Legislative & Regulatory News
Updates about what is happening on the legislative and regulatory level – news events that affect your digestive health.
(Updated June 2012) On March 21, 2010, the U.S. House of Representatives voted 219-212 to approve the “Patient Protection and Affordable Care Act (PPACA).” Identical legislation was passed by the Senate on December 24, 2009. On March 30th, President Obama signed a budget reconciliation bill that made a series of changes to PPACA. Passage of this reconciliation bill was necessary to secure the support of a majority of House Democrats for PPACA.
PPACA and the reconciliation bill will institute sweeping reforms impacting Medicare, Medicaid and the private health insurance market.
[The Supreme Court on June 28, 2012 narrowed the law’s expansion of Medicaid, saying the states can reject it if they want.]
Starting in 2014, the legislation requires guaranteed issue and renewability of coverage and allows rating variation based only on age, rating area, family composition, and tobacco use.
There will be no government-run “public option” as a result of the legislation. Instead, each state will be required by 2014 to establish an “American Health Benefit Exchange” and a “Small Business Health Options Program.” These will be marketplaces where insurance companies can offer plans to individuals and small businesses. Subsidies will be made available to low-income individuals to assist with the purchase of coverage via the exchanges. Tax credits will be offered to small business to assist in providing coverage to employees. Penalties will be enforced on individuals who fail to purchase coverage and on small businesses that fail to offer coverage.
Here is a summary and timeline of the act provided to us by the nonpartisan DDNC, the Digestive Disease National Coalition (http://www.ddnc.org) . . .
90 Days After Enactment
- Establishes high-risk pools for people with pre-existing conditions who have been uninsured for at least six months.
Six Months After Enactment:
- Prohibits insurers from rescinding policies once a beneficiary becomes sick.
- Prohibits insurers from denying coverage to children (up to age 19) who have a pre-existing condition.
- Prohibits insurers from imposing lifetime benefit caps.
- Requires insurers to allow young adults to stay on their parents’ policy until age 26.
- Requires individual and small group market insurance plans to spend 80% of premium dollars on medical services. Large group plans would have to spend a minimum of 85%. If carriers fall below these percentages they will have to rebate the difference to policyholders.
- Begins the process of closing the Medicare Prescription Drug Program “Donut Hole.” Beneficiaries will receive a 50% discount on brand name drugs in the coverage gap.
- [The administration has put implementation of this provision on hold.] Establishes a national, voluntary insurance program for purchasing community living assistance services (CLASS program). Following a five-year vesting period, the program will provide individuals with functional limitations a cash benefit of not less than an average of $50 per day to purchase non-medical services and supports necessary to maintain community residence. The program is financed through voluntary payroll deductions: all working adults will be automatically enrolled in the program, unless they choose to opt-out.
- Requires states to establish health insurance exchanges for individuals and small businesses.
- Establishes subsidies for low income families to purchase coverage through the exchanges. Households making up to four times the federal poverty level, $88,200 for a family of four, will be eligible. Premiums for a family of four making $44,000 would be capped at approximately 6 percent of income.
- Requires employers with 50 or more employees to provide coverage or face penalties.
- Requires most individuals to obtain coverage or face penalties.
- Eliminates pre-existing coverage exclusions for adults.
- Prohibits annual benefit caps.
- Provides guaranteed issue and renewability of coverage for small group and individual plans.
- Allows premium rating variation based only on age, rating area, family composition, and tobacco use.
- Prohibits waiting periods of greater than 90 days for coverage to begin.
- Establishes an excise tax on high-cost employer-sponsored health coverage. The threshold taxable amounts are $10,200 for single coverage and $27,500 for family coverage. Stand-alone dental and vision plans are excluded from the total value of the benefit package subject to the new tax.
- Requires insurance coverage of routine patient care costs associated with clinical trials.
- Reduces or eliminates beneficiary cost sharing for preventive screenings and services in both private and public plans.
