations offer a variation of patient assistance programs (PAPs) to assist patients in accessing treatments. They include:

Support Path (Gilead Sciences):

  • Financial Assistance

    • Provides Co-Pay Coupons for Sovaldi, Harvoni, Harvoni (Generic), Epclusa, Epclusa (Generic), and Vosevi

    • Co-Pay Coupons cover out-of-pocket costs up to 25% of the catalog price of a 12-week regimen (3 bottles/packages) of Sovaldi, Harvoni, Harvoni (Generic), Epclusa, Epclusa (Generic), or Vosevi

    • Excludes patients enrolled in Medicare Part D or Medicaid

  • Insurance Support

    • Researches and verifies patient’s benefits, and gives information they need about coverage options and policies

    • Explain Prior Authorization process and works with HCV Specialist’s office so they can submit PA forms to a patient’s insurance company

    • May be able to provide assistance with appeals process

  • Website: http://www.mysupportpath.com/

AbbVie Mavyret Co-Pay Savings Card:

  • Financial Assistance

    • Patient may be eligible to pay as little as $5

    • Excludes patients enrolled in Medicare Part D, Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, or Veterans Affairs programs)

  • Website: https://www.mavyret.com/copay-savings-card

NeedyMeds:

  • NeedyMeds Drug Discount Card

    • Designed to lower cost of prescription medications by up to 80% at participating pharmacies

    • Price finder tool for the drug discount card

    • No eligibility requirements

    • CANNOT be used in combination with government healthcare programs, but CAN be used IN PLACE of program

    • CANNOT be combined with other offers

  • Website: http://ow.ly/fEJo309cJ7Z

The Assistance Fund:

  • Status: WAITLISTED

  • Requires provider referral

  • Copay assistance

  • Eligibility Criteria:

    • US citizen or permanent resident

    • Diagnosed with the disease for which you are applying

    • Prescribed an FDA-approved treatment for the disease

    • Have prescription coverage for the prescribed treatment

    • Meet financial eligibility criteria based upon household income and size

  • Website: https://tafcares.org/patients/covered-diseases/

Patient Advocate Foundation Co-Pay Relief:

  • Status: CLOSED

  • Maximum award of $15,000

  • Eligibility Requirements:

    • Patient must be insured, and insurance must cover prescribed medication

    • Confirmed HCV diagnosis

    • Reside and receive treatment in the U.S.

    • Income falls below 400% of FPL with consideration of the Cost of Living Index (COLI) and the number in the household

  • Website: https://www.copays.org/diseases/hepatitis-c

Patient Access Network (PAN) Foundation:

HealthWell Foundation:

  • Status: OPEN

  • Co-Pay Assistance with a maximum award of $30,000

  • Minimum Co-Pay Reimbursement Amount: None

  • Minimum Premium Reimbursement Amount: None

  • Eligibility Requirements:

    • Must be being treated for HCV

    • Have insurance that covers HCV prescribed medication

    • Income falls below 500% of FPL

    • Receiving treatment in the U.S.

  • Website: https://www.healthwellfoundation.org/fund/hepatitis-c/

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6. HARM REDUCTION PROGRAMS

Harm Reduction, as it relates to opioid abuse and HCV, are measures designed to serve as preventive or monitoring efforts in combating opioid prescription drug and heroin abuse, and as an effect, helping to prevent the spread of HCV and HIV. The Co-Infection Watch covers the following measures: Syringe Exchange, Expanded Naloxone Access, Good Samaritan Laws, Mandatory PDMP Reporting, Doctor Shopping Laws, Physical Exam Requirements, ID Requirements for Purchase, Required or Recommended Prescriber Education, and Lock-In Programs (Editor’s Note: Program descriptions provided herein).

July 2022 Updates:

Syringe Exchange

Syringe Services Programs (SSPs) exist to provide injection drug users (or those whose prescriptions require injection) with clean syringes and/or in exchange for used ones. (N.b. – states listed as "at least one SSP…” indicate only that a Syringe Services Program (SSP) exists within the state, regardless of the legality of SSPs under state law).

  • States with Syringe Exchange: AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MO, MT, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WV, WI, D.C.

  • States without Syringe Exchange: AL, KS, MS, NE, SD, WY

  • Territories with Syringe Exchange: Puerto Rico, U.S. Virgin Islands

Figure 21. July 2022 Syringe Exchange Coverage

Map Key: Purple = Syringe Exchange(s); Red = No Syringe Exchange(s); Grey = No Information

Expanded Naloxone

Naloxone is a drug used to counteract the effects of opioid overdoses. Expanded Access refers to one of more of the following conditions: Naloxone purchase without a prescription; availability to schools, hospitals, and emergency response units for use in the event of an overdose.

