POLICY BRIEFINGS


FDA Issues


In light of the efforts in Congress to consider legislation that would increase the FDA’s authority over drug compounding pharmacies, Reps. Elijah Cummings (D-MD) and John Tierney (D-MA) released a report from the GAO that they requested on the issue. The GAO report, Drug Compounding: Clear Authority and More Reliable Data Needed to Strengthen FDA Oversight, concluded that the FDA’s authority over such pharmacies should be clarified given the differing federal circuit court decisions on the extent of the agency’s current authority and the resulting gap in oversight of compounding pharmacies. The report said “while FDA and national pharmacy organization officials generally agreed that states regulate the practice of pharmacy and FDA regulates drug manufacturing, there was no consensus on whether compounding drugs in large quantities, in anticipation of individual prescriptions or without prescriptions, and selling those drugs across state lines falls within the practice of pharmacy or is a type of drug manufacturing that should be overseen by FDA.” HHS responded that the findings in the report support the need for legislation to allow FDA to appropriately regulate the evolving industry. The combined bills on the issue reported by the Senate Health, Education, Labor and Pensions (HELP) Committee, S. 959 and S. 957, remain pending in the Senate.


Health Legislation Recently Introduced


H.R. 2845 (MEDICARE), to amend Title XVIII of the Social Security Act to allow retail community pharmacies to deliver diabetic testing supplies to Medicare beneficiaries; WELCH; jointly, to the committees on Energy and Commerce and Ways and Means, July 26.

H.R. 2853 (MEDICAL COSTS), to amend the Public Health Service Act to provide for the public disclosure of charges for certain hospital and ambulatory surgical center treatment episodes; LIPINSKI; to the Committee on Energy and Commerce, July 30.

H.R. 2864 (MEDICARE/MEDICAID), to amend titles XVIII and XIX of the Social Security Act to improve oversight of nursing facilities under Medicare and Medicaid by preventing inappropriate influence over surveyors, and for other purposes; ROYBAL-ALLARD; jointly, to the committees on Ways and Means and Energy and Commerce, July 30.

H.R. 2867 (MEDICARE), to amend Title XVIII of the Social Security Act to provide for the recognition of attending physician assistants as attending physicians to serve hospice patients; TERRY; jointly, to the committees on Ways and Means and Energy and Commerce, July 30.

S. 1405 (MEDICARE), to amend Title XVIII of the Social Security Act to provide for an extension of certain ambulance add-on payments under Medicare; SCHUMER; to the Committee on Finance, July 31.

S. 1408 (HIV/AIDS), to address the dramatic increase of HIV/AIDS in minority communities; GILLIBRAND; to the Committee on Health, Education, Labor and Pensions, July 31.

S. 1411 (VETERANS’ HEALTH), to specify requirements for the next update of the current strategic plan for the Office of Rural Health of the Department of Veterans Affairs for improving access to, and the quality of, health care services for veterans in rural areas; FRANKEN; to the Committee on Veterans’ Affairs, July 31.

S. 1413 (FDA FEES), to exempt from sequestration certain fees of the Food and Drug Administration; PRYOR; to the Committee on the Budget, July 31.

S. 1416 (BLACK LUNG DISEASE), to protect miners from pneumoconiosis (commonly known as black lung disease), and for other purposes; ROCKEFELLER; to the Committee on Health, Education, Labor and Pensions, July 31.

H.R. 2869 (MEDICARE), to amend Title XVIII of the Social Security Act to establish payment parity under Medicare for ambulatory cancer care services furnished in the hospital outpatient department and the physician office setting; ROGERS of Michigan; jointly, to the committees on Energy and Commerce and Ways and Means, July 31.

H.R. 2876 (REFORM), to amend the Internal Revenue Code of 1986 to provide veterans with a one-year exemption from the requirement to maintain minimum essential coverage under the Patient Protection and Affordable Care Act; FLORES; to the Committee on Ways and Means, July 31.

H.R. 2888 (REPRODUCTIVE HEALTH), to authorize assistance to aid in the prevention and treatment of obstetric fistula in foreign countries, and for other purposes; CAROLYN B. MALONEY of New York; to the Committee on Foreign Affairs, July 31.

H.R. 2893 (HIV/AIDS), to address the dramatic increase of HIV/AIDS in minority communities; RANGEL; to the Committee on Energy and Commerce, July 31.

H.R. 2894 (REFORM), to discontinue eligibility of former Members of Congress and their dependents for coverage under the Federal Employees Health Benefit Program (FEHBP) if the Affordable Care Act is repealed; RIBBLE; jointly, to the committees on House Administration and Oversight and Government Reform, July 31.

H.R. 2900 (REFORM), to repeal the Affordable Care Act and the Health Care and Education Reconciliation Act of 2010; to amend the Internal Revenue Code of 1986 to repeal the percentage floor on medical expense deductions, expand the use of tax-preferred health care accounts, and establish a charity care credit; to amend the Social Security Act to create a Medicare Premium Assistance Program, reform EMTALA requirements, and to replace Medicaid and the Children’s Health Insurance Program with a block grant to the states; to amend the Public Health Service Act to provide for cooperative governing of individual and group health insurance coverage offered in interstate commerce; and for other purposes; BROUN of Georgia; jointly, to the committees on Energy and Commerce, Ways and Means, Education and the Workforce, Natural Resources, the Judiciary, House Administration, Appropriations, and Rules, Aug. 1.

H.R. 2914 (MEDICARE), to prevent abusive billing of ancillary services to the Medicare program, and for other purposes; SPEIER; jointly, to the committees on Energy and Commerce and Ways and Means, Aug. 1.

H.R. 2900 (REFORM), to repeal the Affordable Care Act and the Health Care and Education Reconciliation Act of 2010; to amend the Internal Revenue Code of 1986 to repeal the percentage floor on medical expense deductions, expand the use of tax-preferred health care accounts, and establish a charity care credit; to amend the Social Security Act to create a Medicare Premium Assistance Program, reform EMTALA requirements, and to replace Medicaid and the Children’s Health Insurance Program with a block grant to the states; to amend the Public Health Service Act to provide for cooperative governing of individual and group health insurance coverage offered in interstate commerce; and for other purposes; BROUN of Georgia; jointly, to the committees on Energy and Commerce, Ways and Means, Education and the Workforce, Natural Resources, the Judiciary, House Administration, Appropriations, and Rules, Aug. 1.
H.R. 2914 (MEDICARE), to prevent abusive billing of ancillary services to the Medicare program, and for other purposes; SPEIER; jointly, to the committees on Energy and Commerce and Ways and Means, Aug. 1.



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