Florida to enact health care legislation to improve access to ARV therapy

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Apr 15 2010

Florida is poised to enact health care legislation that would add clarity to existing state statutes by requiring that all state-regulated health plans include lifesaving antiretroviral (ARV) HIV/AIDS drugs on their drug formularies or preferred drug lists.

The bills, House Bill 591 by Representative Yolly Roberson (D-North Miami Beach) and SB 1132 by Senator Eleanor Sobel (D-Hallandale Beach), were introduced at the request of AIDS Healthcare Foundation (AHF), which serves more than 15,000 Floridians living with HIV/AIDS through a variety of programs, including free HIV testing and prevention programs; HIV/AIDS health care centers located in Ft. Lauderdale, Miami and Jacksonville, eight AHF Pharmacies located throughout the state, a statewide disease management program; and its Positive Healthcare Managed Care program;. HB 591, which amends the Florida Insurance Code, has cleared the Health Care Regulation Committee of the Florida House of Representatives and in so doing sent a strong message to insurers that delay tactics limiting patient access to medications will not be tolerated.

“HB 591 and SB 1132 represent a prudent public health measure that will protect Florida patients by ensuring access to lifesaving HIV/AIDS drugs as prescribed by their doctor or medical provider”

"HB 591 and SB 1132 represent a prudent public health measure that will protect Florida patients by ensuring access to lifesaving HIV/AIDS drugs as prescribed by their doctor or medical provider," said Michael Kahane, Bureau Chief, Southern Region for AIDS Healthcare Foundation. "The bill will level the playing field among all health insurance providers and health plans operating in Florida by clarifying existing state statute to specifically mandate that all state-regulated health plans operating in Florida include antiretroviral drugs on their drug formulary or preferred drug list. HB 591 prohibits health plans from restricting access to ARVs by requiring prior authorization, step therapy, or instituting any other limitation that would limit patient access. Medicaid health plans, private health insurance plans and health maintenance organizations all will be required to comply with the provisions of this bill. The patient's doctor will be able to make the decision on what medications are appropriate instead of an insurance company - which is the way it should be."

Need for the Legislation

AHF, which treats thousands of patients at its healthcare centers in Florida, Washington, DC and California, first proposed the legislation to Representative Roberson after some Florida HIV/AIDS patients with private insurance encountered difficulties accessing the lifesaving ARVs their medical providers had prescribed. The patients encountered situations where a health plan's formulary may include some, but not all FDA-approved ARVs; where the plan limits the number of ARVs that will be reimbursed (for example: the physician has ordered a regimen that consists of five ARVs, but the plan indicates it will only cover four); and at least one plan that has no ARVs on its formulary whatsoever.

AHF and its patients found that some insurers and health plans in Florida cover the medications without delay. However, some make routine practice of denying claims, or requiring lengthy procedures to authorize payment for—or access to—ARVs, practices that have often resulted in multiple week delays for patients to obtain the needed medications.

"To date, AHF medical providers have successfully reversed every denial of coverage, suggesting that this industry practice of denial is not an issue of inappropriate utilization or prescribing practices by physicians, but is a matter of purposeful delay that is intended, we believe, to avoid paying for crucial lifesaving services that these patients have contracted and paid for through the purchase of their insurance coverage," said Rebecca Colon, Medical Director of AHF NorthPoint Healthcare Center in Ft. Lauderdale. "The claims that are being delayed result in breaks in treatment that can be life-threatening to the patient. When a patient receives an ARV different from what is prescribed, or has a multi-week delay in starting or changing a specific treatment regimen, the patient is at risk of developing resistance to the prescribed ARVs that can result in the need for a different, more complex regimen in order to be effective. Frequently, these newer drugs are more costly, so the delaying tactic is ultimately short sighted. The delay in receiving the proper treatment also results in a public health concern as the virus is more likely to be transmitted when a person is not taking proper medications."

"We provided Representative Roberson and the Health Care Subcommittee with examples of eleven patients who utilized four different health plans where ARVs were denied, later approved, or approved with limitations," added AHF's Kahane. "Interestingly, it was oftentimes the health plans of patients with private insurance that placed far greater restrictions on a patient's access to the lifesaving medications their doctors prescribed than those patients cared for by Medicaid providers, who are required by existing statute to offer ARVs without prior authorization. Our recommendation is to put the requirement in plain language in the statute applicable to both pre-paid and fee-for-service providers, which this bill will do. We thank Representative Roberson and Senator Sobel for their leadership authoring and carrying these bills."

Florida House of Representatives Staff Analysis of HB 591

An analysis of the issue and proposed legislation done by Florida House of Representatives' staff noted the following:

ARV therapy, on average, costs $2700 - $3300/month. Thus, a patient that chooses to pay out-of-pocket versus fight with a plan for reimbursement could be required to pay approximately that amount. The more likely outcome, however, is that treatment is delayed or entirely missed.
Because the effect of the proposed bill is to conform the practices of the commercial plans to the policies already implemented by Florida Medicaid and the Centers for Medicare and Medicaid Services with respect to patients receiving care through Medicare, we believe the bill will directly affect the services available to an estimated 25,000 patients with a diagnosis of HIV/AIDS.
In addition, timely access to the correct ARV regimen reduces the likelihood the patient will develop a drug resistance that results in the need for newer and often more expensive ARVs. Equally important is the reduced cost to Florida's public health system if HIV infected patients are properly managed and receive appropriate ARVs, thereby reducing the opportunity for them to transmit the virus to others. Lifetime treatment costs for a patient with HIV are approximately $600,000.

HB 591 will codify changes that prohibit health plans from restricting access to ARVs by requiring prior authorization, step therapy, or any other limitation that limits access. The five specific state statutes the bill will amend and clarify include: