House Public Health Committee – March 24, 2015 Hearing

The committee met to take up and consider bills. This report focuses on the bills listed below.
 
 
HB 21 – Kacal, Relating to authorizing patients with certain terminal illnesses to access certain investigational drugs, biological products, and devices that are in clinical trials.

• Compassionate use bill
• The process is a misnomer given all the obstacles patients encounter while trying to obtain certain drugs
• Terminal patients must apply for usage of experimental drugs and it may take a very long time
• The bill does not require that a manufacturer provide a drug to a patient and may ask patients to pay for the cost of the treatment
• Naishtat asked if the FDA has recently revamped the application process so it takes less time
  • Have heard that they have changed the application to a one page form
• Zedler asked if any other states have passed this type of legislation
  • Yes; other witnesses will prevent that information

 
Dr. Charles Levenback, MD Anderson

• In support of the bill
• Discussed the story of Andrea Sloan’s treatment
• All stakeholders want the same thing; as many patients as possible who have a clear need should get access to whatever drugs may be able to help them
• Crownover asked how carefully the FDA tries to ensure drugs are safe but not delayed too long
  • The FDA approves most of the requests that they get but the number of requests they get is rather small
• Zedler asked what the different phases are
  • Phase I is a new drug or new combination, if it is determined they are safe they move to Phase II, if they look promising based on those trials they go to Phase III which is a much larger human trial
• Zedler asked how long the process can take; a decade
  • Yes; very long
• Zedler asked if this bill aids clinicians in helping their patient get access to a drug by sidestepping a lot of the paperwork
  • Not exactly sure how the bill works
• Crownover asked if right to try will inhibit TMB from ensuring patients’ safety
  • Don’t believe so; clinicians would be failing in their duties if they suggested any drug; they will use their best judgment to determine what drugs may be beneficial; if TMB determined there was malpractice or poor judgement they should use their abilities to reprimand that clinician
• Crownover asked how drug companies play into this
  • They want to help people but it isn’t one size fits all
• Zedler asked if compassionate use had been available for Sloan would she still be alive
  • She had a terminal illness by the time compassionate use was considered and it was hard to imagine anything would have helped; if she would have received it sooner it could have helped more
• Naishtat supports the bill and asked about false hope
  • There is hope that novel therapeutics have a chance to help patients; every situation is different

 
Kurt Altman, Goldwater Institute

• In support of the bill
• Drafted the model legislation this and other laws are based on
• This type of legislation has been passed in multiple states and is on the way to passage in many more; passed in five states last year
• Discussed the FDA process; Sloan received approval in about 30 days which is very fast; usually takes about 2-4 months in very time sensitive situations
• The new FDA proposal is to limit the approval process from 100 hours to 45 minutes
• Right to try is really about giving patients control over their lives at times when the really need it
• The law allows companies to recoup their expense for the product but does not allow them to make a profit; this law indicates that they manufacturer may provide it for free but allows for their recoupment

 
Mary Robinson, TMB

• Testifying on the bill
• There is an immunity provision in the bill that states TMB may not take action against a provider who makes these drugs available to their patient
• Collier asked if there is a possibility that some type of rebuttable presumption could be used if a drug was used outside of its medical purpose
  • There could be language created for any situation
• Crownover asked if there is any way to distinguish a difference between gross negligence and well-intended use
  • Yes; not aware of any case where TMB took action against a physician who provided a drug within the standard of care
• Naishtat asked about standard of care
  • Altman replied that the immunity in these laws are every narrow; they allow immunity for adverse effects of the investigational drug so that practitioners and manufacturers are not subject to the effect of adverse effects; doctors must still practice within the standard of care
• Naishtat asked if there have been any issues related to that clause in implementations
  • Not that the witness is aware of
• Blanco asked about patient outcomes
  • At this point the laws are very new so there is no study of outcomes

 
Will Decker, Texans for Stem Cell Research

• Testifying on the bill
• The bill will do a lot of good things but there could be unintended consequences if some things are not do ne to the bill
• Have to recognize that not every doctor in Texas is as experienced as Dr. Levenback
• The bill needs to be crafted in such a way that is assists the average doctor in taking care of the average patient
• Terminally ill patients should have the right to do what they want but the assets of those patients should be protected; do not want to give these patients false hope
• 97% of drugs that make it through Phase I will not make it past efficacy testing
• Need to worry about average doctors being persuaded by pharmaceutical companies to push drugs based on making profit
• Patients should not be asked to pay more than the base cost of a drug
• Would like to include a provision to deny drugs to be covered by this process if they show an absence of efficacy
  • If a drug does not show efficacy in the first 20 patients it should not be continued in compassionate use
• Really like the bill and it has the possibility to do great things but it needs to be done responsibly
• Naishtat asked about the vague language in that provision
  • Crafted it deliberately vague so that if there is any fragment of a possibility that there is efficacy that they can continue to be used