- Requires enhanced disclosure of the financial relationships pharmaceutical manufacturers and distributors have with healthcare providers and non-profit organizations. Funding for Continuing Medical Education is an area of focus.
- Requires the NIH to establish a Cures Acceleration Network that will accelerate high need cures by conducting research, enhancing communication between federal agencies and will establish a Cures Acceleration Network Review Board.
- Expands federal support for Comparative Effectiveness Research by creating a “Patient-Centered Outcomes Research Institute.” Findings derived from CER research cannot be used as guidelines for treatment, coverage or reimbursement.
- Establishes an approval pathway at the Food and Drug Administration for generic biologics (with 12 years of exclusivity for the innovator product).
- Establishes a Center for Medicare and Medicaid Innovation to test innovative coverage models based on Institute of Medicine recommendations.
- Establishes an Independent Medicare Payment Advisory Board. This 15 member panel of physicians and healthcare financing experts will be chosen by the President and confirmed by the Senate. The Advisory Board will propose changes to Medicare aimed at bringing the entitlement program in line with reduction targets. Congress cannot modify or filibuster the Advisory Board’s proposals. A supermajority vote of the House and Senate will be required to reject the panel’s recommendations. If rejected, Congress then will be required to find alternative ways to save the same amount of money.
- Establishes a new Medicare reimbursement benefit for pharmacists who offer Medication Therapy Management services.
- Reduces reimbursement for Medicare Advantage plans by $200 billion over 10 years.
- Increases funding for Community Health Centers by $11 million over the next 5 years.
- Establishes new federal initiatives to reduce waste, fraud, and abuse in Medicare and Medicaid including; expanded provider screening, greater oversight of providers and suppliers, enrollment moratoria in areas identified as being at elevated risk of fraud, and increased penalties for submitting false claims.
- Reduces Medicare payments to Disproportionate Share Hospitals starting in 2014 to reflect lower uncompensated costs due to the expansion of health coverage.
New U.S. Health Privacy Rule
(October 1, 2009) Individuals’ genetic information will have greater protections through new regulations issued today by the U.S. Departments of Health and Human Services (HHS), Labor, and the Treasury.
The interim final rule (there’s a 60 day public comment period) will help ensure that genetic information is not used adversely in determining health care coverage. It modifies the HIPAA Privacy Rule to clarify that genetic information is health information. Find details at this U.S. Department of Labor web page.
BETHESDA, MD (February 20, 2009) The National Commission on Digestive Diseases’ long-range research plan for digestive diseases, entitled Opportunities and Challenges in Digestive Diseases Research: Recommendations of the National Commission on Digestive Diseases, is now available in electronic (PDF) format, and soon will also be available in print format.
On July 26, 2005 the then Director of the National Institutes of Health (NIH), Elias A. Zerhouni, MD, chartered the National Commission on Digestive Diseases. The Commission was charged with two main tasks:
- To conduct an overview of the state of the science in digestive diseases research, and
- To develop a 10-year plan for digestive diseases research.
The NIH Director appointed 16 Commission members, including Nancy Norton from IFFGD. In addition to the 16 appointed members, the Commission included 19 ex officio members from the NIH and other federal government agencies involved in digestive diseases research. The members created “working groups” to address major themes; additional working group members were brought in to contribute their expertise and knowledge of current research related to each working group topic.
The Commission then proceeded to address 12 major themes in a Long-Range Research Plan for Digestive Diseases. They organized the plan by categorizing diseases by common causes (etiology), mechanisms, affected organ systems, and other considerations. Each theme includes an overview, a summary of recent research advances, goals for research, and major challenges and steps to achieve the research goals.
The Commission recognized the need for finding ways to achieve and sustain digestive diseases research and developed goals and recommendations for training, education, and the recruitment of new investigators into the field.
WASHINGTON, DC (February 17, 2009) While in Denver, CO, President Obama signed a $787 billion economic stimulus package. This legislation contains additional funding for the National Institutes of Health (NIH) and other federal health and education programs.
