John Culberson – U.S. House of Representatives

I am fully committed to repealing and replacing the Affordable Care Act. One of the very first votes I cast in the 112^th Congress was to repeal the new health reform law and instruct the committees of jurisdiction to begin work on finding common sense patient-centered replacement legislation.

It has been two years since the President signed the flawed Affordable Care Act into law. The last two years have brought us fewer jobs, higher health care costs, burdensome government regulations, and broken promises.

On March 13, 2012, the nonpartisan Congressional Budget Office (CBO) released new estimates on the cost of the president’s health care law, revealing a shocking new sticker price of $1.8 trillion.

The Affordable Care Act isn’t lowering the cost of health care for hard working Americans like the President promised. Middle class families are facing a $2,100 increase in annual health insurance premiums. The National Center for Policy Analysis has found that given recent trends, the employee contribution to a family health insurance premium plus out-of-pocket costs will comprise one half of the household income by 2031 and total household income by 2042!

We need to fix the broken network of government policies that have made such a mess of health care in America. Badly designed government policies are to blame for much of what is wrong with health care today.

It is imperative that we get the federal government out of the way and ensure that doctors and patients are making medical decisions.

What I Support

Fixing the Health Care Spending Problem

• At its core, the health care problem is one of inflation, driven by the overutilization of services, dramatic underpayments, and massive inefficiency.

• Most of the cost-containing tools that helped patients reduce their exposure to exploding costs, such as health savings accounts, were dismantled by the President’s health law.

• And that ultimately is where the President’s Affordable Care Act falls short. If you look at our debt-and-deficits problem, it really is a health-care spending problem. Today, excluding interest, approximately one-fourth of federal spending goes toward government health-care programs, such as Medicare and Medicaid.

• By the time my daughter reaches my age, the non-partisan Congressional Budget Office projects that the share of federal spending going to pay just for health care programs will reach 45 percent.

• There is no serious dispute – on either side of the aisle – that health-care inflation is the primary driver of our unsustainable deficits.
  • As President Obama put it, “If you look at the numbers, Medicare in particular will run out of money, and we will not be able to sustain that program no matter how much taxes go up.”
  • And Democratic officials will even admit that the primary driver of health-care inflation is the current structure of government programs.
    • As HHS Secretary Kathleen Sebelius recently testified regarding Medicare’s flawed fee-for-service structure, “I would say that the current fee-for-service system, yes, is unsustainable.”
    • So the disagreement isn’t really about the problem. It’s about how best to control costs in government health care programs.
      • House Republicans have a plan to empower patients.
      • The President’s plan empowers bureaucrats.

What I’ve Done to Address Current Health Care Issues

Drug Shortages

• Drug shortages have tripled since 2005 and reached a record-high of 178 last year, according to the FDA. Another record-setting pace has been set for 2011, with more than 89 reported in the year’s first quarter alone, according to a University of Utah Drug Information Service study.

• The shortages have caused patients to miss or delay chemotherapy or to get inferior antibiotics, anesthetics and intravenous nutrition.

• No patient should suffer because of a drug shortage that could have been prevented. I support a solution aimed at unwinding the regulations that created these scarcities in the first place.

FDA Reform

• America has consistently been on the cutting edge of health care innovation for decades. However, American companies are increasingly limited by burdensome FDA regulations that are driving some of the best innovators overseas.

• Tufts Center for the Study of Drug Development reports that clinical trials from 2003-2006 were nearly 70 percent longer than those from 1999-2002.

• According to the 2012 California Biomedical Industry Report, about 81 percent of life-sciences CEOs surveyed believe that within five years another country could recreate the ecosystem that has made the U.S. the leading biomedical region in the world.

• I cosponsored a package of ten bills put together by Energy and Commerce Republicans designed to reform the FDA and offer specific solutions that will increase patient access to vital devices.

• The Premarket Predictability Act, authored by Rep. John Shimkus (R-IL), reaffirms the “least burdensome” provisions already included in the law but which appear not to have been followed in recent years. These provisions were enacted to streamline the review of new devices. Second, the PPA would require reviewers to provide the scientific or regulatory rationale for major decisions and establish an expedited approval appellate process. Finally, the PPA would establish two Investigational Device Exemption pathways to create more flexibility in conducting trials for clearance/approval.

• Novel Device Regulatory Relief Act of 2011, authored by Rep. Brian Bilbray (R-CA), streamlines the de novo (lower risk devices) classification process by striking the requirement that an applicant submit a 510(k) application before entering the de novo process.

• Keeping America Competitive through Harmonization Act, authored by Rep. Cathy McMorris Rodgers (R-WA), requires FDA to enter into agreements, when feasible, with Tier One countries on methods and approaches to harmonize regulatory requirements for premarket review, inspections, and common labels.

• Humanitarian Device Reform Act of 2011, authored by Rep. Charles Bass (R-NH), fosters the increased development of devices for those with rare diseases that affect fewer than 4,000 patients by removing the current profit cap and clarifies the 4,000 patients limit applies per year.