  • States with Expanded Naloxone: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, MS, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, D.C.

  • States without Expanded Naloxone: None

  • Territories with Expanded Naloxone: Unknown

Figure 22. July 2022 Expanded Naloxone Coverage

Map Key: Purple = Expanded Naloxone; Red = Restricted Naloxone; Gray = No Information

Good Samaritan Laws

Good Samaritan Laws are laws that are designed to protect emergency services personnel, public or private employees, and/or citizens from being held legally liable for any negative healthcare outcomes as a result of providing "reasonable measures" of emergent care.

  • States with Samaritan Laws: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, MS, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, D.C.

  • States without Samaritan Laws: None

  • Territories with Samaritan Laws: Unknown

Figure 23. July 2022 Good Samaritan Laws Coverage

Map Key: Purple = Good Samaritan Laws; Red = No Good Samaritan Laws; Gray: No Information

Mandatory PDMP Reporting

Prescription Drug Monitoring Programs (PDMPs) are programs established by state and/or federal law that requires prescribing physicians and the fulfilling pharmacies to report to a state agency one or more of the following data points: Patient Names; Specific Drug(s) Prescribed; Prescription Dosage; Date; Time; Form of State-Issued ID.

  • States with PDMP Reporting: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WV, WI, WY, D.C.

  • States without PDMP Reporting: MO, MT, SD

  • Territories with PDMP Reporting: Guam

Figure 24. July 2022 Mandatory Prescription Drug Monitoring Program Coverage

Map Key: Purple = Mandatory PDMP; Red = No Mandatory PDMP; Gray = No Information

Doctor Shopping Laws

Doctor Shopping Laws are those laws designed to prevent patients from seeking one or more of the same prescription from multiple doctors through the use of subterfuge, falsifying identity, or any other deceptive means. While federal law prohibits Doctor Shopping, most states also include provisions that prohibit patients from seeking a new prescription if another physician has denied a similar prescription within a certain period of time.

  • States with Doctor Shopping Laws: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, MS, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, D.C.

  • States without Doctor Shopping Laws: None

  • Territories with Doctor Shopping Laws: None

Figure 25. July 2022 Doctor Shopping Laws Coverage

Map Key: Purple = Doctor Shopping Laws; Red = No Doctor Shopping Laws; Grey = No Information

Physical Exam Required

Physical Exam Requirements are those that mandate that the prescribing physician perform a physical examination on a patient before providing a prescription for a controlled substance to determine if the prescription is medically necessary.

  • States with Physical Exam Required: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KY, LA, MD, MA, ME, MI, MN, MO, MS, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, PA, RI, SC, TN, TX, UT, VA, VT, WA, WV, WY, D.C.

  • States without Physical Exam Required: KS, MT, OR, SD, WI

  • Territories with Physical Exam Required: None

Figure 26. July 2022 Physical Exam Required Coverage

Map Key: Purple = Physical Exam Required; Red: No Physical Exam Required; Grey = No Information

I.D. Required for Purchase of Opioid Prescription

Federal law requires anyone purchase a controlled substance to provide a state-issued identification (“I.D.”) in order to fill the prescription. Mandatory ID requirements go further and require that this information be recorded and stored in an effort to prevent the same patient from obtaining multiple or repeated prescriptions in a given period of time.

  • States with I.D. Required: AZ, CA, CT, DE, FL, GA, HI, ID, IL, IN, KY, LA, ME, MA, MI, MS, MN, MT, NE, NV, NJ, NM, NY, NC, ND, OK, OR, SC, TN, TX, VT, VA, WV, WI, WY

  • States without I.D. Required: AL, AK, AR, CO, IA, KS, MD, MO, NH, OH, PA, RI, SD, UT, WA, D.C.

  • Territories with I.D. Required: Unknown

Figure 27. July 2022 I.D. Required Coverage

Map Key: Purple = I.D. Required; Red = No I.D. Required; Gray = No Information

Prescriber Education Required/Recommended

States that require/do not require that prescribing physicians undergo special training related to safer prescribing and utilization practices.

  • States with Prescriber Education Required: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WV, WI, WY, D.C.

