Access to Therapies
PPTA supports patient access to all medically appropriate plasma protein therapies, which because of important clinical and manufacturing differences, an individual patient may tolerate or respond to one therapy better than another in the same class. Plasma protein therapies are not therapeutically equivalent, pharmaceutically equivalent, or bioequivalent, therefore they are not interchangeable.
An individual with a condition which requires plasma protein replacement treatments should have access to the full range of FDA licensed plasma protein therapies from the most medically appropriate provider. Unfortunately some payers, including state Medicaid programs, attempt to contain costs by limiting patient access to therapies and providers. PPTA advocates against such measures.
"Medicaid 101" - PPTA Presentation
- Medicaid and CHIP Managed Care Proposed Rule CMS-2390-P
- Single Source Provider Contracts Restrict Consumer Choice and Compromise Patient Health
- Impact of Medicaid Reimbursement on Access to Therapies
- Implementation of a Step Therapy Protocol for Anti-hemophiliac Medications Could be Life Threatening and Will Result in Higher Treatment Costs
- Texas Preferred Drug List Letter(IG)
- Idaho Preferred Drug List Letter(IG)
- Letters of Support for Health Insurance – Step Therapy or Fail–First Protocol (MD SB746, HB1015)
- Letters of Support for Coverage for the Treatment of Bleeding Disorders (MD HB 949, MO HB 552)
- Letter in Opposition to MD SB 782, an Act Concerning Health Insurance - Pharmacy Benefits Managers - Speciatly Drugs
- Letter of Support for HB 255, Relating to Age Donate Plasma
- Alabama Bill Talking Points, (SB204/HB255)
The Affordable Care Act is going to change the way the health insurance market works in this nation. There is a need to monitor the changing system to make sure that the changes don’t limit the ability of plasma protein therapies consumers to get the care they need. The new system needs to allow them access to provider that are experts in treating their conditions, to the plasma protein therapies their lives depend upon, and the specialty pharmacy providers that are qualified to deliver these unique therapies to them.
On June 1, Alabama Medicaid implemented an emergency rule to limit Medicaid recipients to one brand pharmaceutical per month. It also put out a proposed rule for comment that would make the emergency rule permanent. PPTA staff had multiple phone conversations with the Pharmacy Director for Alabama Medicaid. During these conversations, PPTA staff stressed the importance of providing Medicaid recipients access to their medically appropriate plasma protein therapies. PPTA and the State Patient Access Coalition (SPAC) sent letters which stressed that the policy was contrary to the National Hemophilia Foundation's Medical and Scientific Advisory Council (MASAC) recommendations, would likely increase costs for other Medicaid services, and would not benefit the Medicaid recipients. Based on the 10 comment letters they received, including the two from us, Alabama Medicaid decided not to continue the one-brand limit. It is reverting back to the four- brand limit effective August 1. (2012)
State Affairs staff supported the efforts of the Hemophilia Council of California to pass AB 389, the Standards of Service for Providers of Blood Clotting Products for Home Use Act. This bill passed and went into effect on January 1, 2013 and establishes standards for the safe and timely delivery of blood clotting products. (2012)
After PPTA, along with other coalition partners, sent two letters to the California Board of Pharmacy urging a two-year delay in the January 1, 2009 implementation date of the California Pedigree law, the Board in late March of 2008 decided to extend the implementation until January 1, 2011. Legislation subsequently delayed the implementation of the pedigree to 2015/16. PPTA participated as part of a coalition of entities from the pharmaceutical and biotechnology industries that sought the same delay. Had the Board not decided to delay, access to life-saving plasma protein therapies, as well as other drugs and biologics, could have been adversely affected. PPTA supported the Hemophilia Council of California sponsored bill on Standards of Service for people with hemophilia, which in April passed unanimously out of the California Senate Health Committee. PPTA offered public support for the legislation through letters to the bill’s authors. In May, PPTA attended the Hemophilia Coalition of California Legislative Day in Sacramento. There were numerous meetings with legislators on SB 1594, Standards of Service for Providers of Blood Clotting Products for Home Use Act. Meeting participants also warned that the proposed reductions in Medicaid reimbursements could have negative impact on patient access. (2008)
- Letters of Support for AB 389, Regarding Standards of Service for Clotting Factor for Home Use: California State Assembly and the Assembly Committee of Health Chair
