PSI Letter to Secretary Sebelius About Patient Assistance Programs

On January 31, 2014 Patient Services Incorporated, (PSI) sent the below letter to Secretary Sebelius to highlight the importance of patient assistance programs for families and to urge the department to refine its message about premium assistance taking into account the numerous assistance models.
Dear Secretary Sebelius:
I would like to first take this opportunity to thank you for all your work to implement the Affordable Care Act (Public Law 111-148). Extending health coverage for people with chronic, catastrophic and rare illnesses and conditions is very important to my organization. For the last 25 years, Patient Services Incorporated, (PSI), the organization that I founded, has worked to fill the gaps in health coverage by providing financial assistance programs that enable patients to maintain their lives despite having an expensive or chronic medical condition. I believe that the work of PSI is consistent with the goals of the Affordable Care Act, and look forward to expanding our work to patients needing assistance in new Exchange plans.
Therefore, I am contacting you to request clarification of comments posted on the U.S. Department of Health and Human Services (HHS) website from a November 4th, 2013, Question and Answer (Q&A) document regarding third party payors who make premium payments to health insurers for qualified plans on behalf of enrollees. As I will explain below, the requested clarification would simply extend an existing OIG opinion to patient assistance programs that help patients in the new Exchanges, thereby eliminating confusion among patients and payors.
PSI is a national nonprofit organization that works with patients who have expensive, chronic and rare illnesses. The PSI model utilizes private donations to subsidize health insurance premiums, copayments for pharmaceuticals and treatments, and coinsurance and expenses associated with Medicare Part B and Part D. We provide these services under guidance of our OIG Advisory Opinion 02-01, and in accordance with the Federal Register/Vol. 70, No. 224/ November 22, 2005 Notice for PAPs. PSI is entering its 25th year and currently provides financial assistance to approximately 17,000 Americans annually in all 50 states and territories. In 1996, I originated the copayment foundation model for patient assistance in the United States. The industry has grown to include 8 other organizations and helps hundreds of thousands of patients obtain the treatments and therapies they need to live and to maintain their quality of life. Any disruption in that model could have dire consequences for the lives of patients across the United States.
In order to maintain high ethical standards I approached the Office of Inspector General (OIG) at the Department of Health and Human Services in 2002, and worked with them to obtain a positive OIG Advisory opinion 02-01. Opinion 02-01 analyzed whether grants provided by a non-profit, charitable organization to financially needy Medicare beneficiaries in order to subsidize their costs of medical care would be grounds for the imposition of sanctions under section 1128A(a)(5) of the Social Security Act or under the exclusion authority at section 1128(b)(7) of the Act or the civil monetary penalty provision at section 1128A(a)(7) of the Act. In conclusion, the opinion determined that sanctions would not be imposed and explicitly provided for a framework for an independent charity model consistent with the model followed by PSI prior to issuance of the OIG opinion-the same model that PSI continues to follow today. Parameters of the independent charity model include:
• Insulating beneficiary decision-making from information attributing the funding of their benefit by any donor;
• A variety of sources refer patients to the program, many of which are not affiliated with any donor that contributes;
• Eligibility for financial assistance is available by any financially qualified patient suffering from the specific chronic illnesses or diseases targeted by the program, regardless of the particular physician, provider, supplier or drug the patient may use;
• All patients have selected their health care providers freely based on their best medical interests;
• Program information is reported to donors on an aggregate basis only within specific disease categories.
This was the first opinion issued to a copayment foundation and set up the “bona fide independent charity PAP arrangement.” This has been the standard that other foundations have since followed. Opinion 02-01 was used as a basis for the Special Advisory Bulletin issued to the OIG in November 2005 titled, Patient Assistance Programs for Medicare Part D Enrollees. PSI has strived to develop our patient assistance program with the strongest ethical guidelines and relied on this guidance in our work assisting Medicare Part D patients with patient assistance.
The mission of PSI has been to assist as many patients as possible to access their treatments and therapies. PSI applauds the Affordable Care Act and its extension of coverage as we will be able to assist many more patients. However, we at PSI are very concerned about potentially conflicting information released by HHS in the November 4th, Q&A Document, specifically the comments provided when asked if third party payers can make premium payments to health insurance issuers for qualified health plans on behalf of enrolled individuals?
The Department of Health and Human Services (HHS) has broad authority to regulate the Federal and State Marketplaces (e.g. section 1321(a) of the Affordable Care Act). It has been suggested that hospitals, other healthcare providers and other commercial entities may be considering supporting premium payments and cost-sharing obligations with respect of qualified health plans purchased by patients in the Marketplaces. HHS has significant concerns with the practice because it could skew the insurance risk pool and create an unlevel field in the Marketplaces. HHS discourages this practice and encourages issuers to reject third party payments. HHS intends to monitor this practice and to take appropriate action if necessary.
PSI is very concerned by this answer as it seems that HHS is ignoring the OIG advisory opinions, Federal guidance publications and 25 years of assistance that nonprofit patient assistance organizations such as PSI has undertaken. While PSI understands the need for HHS to monitor those entities that have lower ethical standards, HHS should clearly distinguish the legitimacy of non-profit patient assistance organizations which are serving a legitimate role in helping patients under federal guidance and other commercial entities and that follow the independent charity model outlined in the OIG’s Opinion 02-01. As stated previously, PSI has worked with patients for over 25 years to access treatments, in many cases by subsidizing the health insurance premium that the patient cannot afford through no fault of their own.
Congress specifically applied the False Claims Act to the Exchanges, and HHS has explicitly recognized that the OIG has jurisdiction to audit, investigate and evaluate the HHS-administered programs in Title 1 of the Affordable Care Act. Therefore, as was done for Medicare beneficiaries, we urge HHS to make this important distinction between legitimate copayment foundations operating consistent with the OIG’s Opinion 02-01 and other organizations when issuing information to payors in the Exchanges or considering new rules and regulations governing patient assistance programs. We are concerned that any ambiguity or threat of new regulation could create unnecessary confusion for patients trying to access care in the coming months and years as the Exchanges are implemented and patients seek to take advantage of its benefits. I urge HHS to recognize that the copayment foundation model, developed by PSI, is an integral part of advancing the goals of the Affordable Care Act.
I would welcome the opportunity to discuss this most crucial service with you. Your staff can reach me at 804-521-7919 or at In addition to this letter, I am requesting a follow up meeting with your staff to discuss our concerns with the November 2013, Q&A document. Thank you for your time and attention to this matter.
Dana Kuhn, Ph.D., President & Founder