New DFS Guidance to Insurance Companies Follows Complaints That Some Insurers May Be Imposing Unreasonable Barriers to Access PrEP - Circular Letter Here

On World AIDS Day, Governor Andrew M. Cuomo today announced the number of people newly diagnosed with HIV in New York State has fallen to historic lows, with the number of new cases of HIV dropping nine percent from 2015 to 2016. In order to help prevent future infections, the Department of Financial Services is also taking action to ensure that insurance coverage for pre-exposure prophylaxis (PrEP), a prescription drug used for the prevention of HIV infection, is available to all covered New Yorkers and that insurance companies cannot deny coverage of PrEP for discriminatory reasons. The guidance follows consumer complaints that some insurers may be imposing unreasonable barriers to access PrEP. Together, these announcements demonstrate the historic success of New York's efforts to End the Epidemic and establish New York as the national leader in the fight against HIV.

"Once the epicenter of the HIV/AIDS crisis, we have made tremendous progress toward mitigating the impact of the disease in New York, and we will continue to do everything in our power to save lives, reduce transmissions and forge a path toward eliminating HIV/AIDS for the rest of the world to follow," Governor Cuomo said. "Thanks to our aggressive public health initiatives that attack the disease from all angles, we are on track to meet our nation-leading goals and end the epidemic."

Commissioner of Health Dr. Howard Zucker said, "Under Governor Cuomo's leadership, New York is experiencing dramatic declines in HIV, which once destroyed so many lives. The decrease in infections demonstrates the power of public health and enables us to dream of a day when we no longer live with the threat of HIV infection."

Financial Services Superintendent Maria T. Vullo said, "Insurers cannot choose to impose harsher restrictions on access to a medication based on discriminatory reasons. There is absolutely no legal justification for denying coverage for PrEP on the ground that the patient is at risk for HIV based on his or her sexual orientation. DFS will not tolerate discrimination in the prescribing or coverage of medically necessary treatments."

In 2016, there were 2,881 new HIV diagnoses in New York State, a nine percent decrease from 2015's 3,163 diagnoses. The decrease is more than double that of the five years leading up to New York's 2014 Ending the Epidemic initiative, when decreases averaged less than four percent annually.

Groups disproportionately impacted by HIV all experienced decreases in new infections as well. New diagnoses among gay, bisexual, and other men who have sex with men fell 12 percent between 2015 and 2016 (1,804 to 1,580), the second straight annual decrease after virtually no change in over a decade. New diagnoses decreased in every age group, with the largest decline, 20 percent, among young people aged 20-24 (505 to 406). HIV in communities of color is down significantly as well. Decreases occurred among white, non-Hispanics (11 percent), black non-Hispanics (7 percent), Hispanics (11 percent), and persons with multi-racial backgrounds (23 percent).

In order to prevent new HIV infections in the future and continue New York's trend towards Ending the Epidemic, DFS today issued guidance to insurers to remove unacceptable barriers to coverage for PrEP and ensure that insurance coverage for PrEP is available to all New Yorkers. The guidelines make clear that insurance companies cannot discriminate against those requesting PrEP based on lifestyle or behavior. Health service providers generally prescribe PrEP, which has been shown to be highly effective in stopping HIV infection when taken as prescribed, for HIV-negative people who are at high risk for HIV.

In the guidance issued today, DFS notes that, when imposing prior authorization requirements on PrEP, insurers must carefully consider whether any such requirement would create an unacceptable barrier to coverage for individuals who would otherwise benefit from the medication. Similarly, when performing prior authorization, concurrent or retrospective utilization review for PrEP, insurers and their utilization review agents must comply with the requirement of New York Insurance Law to use appropriate written clinical review criteria when reviewing for medical necessity. In addition, when making coverage determinations, insurers and their utilization review agents must do so in a non-discriminatory manner.

In the event that an insurer denies coverage for PrEP and deems that it is not medically necessary for a particular individual, the insured has the right to appeal. Any denials of coverage must include information set forth in New York Insurance Law, including the reason and clinical rationale for the denial; instructions on how the insured can appeal the decision; and any additional information necessary to render a decision on the appeal.

A copy of the circular letter can be found here.

Charles King, President and CEO of Housing Works, Inc. "The data clearly shows we are headed in the right direction. Now is the time for all of us to double down on our efforts so that we can realize an end to the epidemic in NYS by the end of 2020."

Guillermo Chacón, President, Latino Commission on AIDS & Founder of the Hispanic Health Network, said, "As we come together to recognize World AIDS Day 2017, more than ever we underline the importance of community/ government/private partnerships to join efforts to end the AIDS epidemic. The road to ending the epidemic must address the social determinants of health, stigma/discrimination as a critical way to reach health equity. The urgent challenge is to ensure those communities most impacted, most vulnerable and affected by HIV such as young gay and bisexual men and other men who have sex with men (MSM) of color, women of color, transgender and gender non-conforming communities and persons who use drugs are part of designing new innovative strategies to reach our common goal of ending the AIDS epidemic by the end of 2020."

C. Virginia Fields, President and CEO, National Black Leadership Commission on AIDS, said, "Today, World AIDS Day 2017, there is much to commemorate as tremendous accomplishments have been made in advancing prevention, treatment and care. We must continue to build upon these successes through continued programming and research efforts so that we can someday, and someday soon, find a cure."

Today's announcements build on Governor Cuomo's 2014 plan to significantly reduce HIV infections by the end of 2020 and achieve the first-ever decrease in HIV prevalence. The current, record-low number of new HIV diagnoses represents a 16 percent decrease from the 3,448 new HIV diagnoses in that year. The plan includes:

• Identifying persons with HIV who remain undiagnosed and linking them to health care;
• Linking and retaining persons diagnosed with HIV to health care and getting them on anti-HIV therapy to maximize HIV virus suppression;
• And providing access to Pre-Exposure Prophylaxis (PrEP) for high-risk persons to keep them HIV negative.

Since the 2014 announcement, New York has committed more than $20 million in additional funding to policies and programs in the New York State Department of Health, designed to meet Ending the Epidemic goals. These include streamlining HIV testing; facilitating access to syringe exchange; enabling minors to consent for HIV prevention and care services; expanding data sharing to enhance linkage to care; and expanding access to affordable housing for persons with HIV.

New York now leads the nation as the state with the largest number of at-risk individuals on PrEP, thanks to new program initiatives that expanded access to both PrEP and post-exposure prophylaxis (PEP). Prescriptions for PrEP have increased fourfold among people enrolled in Medicaid, while the number of uninsured persons accessing services through the PrEP Assistance Program (PrEP-AP) has risen 600 percent in the last 18 months.

New York has also significantly improved viral suppression among Medicaid recipients. By matching Medicaid data with surveillance data, New York identified more than 6,000 individuals with unsuppressed viral loads. Medicaid managed care plans have linked many of these individuals to care, which has resulted in more than 40 percent of them achieving viral suppression.

New initiatives being launched will set a goal of zero AIDS mortality and zero HIV transmission through injection drug use by the end of 2020.

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