Florida Governor Rick Scott signed the Florida Budget on Tuesday, April 17. The budget bill included $1,875,000 for the inclusion of Severe Combined Immunodeficiency Disease (SCID) testing within the Newborn Screening Program. This funding was obtained through the efforts of a coalition including PPTA. The Governor had vetoed the funding in the budget that was signed in 2011. PPTA staff met with the Florida Governor's staff in February of this year to advocate for the funding and to discover what the Governor's objections were to the funding and answer any questions they may have. PPTA staff provided answers to the Governor’s objections and questions. PPTA staff met with stakeholders and legislative staff to inform them of the need for this funding and to ease any concerns they may have on this issue. (2012)
Florida Chapter Law 2012-37 (FL SB 364) was passed by the Florida Legislature in March of 2012 and signed by Governor Scott in April. This law requires blood establishments that collect blood or blood components in Florida to disclose information about the collection and distribution process; the volume of collections, purchases, and distributions; certain financial statements, and corporate ethical policies on the establishment's Internet site. A blood establishment that fails to comply with these disclosures is subject to a civil penalty. The efforts of PPTA state affairs staff led to plasma collection centers being exempt from this law. (2012)
The Florida House and Florida Senate considered bills that would require blood establishments that collect blood or blood components to disclose information including the number of units by component that are distributed, policies related to corporate conduct and executive compensation and financial-related data on their websites. Some versions of the bill also required a $10,000 annual fee to be paid by the blood establishments to the Florida Agency for Health Care Administration. The definition of "blood establishments" under Florida law includes plasma collection centers. PPTA State Affairs, Source and Regulatory staff successfully persuaded legislative staff to include a definition in the bill that would exempt plasma collection centers. The bill ultimately died, because it failed to pass before the Florida Legislature concluded its 2010 regular session. (2010)
Access to Care
In April, PPTA advocated on behalf of patient access issues in Florida. The Florida Legislature was considering the elimination of the Medically Needy program which provides benefits to individuals with high-cost health services including individuals that rely on plasma protein therapies. They were also considering requiring all Medicaid recipients to have their care provided by a Medicaid Health Maintenance Organization (HMO). The Legislature heard from many groups and as a result did not eliminate the Medically Needy Program. In addition, a coalition of PPTA, its member companies and patient organizations were successful in carving out clotting factor from the mandatory managed care that became Florida law during the 2011 Legislative Session. (2011)
- Letter of Support for Florida Prescription Drug Benefit Plans (HB1003)
- Comment Letter to the Florida Chairman, HHS Appropriations Regarding Support the Alpha One Screening and Detection Program
Kentucky Medicaid proposed a rule in August that appeared to require Medicaid recipients to receive their blood clotting factor from a 340B Hemophilia Treatment Center (HTC). PPTA, working with patient groups, responded to the rule and requested that the proposed rule be amended to ensure Medicaid recipients' access to the provider of their choice. Based on our recommendation, Kentucky Medicaid amended their proposed rule to state, "A recipient shall have freedom of choice of provider." This is a clear victory for patient access. (2008)
- Comment Letter to the Kentucky Office of Legal Services on the Department of Medicaid Services' Proposed Administrative Regulation Hemophilia Treatment Reimbursement and Coverage via the 340B Drug Pricing Program 907 K.A.R. 3:205
- Letter of Support for LB 322 to the Honorable Senator Abbie Cornett, Nebraska Senate
New Jersey Tax Bill Defeated
Powerful Assembly and Senate Health Policy Chairmen filed identical bills during the 2008-2009 term of the New Jersey Legislature to create a Bleeding Disorders Treatment Fund, with the revenue resulting from a tax on the manufacturers of clotting factor and specialty pharmacies. PPTA created and led a coalition to oppose the bill. The coalition included the New Jersey Association of Health Plans, Biotechnology Industry Organization New Jersey and the New Jersey Business and Industry Association. The coalition was successful in keeping the bill from passing out of the budget committees, before the legislative session ended on January 11, 2010. (2010)
New York Medicaid proposed implementing a Medicaid reimbursement change for clotting factor based on Actual Acquisition Cost (AAC). The current Medicaid reimbursement benchmark is based on Average Wholesale Price (AWP). The switch to AAC was to begin on August 1, 2011. PPTA, working with NHF and SPAC, has led a campaign to ensure that New York Medicaid implements this change in a way that will not impact patient access. PPTA has participated in multiple meetings and conference calls on this issue. The implementation of the AAC has not yet occurred because New York Medicaid is working to make sure patient access to clotting factor is not impacted by the reimbursement change. The implementation is currently scheduled for January 1, 2013. (2012)
Hemophilia Specialty Pharmacy Program
