Oct 29, 2013
ASCO joined more than 50 organizationsin urging the administration toissue regulations or guidance beforeJanuary 2014 to ensure that healthplans implement an important provisionof the Affordable Care Act (ACA)that would remove an important obstacleto patients interested in participatingin research.
In a jointly signed letter to the U.S.Department of Health and Human Services(HHS) and Labor (DOL), ASCOlends its voice to a call for clear federalguidance on coverage of routine medicalcosts for individuals participatingin approved clinical trials, as requiredunder section 2709 of the PublicHealth Service Act—a provision of thePatient Protection and ACA that goesinto effect on January 1, 2014.
An HHS and DOL announcementeffectively left the implementationdetails of this provision up to theindividual states, which is likely toaffect timely access to potentiallylife-extending research and produce apatchwork of unpredictable coveragethat will confuse patients and theirhealth care providers. According tothe co-signed letter, “Implementationof this provision will be very unevenacross the country, and many consumersmay be denied a new protectionthey should be guaranteed underthe law.”
“While the administration has made itclear that insurance companies mustproceed with compliance, it has leftimportant details unaddressed,” saidASCO President Clifford A. Hudis, MD,FACP. “We know that insured patientswith coverage for clinical trial participationhave faced denials and delayseven in those states that require suchcoverage, a situation that is unacceptableto patients for whom clinicaltrials of new therapies may representtheir best hope for extension of lifeor a better quality of life. This alsounnecessarily delays the developmentof better treatments for everyone.”
The letter builds on ASCO’s earlieradvocacy efforts with 18 cancer organizationsthat resulted in submissionof recommendations to federalagencies on how to implement thecoverage requirement. ASCO is alsodeveloping detailed information onthe new law for patients with cancer,investigators, and research staff andwill be closely tracking implementationof the law.
ASCO and the other organizations signing the letter identified four key issues that should be addressed through federal rulemaking to ensure that the clinical trials provision of the ACA is fully implemented:
In a jointly signed letter to the U.S.Department of Health and Human Services(HHS) and Labor (DOL), ASCOlends its voice to a call for clear federalguidance on coverage of routine medicalcosts for individuals participatingin approved clinical trials, as requiredunder section 2709 of the PublicHealth Service Act—a provision of thePatient Protection and ACA that goesinto effect on January 1, 2014.
An HHS and DOL announcementeffectively left the implementationdetails of this provision up to theindividual states, which is likely toaffect timely access to potentiallylife-extending research and produce apatchwork of unpredictable coveragethat will confuse patients and theirhealth care providers. According tothe co-signed letter, “Implementationof this provision will be very unevenacross the country, and many consumersmay be denied a new protectionthey should be guaranteed underthe law.”
“While the administration has made itclear that insurance companies mustproceed with compliance, it has leftimportant details unaddressed,” saidASCO President Clifford A. Hudis, MD,FACP. “We know that insured patientswith coverage for clinical trial participationhave faced denials and delayseven in those states that require suchcoverage, a situation that is unacceptableto patients for whom clinicaltrials of new therapies may representtheir best hope for extension of lifeor a better quality of life. This alsounnecessarily delays the developmentof better treatments for everyone.”
The letter builds on ASCO’s earlieradvocacy efforts with 18 cancer organizationsthat resulted in submissionof recommendations to federalagencies on how to implement thecoverage requirement. ASCO is alsodeveloping detailed information onthe new law for patients with cancer,investigators, and research staff andwill be closely tracking implementationof the law.
ASCO and the other organizations signing the letter identified four key issues that should be addressed through federal rulemaking to ensure that the clinical trials provision of the ACA is fully implemented:
- Prevention, Detection, and Treatment of Complications: Explicit safeguards should ensure that the prevention, detection, and treatment of complications arising from clinical trials are covered under the definition of “routine costs.”
- Meaningful Access to Clinical Trials: Regulations should prevent group health plans and insurance issuers from requiring patients to travel unreasonable distances to enroll in a clinical trial with an in-network provider.
- Prevention of Delays and Administrative Barriers: Safeguards should protect patients from delays and administrative barriers that undermine access to clinical trials, including preventing financial incentives arising from new delivery models from inadvertently creating barriers for patients to participate in clinical trials.
- Determining a Life-Threatening Condition: Determination about whether an individual is an appropriate candidate for participation in a trial that qualifies for coverage should be made by the patient’s health care professional.