Reimbursement FAQs: IVIG Access, Specialty Tiers, Drug Shortages and More

The rising cost of healthcare continues to be a hot-button issue for the healthcare industry and patient advocacy groups. Chronic diseases, in particular, appear to be targets for cost-saving measures. As a result, several groups are focusing their advocacy efforts on reimbursement issues that they believe threaten patients’ access to care. Following is a summary of some of these issues and the viewpoints of key opinion leaders.

Medicare IVIG Access Act

The current Medicare Part B reimbursement methodology does not allow equal access to care in all settings. In the case of intravenous immune globulin (IVIG), Medicare Part B pays for the drug only for patients with primary immunodeficiency diseases (PIDD). In addition, Medicare Part B does not reimburse for the supplies, nursing or infusion pump unless the patient is certified homebound.

The American Academy of Allergy, Asthma and Immunology (www.aaaai.org), the Clinical Immunology Society (www.clinimmsoc.org/educational-resources/ivig/medicare-ivig-access-act-summary) and the Immune Deficiency Foundation (primaryimmune.org/idf-advocacy-center/ivig-reimbursement) support and advocate for legislation currently under consideration. House Bill 1845 and Senate Bill 960 direct that a three-year demonstration project be conducted to study the benefits of providing coverage and payment for items and services necessary to administer IVIG in the home.

Drug Reimbursement Under the CMS OPPS

The Centers for Medicare and Medicaid Services (CMS) has proposed to set the payment level of separately payable non-pass-through drugs and biologicals at the average sales price (ASP) plus 4 percent, which is less than the current outpatient prospective payment system (OPPS) level of ASP plus 5 percent.

The Plasma Protein Therapeutic Association (PPTA) (www.pptaglobal.org/ news/news.aspx?nid=90) believes the payment rate should be no less than ASP plus 6 percent to help ensure that hospital outpatient departments remain a viable option for beneficiaries to receive therapies such as alpha-1 proteinase inhibitor, blood clotting factors and IVIG. “PPTA has long advocated for parity between the statutory physician office rate of ASP plus 6 and the OPPS rate,” said Julie Birkofer, senior vice president, North America, PPTA. “This inequality between sites of service has been problematic in the past for patient access to plasma protein therapies.”

The PPTA also commented on the use of the 340B Drug Pricing Program, which limits the cost of covered outpatient drugs to certain federal grantees, federally qualified health center lookalikes and qualified hospitals, when determining ASP pricing. The number of 340B hospital sites has more than doubled in three years, from 2,213 enrolled in the fourth quarter of 2008 to 4,427 enrolled today. According to the PPTA, this growth of the 340B program will exacerbate the flawed nature of the agency’s rate-setting calculation.

Although PPTA advocates for removing 340B sales from the CMS rate-setting calculation, it cautioned against establishing two payment rates — one for 340B hospitals and one for non-340B hospitals. “Reducing Medicare payments to 340B hospitals [through a separate payment rate] for separately paid drugs would undermine the purpose of the 340B program to reach more eligible patients and provide more comprehensive services,” said Birkofer.

The Affordable Care Act

Many sources continue to fund political action committees representing the special interests of patient advocacy groups and medical associations. All are concerned that changes in policy could impact reimbursement, which could have a negative impact on patient care.

The American Academy of Neurology (AAN) (www.aan.com/advocacy/issues/?event=home.showIssue&id=29) and the AAN Professional Academy support legislation to replace the current CMS formula based on the Sustainable Growth Rate (SGR) with one based on the Medical Economic Index, which measures annual practice cost increases. Paying physicians according to the actual costs associated with treating patients is necessary to maintain consistent access to providers. Additionally, they would like to see neurologists recognized as “principal care providers” for patients with complex neurological conditions.

The National Hemophilia Foundation (NHF) (www.hemophilia.org/NHFWeb/MainPgs/MainNHF.aspx?menuid=333& contentid=1350&rptname=advocacy) remains committed to making sure the gains that patients made under the Affordable Care Act remain intact. Although NHF has not endorsed any specific legislative proposal, its public policy team is working to shape the policies that most affect the bleeding disorders community. Specifically, it is working to ensure that health reform legislation recognizes the specialized needs of individuals with rare diseases and includes:

• private market insurance reforms, including the elimination of lifetime caps and pre-existing conditions clauses;
• provisions to ensure the affordability of insurance coverage such as limits on out-of-pocket costs; and
• access to specialists and the full range of therapies.

Specialty Tiers

Several advocacy groups support the growing popularity for state legislation to limit the use of specialty drug tiers. Instead of paying a fixed copayment, specialty tiers require patients to pay as much as a 33 percent coinsurance. The concern is that the increased use of specialty tiers will result in unaffordable out-of-pocket expenses for patients with chronic diseases. Therefore, advocacy groups would like to see limits in place to cap the out-of-pocket liability patients must pay for their medications.

According to Dominick Spatafora, president of the Neuropathy Action Foundation (www.neuropathyaction.org) and member of the Alliance for BioTherapeutics (www.bioalliance.org), “The specialty tier formulary simply makes treatment for these costly yet life-saving and life-enhancing therapeutics unaffordable for most patients.” Tina Tockarshewsky, president and CEO of the Neuropathy Association, adds that “patients shouldn’t fear for their lives or their livelihoods because a life-sustaining treatment is being taken away.”

The Alliance for Biotherapeutics is particularly concerned that specialty tiers are limiting affordable access for patients with chronic diseases. Abbie Cornett, president and chair of the Alliance for BioTherapeutics and Nebraska state senator, said: “The Alliance is actively pursuing state legislation to address these very serious issues. We are working closely with patient and industry allies to find solutions at the state and federal level.”

Drug Shortages

Drug shortages compromise care and safety, disrupt medical trials and increase the cost of healthcare. Unless a manufacturer is the sole source provider of a drug, no current law exists that allows the U.S. Food and Drug Administration (FDA) to require mandatory reporting of impending shortages. In response to concerns, H.R. 2245, titled Preserving Access to Life-Saving Medications Act of 2011, was introduced. If passed, it would give the FDA authority to impose civil monetary penalties if a manufacturer fails to give notice of a discontinuation or disruption of a drug that results in a drug shortage.

TheAmerican Society of Health-Systems Pharmacists (ASHP) (www.ashp.org /menu/AboutUs/ForPress/PressReleases/PressRelease.aspx?id=643) supports H.R. 2245. “The rapid increase in the number of drug shortages in recent years is akin to a public health crisis and is the cause of serious patient harm,” said ASHP President Stan Kent, MS, FASHP. “We are pleased to see that Congress is working to address this critical issue and will advocate strongly for its passage.”

Editor’s Note: The content of this column is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.