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DIGESTIVE DISEASE NATIONAL COALITION KEY PRIORITIES- 2012

Research; DDNC Supports:

• $32 billion for the National Institutes of Health (NIH) in FY13. $1.94 billion for the National Institute of Diabetes and Digestive and Kidney Diseases.

• Implementation of the recommendations of the National Commission on Digestive Diseases' report entitled, "Opportunities and Challenges in Digestive Diseases Research: Recommendations of the National Commission on Digestive Diseases."

•  Support for the Pancreatic Cancer Research and Education Act (H.R. 733 / S. 362)

1. Provides advice on overall research objectives for pancreatic cancer research and develops a strategic plan for pancreatic cancer research awareness.
2. Provides recommendations to the director oftheNIH and the Director of National Cancer Institute (NCI) regarding NIH and the Director of the Centers for Disease Control and Prevention (CDC) to develop a communication tool kit for patients and their families that focuses on specific pancreatic cancer issues relating to patient choices and patient care.

• Support for the Functional Gastrointestinal and Motility Disorders (FGIMD) Research Enhancement Act (H.R. 2239)

1. Expands emerging research activities into pediatric FGIMDs through partnerships with Institutes and Centers at NIH.
2. Stimulates treatment development by calling on the Food and Drug Administration (FDA) to expand and advance efforts to craft guidance for industry that establishes a formal process for the review, approval, and monitoring of treatments for FGIMDs.

• Support for the Department of Defense's Peer Reviewed Medical Research Program. Digestive Disease National Coalition Celiac Awareness Program

Patient Care; DDNC Supports:

• Support for the Supporting Colorectal Examination and Education Now (SCREEN) Act (H.R. 3198)

1. Provides for clinical and community interventions to improve screening rates for colorectal cancer.
2. Eliminate numerous barriers facing patients not taking advantage of their coverage by waving Medicare co-insurance for screening and would provide coverage for a preoperative visit with a gastroenterologist prior to receiving a colonoscopy.
3. Sets goals for screening rates and implements a preventative services payment modifier for colorectal screens.
4. Support states by authorizing existing grant programs for screening.

• Support for the Colorectal Cancer Prevention, Early Detection, and Treatment Act (H.R. 912 / S. 494)

1. Revises provisions related to the National Cancer Program, including requiring the establishment of an entity within the NCI to increase ongoing efforts to advance new technologies in cancer research.
2. Requires the Secretary of Health and Human Services to award grants for research on cancers with a low five-year survival rate and rare cancers.
3. Expands coverage of colorectal screenings, by providing grants and allowing states to provide coverage for such screenings under Medicaid.

• Correction of the anomaly in patient cost-sharing for colo rectal cancer screenings.

1. The health care reform law corrected one anomaly and created another by clarifying that the patient deductible should be waived even if a polyp or lesion is discovered during colonoscopy. CMS has interpreted the law as disallowing the waiver of patient co-pay if a polyp or lesion is found. Congress should correct this anomaly to ensure that patients are not responsible for costsharing for important preventive services such as colorectal cancer screenings.

• Support for the Patient Access to Medical Innovation Act: Humanitarian Device Reform Act (H.R. 3211 / S. 1865)

1. Eliminates the Humanitarian Device profit restriction.
2. Accelerates the availability of innovative medical technologies to treat rare diseases and disorders.
3. Ensures continued patient access to essential treatments while also promoting innovation and the development of new medical technologies for the millions of Americans suffering from rare diseases and disorders. 

• $4.4 billion for FDA in FY13

1. Keep funding consistent with the allocations the agency has received in recent years.
2. Promotes Congressional efforts to reduce bureaucracy at the FDA. -Helps to expedite the development of new, crucial treatments and therapies.
3. Assists FDA in addressing drug shortages

• Support for the implementation of the Food Safety Modernization Act (P. L. 111-353)

• Ambulatory Surgical Center Quality and Access Act (H.R. 2108 / S. 1173)

1. Directs Medicare to revise the requirements and the formula for payments for services, including an implantable medical device, furnished to individuals in ambulatory surgical centers.
2. Revises requirements for reporting of data by ambulatory surgical centers and hospital outpatient departments.
3. Directs the Medicare Payment Advisory Commission to study and report to Congress on outpatient surgical services.

• Support for The Medicare Home Infusion Therapy Coverage (H.R. 2195/S. 1203)

1. Provides for Medicare coverage of home infusion therapy and home infusion drugs.
2. Directs the Secretary of Health and Human Services to implement the Medicare home infusion therapy benefit in a manner that ensures that: (I) Medicare beneficiaries have timely and appropriate access to infusion therapy in their homes; and (2) there is rapid and seamless coordination between drug coverage under Medicare part D (Voluntary Prescription Drug Benefit Program) and home infusion therapy services coverage under Medicare Part B.

• Support for drug shortage legislation including: Tlte Drug Shortage Prevention Act (H.R. 3839) and The Preserving Access to Life Saving Medications Act (H.R. 2245 / S. 296)

1. Mandates expedited review of drugs vulnerable to shortage in order to prevent shortages in the first place.
2. Requires the FDA to a use more refined regulatory process that addresses manufacturing problems without instigating drug shortages.

• Expansion of the Social Security Administration's Compassionate Allowances program to include additional life threatening digestive diseases

Prevention and Awareness; DDNC Supports:

• $44.6 million for CDC's Colorectal Cancer program in FY13.
• $50 million for CDC's Division of Viral Hepatitis FY13.
• Support for the Viral Hepatitis Testing Act (H.R.3381 and S. 1809)

1. Establishes a national system for hepatitis screening.
2. Encourages the CDC to update hepatitis-screening guidelines.
3. Authorizes Congress to appropriate funds for hepatitis-screening activities.

• Support for continued development and implementation of the HHS' Viral Hepatitis Action Plan

• Level Funding for the CDC's Inflammatory Bowel Disease Epidemiology Program in FY13 $686,000.

1. The President's FY13 budget proposes an elimination of funding. The DDNC recommends continued funding at the FY12 level of $686,000.

• Adequate labeling of food and drug products so that patients with conditions, such as Celiac Disease, are properly informed.

• Support for a Resolution declaring a National Celiac Awareness Month

1. Which promotes work with health care providers and celiac disease advocacy and education organizations to encourage screening and early detection of celiac disease.
2. Supports increasing funding for celiac disease research.

Reviewed 2/19/2013