Combine With Medicare Part D to Help Patients Afford Prescriptions

According to the 2003 U.S. Census, 29 million people in the United States make less than 200% of the federal poverty level and have no health insurance. Many persons have difficulty affording prescribed medications. In addition to Medicare Part D, there are more than 350 public and private patient assistance programs, including programs by pharmaceutical companies, that help patients pay for prescriptions.

Impact of Medicare Part D

Medicare Part D’s introduction caused much confusion about patient assistance programs and Medicare beneficiaries. On April 18, 2006, the Department of Health and Human Services Inspector General announced that drug manufacturers can continue providing free medication to low income Medicare beneficiaries even if the beneficiaries are enrolled in Part D. This opinion was a reversal of a November 2005 opinion from the Inspector General, stating that such programs may be illegal and causing many pharmaceutical companies to announce that their patient assistance programs would not be available to any Medicare patients—whether they were enrolled in Part D or not. As of April 2006, drug manufacturers can legally provide assistance to low income Part D enrollees if they follow two rules: They cannot seek payment for free drugs provided and they must ensure that the assistance is based solely on financial need, using a methodology that does not take into account an enrollee’s choice of drug plan.

There are two types of patient assistance programs, PAP (A) and PAP (B). To qualify for the PAP (A) the patient must not have any other means of assistance; be taking a drug from the PAP (A) coverage list; and show financial need by having an income less than 325% of the federal poverty level and—if enrolled in a Medicare Part D plan—having already spent 3% of their income on outpatient prescription drugs in that year. PAP (B) has similar qualification guidelines, but an income threshold of 250% of the federal poverty level.

The Centers for Medicare & Medicaid Services (CMS) has posted updated information on its policy with respect to PAPs—including CMS’ Coordination of Benefits guidance, PAP Data Sharing Agreement documents, an Outside the Benefit Q&A, and the PAP Attestation document (www.cms.hhs.gov/PrescriptionDrugCovGenIn/07_PAPData.asp). CMS plans to update these resources regularly.

The recent opinion did make it clear that any medicine provided by PAPs cannot count toward the $3,600 out-of-pocket expense that a Medicare enrollee must spend to get to the other side of the “donut hole,” during which they must pay 100% of drug costs. At press time, several pharmaceutical companies had agreed to continue their patient assistance programs in some form for Medicare patients; these include Eli Lily, AstraZeneca, Johnson & Johnson, GlaxoSmithKline, Merck, Procter & Gamble, Novartis, and Schering-Plough. At present, Amgen and Centocor do not have programs for Medicare patients. The site www.rxassist.org has a list of assistance programs and a section for physicians on patient assistance program eligibility criteria and Medicare Part D.

Patient Assistance Programs

The Web site www.needymeds.com compiles applications for medication assistance programs. Another helpful Web site is www.healthassistancepartnership.org, which contains a variety of information and contacts for assistance. The pharmaceutical industry sponsors www.phrma.org, which gives information and interactive patient applications.

Many of the programs have eligibility requirements and online applications. Each drug program has specific eligibility criteria. The medication will be sent either to the physician’s office or directly to the patient’s home, and refill requirements vary from plan to plan. Some plans automatically refill prescriptions, with the requirements of filling out a new application only once a year; other plans require a new application every 90 days; and still other plans require a new application every month with each refill.

With hundreds of programs and many needy patients, it can be time-consuming to enroll patients in PAP programs—especially if a patient needs more than one medication. In Kearney, Neb., Sentinel Healthcare of Kearney created an assistance program to help local physicians and their staff enroll patients. It began in July 2002 and currently serves 2,500 patients; last fiscal year the program assisted patients in receiving more than $3 million of medications. The program is run by a staff supervisor and four assistants; staff salaries are paid by administration fees from PHO contracts. Other programs have a small co-pay for each medication applied for, to fund a staff position to help process applications. The site www.rxassist.org contains many other examples of programs and advice on starting a program in your community.

The ACR and the Regional Advisory Council actively monitor this issue. If you have questions or comments, please contact the ACR’s coding and reimbursement specialists, Resaee Freeman, CPC, or Melesia R. Collins, CPC, at (404) 633-3777.

Dr. Blakely is a rheumatologist at Kearney Arthritis Institute in Kearney, Neb., and Melesia Collins is an ACR coding specialist.