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Thursday, October 23, 2014

The article “Unintended Consequences: How Government Policies Have Increased the Cost of Cancer Care" in the Sept. 25 issue gives a highly inaccurate and one-sided view of the oncology issue as it relates to the 340B drug discount program.

 

In truth, several powerful forces are at work to drive private practices and hospitals into closer working relationships. These include financial pressures on private oncologists due to lower Medicare reimbursements under the Medicare Modernization Act of 2003, the move towards integrated delivery systems and accountable care organizations. There is no credible data showing 340B hospitals are buying up oncology practices any faster than hospitals outside the program.

 

The 340B program was specifically designed to give safety-net hospitals an additional funding mechanism to stretch their resources. Since they must serve high percentages of poor patients in order to be eligible for the program, savings from 340B are de facto used to help the underserved.

 

Private oncologists regularly shunt their poorest patients to the nearest safety-net provider for treatment. Why? Because they make little or no money on these individuals. In turn, safety-net hospitals are obligated to treat all patients, regardless of their ability to pay. This is why they receive discounted chemo drugs from the pharmaceutical industry under 340B. I could understand private oncologists’ resentment more if they actually treated the underserved. Most do not.

 

Safety-net hospitals sometimes do charge more for oncology services to our insured patients – because we must shoulder the enormous burden of caring for all the people who cannot pay for treatment. Hospitals also offer a much broader range of oncology services, including advanced diagnostics, surgery, radiation therapy, infusion services, patient and family counseling, home care services and palliative care.

 

The 340B program grew between 2005 and 2011 for two reasons. First, Congress made rural hospitals eligible – most of which have 25 beds or less. Second, the Health Resources and Services Administration changed its bookkeeping rules, requiring hospitals to register off-site clinics as separate 340B entities. In fact, since 2010 there have been only six net-new Disproportionate Share Hospital added to the program.

 

As much as they would like, private oncologists cannot turn the clock back to better financial times. Changes in the healthcare marketplace are steadily pushing specialty practices of all kinds into the arms of hospitals. Blaming the 340B drug discount program is both misleading and unproductive.

 

Robert Chapman, MD

Director

Josephine Ford Cancer Institute

Detroit, Michigan 


Tuesday, October 07, 2014

 

By Andrea Branas, MSE, MPT, CLT

Lead Physical Therapist

Abramson Cancer Center

Good Shepherd Penn Partners

 

There are currently more than 3.2 million breast cancer survivors in the United States. During Breast Cancer Awareness Month, related news in the media typically includes patient stories, celebrations, and treatment options. Not as well covered in the lay media, though, is another aspect of the disease that affects survivors – i.e., the risk of developing lymphedema.

 

This life-altering abnormal accumulation of fluid just underneath the skin is one of the most common side effects following treatment for breast cancer and can affect a person’s ability to complete daily tasks, as well as self-image. If left untreated, breast cancer-related lymphedema will continue to progress, causing more serious side effects over time. Research has found that the best treatment for lymphedema is to minimize the risk of developing it.

 

“Strength After Breast Cancer” is an evidence-based rehabilitation program designed to minimize a woman’s risk of developing lymphedema. The program begins with educating survivors about all aspects of lymphedema and giving participants an individualized assessment of strength, range of motion, and upper body issues. Physical therapists then work with patients in small-group settings to teach techniques that will restore strength and encourage a healthy exercise regimen that will last a lifetime. Slowly progressive strength training has been shown to reduce the risk of developing lymphedema and can reduce the risk of lymphedema symptoms worsening.

 

The program is a joint creation of Kathryn H. Schmitz, PhD, MPH, Senior Fellow in the Center for Clinical Epidemiology and Biostatistics at Abramson Cancer Center of the University of Pennsylvania, and therapists from Good Shepherd Penn Partners, a Philadelphia-based post-acute therapy provider. A grant awarded to Dr. Schmitz from the National Cancer Institute funded the effort to translate the results of a large clinical trial into a program that could be broadly disseminated to breast cancer survivors across the U.S. and beyond.