  • States without Prescriber Education Required: KS, MO, MT, ND, SD

  • Territories with Prescriber Education Required: Unknown

Figure 28. July 2022 Prescriber Education Required Coverage

Map Key: Purple = Prescriber Ed Required; Red = No Prescriber Ed Required; Gray = No Information

Medicaid Lock-In Program

Lock-In Programs are laws requiring that patients either receive prescriptions from only one physician and/or fill prescriptions from only one pharmacy.

  • States with Medicaid Lock-In Program: AL, AK, AZ, AR, CA, CO, CT, DE, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, MS, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WV, WI, WY, D.C.

  • States without Medicaid Lock-In Program: FL, HI, SD

  • Territories with Medicaid Lock-In Program: Unknown

Figure 29. July 2022 Medicaid Lock-In Coverage

Map Key: Purple = Medicaid Lock-In; Red = No Medicaid Lock-In; Gray = No Information

July 2022 Notes:

  • In March 2020, the U.S. Drug Enforcement Agency (DEA) issued guidance regarding telehealth and physical exam requirements through the duration of the COVID-19 public health emergency, specifically with regard to physical exam requirements.

  • Good Samaritan Laws may have a carve out for individuals illegally dispensing opioids or other illicit drugs.

  • Doctor shopping laws in several states are found under "“fraud” statutes related to obtaining opioid prescriptions.

  • Medicaid Pharmacy Lock-In Programs: Florida and Hawaii allow for but do not mandate. Medicaid Pharmacy Lock-In by way of rule-making or waiver. Program activity is designated by Managed Care Organization.

  • New Jersey has updated interpretation of existing state law to include mandatory PDMP reporting for certain controlled substances.

  • CANN is no longer able to independently verify the existence of an SSP in Kansas. KS state laws prohibit SSPs and syringes are included in the state’s drug paraphernalia law.

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7. COVID-19 IMPACT ON HIV & HCV

The Community Access National Network’s blog began 2021 by assessing COVID-19’s impact on HIV, HCV, and Substance-Use Disorder. We've subsequently followed-up by asking, COVID-19: How Far We’ve Come & How Far We Have to Go? We continue to monitor developments in light of the ongoing COVID-19 pandemic and its impacts on public health.

Additional Resources and Relevant Issues:

  • Declaration of Public Health Emergency Renewed - On July 15, 2022, the U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra renewed the existing declaration of a public health emergency (PHE) due to COVID-19. The previous declaration was set to expire in October 2022. To review some potential changes when the PHE ends, click here.

  • 2020 HIV Surveillance Report Proves Earlier COVID-19 Concerns - In May 2022, CANN reviewed the U.S. Centers for Disease Control and Prevention’s (CDC) 2020 surveillance report. The annual report confirmed what many advocates suspected would occur as a result of the COVID-19 pandemic: activities related to HIV testing, linkage to care, and retention in care took a dramatic downturn during 2020. What this means for the future of the HIV epidemic in the United States is unclear but many advocates remain concerned that years of gains have been lost due to decades of disinvestment in public health.

  • A Collision of Pandemics: HIV and COVID-19 - An assessment in The Lancet reviews the cooccurring pandemics of HIV and COVID-19, under the lens of how people living with HIV faired with COVID-19, given the exceptional number of publications with contradictory findings. The analysis reviewed the findings of almost 200,000 COVID-19 patients, with 19,955 who were living with HIV and 180,524 who were not. The authors concluded that both HIV and the higher likelihood of PLWHA to have at least one comorbidity increased the likelihood of poorer COVID-19 outcomes. The authors state a desire to continue this analysis in an ongoing basis.

  • HIV Care Fell in Black Communities During COVID. Here’s How Congress Can Get It Back on Track. - While advocates have successfully lobbied Congress to expand HIV-related funding in the past, the programs those funds go towards are often broad in design, not necessarily reaching the communities most in need. The Hill explores the dynamics of the relationship between broad HIV-public policy, existing gaps in mandatory sex education and lack of standardized sex education, and where private industry has failed to engage racial and ethnic communities, leading to and maintaining the health disparities plaguing the nation.

  • HIV and COVID-19 - What We’ve Learned - In a Podcast hosted by the Infectious Disease Society of America, health care and public health professionals discuss both the specific clinical considerations for people living with HIV experiencing a COVID-19 infection and the broader impacts of the COVID-19 pandemic on the HIV community and efforts to end the HIV epidemic.

  • People with HIV Face Higher Risk of Breakthrough COVID, Study Says - Forbes covers a study in JAMA Network Open that argues people living with HIV should be a high priority group for COVID-19 booster shots because of a 28% higher risk of contracting breakthrough COVID-19 than their peers. Researchers found no link between viral suppression and breakthrough COVID-19, however, younger people living with HIV were more likely to experience a breakthrough than older people living with HIV. This may be reflective of poor public health messaging, access to boosters, and/or risk assessments of the age cohorts.