 
David Bales, Texans for Stem Cell Research

• Main goal from the beginning was to push the FDA to fund more clinical trials
• Did not get information from the Medical committee to bring to bill authors until recently; planning to work with authors to try and get their language included

 
Michelle Wittenburg, Friend of Andrea Sloan

• Discussed the reasons Phase I was chosen; if a drug is past Phase I safety has been proven
• Phase II determines efficacy and drugs take much, much longer to get past this milestone
• Working very hard to make people aware of compassionate use but, effectively, the people who are going to be suggesting compassionate use are not going to be doctors outside of the MD Andersons of the world
• Zerwas noted when he was deciding on treatment for his wife they chose MD Anderson because that’s where trials were being done; there was potential for a compassionate use at one point and the feeling was that it would not be worth trying because it is so difficult to achieve; very glad Kacal brought the bill forward; it will not compromise Phase II trials; these are situations where people are clinging to the last possibility of hope
• The FDA does not track efficacy through the compassionate use process because patients are in the last phases of hope
• Blanco asked Decker back
  • Decker noted everyone is saying the same thing; need to have some signs of efficacy in Phase II; not being paid to be here; not a lobbyist; here for the well-being of the citizens of Texas; would be happy to change language to an interim study; nobody would have been excited about the drug Sloan was given if there hadn’t been some signs of efficacy in Phase II; do not need to worry about the good pharmaceutical companies in these situations; need to worry about the bad guys who will be pushing their products; do not want to see patients taken advantage of
• Blanco asked how the 20 patients number was determined
  • If the first 20 patients fail then the odds a drug works is less than 5% and that is a general standard for efficacy
• Blanco asked if this pus patients without insurance at a lower chance for having compassionate use
  • Not sure insurance covers these types of things anyway
• Blanco asked if it puts poorer patients at a disadvantage
  • Poor people are disadvantaged in many areas of life; that is a reality but it isn’t reasonable to deny patients who can afford to pay
• Zerwas asked about previous comments
  • The history of medicine is fraught with fraud; the FDA is intended to protect desperate people from those trying to make money off of desperate people; if the bill is passed as it currently is written bad actors will try to take advantage of desperate people

 
Kacal Closed

• There is no such thing as false hope in these situations; these patients just want one more day with their loved ones
• When a patient is diagnosed as terminal time is of the essence
• Guerra commented that patients at the end of their lives should have the right to try therapies that may extend their lives

 
Bill left pending
 
HB 1945 – Greg Bonnen, Relating to the provision of direct primary care.

• Allows physicians to accept a fixed rate for treatment during a specified period of time
• Committee sub:
  • Adds language that an insurer or HMO should not be billed for direct primary care services under a direct primary care agreement; also covers workers compensation
• Crownover asked for a walkthrough
  • May have a high deductible coverage then contract directly with PCP for primary care services; there is added value in that people may receive better care and it may be more efficient for providers and patients
  • What is being purchased are the primary care services so no other services are involved; other care from other providers would be beyond the scope; still encouraged to carry insurance
• Crownover asked if the insurance does not cover the direct primary care in any way
  • That would be a fair assessment; the patient would receive a statement which could be given to an insurer and may or may not be covered; for the most part what you have paid for in your contract for primary care would not be billed by the provider to the insurer
• Coleman asked if the fee to be part of the doctors group could apply to a deductible under insurance
  • Probably not; this is new territory so unsure; this is not an insurance product so it should not be treated as such by the state
• Coleman noted the care is not insurance and not paid for by insurance but if it could be included in their deductible it would be a benefit; more of an expenditure made for direct primary care
  • Bonnen noted expenditures outside the purview of the contract could be requested to the insurer for compensation and this might be eligible for reimbursement as well
• Coleman believes there could be some value if it is possible to have the expenditure put toward a deductible
• Crownover asked if this is being done in any other state
  • It is becoming more common in practice and because of that the relationship needs to be clarified in statute
• Crownover asked what the difference is between direct primary care and concierge care
  • This is more what an average person would need or want in primary care services and concierge care is more than that; in concierge care a person could ask for a provider to go on vacation with them or allow for services to be available 24/7
• Blanco asked if there would be citizenship requirements
  • Do not believe so; health care providers do not generally ask those types of questions in practice
• Naishtat asked prohibiting interference in the bill; prohibits TMB from initiating disciplinary action solely for providing direct primary care to patients
  • Does not speak to quality of care or whether care was provided competently; prevents a cause of action for using this business model