• Patients Come First Act, authored by Rep. John Shimkus (R-IL), reaffirms the mandates of the Safe Medical Devices Act of 1990 that FDA require Premarket Approvals from the more complex, pre-amendment Class III devices or move them to Class II. The act also codifies GAO’s recommendations that Congress reform FDA’s current device recall authority.

• Cultivating Scientific Expertise to Foster Innovation Act, authored by Rep. Michael Burgess, M.D. (R-TX), fixes FDA’s conflict of interest policies to ensure the most knowledgeable experts are able to serve on FDA advisory committees.

• Food and Drug Administration Mission Reform Act, authored by Rep. Mike Rogers (R-MI), clarifies that establishing a predictable, consistent, and transparent regulatory environment, facilitating innovation and applying a patient-focused, risk-benefit framework is part of FDA’s mission to ensure the agency takes them into account.

• Modernizing Laboratory Test Standards for Patients Act, authored by Rep. Michael Burgess, M.D. (R-TX), clarifies that FDA does not have authority over Lab-Developed Tests, which are developed within labs and not sold as medical devices, and Direct-to-Consumer Tests.

• Guidance Accountability and Transparency Act, authored by Rep. Brett Guthrie (R-KY), requires public notice and involvement in the development of level 1 guidance documents, which set forth initial interpretations of law or changes in interpretation of regulatory requirements, and if the agency is not able to comply, requires FDA to provide an explanation. The bill also requires FDA to finalize draft guidance documents by a certain date.

• FDA Renewing Efficiency from Outside Review Management Act of 2011, authored by Rep. Erik Paulsen (R-MN), reauthorizes the third party inspection program and reforms the third party review program to foster better participation, decrease approval times and conserve FDA resources.

Hospital Funding

• Cosponsored the Help our Hospitals Act of 2011 (H.R. 3633) which repeals the reduction in Disproportionate Share Hospital (DSH) payments made by Section 3133 of the Affordable Care Act.

• Under federal law, states are required to make Medicaid (DSH) payments to hospitals treating large numbers of low-income and Medicaid patients.

• States receive federal matching funds for making DSH payments up to a capped federal allotment.

Medical Liability Reform

• I voted for the Protecting Access to Healthcare Act (H.R. 5) which will help prevent the frivolous lawsuits against doctors that have led to skyrocketing increases in malpractice insurance premiums. Skyrocketing premiums have forced many Texas doctors, particularly in high-risk specialties like neurosurgery and obstetrics, to leave the state or give up the practice of medicine.

• In Texas, our physicians were being sued at twice the national average and doctors practicing in high-risk specialties like obstetrics either left the state or gave up the practice of medicine.

• Two-thirds of Texas’ 254 counties had no OB-GYN. Sixty percent of Texas counties had no pediatricians.

• But in 2003, the Texas legislature enacted sweeping medical liability reforms that started to fix the problem.  Since then, claims and lawsuits in most Texas counties have been cut in half. And, the number of doctors applying to practice medicine in Texas has increased by 60 percent.

Medicare Reform

• Ten thousand baby boomers a day turn 65, and this will continue for the next 19 years.

• The number of people eligible for Medicare will nearly double from 46 million to 80 million by the time all the boomers reach 65.

• It is estimated the cost of Medicare will grow from $500 billion a year today to $929 billion by 2020.

• Medicare is going broke. In ten years, anyone who is 53 years old today won’t be able to get the Medicare benefits they are expecting because the Medicare Hospital Fund will be insolvent.

• One in three primary care doctors limits the number of Medicare patients they see because of low and unreliable government payment.

• House Republicans have a plan that guarantees Medicare will fulfill its promise of health security for America’s seniors.

• The House Republican budget doesn’t change Medicare for anyone who is 55 years older or over, but for younger Americans is ensures that Medicare will be there for them when they retire.

• When younger workers become eligible for Medicare, they will be able to choose from a list of guaranteed coverage options.

Physician Shortage Crisis

• Physician shortages are expected to reach 62,900 by 2015 and 91,500 by 2020.

• I cosponsored the Empowering Patients First Act (H.R. 3000) which contains incentives to reduce physician shortages.

• The bill creates a new Health Professional Student Loan (HPSL) program for medical schools to offer loans to their students that allows for deferment of payments until after residency

• The bill provides that those physicians who agree to, or have already served for at least 5 years (3 years in under-served areas) as a primary care provider, will be eligible to have up to $50,000, over a 5 year period, of their graduate medical loan re-paid.

SGR Fix

• In December 2011, I voted for a two year Sustainable Growth Rate (SGR) patch that would have allowed time for Congress and the physician community to work toward development of a long term solution.

• On average, 25 percent of a physician’s practice revenue is Medicare related. Neglecting a long-term fix for Medicare physician reimbursement makes it very difficult for physicians to budget for their businesses.

• We need to fix the flawed Medicare reimbursement system so that physicians can afford to practice medicine and Texas seniors will continue to have access to affordable health care through the Medicare system.