Nov. 14 Letter from Senator Pat Toomey re: 21st Century Cures, NIH & CDMRP

Dear Frank,

Thank you for taking the time to contact my office about the 21st Century Cures Act. I appreciate hearing from you.

There are currently over 7,000 rare diseases but fewer than 500 FDA-approved cures or treatments. New life-saving therapies are being discovered every day at Pennsylvania's leading medical institutions, but standing in the way of bringing these cures to market are multiple federal barriers. That is why I introduced along with Senator Bob Casey (D-PA) the Preserving Access to Orphan Drugs Act (S. 1128, 113th Congress). Our bill removes Obamacare taxes known to discourage drug makers from producing therapies used solely to treat rare conditions, since the pool of potential beneficiaries of these drugs is significantly smaller than in other diseases.

Specific to your concerns, Representative Fred Upton (R-MI) introduced H.R. 6 on May 19, 2015. Among its provisions, this legislation increases funding for the National Institutes of Health, requires the Food and Drug Administration to incorporate patient perspectives into the regulatory processes, authorizes a new set of standards for medical technology, and seeks to expedite clinical trials in order to bring safe and effective drugs to market.

On July 10,2015, the House passed H.R.6 in a 344-77 vote. It is currently pending before the Senate Committee on Health, Education, Labor and Pensions, which is now working on similar legislation. Please be assured that I will keep your thought in mind as this measure makes its way through the Senate..

Thank you again for your correspondence. Please do not hesitate to contact me in the future if I
can be of assistance.


Pat Toomey
U.S. Senator

Response from Congressman Tim Murphey Regarding 21st Century Cures, HR6

November 21, 2016

Dear Mr. Austin,

Thank you for contacting me and expressing your concern regarding medical research and funding. I appreciate hearing from you on this very important topic and for the opportunity to provide you with an update on my work to support research into medical advancements and therapies.  

With health care innovation advancing at lightning speed, it is critical that our policies reflect and support medical breakthroughs and not lag behind life-saving cures. Towards that end, in 2013 the House Energy and Commerce Committee, on which I serve, started a multi-year initiative called “A Path to 21st Century Cures” to bring together stakeholders to discuss how Congress can help accelerate the discovery, development, and delivery of promising new treatments for patients. Through the Cures process dozens of hearings and roundtables were convened, some right here in Southwestern Pennsylvania, seeking input and soliciting ideas from patients, providers, and researchers. Many of the participants in those events echoed my frustration that government red tape is stymying medical innovation and patients’ access to potentially lifesaving treatments. For example, I heard from a local pulmonary fibrosis (PF) patient who saw a new medication that would help treat PF delayed by the Food and Drug Administration’s approval process for over two years, despite the drug receiving universal acceptance for efficacy and safety. 

In 2015 based on the information and lessons learned in that process, we drafted H.R. 6, the 21st Century Cures Act which will bring our health care innovation infrastructure into the 21st Century, delivering hope for patients and loved ones and providing necessary resources to researchers to continue their efforts to uncover the next generation of cures and treatments. You can learn more about this process and the legislation atEnergyCommerce.House.Gov/Cures. 

By improving and modernizing our nation's drug and treatment approval process, we will be helping patients with all types of uncured conditions.  In order to ensure that progress continues in the fight against cancer and other life-threatening diseases. I have long been a supporter of research into specific cancers and diseases, and full funding for NIH is an important step to ensure that lifesaving research continues. As Chairman of the House Energy and Commerce Subcommittee on Oversight and Investigations, I have sought to maximize NIH dollars for medical research. Towards that end, I have tasked the Government Accountability Office with conducting a review of university “indirect cost” rates for NIH-funded research projects. This report will ensure taxpayer grant money is used for research and not wasted on overhead expenses like administrator salaries and building construction that are the responsibilities of the institutions receiving the grants.  

It is an honor to represent you and Pennsylvania’s Eighteenth District in Congress. To stay in touch with what I’m working on and latest news from Congress, you can follow me on Twitter @RepTimMurphy or you can find me on Facebook at www.facebook.com/RepTimMurphy. I also encourage you to sign up for my e-newsletter by visiting www.murphy.house.gov.

Sincerely,

Tim Murphy
Member of Congress

Senator Casey on HR6 & 21st Century Cures

Dear Mr. Austin:

Thank you for taking the time to contact me about medical innovation legislation in Congress. I appreciate hearing from you about this issue.

H.R. 6, the 21st Century Cures Act, was introduced by Representative Fred Upton of Michigan on May 19, 2015. To develop this bill, the Committee on Energy & Commerce in the House of Representatives held numerous hearings and received feedback from key stakeholders on how Congress can help to accelerate the development of new treatments and cures in the United States. The final bill included provisions addressing the full drug and device development process, from basic scientific research to the delivery of new treatments to patients. The 21st Century Cures Act passed the House on July 10, 2015, and has been sent to the Senate. It has been referred to the Senate Committee on Health, Education, Labor, and Pensions (HELP), of which I am a member.

Starting in early 2015, the HELP Committee began to develop its own proposal similar to the 21st Century Cures Act. The Committee held several hearings, and a number of bills have been introduced relating to this innovation agenda. The Committee held three executive sessions to consider nineteen of these bills; ultimately, many of these bills may be packaged together into a single proposal for consideration in the full Senate and eventual negotiations with the House to reconcile the differences between the two proposals.

Although the HELP innovation bills have been reported out of the Committee, discussions continue regarding whether they will be packaged together, whether some may advance independently, and what any final package will look like. Please be assured that I will remain involved in this process as it moves forward, and that I will keep your views in mind.