 

The program is based on the results of the randomized, controlled Physical Activity and Lymphedema (PAL) trial, which assessed the safety of progressive strength training in breast cancer survivors, who participated in a supervised, slowly progressive strength training program. Results published in The Journal of the American Medical Association (2010:304:2699-2705) and the New England Journal of Medicine (2009;361:664-674) showed that supervised, slowly progressive strength training is safe for breast cancer survivors. Additionally, women who performed strength training were less likely to develop lymphedema than those who were not strength training.

 

In the past five years, Strength after Breast Cancer has grown into one of the largest exercise programs for breast cancer survivors in the country and is recognized by the American Physical Therapy Association as an innovative practice model. At this five-year milestone, a new examination of the PAL trial data and the program will soon be published in the Journal of the National Cancer Institute. Giving light to the common challenge of translating research findings into real-world tactics, the new data highlight that participants in Strength After Breast Cancer received the same benefits as participants in the original PAL trial.

 

Prior to the PAL trial, misconceptions existed around exercise in breast cancer survivors. Standard of care included discouraging survivors from lifting objects greater than about five pounds, which left many survivors unable to perform simple daily tasks, such as handling groceries or even holding children. Despite the clinical evidence, many health care providers still discourage this activity, instilling unnecessary fear and limitations on survivors; yet, if done properly, exercise can be extremely beneficial.

 

Specialists in the Strength After Breast Cancer program work to ensure that participants learn correct form when strength training and stress common errors that may lead to injury. Participants are encouraged to “start low and progress slow,” as the program is shown to work best when therapists collaborate with patients to build a regimen based on their individual needs and health goals.

 

Lymphedema is a life-long condition. One way to minimize the risk of developing lymphedema is a simple exercise routine. Moving forward, I challenge all those working with cancer patients to encourage those at risk, or already diagnosed, to adopt an appropriate, supervised exercise regimen and to meet with a physical therapist early -- ideally, at the time of diagnosis. When any degree of physical therapy is included in the overall treatment package, patients are more likely to experience a pleasant and safe recovery.

 

I have had the pleasure of working closely with survivors and their caregivers since the inception of the program at Good Shepherd Penn Partners in 2011. Day after day, participants continually express their gratitude for providing them with the tools to take back their strength. Empowering cancer survivors’ to improve their health is crucial for complete restoration.

 

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Andrea Branas is Lead Physical Therapist for Good Shepherd Penn Partners at the Abramson Cancer Center of the University of Pennsylvania. She received her MSE from the University of Pennsylvania and her MPT from the University of the Sciences in Philadelphia. Good Shepherd Penn Partners is home to one of the largest teams of Certified Lymphedema Therapists in the nation. In addition to Strength After Breast Cancer, Good Shepherd Penn Partners offers a complete rehabilitation plan for lymphedema including all aspects of CDT, Complete Decongestive Therapy; as well as physical therapy-based treatment for cancer related fatigue. Strength After Breast Cancer is also available via UCSF Medical Center and Virtua Health. For more information, visit www.pennpartners.org/strength


Wednesday, September 24, 2014

Michael A. Thompson, MD, PhD

Medical Director Early Phase Cancer Research Program, Patient-Centered Research

Co-PI, Aurora NCI Community Oncology Research Program (NCORP)

Aurora Research Institute

Aurora Cancer Care

 

Overview

The NCI Community Oncology Research Program (NCORP) Inaugural Investigator’s meeting was held at the NCI Shady Grove facility in Rockville, MD on September 22, 2014. Interestingly, this is a beautiful new Leadership in Energy & Environmental Design (LEED) Gold facility. I’ll give high level overview of the meeting.

 

Introductions and overview by NCORP leadership including Barry Kramer, MD, MPH, and Worta McCaskill-Stevens, MD, MS, noted changes from prior Community Clinical Oncology Program (CCOP) and National Cancer Institute Community Cancer Centers Program (NCCCP) structures. The NCI has published An Overview of NCI’s National Clinical Trials Network (NCTN).” There is a shift from expansion in primary sites (as in the NCCCP) to an 842 component and subcomponent network that includes large health systems as well as consolidated CCOP and NCCCP sites. This can be visualized on the yet to be released interactive NCORP map that allows viewing by different site characteristics and subcomponent sites.

