Medicare prescription insurers told to provide a 30-day supply of drugs to avert coverage emergency

The federal administration has told Medicare Part D insurers that they must provide a 30–day supply of any drug a beneficiary was taking prior to the changes in the law which occurred on January 1, according to reports in the New York Times.  The new directive also says that low-income patients cannot be charged a co-pay more than $2 for a generic drug or $5 for a name-brand one.

Over 42 million elderly and disabled Medicare recipients became eligible for prescription coverage on January 1, 2005 as part of a new Medicare Part D program.  Six million low-income participants, whose prescriptions were previously covered by Medicaid, were automatically switched to the new Medicare coverage.  However, hundreds of thousands of dual-eligible people were being told incorrectly that they had to pay the $250 deductible required of higher-income participants as well as significantly higher co-pays.  Pharmacists have been spending hours on the telephone trying to verify eligibility for the low-income program or find which insurance company had been assigned to a particular individual.

In addition, some higher-income people who had signed up for one of the many Medicare Part D insurance plans found that they were not on the federal computerized list of subscribers system when they tried to refill prescriptions at their pharmacies.

About 20 states including California, New York, Pennsylvania, Ohio, and all New England have adopted emergency procedures to continue coverage of prescription drugs for low-income people previously on Medicaid.  Some have declared public health emergencies.

More stories about emergency coverage on Bloomberg,com and in the Los Angeles Times.

To compare Medicare prescription plans or enroll in one, you can visit Medicare’s web site.

Posted by Kate Murphy on January 16th, 2006
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Medicare coverage of off-label drugs in clinical trials: four trials now open

In January 2005, the Centers for Medicare and Medicaid Services made a National Coverage Decision (NCD) that they would cover off-label use of certain drugs if they were part of 9 specific NCI-sponsored clinical trials.  Trials include treatment for colorectal cancer, pancreatic cancer, cancer of the larynx, and gastrointestinal stromal tumors.The NCD covered drugs are:

• oxaliplatin (Eloxatin™
• irinotecan (Camptosar™)
• bevacizumab (Avastin™)
• cetuximab (Erbitux™)

Four of the nine trials are now open and recruiting patients according to the National Cancer Institute — four trials for colorectal cancer and one for patients with cancer of the larynx.  Plans for the other five trials — one for metastatic colorectal cancer, two for rectal cancer, one for pancreatic cancer, and another for gastrointestinal stromal tumor are currently in the process of being reviewed for approval by the NCI.

Trials recruiting patients now include

• A nationwide randomized phase III trial for patients who have not yet received chemotherapy for metastatic colorectal cancer comparing FOLFIRI or FOLFOX combined with (1) bevacizumab (2) cetuximab or (3) both bevacizumab and cetuximab.  NCI information for C80405.
• A phase II trial for patients newly diagnosed with metastatic colorectal cancer.  Chemotherapy regimens will be based on levels of the enzyme thymidylate synthase (TS) expressed by the individual patient’s tumor.  Patients with high levels of TS will randomly receive either (1) bevacizumab, oxaliplatin, and irinotecan or (2) bevacizumab and FOLFOX.  Those with low levels of TS will receive bevacizumab and FOLFOX.  NCI information for E4203.
• A randomized phase II trial for patients with high risk stage II colon cancer after surgery to remove the colon tumor (adjuvant therapy).  Patients will be randomized to receive either (1) FOLFOX or (2) FOLFOX with bevacizumab. NCI information for E5202.
• A randomized phase III trial that compares radiation therapy for cancer of the larynx without and without cetuximab.  NCI information for RTOG-0522.

The National Cancer Institute’s cancer.gov clinical trials listings provide detailed information about the study protocols, who is eligible for each study, where the study is being conducted, and who to contact for enrollment.

Centers for Medicare and Medicaid Services will continue to cover the four drugs for treatment that includes:

• Uses that are part of the FDA approved label.
• Uses supported by one of the recognized reference lists of drugs (compendia)
• Off-label use that has been determined by a local Medicare contractor to be medically acceptable.

Since 2000, Medicare has covered the routine patient care costs during clinical trials.  In addition, some insurance plans pay for such care.  A number of states now require insurance to cover routine care costs during cancer clinical trials.  Routine care includes usual medical care such as doctor visits, hospital stays, tests and similar services that patients would receive even if they were not in a clinical trial.  Special research requirements such as data collection or unusual testing necessary for the clinical trial only are usually not covered by either Medicare or insurance but are frequently paid for by the clinical trial program itself.  NCI has additional information about Medicare and cancer clinical trials.

Posted by Kate Murphy on January 16th, 2006
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NCI Comments on Its FY 2006 Budget

Last month Congress passed and the President signed the fiscal year (FY) 2006 Labor-HHS approriations bill. The following article from the January 1, 2006 edition of the NCI Cancer Bulletin gives us NCI’s view on the effect of the reduced funding the bill provides:

FY 2006 NCI Budget Update

On December 30, President Bush signed the appropriations bill for the Departments of Labor/HHS and Related Agencies for fiscal year 2006. The bill includes $28.6 billion for NIH and $4.842 billion for NCI. However, there is a 1 percent across-the-board reduction that reduces the NIH and NCI budget amounts by $286 million and $48 million, respectively. The revised amount for NCI is $4.793 billion, which is $32 million less than what NCI obligated last year.