Of note, this is supplemental funding that will temporarily bolster currently available resources for federal agencies. It does not increase their annual baseline budgets.
The stimulus package allocates a total of $10.4 billion to the NIH. The funding is to be distributed as follows:
- $7.4 billion to be distributed to the NIH’s Institutes, Centers, and the Common Fund for research activities in allocations which are proportional to their current budgets.
- $800 million to the Office of the NIH Director for trans-NIH initiatives.
- $400 million as a transfer of funds from the Agency for Healthcare Research and Quality (AHRQ) to the Office of the NIH Director to be distributed to the NIH’s Institutes and Centers for Comparative Effectiveness Research.
- $1.3 billion to the National Center for Research Resources (NCRR) for extramural facilities construction, shared instrumentation, and other capital research equipment.
- $500 million for intramural building and facilities construction.
In a subsequent briefing, the NIH Acting Director, Dr. Raynard Kington, pointed out that these funds will be available for two years, so NIH will only be funding projects which can demonstrate significant gains in that time period. He also made the point that these funds will be forward-looking and not necessarily used to fill in the areas of the NIH budget which have received cuts. However, each Institute and Center Director will be evaluating their programs and deciding on the best candidates for a two year infusion of funds, and these may be programs which had received funding cuts in the past.
Dr. Kington specifically identified the following three areas as candidates to receive the bulk of the NIH supplemental funding (no details or dollar amounts were provided):
- Meritorious R01s that have been highly scored, but not yet funded, will be reviewed, and those research projects which could be advanced within a two year time frame will be given preferential consideration for funding. Dr. Kington went on to state that given the uniqueness of the situation, research projects will not be selected formulaically.
- Some existing grants will be supplemented through competitive or administrative mechanisms.
- NIH will initiate a Challenge Grant program to fund cross-cutting research projects that can be completed within two years. A new RFA will be issued in the near future and the peer-review process will be completed in an abridged manner considering the time constraints.
IFFGD is a member of the Ad Hoc Group for Medical Research, a coalition of nearly 300 member groups in support of increased funding for the U.S. National Institutes of Health (NIH). Here is a letter submitted to the new administration's transition team.
December 16, 2008
Dear President-elect Obama:
Investment in scientific discovery is crucial to improve the nation’s health and economy in both the near- and long-term. The Ad-Hoc Group for Medical Research, the oldest coalition advocating for medical research, thanks you for your strong support for science and research and for your commitment to double funding for key science agencies, including the National Institutes of Health (NIH) over the next ten years.
Because you understand the crucial role the life sciences play in the economic and physical health of the nation, we urge you to:
- Include at least $1.2 billion in NIH funding in any immediate economic stimulus effort, and include this funding in the base for subsequent budget years; and
- Appoint a permanent NIH director who understands the complexity and breadth of NIH’s mission and who can help deploy scientific research investments wisely for maximum economic and health benefit.
Lookig ahead, we will stand with you to help make your pledge to double the NIH a reality. Our nearly 300 patient groups, scientific and medical societies, research institutions, and industry organizations are keenly aware that six years of stagnant funding that has decreased purchasing power by nearly 15 percent, limiting criticalbreakthroughs that can advance the health of our citizens. Funding increases will providean immediate infusion into the nation’s proven and highly competitive biomedicalresearch infrastructure, creating and preserving jobs and high-wage industries whilefinding new treatments and even cures for many devastating diseases.
The nation invests less than $100 per person annually for all the research conductedand supported by NIH. Yet the return on investment has been spectacular: life expectancy has increased, deaths from heart disease, cancer and stroke are declining, andnew treatments have virtually eliminated transmission of HIV virus from mother to child.
Research contributes to the economic strength of the nation by creating skilled jobs in communities nationwide, new products, and improved technologies. The nation’s medical schools, teaching hospitals, universities, and research institutes where much of this research takes place are among the largest employers in their respective communities. According to a June 2008 Families USA study of FY2007 federal NIH investment:
- Every dollar of NIH funding generated more than twice as much in state economic output: an overall investment of $22.846 billion from NIH generated a total of $50.537 billion in new state business.
