July 29, 2018

State officials awarded a contract to CVS last year that allowed the national pharmacy company not only to control federal money for HIV drugs in Ohio, but also to require patients to buy their medicine only at CVS pharmacies.

Critics say that the contract arranged by the administration of Gov. John Kasich does not make the $8.1 million worth of drugs as widely available as they would be in an open pharmacy network that went beyond CVS. Nor is it the best way to ensure that HIV patients take their potentially life-saving drugs as they should, they say.

These questions come amid others about whether CVS is benefiting from outsized profits on billions of dollars of business it does with another state agency — the Ohio Department of Medicaid. State legislators, the state auditor and attorney general all are probing that setup.

CVS Caremark also took charge of a mailing to patients last year that potentially exposed their HIV-positive status to the public. But CVS Caremark wasn't supposed to be handling that mailing, according to the state's request-for-proposals that resulted in CVS getting the contract for the HIV assistance program.

The Ryan White HIV/AIDS Program provides 6,500 needy, HIV-positive Ohioans with drugs that allow them to live near-normal lives despite carrying an otherwise-fatal virus. The drugs are free for patients who qualify for the state to serve as the "payer of last resort."

The Ohio Department of Health would not answer several questions because of pending lawsuits, including whether anyone other than CVS — with its large retail and mail-order operations — could have even offered a closed network of the kind for which the state expressed a preference going into the process.

A local HIV clinic raised concerns last year as state officials were looking for a pharmacy benefit manager (PBM) to administer federal money meant to pay for HIV drugs. The clinic, Equitas Health, said the benefit manager should make the money available to an open network of pharmacies, and that it was worried "about the potential for the PBM to monopolize the program."

The Ohio Department of Administrative Services replied that "the program does not anticipate an open network."

It proceeded to give the business to CVS over the only other company that bid, Oakland, California-based Ramsell Corp., which didn't respond to a request for comment.

CVS has perhaps the only pharmacy benefit manager in the country that could require that all the money in the program be spent at its own mail-order and storefront pharmacies, which it did. A letter the health department sent to participants in the Ohio Drug Assistance Program said, “CVS Caremark will provide ALL of the medications covered on the formulary.”

The arrangement left some outsiders perplexed. Why, if the goal was to make HIV drugs as widely available as possible to eligible Ohioans, would the network be restricted to CVS mail-order and storefront pharmacies?

Kasich administration officials wouldn't answer that question.

CVS spokesman Michael DeAngelis said in an email that as the nation's No. 1 retail chain, CVS provides program participants "with broad access to prescribed medication and pharmacy services through both a mail-order option for prescription home delivery and the ability for a member to receive their prescription at approximately 400 CVS Pharmacy locations throughout Ohio."

But that still excludes a good number of pharmacies, one critic said.

"If a person lived next door to a Walgreens, and CVS was 3 miles away, you'd be making people walk past their next-door neighbor to get their drugs," said Terry Kilgore, an attorney who is himself HIV positive. He also is handling a lawsuit over CVS's mailing, through a subcontractor, of prescription cards for the Ohio Drug Assistance Program.

In its proposal to the state, CVS argued that if patients were kept within its pharmacy network, the company would bring superior resources to ensure compliance — making sure that patients take their drugs as prescribed, thus driving down their viral loads as far as possible.

"Limiting the number of providers within a pharmacy network is an important way to improve oversight of patient care and control costs. Our exclusive specialty network does just that and maintains access, convenience and outcomes for members," the company said in the proposal it submitted to the Ohio Department of Administrative Services, which handles procurement and contracting for many state agencies.

DeAngelis said CVS has a team of specially trained pharmacists and nurses working on the program, and it offers technical features such as "digital adherence messaging for HIV patients."

However, that limited network excludes some HIV/AIDS specialty clinics that offer "wraparound" services such as medical and dental care, mental-health counseling, pharmacy and other support.

"This absolutely breaks the continuum of care just like for the oncology patients and, really, any 'specialty' drug," Scott Knoer, chief pharmacy director for the Cleveland Clinic, said in an email.

>>Don't miss our Reddit AMA from July 17, 2018 with reporters Marty Schladen, Cathy Candisky and Lucas Sullivan about the Side Effects series and the rising cost of prescription drugs.  Find it here

The Dispatch reported in June that CVS and other pharmacy benefit managers were forcing some oncology patients to use the PBMs' own mail-order pharmacies to get their expensive cancer drugs. Some patients complained of delays and other problems getting their medicine — and that they'd much prefer to get their drugs in clinics where their doctors and other health professionals are located.

HIV drugs also are expensive — typically costing $3,500 to $4,500 a month. And the operators of nonprofit Equitas Health say they've had great success administering those drugs in the context of their other services.

“Our viral-supression rate is approaching 90 percent for our HIV-positive patients," said Equitas President and CEO William J. Hardy. "That is almost twice the national rate, which is 49 percent. We know that is in part because of our patient-centered, medical-home model and the fact that they can leave their physician or nurse and walk down the hall or go down the stairs and see the pharmacist, get their medications, access medication-support programs and do consultations. We think that’s a critical component of our model.”

The state health department says its rate has ranged from 85 to 89 percent from 2014 to 2017.

Equitas' chief pharmacy officer Aaron Clark said that when patients first receive specialty medications at Equitas, they meet in a private room with a pharmacist for 15 to 30 minutes. Then there are follow-ups at a minimum of once every three months. The goal is "viral suppression" — driving HIV levels so low that they're undetectable by standard tests.

"Undetectable means untransmissable," Hardy said.

It also means there's not enough of the HIV virus to kill off enough CD4 cells to leave the body vulnerable to opportunistic diseases that can kill AIDS sufferers.

The request-for-proposals that the Department of Administrative Services issued in February said that whoever got the contract to become the pharmacy benefit manager to the drug-assistance program "shall send prescription cards to (the Department of Health), who will then forward to clients via US mail services."

Somehow, though, CVS came to be in charge of the process and hired a subcontractor. That company last year sent out more than 6,000 letters to participants with the letters "HIV" clearly visible above the addressees' names.

CVS and the state are now being sued on claims that both of them unlawfully disclosed private health information.

The health department has yet to respond to a July 3 open-records request seeking communications among its staff and with CVS regarding the decision to allow the company to handle the mailing. It was asked Monday why the state's own request-for-proposal wasn't followed — in other words, why the health department didn't handle the mailing itself, as it said it would.

That question also wasn't answered.