The lame duck Congress has laid an egg, which may be golden or otherwise, depending on one’s point of view. The egg is an updated and expanded version of 21st Century Cures Act, which originally passed in the House of Representatives back in July 2015. To gain Senate approval, the Cures Act sponsors modified several provisions and folded in other pending health-related bills.
The new version of the Cures Act was released right after Thanksgiving. The legislation, which weighs in at 312 pages, gained passage in both chambers by wide margins (392-26 in the House, 94-5 in the Senate) and was signed into law by President Obama on December 13. The following is a brief summary of key provisions likely to impact healthcare providers:
Over the next ten years, the National Institutes for Health (NIH) will receive significant new funding to support the development of new treatments:
- $1.802 billion to fund the Cancer Moonshot, aimed at making more therapies available to more patients and to improving cancer detection and prevention.
- $1.5 billion will go to the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, an effort to map and understand the functioning of the human brain, leading to new cures and treatments, in part for Alzheimer’s and epilepsy.
- $1.564 million for the Precision Medicine Initiative, which focuses on tailoring medicine to address individual differences and response potential in patients.
- $30 million to support work the field of regenerative medicine using adult stem cells.
Reducing administrative burden
The Cures Act directs key federal agencies to review and simplify regulations applicable to researchers, including financial disclosure requirements and monitoring of sub-recipients.
The Cures Act invests $1 billion over the next two years to combat the opioid crisis. These funds will be distributed to the states for prescription drug monitoring programs, prevention activities, training for health care providers, and opioid treatment programs.
FDA approval process
The Food and Drug Administration will receive an additional $500 million each year to accelerate the approval process for new drugs and devices. Also, the Cures Act contains several provisions intended to modernize the FDA’s approvals mechanisms to bring needed medicines and devices to market faster for the patients who need them. These include “summary level” reviews for new drug indications, enabling pharmaceutical companies to submit their own analyses of a drug’s merits rather than supplying the FDA with raw data that enables the regulatory body to draw its own conclusions.
Off-Campus Hospital Outpatient Departments (HOPDs)
Under The Bipartisan Budget Act of 2015 and its implementing regulations (BBA ’15), services furnished in HOPDs that commenced operations after November 2, 2015, will be paid at the applicable Medicare Physician Fee Schedule or ambulatory surgery center rates effective January 1, 2017. However, the Cures Act provides an exception for those HOPDs that were “mid-build” prior to November 2, 2015, i.e., the hospital had a binding written agreement with an outside, unrelated third-party for the HOPD’s construction.
A hospital must submit a “mid-build” certification and an attestation that the HOPD will qualify as “provider-based” within 60 days of the Cures Act’s enactment to take advantage of this exception. These “mid-build” HOPD will receive the full HOPD payment rate beginning January 1, 2018. The Cures Act directs CMS to audit the accuracy of the required certifications and attestations.
Another provision of the Cures Act provides that PPS-exempt cancer hospitals are not subject to BBA ’15 HOPD payment changes to ensure these facilities’ payments continue under their existing separate system. Cancer hospital HOPDs also must subject an attestation regarding compliance with the “provider-based” requirements, and CMS is directed to audit these attestations, as well.
DME infusion drugs
Based on OIG’s recommendations, the Cures Act directs CMS to set payment amounts for Part B drugs infused through DME using the same methodology used for most physician-administered drugs: 106 percent of average sales price.
Antimicrobial resistance monitoring
The Cures Act requires new reporting requirements for hospitals related to antibiotic stewardship activities, with the expectation these reports will be made available to the public.
EHR interoperability and information blocking
Congress looks to expedite interoperability among EHRs by facilitating the development of a voluntary model framework and common agreement on the secure exchange of health information. Congress also has authorized penalties for interfering with lawful sharing of electronic health records.
Local coverage determinations
The Cures Act directs CMS to require its contractors to be more transparent regarding local coverage determinations. This includes posting all LCDs on a public website, including a summary of the evidence considered in developing the LCD and responses to comments received from providers regarding the LCD.
HOPD vs. ASC price transparency
CMS will receive $6 million to create a price transparency website to permit beneficiaries to compare HOPD and ASC Medicare payments and associated beneficiary liability.
Hospital readmission reduction program
The Cures Act requires CMS to include a measure of patient socio-economic status in its calculation of hospital readmission rates.
Helping Families in Mental Health Crisis Act
First introduced following the 2012 Sandy Hook tragedy, the Helping Families Act is one of several health-related bills languishing in Congress that were incorporated into the expanded Cures Act. The Helping Families Act promotes evidence-based psychiatric care and research activities, ensures better coordination of federal mental health resources, addresses the critical psychiatric workforce shortage and improves enforcement of mental health parity.
Physician Payments Sunshine Act
As introduced in the House, the Cures Act would have amended the Physician Payments Sunshine Act to eliminate reporting requirements for textbooks, medical journal reprints and continuing medical education courses. However, when Sen. Chuck Grassley (R-Iowa)—who had been the driving force behind inclusion of the Sunshine Act in the Affordable Care Act before opposing the latter's final passage—threatened to oppose the bill, the bill’s sponsors were quick to strip out that provision.
The Cures Act will cost $6.8 billion over the next ten years, which is funded by steep cuts to the Prevention and Public Health Fund created under the Affordable Care Act and a draw-down from the Strategic Petroleum Reserve.