 

The NCORP budget includes $42.7 million to 46 NCORP community sites.

 

Cancer Care Delivery Research (CCDR)

Cancer Care Delivery Research (CCDR) is a major new initiative for NCI. Comments included that we have been doing CCDR, we just didn’t call it that. Dr. Kramer noted that we are moving from a "can it work" (efficacy) to "does it work" (effectiveness) focus in NCORP in addition to traditional treatment trials.

 

Questions from the sites included how this would be funded. The answer included current NCORP funding as well as in the future the potential for blended funding from NIH (e.g., RO1) as well as non-NIH dollars (e.g., American Cancer Society, Livestrong, Patient-Centered Outcomes Research Institute) utilizing the NCORP network. Rachel Ballard-Barbash, MD, MPH, noted prior efforts and large data networks including the Surveillance, Epidemiology, and End Results (SEER) program and NCI virtual data warehouses. Dr. Ballard-Barbash thought that CCDR was timely in the context of efforts from the Institute of Medicine (IOM) and Choosing Wisely Campaigns from organizations such as ASCO and ASH. Local resources such as electronic health records (EHRs) could be leveraged with QOPI and registries as well as incorporate genomics and other “-omics.”

 

Multiple areas were reviewed under CCDR including: patient navigation, care coordination, multi-disciplinary conferences (MDCs), genetic counseling, adding patient reported outcomes (PRO) data into electronic health records. Penny Mohr, MA, presented “Opportunities for Collaboration with the Patient-Centered Outcomes Research Institute (PCORI).” CCDR is aimed at system level interventions rather than at individuals, but can include evaluating and modulating individual risk behaviors such as tobacco use and obesity including leveraging tele-health.

 

Implementing Precision Medicine Treatment Trials within NCTN

Drs. McCaskill-Stevens and Margaret Mooney, MD, MBA, discussed activated and future NCI molecular studies including the concepts of: Basket (e.g., MATCH -- different cancers, separate study arms, single drug, single mutation), Umbrella (Lung-MAP & ALCHEMIST, single cancer, different drugs, different mutations), and Exceptional Responders Pilot Study (-omics in exceptional responding patients). Other study types include an MDS national registry. Apparently NCI MATCH is expected to open for accrual in Q1 2015, not November 2014 as previously noted at the last ECOG-ACRIN meeting. Molecular studies will pay for screening biopsies.

 

Cardiotoxicity

Lori Minasian, MD, updated us on the NCI Community Oncology Cardiotoxicity Task Force. This tied in to many prior and future NCORP research base studies involving the cross-disciplinary collaborations of cardiology and oncology. The focus on cardio-oncology toxicity was related to the increase in cancer survivors. Future studies will incorporate standardized assessments and endpoints. The Symptom Management and Quality of Life (SxQOL) Steering Committee (SC) recommendations were to strengthen the preclinical foundation for trials and to conduct fewer trials using novel approaches.

 

Cancer Prevention and Control Research Agendas

The NCORP research bases included reviews of prior studies, open studies, and future concepts. While this was very detailed, information is or will be available on those websites and change over time.

 

I previously mentioned studies from URCC.

Upcoming NCORP RB meetings are coming for Wake Forest, Alliance and ECOG-ACRIN.

 

 

Patient Log and EDRN

Cynthia Whitman, Diane St. Germain, RN, MS, and Sudhir Srivastava, PhD discussed NCORP grant funds, patient logs and the EDRN - Early Detection Research Network. The NCCCP used a screening and accrual log to address cancer clinical trial accrual (JOP 2014) A patient log may be used in NCORP, but focused on cancer control, prevention, and CCDR. Four EDRN-related RFAs are coming including for component CVCs - Clinical Validation Centers - looking for high quality samples.