In a message to NCI staff, NCI Deputy Director Dr. John Niederhuber noted that “Over the past few years, we have become accustomed to adjusting to budget constraints and the current year is no different. It remains critical that we continue to engage in careful planning, monitoring, and reporting of progress made towards NCI’s challenge goal to eliminate the suffering and death due to cancer. NCI’s Strategic Priorities are a clear signal of where we will be focusing our valuable resources in the year ahead and beyond.”

Click here to read the original article.

Posted by Dusty Weaver on January 13th, 2006
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Clinical Trial Open: Vaccine therapy after resection of liver mets

 Vaccine Therapy in Treating Patients With Liver Metastases From Colorectal Cancer

A clinical trial for people with colorectal cancer who have had surgery to remove liver metastases is actively enrolling patients at Duke Comprehensive Cancer Center in Durham, North Carolina.  After surgery, patients in the study will be randomized to receive vaccine therapy in one of two ways.

• Arm 1:  Patients will have some white blood cells removed from their blood and the dendritic cells treated in the lab with the two vaccines being used for the trial (PANVAC-V and PANVAC-F). On the first day of trial treatment, patients will receive their own dendritic cells, which have been treated with PANVAC-V, by an injection under the skin (autologous DC).  On the second day, autologous dendritic cells treated with PANVAC-F will be injected.  The second-day treatment will be repeated 1, 7, and 11 weeks later.
• Arm 2:  Patients will not have dendritic cells removed and treated for autologous injection.  Instead they will receive PANVAC-V on the first day of treatment and PANVAC-F at the beginning of the 4th, 8th, and 12 weeks. They will also receive  receive sargramostim (GM-CSF) for three days at the time of each vaccine treatment. 

The goal of the phase II clinical trial is to compare disease-free survival for two years after liver resection using two different approaches to vaccine therapy.

To be eligible for the trial a patient must:

• Have confirmed liver metastases from colorectal cancer.
• Have had surgery to remove those liver mets completely — no evidence of remaining cancer.
• Have completed up to 6 months of chemotherapy within the previous 1 to 3 months.
• Not have had their spleen removed.

The National Cancer Institute clinical trials database health professional version has more specific requirements for trial participation.

Patients may also want to see the NCI patient version of the trial.

PANVAC-V is vaccinia-CEA-MUC-1-TRICOM vaccine.  PANVAC-F is fowlpox-CEA-MUC-1-TRICOM vaccine  Both are used in both arms of the trial.

For more information or to enroll contact:

• Michael Moore, MD
•  919–681–3480
• Duke Comprehensive Cancer Center

You may also want to use the C3 Clinical Trials Matching Service at 1–866–278–0392.

Protocol ID: 
DUMC-5883-04-6RO
NCT00103142

Protocol Title:  Phase II Randomized Study of Adjuvant Vaccine Therapy Comprising Vaccinia-CEA-MUC-1-TRICOM Vaccine (PANVAC-V) and Fowlpox-CEA-MUC-1-TRICOM Vaccine (PANVAC-F) Administered With Autologous Dendritic Cells or Sargramostim (GM-CSF) in Patients With Completely Resected Hepatic Metastases Secondary to Colorectal Cancer

Posted by Kate Murphy on January 9th, 2006
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Elizabeth Parcells 1951-2005

Our dear friend Elizabeth Parcells died on December 29, 2005 at home with her family, in the way she had so very much wished.  Elizabeth’s courage and sheer joy has encouraged all of us on the ACOR Colon Discussion List as she moved with grace and dignity through the last months of her life.  She kept her sense of humor, her optimism, and her willingness to share both difficult times and better days.

A concert soprano, she made her last work putting her music up on a web site where it could be freely enjoyed by everyone and where she could continue her work to make people aware that colorectal cancer was preventable through screening.

In February, 2005 she returned to the concert stage at Carnegie Hall after two years of struggling with colorectal cancer.  She had decided to make that performance an opportunity to spread the word about colorectal cancer.  She had ordered enough blue buddy bracelets for the entire audience.  Afterwards she wrote:

Before I began to sing, I made a few remarks.  I thanked Pro Musicis Foundation for their faith in me over the years, and especially when they invited me to sing in spite of my cancer situation.  Then I spoke directly to my audience and told them that I had a very personal message and a gift for each one of them.  I asked them to be aware that colon cancer can be treated early and even prevented by a colonoscopy, that there was a buddy bracelet for each of them to remind them or a loved one of this, to get the bracelet, to wear it for me, and get the test for themselves.  I added that if my initiative saved but one life, it would all be worth it.

When I came back on stage after the intermission, it was a joy to see a blue bracelet on every wrist in the hall!

Of all the triumphs I could wish for as a singer and a human being, this was the greatest moment of all.

 Her family has added a memorial page to her website where stories and memories of Elizabeth can be shared.  Send messages to Charlie Parcells, and he will post them there.

The funeral will be held on January 4, 2005 at the Jefferson Avenue Presbyterian Church in Detroit, Michigan.  Calling hours are from 2 to 9 p.m. on January 3rd at the Verheyden Funeral Home, 8325 East Jefferson Avenue, Detroit.

An obituary for Elizabeth — or Betsy as she was known in the musical world — appeared in the January 8th edition of the *Boston Globe.*

Posted by Kate Murphy on January 1st, 2006
Posted in: Research & Treatment News | No Comments »