The North Carolina Division of Medical Assistance released their Hemophilia Specialty Pharmacy Program draft policy in October. The draft policy contained language that would allow the state to require Medicaid recipients to receive their clotting factor from the least costly provider as well requiring Medicaid recipients to switch to the therapy that is the least costly to the state. The State Patient Access Coalition (SPAC), staffed and managed by PPTA, responded to this draft policy by requesting the removal of the least costly alternative language from the final policy. SPAC's letter stated that least costly alternative policies are "contrary to quality patient care for individuals with hemophilia." After reviewing the SPAC letter, North Carolina removed the least costly alternative from the policy. (2012)
- Comment letter to State of North Carolina, Department of Health and Human Services regarding Hemophilia Specialty Pharmacy Program (Proposed Policy 9B)
North Carolina Budget Proviso Language
The North Carolina Senate's Appropriations Act for 2010 (SB 897) included a proviso that would require the creation of a specialty drug provider network for hemophilia, hepatitis C, and intravenous immunoglobulin (IVIG) drugs. Staff worked closely with the members of the Association and the patient organizations to persuade the North Carolina General Assembly to change the language during conference. The effort of the coalition was successful. PPTA suggested language to North Carolina leadership in a letter sent on June 15, 2010 that was incorporated into the Conference Report, which reads:
SECTION 10.23. The Department of Health and Human Services shall work with specialty drug providers, manufacturers of specialty drugs, Medicaid recipients who are prescribed specialty drugs, and the medical professionals that treat Medicaid recipients who are prescribed specialty drugs to develop ways to ensure that best practices and the prevention of overutilization are maintained in the delivery and utilization of specialty drugs. (2010)
Removal of Prior Authorization Sunset
PPTA attended the Hemophilia of North Carolina's Patient Advocacy Day in Raleigh, North Carolina and was assigned to a group of five that included two patients and two parents. The group met with Senators and Representatives to discuss the concerns of the patient community including the July 1, 2009, sunsetting of a Medicaid statute that exempts clotting factor from the Medicaid prior authorization process. As a result of the group’s efforts, Senator Malone offered to sponsor a bill that will eliminate the sunset and make permanent the clotting factor exemption. He stated the bill would be the first one he files in January of 2009. (2008)
- Letter to Texas Health and Human Services Commission, Jr. Regarding Comments on Proposed Rule Concerning Specialty Drugs
- Comments on Texas Medicaid Reform Proposal
The House and Senate proposed budget language this year that would limit the provision of hemophilia services to one 340B provider in the state. A coalition of patient groups, manufacturers and specialty pharmacy were able to persuade both chambers to adopt language that would allow more than one provider of care through a competitive Procurement process. (2009)
In January, PPTA demonstrated to the West Virginia Office of Pharmacy Services that the West Virginia Medicaid program was inappropriately reimbursing alpha-1proteinase inhibitors at the generic rate of (average wholesale price) AWP-30 percent instead of the brand rate of AWP -15 percent. In its response to PPTA's letter, West Virginia states that providers may "reverse and resubmit any claims paid in error for up to one year from date of service." This decision is a clear victory in furthering PPTA's objective of ensuring access to plasma protein therapies. (2008)
- West Virginia Office of Pharmacy Services - Response to PPTA on Reimbursement Rate for alpha-1 proteinase inhibitors
State Patient Access Coalition
PPTA is a member of the State Patient Access Coalition (SPAC). SPAC represents the world's leading manufacturers of clotting factor and the nation’s leading distributors of clotting factor. Clotting factor therapies are vital for individuals with bleeding disorders, including hemophilia and von Willebrand Disease.
The coalition works together in support of these principles:
- Patients need access to affordable health care insurance.
- Patients need access to quality providers.
- Ensure unfettered access to drugs and biologics.
- Reimbursement for providers should adequately reflect the positive impact that clotting factors give patients.
- Comment letter to the Illinois Bureau of Pharmacy Services regarding Medicaid Actions Negatively Impacting Patients
PPTA Comments on the IQWiG Rapid Report on Haemophilia Therapies +
On October 11, 2012, the German Federal Ministry of Health (BMG) commissioned the Institute for Quality and Efficiency in Health Care (IQWiG) to assess the treatment of haemophilia patients through the production of a Health Technology Assessment (HTA) Rapid Report.Read More
New Supplement Addresses Hemolytic Complications of IVIG Infusions +
Plasma Protein Forum Highlights +
The 2015 Plasma Protein Forum concluded June 17 with panels that covered industry challenges, patient voices, benefits of plasma donation, self-sufficiency, and regulatory issues. More than 300 people from across the industry attended the two-day event in Washington, D.C.Read More
The Source, the international magazine of the plasma protein therapeutics industry is published quarterly. Read the current issue.