- NIH grants and contracts created and supported more than 350,000 jobs that generated wages in excess of $18 billion in the 50 states. The average wage associated with the jobs created was $52,000.
The recent history of the NIH budget has hindered scientific discovery and is limiting the capacity of a key engine for today’s innovation-based economy. Additional funding in the stimulus package and rapid selection of an NIH director would be crucial first steps to returning the NIH to a course for even greater discovery. These investments would give patients, their families and researchers renewed hope for the future, and can help ensure the future of America’s medical research enterprise and leadership.
Update: Senate Committee Budget Process
WASHINGTON DC (June 24, 2008) Today the Senate Labor, Health and Human Services, and Education Appropriations Subcommittee approved its Fiscal Year 2009 spending bill. The House Labor-HHS-Education Appropriations Subcommittee took similar action on their annual spending bill last week.
The “Chairman’s Statement” from Senator Tom Harkin includes general information on the bill, including the following:
National Institutes of Health – The Subcommittee legislation provides more than $30 billion to fund biomedical research at the 27 Institutes and Centers that comprise the NIH. This represents an increase of $1 billion over the FY 2008 level and President’s budget request. The Subcommittee’s increase will allow the NIH to award the highest number of new research project grants in its history and keep up with the biomedical inflation rate for the first time in six years.
The full Senate Appropriations Committee is scheduled to consider the FY 2009 Labor-HHS-Education Appropriations bill on Thursday, at which time more detailed information on the bill will be made available.
Update: House Subcommittee Begins its Budget Process
WASHINGTON DC (June 19, 2008) The House Labor Health, Human Services and Education Appropriations Subcommittee is currently marking-up (considering, amending) its fiscal year 2009 spending bill. This bill will provide funding for federal health and education programs during the upcoming fiscal year. Preliminarily information indicates that, among the many provisions, the House’s fiscal year 2009 Labor Health, Human Services and Education Appropriation bill will include:
- A $1.2 billion funding increase for the National Institutes of Health, which could fund up to 1,000 new grants.
- A $156 million funding increase for the Centers for Disease Control and Prevention.
- $75 million for a new State Health Access Grants program to expand State health coverage initiatives for the uninsured.
Update: NIH Budget Increases Adopted by Senate
WASHINGTON, DC (March 13, 2008) The Senate voted 95 to 4 in favor of adopting the “Specter/Harkin” amendment to the Senate’s fiscal year (FY) 2009 budget resolution. This amendment authorizes an additional $2.1 billion for the National Institutes of Health (NIH) in FY 2009, bringing the agency's total potential funding level up to $32.2 billion.
Many thanks to those of you that responded to the Action Alert that we sent to you by urging your Senators to support the amendment. This is an important first step to increasing funding for NIH in FY 2009. The budget process is not yet over.
For more information, please see the interesting floor statement by Senator Arlen Specter (R-PA) located here: Go»
President's Fiscal Year 2009 U.S. Budget Proposal
WASHINGTON, DC (January 2008) The second session of the 110th U.S. Congress convened in January 2008 with lawmakers receiving President Bush’s State of the Union Address on January 28th. The following week the president sent his final budget proposal (for fiscal year 2009) to Capitol Hill. The $3 trillion plan calls for historic increases in defense and homeland security spending and significant cuts in domestic discretionary programs. Among the agencies hardest hit was the Department of Health and Human Services.
The House and Senate budget committees have initiated hearings with cabinet officials on the White House plan and will soon begin the process of drafting their own budget for fiscal year (FY) 2009. This non-binding budget resolution will serve as a blueprint for future legislative action this year on appropriations and revenue measures.
Some highlights of the President’s budget proposal include:
National Institutes of Health
$29.307 billion for the National Institutes of Health (NIH), the same level of funding as FY 2008.
- $1.858 billion for the National Institute of Diabetes and Digestive and Kidney Diseases at NIH, an increase of $2 million over FY 2008.