 
John Davidson, Texas Public Policy Foundation

• In support of the bill
• Today there are about 4,600 direct primary care practices in the US
• Coincides with ACA regulation, physician access issues, physicians wanting to shift their business model to a model where they can spend more time with current patients and see fewer patients
• Model has multiple benefits including fewer hospitalizations, specialist visits, surgeries and ER visits; patients that choose this model get a far higher quality of quality care
• It has been found that this model brings cost savings for clients
• ACA does have provisions that acknowledge the existence of this type of business model
• Other states have laws acknowledging this as well giving physicians certainty that they can enter into these agreements
• Goes a long way to restoring the relationship between physician and patients
• Coleman asked if there are any safeguards for high-need patients to ensure they have the opportunity to participate
  • Yes; this model is arguably tailored toward people with chronic conditions that need to be managed in order to avoid costlier care; they may have a higher monthly subscription rate but that would be worked out between the patient and the physician
• Naishtat asked if this agreement is allowed in law now
  • Yes; this bill provides a level of regulatory certainty on the part of the physician ; nothing prohibits this now

 
Chris Larson, Texas Academy of Family Physicians

• In support of the bill
• Opened a direct primary care practice because prevention is the most effective method of ensuring health
• Prevention takes time and time is not a commodity that fee for services doctors have
• Most PCPs have to write prescriptions or refer to specialists because of the lack of time to discuss real issues with patients
• Zedler made the point that this helps with coding and billing issues with insurance
• Sheffield asks how this differs from concierge medicine
  • Difference in price points and likely a difference with the relationship with insurance companies

 
Mary Robinson, TMB

• Naishtat asked if this compromises TMBs ability to do their duties
  • Don’t really see any affect this would have on TMB action

 
Bonnen closed

• The real value is the protection of the sanctity of the business model
• Simply codifies the business model

 
Bill left pending
 
HB 2171 – Sheffield, Relating to information maintained in the immunization registry with the consent of an individual after the individual becomes an adult.

•  Information is maintained with the consent of an individual after they become an adult
• ImmTrac is a useful tool that serves as a resource in the event of a public health emergency
• When a child turns 18 the information is expunged and is usually needed when a child enrolls in college
• There are many reasons why vaccination records are necessary
• This bill will extend the time the information is kept from 18 years of age to 26 years of age
• Does not impact families who have never consented to be in the ImmTrac registry
• Crownover asked if the bill requires anybody to become vaccinated
  • No
• Crownover asked if it requires anyone to be in the ImmTrac registry
  • No

 
Anna Dragsbek, Immunization Partnership

• In support of the bill
• Extending the age that records are maintained will give an opportunity to kids who do not realize the importance of this registry when they are so young

 
Reed King, Self

• Against the bill
• This bill is about the control of information

 
Patrick Hodges MD, March of Dimes

• Extending the age from 18 to 26 will ensure these young people have the information available when they need it

 
Lindsay Schibe, Self

• Against the bill
• Allows expired parental consent to count for adult consent from the ages of 18 to 26
• HB 2171 does not set a time for response before a person’s data is expunged
• This bill sets a dangerous precedent for assumed consent

 
Maria Perez, Self

• In support of the bill
• Discussed the issues that arise when a young person wishing to enroll in college cannot find their immunization record

 
Chelsea Barlow, Self

• Against the bill
• Concerned that a doctor only needs to put forth reasonable effort to contact a young person

 
Roberta Mercer, Self

• In support of the bill
• At age 18 young adults are not thinking of their health or the importance of maintaining their immunization records

 
Dianne Doggett, Self

• Against the bill
• 17 year old son with autism
• Common perception that vaccines cause autism within the autism community
• This bill makes the autism community feel attacked – it is just one more way the state can vaccinate kids with autism without parental consent
• State is required to give notice, but if you cannot reach 18 year old, consent is considered presumed

 
Shopa Fuller, Texas DNP Society

• In support of the bill
• Can decrease the repetition of vaccine injections

 
Dawn Richardson, National Vaccine Information Center

• Against the bill
• The bill is in conflict of Occupations Code Sec. 159.005 which deals with adult consent
• Young adults may be young but they still have rights that need to be protected

 
Courtney Sherman, Texas DNP Society

• In support of the bill
• Many times parents have to scramble when getting their children ready for college because their records on ImmTrac were purged

 
Judy Powell, Parent Guidance Center

• Against the bill
• Do not want to extend parental rights and trump their adult children’s rights
• Bill creates a separate registry for people 18-26 for whom additional consent has not been received

 
Ryan Van Ramshorst, Texas Pediatric Society

• In support of the bill
• Keeping a record of vaccines for school use, preventing public health emergencies and preventing duplicate vaccines is very important

 
Michelle Schneider, Texans for Vaccine Choice

• Against the bill

 
Dragsbek returned

• It is not the physician’s duty to contact people about re-consenting their participation on ImmTrac; it is DSHS’s responsibility
• There is no assumed consent in the bill; the data is simply protected until it is either re-consented or expunged

 
Bill left pending
 
HB 2474 – Sheffield, Relating to requirements for and the transparency of epidemiological reports and immunization exemption information and reports.

