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



Erlanger Health System Hosts 5th Annual OBGYN Conference In March

Registration is open for the fifth annual Erlanger Health System OBGYN Conference for nurses and physicians on  March 8 and 9 . This year, the conference features key note speaker Lisa A. Miller, CNM, JD founder of Perinatal Risk Management and Education Services (PREMES). Ms. Miller, a certified nurse-midwife for more than 30 years and an attorney since 1990, has ... (click for more)

Tennessee Department Of Health Announces 8 Pediatric Deaths And 1 Pregnancy-Related Death Due To The Flu

The Tennessee Department of Health has been notified of eight pediatric deaths and one pregnancy-related death associated with seasonal flu during the 2017-2018 flu season. Officials said, "We continue to send our deepest condolences to the families who have lost a loved one due to influenza."   Free flu vaccine is still available at all TDH public health clinics, ... (click for more)

1 Person Killed In Accident Involving 18-Wheeler On Ochs Highway

One person was killed Saturday morning on Ochs Highway. Another person in the same vehicle was taken to the hospital. An 18-wheeler was coming down the mountain, and hit three cars traveling up the mountain. Ochs Highway was closed in both directions, and HAZMAT crews were at the scene. The wreck happened at mid-morning. (click for more)

Hixson Home Destroyed By Fire Early Saturday Morning

A home was destroyed by fire early Saturday morning in Hixson. Around  2:30 a.m. , the Dallas Bay Volunteer Fire Department responded to a possible house fire at  904 Wesley Drive  in Hixson. When the first unit arrived on the scene, they reported the second floor of the home was completely engulfed with fire. Firefighters conducted a defensive ... (click for more)

Six Things We Can Do About Mass Shootings

All politics aside, the recent shooting in Florida, and every other shooting in a public place, is a senseless and, possibly, preventable tragedy. It is absurd that we can’t gather in a free society without the fear of some nut job or terrorist using us as targets.   And then the cries of “do something!” from every quarter. But, other than the obvious attempt by agenda-pushers ... (click for more)

Roy Exum: The Saturday Funnies

It wasn’t lost on me that during Valentine Week, when we most remember those we love, this first story was included in my weekly email. As has become my habit, every Saturday I try to come up with a new edition of The Saturday Funnies because I get some delightful ones that are shared by my friends during the week. We must never waste a giggle. So in keeping with my ... (click for more)