HRSA Rules on PPACA Extension of Orphan Drug Rule

The Health Resources and Services Administration (HRSA) issued a final rule which specifies the discounts available to certain safety net providers when purchasing orphan drugs from drug manufacturers pursuant to the 340B drug program which was expanded under the PPACA.

Senate Finance Committee Hearing on Meaningful Use Deadline

The Health IT industry and providers testified at a Senate Finance Committee hearing that the current “meaningful use” deadlines for the three-stage program could either cause providers to stop their adoption of electronic medical records or to rush implementation, thus leading to safety concerns. The Administration has indicated it opposes further delay and Chairman Max Baucus (D-MT) seemed content to let the deadlines proceed as is. However, Senator Baucus also said something must be done to help rural health clinics get the funding they need to install the health technology.

House Members Ask CMS to Modify Stroke-Related Measures

The House Congressional Heart and Stroke Coalition, headed by Reps. Chris Smith (R-NJ) and Lois Capps (D-CA), sent a letter to the Centers for Medicare and Medicaid Services (CMS) expressing their concern that the 30-day stroke mortality and stroke hospital readmission measures included in the FY 2014 hospital inpatient prospective payment system (IPPS) could have an adverse impact on access to care given to stroke patients. They encouraged the agency, before issuing a final rule, to work with providers to revise the measures to recognize stroke severity in order to mitigate the possible negative outcomes.

IOM Reports on Medicare Payment Adjustment for Geography

The Institute of Medicine (IOM) issued a report, Variation in Health Care Spending: Target Decision Making, Not Geography, which recommends that Congress eliminate geography as a factor in setting Medicare payments. The report said that, while geographic variation in spending and utilization is real, medical care decisions are made at the provider, not regional, level and result in varying degrees of quality care. It was also recommended that CMS continue to test payment reforms that provide incentives for the clinical and financial integration of health care delivery systems that encourage coordination of care, real-time sharing of data, receipt and distribution of provider payments and the assumption of some or all of the risk of managing the care continuum for their populations.

Medicaid Issues

The Government Accountability Office (GAO) issued a report, Approval Process Raises Cost Concerns and Lacks Transparency, stating that HHS’s actions are inadequate to ensure that state Medicaid demonstration projects are “budget neutral”. GAO said the budget neutrality process needs to be updated and assure the reliability of the data. GAO recommended that Congress consider requiring HHS to give increased attention to fiscal responsibility in approving state demonstration proposals. Also, Senators Max Baucus (D-MT) and Charles Grassley (R-IA) have asked HHS to bar state dental clinics from participating in Medicaid if they fail to follow state licensing laws. They cited a Senate Finance Committee report, the Joint Staff Report on the Corporate Practice of Dentistry in the Medicaid Program, which found that dental management companies often fail to meet quality and compliance standards, thus leading to unnecessary treatment, the improper administration of anesthesia and overcharging the Medicaid program.

NIH Issues

Under the National Institutes of Health (NIH) Big Data to Knowledge, or BD2K program, the agency announced it will award up to $96 million over four years to establish six to eight investigator-initiated Big Data to Knowledge Centers of Excellence in an effort to improve biomedical data set research. Applications are due by November 20, 2013.

FDA Issues

At a hearing held by the Senate Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights, the Federal Trade Commission (FTC) witness testified that so-called “pay for delay” agreements between drug companies raise substantial antitrust concerns and cost consumers $3.5 billion per year. She said the FTC has taken and will continue to take aggressive action to monitor and deter such agreements, but will not contest all of them. Chairwoman Klobuchar (D-MN) and Senator Grassley (R-IA) touted their proposed legislation, S. 214, that would make such agreements illegal unless the pharmaceutical company parties can prove that the agreements are not anticompetitive. Senator Grassley urged the FTC to continue to combat such agreements so that consumers can have access to lower priced generic drugs as soon as possible.

Health-Related Hearings and Markups

Senate Appropriations Defense Subcommittee: will mark up draft legislation that would make FY 2014 appropriations for departments, agencies and programs under its jurisdiction. 10:30 a.m., 192 Dirksen; July 29.

House Energy and Commerce Committee: will begin mark up H.R. 2810, legislation to amend title XVIII of the Social Security Act to reform the sustainable growth rate and Medicare payment for physicians’ services, and for other purposes; opening statements only; 4:00 p.m., 2123 Rayburn Bldg; July 30.

Senate Budget Committee: will hold a hearing titled “Containing Health Care Costs: Recent Progress and Remaining Challenges;” 10:30 a.m., 608 Dirksen Bldg; July 30.

House Energy and Commerce Committee: will mark up H.R. 2810, legislation to amend title XVIII of the Social Security Act to reform the sustainable growth rate and Medicare payment for physicians’ services, and for other purposes;10:00 a.m., 2123 Rayburn Bldg; July 31.

House Ways and Means Subcommittee on Human Resources hearing “Improving the Safety Net: Better Coordinating Today’s Maze of Programs to Ensure Families Receive Real Help.” 2 p.m., 1100 Longworth, July 31.
House Science, Space and Technology’s Research and Technology Subcommittee: will hold a hearing titled “The Frontiers of Human Brain Research.” 10 a.m., 2318; July 31.

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