• Parents have a right to know information that is vital in protecting their children from disease
• Bill would require de-identified immunization information available at the campus level of school districts
• Information does not include name, birthday, age or any other identifying information, just percentages
• Naishtat asked if the bill will require more work for schools or districts
  • They will use the same form but system reporting is different
• Naishtat asked if any type of lists will be created
  • Only aggregate amounts of vaccine exemptions will be tracked by schools and districts; information will also be suppressed if there are small numbers of children in a campus
• Crownover asked if the information will be split up by classroom
  • No

 
Anna Dragsbek, Immunization Partnership

• The bill does not breach anyone’s privacy
• Schools aren’t being asked to do anything new; the information is just reported differently
• This bill protects fragile children

 
Judy Powell, Parent Guidance Center

• Against the bill

 
Ryan Van Ramshorst, Texas Pediatric Society

• In support of the bill
• Support more comprehensive epidemiological reporting
• Increasing public awareness is extremely valuable
• Parents have the right to know of vaccine objectors in their children’s schools; this is extremely important for children who cannot have their children vaccinated because of immune system issues
• Zedler asked what could be dine once the information is received
  • If there is a high exemption rate at a certain school a parent may choose to send their child to a different school

 
Reed King, Self

• Against the bill
• Concerned about the release of information at a more personal level than is required by law
• Bill could create a situation where children are ostracized because of the data being released

 
Shawn Siegel, Self

• Vaccines can be dangerous to children

 
James Swan, Self

• In support of the bill
• Lost his immune system and the effect of vaccines when he had a bone marrow transplant and chemotherapy
• It is important for people other than parents to know where a large amount of vaccine exemptions are; old people and sick people can be affected by people without vaccines as well
• Zedler asked if he found out a school near him had a high exemption rate what he would do
  • Perhaps just try to avoid children and participate in fewer community activities

 
Dawn Richardson, National Vaccine Information Center

• Against the bill
• California has similar legislation to the bill being proposed; starting to see angry parents lashing out
• It is easy to determine which children aren’t vaccinated and this bill will pit parent against parent
• Numbers of children who are delinquent on vaccines and provisionally enrolled are far higher than the children with exemptions and immunologically the same
• We do not publicize the numbers of children who are infected with particular viruses
• Davis asked if the witness would be supportive if the language was more specific and lined out which vaccine exemptions are given
  • Maybe the state should require reporting for workplaces, airports, etc

 
Courtney Sherman, Self

• In support of the bill
• Parents deserve to have information such as is suggested in the bill

 
Chelsea Barlow, Self

• Against the bill
• Targeting unvaccinated populations and presenting them as a health risk is a disservice to all parents

 
Lindsay Schibe, Self

• Against the bill
• There is much more information that would be more relevant to parents choosing their children’s schools than just a percentage of children with vaccine exemptions

 
Jill Guerero, Self

• In support of the bill
• Son has leukemia and cannot get vaccinated
• Need to know were potentially unvaccinated children are

 
Michelle Schneider, Texans for Vaccine Choice

• Against the bill

 
Patrick Hodges MD, March of Dimes

• In support of the bill
• The bill isn’t perfect but it is a good start
• Will definitely help parents of immunocompromised children feel more comfortable about where their children attend school
• Zedler noted because the list does not identify which vaccines children have received either more information needs to be provided or no information at all

 
Gina DeHoyos, Self

• Bill could give a false sense of security

 
Shopa Fuller, Texas DNP Society

• In support of the bill
• Making data available is crucial to improving population health

 
Kelly Patson, DSHS

• Resource witness
• Sheffield asked about the FERPA issue mentioned earlier
  • As long as data is provided in aggregate the bill does not go against FERPA regulations

 
Sheffield closed

• Parents have the right to information as long as privacy is protected

 
Bill left pending
 
Pending Business
 
CSHB 751 – Zerwas, Relating to the prescription and pharmaceutical substitution of biological products.

• Adopted unanimously as substituted

 
CSHB 1282 – Zerwas, Relating to a human papillomavirus-associated cancer strategic plan developed by the Department of State Health Services.

• Adopted unanimously as substituted
• Sent to local calendar