With open enrollment ending in less than two months, federal rules remain unclear, leaving patients, advocates and drug programs in limbo. They’re concerned about how recent guidance recommending that third parties refrain from making payments to help patients with cost sharing or premiums may affect these programs.聽

In addition, they’d like a clearer assurance that the programs are not in violation of the federal anti-kickback statute. In 2005, the Department of Health and Human Services’ that such financial assistance offered to Medicare patients violated that statute, which prohibits businesses that receive federal health program reimbursements from offering something of value, in this case a subsidy, to induce beneficiaries to use their products.

“Drug manufacturers are commercial entities, and the FAQ states that we聽诲颈蝉肠辞耻谤补驳别听issuers from accepting premium payments and cost-sharing obligations on behalf of a [qualified health plan] enrollee,” said an official from HHS’ Centers for Medicare & Medicaid Services in an email. The official said that many insurance companies already have policies prohibiting the acceptance of cost-sharing payments from anyone other than the enrollee or a family member.

Drug manufacturers have been criticized for cost-sharing assistance programs that encourage patients to use a brand-name drug when a cheaper generic alternative is available. Even though consumers may get the drugs at a discounted price, insurers are left paying the expensive tab for their share of the cost.

But for many patients there are no generic alternatives for critical drugs to treat medical conditions such as rheumatoid arthritis, cancer or multiple sclerosis. In the case of multiple sclerosis, for example, at least 10 disease-modifying therapies cost between $40,000 and $60,000 annually, says Nancy Law, executive vice president of programs and services at the National Multiple Sclerosis Society.

Such drugs are typically and may require patients to pay coinsurance of as much as 50 percent rather than the flat copayments that are charged for less costly drugs. Even with good insurance, many patients can’t afford the medicine without financial help.

“What we find is that people can’t afford their high deductibles or copays,” says Law.

Advocates for patients with serious illnesses聽who are anxiously awaiting word from HHS were reassured when, in a , D-Wash., HHS Secretary Kathleen Sebelius said that exchange plans weren’t considered federal health care programs. Many took that to mean that the聽plans aren’t subject to anti-kickback rules. But a few weeks later, the raised concerns again with its discussion about discouraging cost sharing assistance. In December, the , an advocacy group for people with chronic diseases, sent a seeking clarification.

The group is still waiting for answers. “We’re having a hard time getting their attention on this,” says Marc Boutin, executive vice president at NHC.

More From This Series Insuring Your Health

In the absence of clear guidance, some drug companies have decided to provide cost-sharing assistance to people in marketplace plans while others are holding off, say experts. “Most companies are relying on the advice of their general counsel, and my sense is that that has been mixed,” says Caroline Pearson, vice president at Avalere Health, a research and consulting company with expertise in pharmaceutical firms.

In the case of Medicare, independent charitable organizations have stepped in to offer a workaround that enables many older patients to get the drugs they need. Such organizations聽are permitted to act as go-betweens. They solicit money from drug companies for specific diseases and provide financial assistance to needy patients to cover drug and other medical costs.聽

Alyce Yout, 69, has , an inherited condition that causes low levels of a protective protein in the blood, which results in damaged tissues, especially in the lungs. Weekly infusions of , a blood plasma product, help slow the progression of the disease. But without financial assistance from a nonprofit called ., Yout, who lives in Rockland, Mass., and whose income is less than $30,000 annually, says she would be unable to afford the through her Medicare Part D drug plan.

“It’s life-or-death important that they be in place for me,” she says.

If drug companies aren’t permitted to provide direct assistance to people in marketplace plans, presumably the nonprofits could step into the breach as they do with Medicare patients, say experts.

The charitable groups aren’t a perfect solution, however. The , for example, provides cost-sharing assistance of up to $10,000 annually to help cover medication costs, primarily, for patients who have one of more than 50 diseases. But at times some of the designated disease funds don’t have sufficient money to meet demand, says Patrick McKercher, the foundation’s president.

“Sometimes [the nonprofits] have money for MS drugs and sometimes they don’t,” says Law. “It can be frustrating to figure out where to tell people to go.”

Even so, if HHS says drug companies can’t provide direct help to patients, McKercher says nonprofit organizations will respond quickly to solicit additional funds for exchange patients. “We’d be in there, knocking on doors, as an immediate effect of that,” he says. “We can do it tomorrow.”

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