CuresActCongressWith the focus on the future of the Affordable Care Act, the most recently enacted federal healthcare law—the 21st Century Cures Act—is getting less attention than it deserves.  The Cures Act, 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  December 13, 2016.

The following is a brief summary of key provisions likely to impact healthcare providers:

Research Funding.  Over the next ten years, the National Institutes of Health 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 improving cancer detection and prevention.
  • $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 in 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.

Opioid Crisis.  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 healthcare 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 approval 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” HOPDs 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.

Durable Medical Equipment (DME) Infusion Drugs.   Based on the 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% 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.

Electronic Health Record (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 EHRs.

Local Coverage Determinations.  The Cures Act directs CMS to require its contractors to be more transparent regarding local coverage determinations (LCDs).  This consists of 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 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 the 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.

Price Tag.  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.