Again, thank you for sharing your thoughts with me. Please do not hesitate to contact me in the future about this or any other matter of importance to you.

For more information on this or other issues, I encourage you to visit my website, http://casey.senate.gov. I hope you will find this online office a comprehensive resource to stay up-to-date on my work in Washington, request assistance from my office or share with me your thoughts on the issues that matter most to you and to Pennsylvania. 

Sincerely,

Bob Casey

United States Senator

Medication moves from tier 1 ($14 copay) to tier 3 ($100 copay)...Thank You (NOT)

UPMC for Life

UPMC Health Plan Medicare Program

October 31,2016

7.10.2230 AT 0.274 92765DII.p06 179622743

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Address Deleted

Dear Mr. AUSTIN:

As health care costs continue to rise, UPMC for Life strives to improve the value and
affordability of the health care benefits we offer our members. One of the ways we do this is to make changes to the list of covered prescription drugs our members use. The list of covered prescription drugs is called a formulary. Our goal is to give you the most value possible for your money. In order to do this, we must sometimes change the drugs that are covered by our plan. Medications may be added or removed from the formulary. How a medication is covered may also be changed. All changes to the formulary are made with the help of our local doctors and pharmacists.

Effective January 1, 2017, UPMC for Life's coverage of dextroamphetamine/amphetamine

ER will move from a Tier 1 copayment to a Tier 3 copayment. Our records show that you

have used dextroamphetamine/amphetamine ER as prescribed by your doctor. Amphetamine/dextroamphetamine immediate tablet, dexmethylphenidate immediate release, dextroamphetamine immediate release, and methylphenidate immediate release work similarly to dextroamphetamine/amphetamine ER and are available at a lower copayment. You can continue to get dextroamphetamine/amphetamine ER in 2017 at a Tier 3 copayment. Or you can share this letter with your doctor and discuss trying a lower tier formulary medication.

To request an exception, contact Member Services at 1-877-539-3080, or ask your doctor to contact Pharmacy Services at 1-800-979-8762. You or your doctor can also fax your request for an exception to 412-454-7722. For more information about filing an exception, please see Chapter 9, Section 6 of your Evidence of Coverage CEOC).

You have the right to file a grievance if you disagree with our decision to change the tier of your medication. To file a grievance, please call UPMC/or Life Member Services at 1-877-539-3080. For more information about filing a grievance, please see Chapter 9, Section 10 of your EOC.

If you have any questions, contact UPMC for Life toll-free at 1-877-539-3080. TTY users should
call 1-800-361-2629. Our hours of operation change throughout the year. We are available to
take your call October 1 through February 14 from 8 a.m. to 8 p.m. seven days a week and
February 15 through September 30 from 8 a.m. to 8 p.m. Monday through Friday and from 8
a.m. to 3 p.m. on Saturday.

Sincerely,

UPMC for Life Pharmacy Services

The UPMC for Life HMO and PPO plans, the UPMC for Life Dual (HMO SNP) plan, and the
UPMC for Life Options (HMO SNP) plan have contracts with Medicare. UPMC for Life Dual
also has a contract with the Pennsylvania Medical Assistance (Medicaid) program. Enrollment in
UPMC for Life depends on contract renewal. UPMC for Life and UPMC for Life Options are
products of and operated by UPMC Health Plan Inc., UPMC Health Network Inc., and UPMC
Health Benefits Inc. UPMC for Life Dual is a product of and operated by UPMC for You Inc.

The formulary may change at any time. You will receive notice when necessary. This
information is not a complete description of benefits. Contact the plan for more information.
Limitations, copayments, and restrictions may apply. Benefits and copayments may change on
January 1 of each year. 

21st Century Cures

We are at a critical point for the 21st Century Cures Act. With limited days to pass the bill before year’s end, Congress must hear from you about why these policies are vital to people living with MS. 

Today we are joining thousands of activists who support this bill in a “day of action” to make sure our voices are heard on Capitol Hill. Together we are stronger! With this legislation, Congress can establish a data collection system to track the incidence and prevalence of neurological conditions, provide new funding for the National Institutes of Health and the Food and Drug Administration and create vital incentives to bring new treatments to patients. Further delaying this legislation will result in delays in the discovery, development and delivery of life-saving treatments. Join us and contact Congress today.

Department of Defense, CDMRP & MSRP Letter

The Department of the Army

Headquarters, U.S. Army Medical Research and Materiel Command

810 Schreider Street

Fort Detrick, Maryland, 21702-5000

November 4, 2016

Dear Mr. Austin:

On behalf of the Department of Defense, U.S. Army Medical Research and Materiel Command, Congressionally Directed Medical Research Programs (CDMRP), I would like to express our sincere gratitude for your exemplary efforts as a consumer reviewer for applications submitted for the fiscal year 2016 Multiple Sclerosis Research Program  (MSRP).  The continued success of this highly visible and competitive program is dependent on maintaining the highest standards of excellence in scientific peer review.  We recognize that you have responded generously with your time and valuable perspective to fulfill the demanding requirements of this peer review process.  Because of your hard work and dedication, the MSRP draws that much closer to fulfilling its mission.

Please know you have the thanks and appreciation from researchers, fellow consumers, and the entire CDMRP community.  If you have any further questions or concerns please contact our Public Affairs Manager, Gail Whitehead, atpatricia.g.whitehead4.ctr@mail.mil, or by phone at 301-619-7783.

 Sincerely,                                                 

Wanda L. Salzer, M.D.

Colonel, U.S. Air Force, Medical Corps

Director