New guidance clarifies ability of RWHAP providers to partner with city, county, and local jails for HIV/AIDS care and medication and carries  340B program implications.

As 2018 comes to a close, we wanted to share some updates on important Ryan White HIV/AIDS Program (“RWHAP”) guidance.

The HIV/AIDS Bureau (“HAB”) has posted several important Policy Clarification Notice (“PCN”) updates and Program Letters to its “Policy Notices and Program Letters” webpage (https://hab.hrsa.gov/program-grants-management/policy-notices-and-program-letters).  HAB has issued an updated policy for providing RWHAP funded care in correctional settings that gives local jails more flexibility.  Additionally, it issued a Federal Register notice regarding upcoming changes to the Ryan White Service Report (“RSR”), 83 Fed. Reg. 54,363 (Oct. 29, 2018) (link below).

Policy Clarification Notices:

HAB has issued two new PCNs and updated another:

• New – PCN 18-01 (replacing 07-05, 13-05, and 13-06): Clarifications Regarding the use of Ryan White HIV/AIDS Program Funds for Health Care Premium and Cost Sharing Assistance
• New – PCN 18-02 (replacing 07-04): The Use of Ryan White HIV/AIDS Program Funds for Core Medical Services and Support Services for People Living with HIV Who Are Incarcerated and Justice Involved
• Revised – PCN 16-02: Ryan White HIV/AIDS Program Services: Eligible Individuals and Allowable Uses of Funds

Of the three, PCN 18-02, relating to correctional care, is the most notable.  The changes to PCNs 16-02 and 18-01 only include minor substantive clarifications.

Using Ryan White Resources (and 340B Drugs) in Correctional Settings Such as Jails and Prisons

In 2007, HRSA issued guidance indicating that RWHAP funding may only be used for incarcerated persons for transitional care, to prepare individuals who are eligible to receive RWHAP services and who expect to be released within 180 days.  In November, HRSA released updated guidance that supersedes the 2007 guidance and builds upon it.  Most notably, the new guidance clarifies that RWHAP funds may be used in local jail settings without implicating the payer of last resort provision.

The new guidance reiterates that the RWHAP payer of last resort provision precludes the use of RWHAP funding in federal and state prisons because those entities are responsible for providing health care services to all individuals incarcerated.  PCN 18-02 notes that the payer of last resort provision applies to situations in which “payment has been made, or can reasonably be expected to be made under…any Federal or State health benefits program…”  PCN 18-02, p.1.  HAB states that “[t]hus, local payers, such as local jails, are not subject to the payor of last resort provision and HRSA RWHAP may be the primary payor” (emphasis added).  PCN 18-02, p.2.  RWHAP core medical and support services can also be provided to individual under community supervision on a short-term or transitional basis (e.g., halfway houses and supervised release).

The guidance carries significant importance because RWHAP grantees that provide health care to individuals detained in local jails or halfway houses also can create a 340B program patient relationship with the person living with HIV/AIDS and can use discounted 340B drugs when filling prescriptions for those individuals.  Local jails, which struggle with the burden of medication costs for individuals in custody, may be able to negotiate drug reimbursement rates with those providers that result in significant savings.

Though the PCN establishes some much-needed clarity, the relationship between RWHAP providers and detention centers such as local jails can be complicated and can implicate other federal laws.  We recommend working closely with your legal counsel in establishing such relationships.

Program Letters:

The two new Program Letters focus on in large part on clinical matters, though one directly affects the administration of Part B AIDS Drug Assistance Programs (“ADAPs”), as well as Part A, C, and D recipients offering Health Care Premium Assistance.  Specifically, the HAB Program Letter of Oct. 26, 2018 notifies RWHAP recipients that a new drug, Trogarzo (representing a new class of anti-retroviral drug, described as a “CD4 post-attachment HIV-1 inhibitor”), has been added to the U.S. Department of Health and Human Services (“HHS”) Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV.

The HAB letter reminds ADAPs that they must include at least one drug from each class of antiretroviral medications in their formularies, noting that Trogarzo is (or at least was as of the date of the Program Letter) the only drug in this new class.

Though not explicitly noted by HAB in this Program Letter, Part A, C, and D recipients offering Health Care Premium Assistance should also consider the impact of the addition of Trogarzo to the HHS Guidelines.  Pursuant to PCN 18-01, for premium assistance to be allowable, the coverage obtained must include “…at least one U.S. Food and Drug Administration (FDA) approved medicine in each drug class of core antiretroviral medicines outlined in the [HHS] Clinical Guidelines for the Treatment of HIV…”  These guidelines include the HHS Guidelines for the Use of Antiretroviral Agents to which Trogarzo has been added.  See https://aidsinfo.nih.gov/guidelines.

The second letter, dated October 19, 2018, encourages messaging on the importance of viral suppression in preventing the spread of HIV/AIDS.

2019 RSR Updates (83 Fed. Reg. 54,363):

Finally, HAB is updating the RSR to require more robust information regarding services funded with program income and ADAP rebates for 2019 (RSR to be submitted in March 2020).  See https://www.gpo.gov/fdsys/pkg/FR-2018-10-29/pdf/2018-23547.pdf.

One important impact of these changes to the RSR may be enhanced oversight of subrecipient’s uses of program income by “prime” recipients (e.g., states and municipalities) in jurisdictions where such oversight has historically been less robust.  Subgrantees are reporting anecdotally that prime recipients are asking for more detailed accounting of how RWHAP program income is being tracked and spent.

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Feldesman Tucker Leifer Fidell LLP is proud to represent RWHAP recipients and other Ryan White stakeholders in its nationwide practice.  FTLF provides grants management and 340B program expertise to its RWHAP clients, and offers intensive trainings on program income and 340B program compliance.  Please contact Scott Sheffler (ssheffler@feldesman.com) or the FTLF attorney with whom you regularly work with any questions.