 

CT AIM

Stephen Grubbs, MD, Bryan Weiner, PhD, and Eileen Dimond, RN, MS, discussed the Clinical Trial Assessment of Infrastructure Matrix Tool (CT AIM). Data was presented at the ASCO 2014 meeting by Dimond et al. Abstract 6512. CT AIM “showed utility across the sites for promoting quality improvement, benchmarking research performance, progress reporting and providing metrics for communicating infrastructure needs. Use in research beyond oncology and outside the community setting is plausible.” CT AIM will be further discussed at the upcoming (9/28-29/2014) ASCO Community Research Forum.

 

NCI CIRB

Linda Parreco, RN, MS, bravely was the last full presentation of the day and discussed the history of the NCI Central IRB (CIRB). In 2013 an “early phase” group was added and the CIRB received AAHRPP accreditation. In January 2015 the NCI CIRB will include Cancer Prevention & Control Studies. Plans are for future CCDR studies via the NCI CIRB as well.

 

 

Conclusions

The changes in the NCTN and CCOP/NCCCP moving to NCORP have been fast, disruptive, flatly funded (mainly) and not without consternation in many areas of the cancer research community. This meeting did seem to allay some worries, lay groundwork for implementing the new structure and highlighted future priorities. My gut feeling was that many people did leave more excited and energized than before they started. I did. Funding is lean, but with new opportunities.

 

More emphasis will be on CCDR, cancer control and cancer prevention studies. Cross-disciplinary collaboration (e.g., Cardio-Oncology, neuropathy, exercise/metabolism, etc.) will increase and work on standardizing assessments and endpoints as well as coordinate to prevent study overlap. Molecular studies, increasing analysis of accrual barriers (e.g. CT AIM), and efficiencies such as NCI CIRB will help us.

 

More terse notes and links are included in my #NCORP tagged tweets at the meeting. I also started using #CCDR as a Twitter hashtag.

 


Thursday, September 11, 2014

 

By Michael A. Thompson, MD, PhD

Medical Director Early Phase Cancer Research Program, Patient-Centered Research 

Co-PI, Aurora NCI Community Oncology Research Program (NCORP)

Aurora Research Institute

Aurora Cancer Care

 

The NCI Community Oncology Research Program (NCORP) includes these research bases: http://ncorp.cancer.gov/about/sites.html#research-bases

 

University of Rochester Cancer Center

The University of Rochester Cancer Center (URCC) is an NCORP Research Base (http://urcc-ccop.com/ccop). Gary Morrow, PhD, MS, is the Director, and kicked off the Inaugural URCC NCORP Meeting last week in Rochester, NY.

 

Our health system (Aurora NCORP) was a new site, so this was a new meeting for us. Some of the other previous CCOP sites had new principal investigators and staff. The URCC NCORP members have had impressive accrual over the history of the URCC CCOP research base.

 

URCC has an NIH R25 grant which is being used to train researchers in Cancer Care Delivery Research (CCDR).

 

URCC NCORP Active Protocols (selected)

10055 Cognitive -- NCT01382082 -- Assessment of Cognitive Function in Breast Cancer and Lymphoma Patients Receiving Chemotherapy at Pre-Treatment, Post-Treatment, and at Six Month Follow-Up (CANTAB)

 

12107 PSYCHED -- NCT02054715 -- Evaluation of Psychoeducation for Cancer Patients Eligible for Clinical Trials

 

13059 GAP70+ -- NCT02054741 -- an NIH RO1 study -- A Geriatric Assessment Intervention for Patients Aged 70 and Over Receiving Chemotherapy for Advanced Cancer:  Reducing Chemotherapy Toxicity in Older Adults (amendments pending)

 

13070 COACH -- NCT02107443 -- Patient-Centered Outcome Research Institute (PCORI) funded -- A Geriatric Assessment Improving Communication for Chemotherapy: Addressing Concerns of Older Cancer Patients and Caregiver

 

Conclusions

Many active clinical trials and concepts were reviewed. A number of these involved energy balance, exercise, and symptom interventions. A few general thoughts:

 

Minority accrual has been and is consistently lower than wished at nearly all sites in the country (with a few exceptions).

Minority accrual ideally should be the same percentage as the prevalence of the minority population for that specific disease.

