Alexander Calls For Administration To Clarify Position On Patient Access To Personal Health Information

Thursday, February 20, 2014

Senator Lamar Alexander on Thursday asked Health and Human Services Secretary Kathleen Sebelius to clarify the administration’s position on patient access to personal health information.

The FDA last year said in a warning letter to genetic test maker 23andMe it was taking action to stop the company from marketing certain tests directly to consumers that FDA does not trust individuals with test results, that there is a “risk that a direct-to-consumer test result may be used by a patient to self-manage.”

Earlier this month, Secretary Sebelius said in an HHS press release, “Information like lab results can empower patients to track their health progress, make decisions with their healthcare professionals, and adhere to important treatment plans.”

In a letter to Secretary Sebelius, Senator Alexander said, “Some centers within your department seem to be in agreement with the goal to make personal health information available directly to consumers, as shown by the final rule allowing clinical laboratories to give complete test reports directly to patients, published by the Office of Civil Rights, Center for Medicare and Medicaid Services, and Center for Disease Control and Prevention.  …However, your statement and the final regulation appear to be in direct conflict with the Food and Drug Administration’s warning letter from November 22, 2013, to 23andMe, Inc., a direct-to-consumer genetic testing laboratory.  FDA stated one reason it was taking action to stop 23andMe is that FDA does not trust individuals with test results, because results are not adequately understood by patients.”

Senator Alexander said the conflict “will slow down the access to or availability of novel diagnostics and targeted therapies.” He added, “Targeted drug therapies rely on the availability of a wide array of diagnostic products, and consumers who want to take control of their health should have the right to their personal information to help in making personal health care decisions.”

Senator Alexander asked Secretary Sebelius to state the HHS position on greater direct access to personal health information for patients and also requested the criteria used to evaluate the types of tests indicated in the conflicting statements.

The full text of the letter is below:

February 20, 2014

The Honorable Kathleen Sebelius

Secretary of Health and Human Services

U.S. Department of Health and Human Services

330 Independence Avenue, SW

Washington, DC 20201

Dear Secretary Sebelius:

I write today to ask for clarity on conflicting decisions made by your Department regarding consumer access to personal health information.  This is the information age; individuals should have direct access to personal health information, and federal policies should clearly support that goal. Recent actions by the Food and Drug Administration (FDA) indicate a resistance to the importance of personal health information. 

Some centers within your department seem to be in agreement with the goal to make personal health information available directly to consumers, as shown by the final rule allowing clinical laboratories to give complete test reports directly to patients, published by the Office of Civil Rights, Center for Medicare and Medicaid Services, and Center for Disease Control and Prevention.[1]  In a press release on February 4, 2014, you stated, “Information like lab results can empower patients to track their health progress, make decisions with their healthcare professionals, and adhere to important treatment plans.”[2]  However, your statement and the final regulation appear to be in direct conflict with the Food and Drug Administration’s warning letter from November 22, 2013, to 23andMe, Inc., a direct-to-consumer genetic testing laboratory.  FDA stated one reason it was taking action to stop 23andMe is that FDA does not trust individuals with test results, because results are not adequately understood by patients. FDA cautioned: “risk of serious injury or death is known to be high when patients are either non-compliant or not properly dosed,” and there is a “risk that a direct-to-consumer test result may be used by a patient to self-manage.” [3]

These are two conflicting actions from your Department in just a few months’ time and raise questions about your agency’s commitment to making personal health information available to support medical innovation. The conflicting decisions coming from agencies within your Department will slow down the access to or availability of novel diagnostics and targeted therapies.  Targeted drug therapies rely on the availability of a wide array of diagnostic products, and consumers who want to take control of their health should have the right to their personal information to help in making personal health care decisions.

What is your Department’s position on greater direct access to personal health information for patients? Further, please describe what criteria were used to evaluate the types of tests described in these two actions that resulted in such opposite outcomes.

I appreciate your prompt attention to this request. If you have any further questions, please have your staff contact Grace Stuntz or Alicia Hennie on my staff at (202)-224-6770.

Sincerely,

Lamar Alexander

Ranking Member, Senate Committee on Health, Education, Labor, and Pensions


Aledade Partners With Qsource To Create Primary Care Physician-Led ACO In Tennessee

Maryland-based Aledade, Inc. has announced a partnership with Qsource to help independent primary care physicians in Tennessee form and operate an Accountable Care Organization. Aledade partners with independent doctors to create and run ACOs, networks of physicians who band together to deliver coordinated care to patients.  They operate under a payment structure that rewards ... (click for more)

Department Of Health Southeast Regional Office, Grundy County Health Department Receive Awards

The Tennessee Department of Health Southeast Regional Office and the Grundy County Health Department were honored at the 22nd Annual Excellence in Tennessee Awards Banquet.  The Southeast Regional Office received the TNCPE Level 1 Interest Award which is the beginning level for organizations interested in adopting and applying performance improvement principles.  Grundy ... (click for more)

Robber Is Shot By Victim In Attempted Robbery On East 43rd Street

One person was shot during a robbery attempt at 4314 Rossville Blvd. around 1:50 p.m. on Thursday.  The Chattanooga Police Department is investigating the robbery that ended in a shooting near East 43rd St. at Miller Auto Sales.  The robbery victim shot the suspect.  The suspect was taken to the hospital for treatment of injuries. Chattanooga ... (click for more)

Fire On Crutchfield Street Ruled Arson

Chattanooga fire investigators have determined that last Thursday’s fire at 1207 Crutchfield St.  that nearly killed four people was deliberately set. Lt. Henry McElvain with the Fire Investigation Division said he cannot divulge the reason why he thinks it’s arson, but he is asking for help from the public. If anyone has information that can help solve this case, call ... (click for more)

The Problems With Prescription Drug Addiction

In Tennessee today, we have a major problem with prescription drug addiction, particularly when powerful opioid pain relievers are concerned.    For the first time in 2012, Tennesseans abused prescription opioid drugs more than alcohol.  Our young people ages 18-25 abuse prescription opioids at a 30 percent higher rate than the national average.  In just five ... (click for more)

Roy Exum: I Recall J.C. Owens

If you were to go to Oakville, Ala, a little ways from Decatur, about the biggest thing you’d find would be some 20 or so Indian mounds, where the early tribes would bury their dead many centuries ago. But if you sniffed around a bit, you’d learn it was the birthplace of James Cleveland Owens, a man whose name is of no consequence to anyone. I’m proud to say I talked to him ... (click for more)