  • Assessing the HIV Community’s Needs and Concerns About Long COVID - POZ Magazine reviews a survey of people living with HIV about their concerns regarding “long COVID”. The survey revealed both patients and providers felt like they lacked adequate information and resources to navigate long COVID and the mental health burdens, especially the risk of retraumatizing survivors of the AIDS Crisis, were extraordinary. As has been the case all along, many participants emphasized leveraging the knowledge of HIV to combat the COVID-19 pandemic.

  • KHN: Different Takes: The Future of COVID is Not Promising; Is it Time to Start Masking Again - Kaiser Health News reviews three articles discussing the 2022 summer COVID-19 surge, the emergence of yet another variant with a propensity of even more infectiousness, and the need to engage in easy to access preventative tools like masks. If COVID-19 is here to stay, exactly how bad does that look?

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8. LATEST NEWS

  • Renewal of Determination That a Public Health Emergency Exists - On June 30, 2022, the U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra renewed the ongoing declaration of public health emergency regarding the opioid crisis. The declaration is the latest in extensions regarding the opioid crisis, originating in October 2017.

  • HHS Announces Notice of Proposed Rulemaking: Section 1557 of the ACA - On July 25, 2022, the U.S. Department of Health and Human Services (HHS) announced a long-awaited “notice of proposed rulemaking” for the Affordable Care Act’s non-discrimination provision, known as Section 1557. The notice outlines the Biden Administration’s aims with a new Final Rule, speaking explicitly on the issues of gender affirming care, abortion access, formulary designs, and more. Section 1557 has been volleyed back and forth in courts since the Obama administration issued a Final Rule in 2016. This iteration will be the first since the Supreme Court’s ruling in Bostock, which HHS relies upon heavily.

  • Conservatives Take a New Swing at the Affordable Care Act - POLITICO covers the issues at the heart of a case pending before Judge Reed O’Connor in Texas. Kelley represents the situation of - you guessed it, dentists (among others) - who wish to be able to discriminate against people accessing PrEP and contraceptives by attacking the very structures of the ACA that mandate these services as “preventative”. The effort is indeed another politically driven swipe at dismantling the ACA.

  • Allen County (Ind.) HIV Spike Due to Increased Contact, Testing - Allen County, Indiana, is seeing a surge in new HIV diagnoses with diagnoses for the year already surpassing last year’s total. The local department says this wasn’t entirely unexpected and does not attribute the spike to having any relationship to a surge in overdose deaths and a higher percentage than normal being attributed to heterosexual sexual contact. Rather, the health department states the driving issue of these new HIV diagnoses is because of a relaxation of COVID precautions and more testing.

  • The HIV/AIDS Battle is a Global Health Fight That We Can Win - In an opinion piece in Forbes, CEO of One Campaign, Gayle Smith, argues that despite the losses incurred due to the COVID-19 pandemic, HIV/AIDS can be defeated globally, if we have the will to do so. Recounting a past when public health threats brought politicians together and a need to replenish global funding as politicians look away from the ongoing fight against HIV/AIDS, Smith argues now - with the tools to succeed in sight - is not the time to abandon our neighbors in this global fight. We “urgently need a victory”.

  • Monkeypox: Not Enough Vaccine Available, One in Ten May End Up in Hospital - AIDS Map assesses the threat of Monkeypox, who is experiencing infections, containment strategies, and vaccine efforts as the virus makes its presence known in non-endemic countries worldwide. Reviewing previous outbreaks, while one in ten people were hospitalized, most of those were for isolation and observation purposes, with only 3 out of 3506 patients being admitted into intensive care units. While this doesn’t present an immediate threat of mortality, short and long term impacts of yet another infectious disease outbreak, largely affecting MSM, does pose a significant public health threat.

  • Stay Informed About AIDS 2022 with Daily Updates from HIV.gov - Staff from HIV.gov will be attending the International AIDS Conference in Montreal, Canada in July. This is the first in-person event since 2019. Representing a global brain trust with regard to HIV, AIDS, and associated health impacts, this blog outlines what to expect from the United State’s government attendees.

  • Resurgence of Meningococcal Disease Among MSM Causes Alarm - ADAP Advocacy Association’s blog reviews a disturbing return of meningitis among MSM. The outbreak has been raging since March, appearing to originate in Florida. Because meningitis is easily transmitted between people by way of coughing or kissing and can escalate quickly into a fatal illness within a matter of days. The blog aims to raise awareness of the signs and symptoms of a meningitis infection and encourage vaccination.

