Following breakthroughs in bipartisan negotiations after the election, the 21st Century Cures Act is on a path toward passage. This long discussed legislation would inject billions in new funding for the National Institutes of Health (NIH) and reform the drug and device review process at the Food and Drug Administration (FDA). AAHKS supported the bill in a joint letter with the AAOS in August.
The Cures Act was approved by the House Rules Committee on Wednesday, November 30th. The Senate is expected to pass the bill under expedited review sometime in the next week. In spite of this plan, several challenges have arisen. First, two exemptions to the Physician Payments Sunshine Act (section 4009) were removed, as demanded by Sen. Grassley (R-IA) as a condition of him not blocking the bill. Grassley authored the original Sunshine Act and objected to creating exemptions. Second, Sens. Elizabeth Warren (D-MA) and Bernie Sanders (I-VT) are leading some colleagues in opposition to the bill claiming that it has been “hijacked” by the pharmaceutical industry.
The Cures Act moving now is largely unchanged from the version that was passed by the House of representatives earlier in July 2015, but it now contains less funding for the NIH, which would get $4.8 billion instead of $8.75 billion, and the Food and Drug Administration, which would get $500 million instead of $550 million. The breakthrough resolves long-standing differences over how the will be paid for. Most of the new spending offsets come from tapping the Strategic Petroleum Reserve and the ACA’s Prevention and Public Health Fund.
The legislation has additionally gained momentum by including major portions of a House mental health reform bill that would boost the Department of Health and Human Services’ oversight of mental health providers and would call on the HHS Office of Inspector General to investigate claims that electronic health record companies or hospitals are preventing doctors from electronically sharing patient health records. The bill has also become a vehicle for other health initiatives including responses to the opioid epidemic, creating FDA standards for clinical decision support software, and accounting for socioeconomic status differences in the hospital readmission penalty program.
Among the Medicare provisions added are several sections from the House-passed Helping Hospitals Improve Patient Care Act (HIP-C). The updated Cures legislation includes a legislative fix for hospital off-campus outpatient departments that were under construction in November 2015 when a law was enacted to deny OPPS payments for any new off-campus departments. While this provision provides targeted relief for a previous site-neutral payment reform, the bill also calls on the Secretary to develop HCPCS versions of MS–DRG codes for at least 10 surgical procedures; laying the groundwork for additional alignment of inpatient-outpatient payments.