- $428.7 million for the Division of Digestive Diseases and Nutrition (DDN) at NIDDK, a decrease of $500 thousand dollars from FY 2008.
- $1.057 billion for the Office of the Director at NIH, a decrease of $52 million over FY 2008.
- $41.919 million for the Office of Research on Women’s Health at NIH, the same level of funding as FY 2008.
Food and Drug Administration
$2.4 billion for the Food and Drug Administration (FDA), not including user fees, an increase of $130 million over FY 2008.
- $739 million for the Human Drug Program at FDA, an increase of $58 million over FY 2008.
Centers for Disease Control and Prevention
$5.691 billion for the Centers for Disease Control and Prevention (CDC), a decrease of $433 million from FY 2008.
Maryland, Bethesda: NIH State-of-the-Science Conference on Prevention of Fecal and Urinary Incontinence in Adults
The U.S. National Institutes of Health (NIH) conducted an NIH State-of-the-Science Conference on Prevention of Fecal and Urinary Incontinence in Adults on December 10–12, 2007.
We are pleased that the conference resulted in a strong statement by the NIH about the huge unmet need of those who are affected by incontinence.
The conference was convened to assess the available scientific evidence relevant to the following questions:
- What are the prevalence, incidence, and natural history of fecal and urinary incontinence in the community and long-term care settings?
- What is the burden of illness and impact of fecal and urinary incontinence on the individual and society?
- What are the risk factors for fecal and urinary incontinence?
- What can be done to prevent fecal and urinary incontinence?
- What are the strategies to improve the identification of persons at risk and patients who have fecal and urinary incontinence?
- What are the research priorities in reducing the burden of illness in these conditions?
For several years, Nancy Norton and IFFGD vigorously encouraged NIH to convene this conference. Ms. Norton served on the Planning Committee for the conference and was one of 21 speakers who presented information to the independent 15-member conference panel, which drafted a consensus and state of the science report. Ms. Norton spoke on the Impact of Fecal and Urinary Incontinence on Health Consumers, Barriers on Diagnosis and Treatment, A Patient Perspective.
The Panel found that fewer than half of individuals experiencing fecal or urinary incontinence — the inability to control bowel movements or urination, respectively — report their symptoms to healthcare providers without being prompted. The secrecy and distress surrounding these issues erode the quality of life for millions, and hamper scientific understanding and development of prevention and treatment strategies.
Healthcare provider education about incontinence is needed. But, the Panel reported, provider education alone will be insufficient to improve detection, prevention, and treatment. Public policy changes, including appropriate reimbursement, regulation, and management are also needed. Raising public awareness is a priority. To help reduce the stigma associated with these conditions, the panel had the following messages for those experiencing incontinence:
- You are not alone
- Some medical conditions can cause incontinence and can be treated
- Incontinence does not need to be a part of aging
- Lifestyle changes and behavioral interventions can prevent incontinence in many cases
- You should tell your healthcare provider
Though fecal and urinary incontinence can affect men and women at all life stages, both conditions disproportionately affect women, especially those who have given birth, as pelvic muscle injury during childbirth and routine episiotomy are associated with a higher rate of fecal incontinence. For this reason, the panel recommended that episiotomy not be routinely performed during childbirth.
The 15-member conference panel included experts in the fields of geriatrics, nursing, gastroenterology, obstetrics and gynecology, internal medicine, urology, general surgery, oncology, neurosurgery, epidemiology, biostatistics, psychiatry, rehabilitation medicine, environmental health sciences, and healthcare financing, as well as a public representative.
We thank the conference sponsors – the NIH Office of Medical Applications of Research (OMAR) and the National Institute of Diabetes and Digestive and Kidney Diseases, along with other components of the NIH – for making the conference possible.
The text of Ms. Norton’s presentation on The Patient Perspective is available on this IFFGD web page - Go ».
You may access information about the conference, including the Final Conference Statement at this NIH web page - Go ».