 

CCDR will be an increasingly important research strategy as the NCORP sites implement new studies. This will supplement new cancer control and cancer prevention studies.

 

Cross-disciplinary collaboration (e.g., Cardio-Oncology, neuropathy studies) will increase. How these studies are reviewed in siloed study sections is not clear.


Wednesday, September 10, 2014

By Joy Larsen Haidle, MS, CGC

President-elect, National Society of Genetic Counselors

Genetic Counselor, Humphrey Cancer Center, Minneapolis 

 

The Journal of the American Medical Association published a study on Sept. 8, 2014, by Mary-Claire King, PhD, which recommends that all U.S. women over the age of 30 receive genetic testing for BRCA1 and BRCA2 mutations, whether or not they have a family history of breast or ovarian cancer.

 

Over the years, I have been extremely impressed by the dedication and amazing scientific contributions of Dr. Mary-Claire King to help identify and support individuals at risk for hereditary breast cancer. She is a well-respected researcher and her opinion is important to consider. However, as a genetic counselor who has worked with and advocated for families at risk for hereditary cancer risk for close to 20 years, I have concerns regarding her recent recommendation.

 

First, the data utilized to support this recommendation was generated on a very specific high-risk population, Ashkenazi Jewish men from Israel. In the Ashkenazi Jewish population, approximately 1 in 40 people carry a mutation in BRCA1 or BRCA2 versus 1 in 300 to 1 in 500 individuals from the general population. It is very difficult to take data from a high-risk population and apply it to the average person in a meaningful way.

 

In addition, three founder mutations in BRCA1 and BRCA2 account for close to 90 percent of the mutations identified in individuals who are of Ashkenazi Jewish descent versus thousands of other mutations that have been identified in other populations. In this population, testing is often done for just these three mutations rather than full evaluation of both genes by sequencing and large rearrangements (deletions or duplications of the gene).

 

This is a difference in cost from roughly $475 versus $2,000-$4,000. Without a personal or family history suggestive of a potential inherited risk, the cost of the test would likely not be covered by most insurance companies as the average person would not meet current coverage criteria. These are very important factors impacting the ability to offer quality, easy-to-interpret testing in a cost-effective manner.

 

Many laboratories suggest a roughly 4 percent variant of uncertain significance rate on BRCA1/BRCA2 DNA testing. These are results where the meaning is unknown and the results should not be used in medical management decisions. However, it is a test result that is often misinterpreted and misunderstood, and has the potential to cause unnecessary anxiety and harm.

 

In Dr. King’s commentary regarding the article, she suggests that laboratories only report clear normal or clearly harmful results and withhold variant results. The reason to withhold the variant results is to decrease confusion or misinterpretation of the results by patients or providers, but it also reveals a need for greater preparation and education of providers and the public before the value of general population screening could be fully realized. In addition, it emphasizes the importance of risk assessment and genetic counseling by an expert such as a genetic counselor.

 

I understand Dr. King’s concept and her concerns that have led her to recommend universal screening, but the current system needs to do a better job at collecting sufficient family history information to accurately identify and triage patients who might benefit from genetic counseling and/or genetic testing. Without a systematic process to collect this information and without significant education for providers and the general public, many individuals may not have their mutation identified until after a cancer has occurred.

 

It is premature to suggest that the medical system is prepared to implement general population screening of BRCA1 and BRCA2 mutations, and more harm than good can happen as a result. A significant amount of work must be done to get the medical system and providers ready to handle the volume of patients, ensure that patients receive high-quality care and understand their results, ensure the psychosocial issues associated with genetic testing are addressed, and guarantee access to experts before making potentially life-changing medical decisions. In addition, significant education is needed for the medical community and the lay public to fully realize the benefits of the technology to reduce cancer risks. 

 

The data from Dr. King’s study is important and I am grateful that she has initiated a conversation about how the population might maximize the benefit from genetic screening. It is imperative, however, that genetic counseling and risk assessment remain a part of the process for patients to make the best health choices for themselves. It is premature to make this leap without putting the safeguards in place to protect the patients utilizing the DNA testing and resources to ensure the information is used well.