  • As Biden fights Overdoses, Harm Reduction Groups Face Local Opposition - Despite the American Rescue Plan’s inclusion of $30 million to support harm reduction programs, local organizations are struggling to find support in state legislatures, often operating in a legal grey area or outright working against the laws of their state. One example is how about half of states still maintain paraphernalia laws which would encompass fentanyl test strips, others hold no carve out for syringe exchange programs. In San Francisco, some residents maintain outdated and moralistic views that these harm reduction services promote drug use. In order to effectively implement harm reduction strategies, well-intentioned but misaligned state laws and stigma must be addressed.

  • 988: national Suicide Prevention Lifeline Launches New 3-Digit Number - After much lobbying, the National Suicide Prevention Lifeline now only requires a 3-digit dial: 988. The code is available across the United States, in an effort to streamline access to mental health crisis intervention. Some of the hope in the program is to reduce reliance on police intervention and to help people needing help connect with a qualified counselor and other resources. Advocates fear, though, a mandate for “crisis intervention teams”, which may include police, putting people at risk of violence. Administrators are concerned the need may outstrip the resources allocated to run the hotline.

  • New Federal Implementation plan for Viral Hepatitis National Strategic Plan - In May, the U.S. Department of Health & Human Services (HHS) released the Viral Hepatitis Federal Implementation Plan outlining federal commitments to elimination viral hepatitis in the United States by 2030. The implementation plan is the tool by which the Viral Hepatitis National Strategic Plan is activated. Recognizing viral hepatitis is a syndemic to STIs, HIV, substance use, and mental health, HHS prioritizes integrated strategies to successfully address all of these public health concerns concurrently.

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9. CONTACT

Jen Laws, President & CEO

jen@tiicann.org

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10. REFERENCES

Available upon request.

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Jen Laws, President & CEO

Jen Laws (Pronouns: He/Him/His) is the President & Founder of Policy Candy, LLC, which is a non-partisan health policy analysis firm specializing in various aspects of health care and public health policy, focusing on the needs of the HIV-affected and Transgender communities. In that capacity, Jen has served as the President & CEO of the Community Access National Network (CANN), beginning in January 2022. He previously served as the Project Director of CANN's HIV/HCV Co-Infection Watch, as well as 340B Policy Consultant.

Jen began his advocacy efforts in Philadelphia in 2005, at the age of 19, coordinating team efforts for a corporation participating in the AIDS Walk. His connection to HIV advocacy grew when partnering with Mr. Friendly, a leading anti-HIV-stigma campaign.

He began working in public health policy in 2013, as a subcontractor for Broward Regional Planning Council evaluating Marketplace plans for plan year 2014, advising and educating constituents on plan selection. Jen was a member of South Florida AIDS Network and has worked with Florida Department of Health, Broward and Miami-Dade County Health Departments, Pride Center South Florida, and other local organizations to South Florida in addressing the concerns and needs of these intersecting communities. During this time, Jen was seated on the board of directors for the ADAP Advocacy Association.

Having moved to the New Orleans area in 2019, Jen resumed his community-based advocacy as the chair of Louisiana's Ending the HIV Epidemic planning subcommittee for Data-based Policy and Advocacy, regular participation as a community member and "do-gooder" with other governmental and non-governmental planning bodies across the Louisiana, and engages with other southern state planning bodies. He continues his advocacy in governmental health care policy evaluation, which has been utilized to expand access to quality healthcare by working with RAD Remedy to deliver the nation's foremost database of trans* competent health care providers. Lending his expertise on policy matters ranging from 340B impact on RW providers and patients to strategic communications and data analysis, Jen's approach to community engagement is focused on being accessible across all stakeholder groups and centering the perspectives of PLWHA and Transgender people. He is a community ambassador alumni of the CDC's Let's Stop HIV Together campaign.

In his personal life, Jen enjoys spending his time being "ridiculously wholesome" with his partner, Aisha, and her two amazing daughters. In their personal time, when not immersed in crafts or house projects, they can be found seeking opportunities to help their neighbors, friends, and community members (who have come to rightfully expect exquisite gift baskets of Aisha's homemade jams and jellies from time to time). Jen strives to set a good example both in his personal professional life of integrating values into action and extending the kindness and care that have led him to a life he calls "extraordinarily lucky".

https://tiicann.org
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Watch 02: April 2022