BETHESDA, MD 22 Dec 2016—The 21st Century Cures Act—conceived as a means to change the way the United States treats disease—was signed into law by President Barack Obama on December 13, 2016.
"We're tackling cancer, brain disease, substance abuse disorders, and more," the president proclaimed during the signing ceremony at the White House. "And none of this work would have been possible without bipartisan cooperation in both houses of Congress."
With at least 88% of legislators in each major political party in the House of Representatives and the Senate voting in favor of the 21st Century Cures Act, it passed with overwhelming majorities.
The House Energy and Commerce Committee, whose members introduced the act in May 2015 and became its initial cosponsors, called the legislation an "innovation game-changer, a once-in-a-generation, transformational opportunity to change the way we treat disease."
What eventually emerged from Congress was 312 pages of various provisions, some of which fall outside the original tripartite description of "discovery, development, and delivery of 21st century cures."
"By and large," said Christopher Topoleski, director of federal legislative affairs for ASHP, "we're supportive of the Cures package."
As examples of provisions of the act supported by ASHP, Topeleski pointed to those that authorize additional funding for the National Institutes of Health ($4.8 billion), funding of the so-called Cancer Moonshot ($1.8 billion), and increased funding for state responses to opioid abuse ($1 billion).
And ASHP was encouraged to see the act will promote streamlined approvals of antimicrobial drugs for limited populations, increased use of electronic health records, and expansion of telehealth services, Topoleski said.
However, he noted, "There are some aspects to this bill that were not something that we would necessarily support as standalone measures."
Removal of $3.5 billion from the Prevention and Public Health Fund, which was established by the Affordable Care Act of 2009, is one such aspect, Topoleski said. Another is the provision setting an immediate start date—January 1, 2017—for payments on Medicare Part B–covered drugs infused by durable medical equipment to be based on the formula of average sales price plus 6% instead of 95% of the average wholesale price.
But other, positive aspects of the 21st Century Cures Act, such as commitment of additional funding for opioid-abuse countermeasures included in the Comprehensive Addiction and Recovery Act of 2015, outweigh the downsides, he said.
ASHP in the spring and summer of 2016 had lobbied for additional funding to fight the opioid abuse epidemic, Topoleski said. And ASHP has long lobbied on its own and through the Alliance for a Stronger FDA for increased funding of the agency. The 21st Century Cures Act provides FDA with $500 million for regulatory modernization and personnel recruitment and retention.
Below are some of the highlights of the 21st Century Cures Act, which contains 240 sections.
Innovation projects, state responses to opioid abuse. The National Institutes of Health will receive $4.8 billion over 10 years for the Precision Medicine Initiative, Brain Research through Advancing Innovative Neurotechnologies Initiative (also known as the BRAIN Initiative), cancer research, and adult stem cell regenerative medicine. FDA will receive $500 million over 10 years to implement various provisions that are intended to speed the approval of pharmaceuticals and medical devices without compromising standards for safety and effectiveness. The new Account For the State Response to the Opioid Abuse Crisis will receive $1 billion over two years for grants to states to supplement their opioid abuse prevention and treatment activities.
Discovery. The secretary of the Department of Health and Human Services (HHS) is encouraged to carry out a Precision Medicine Initiative; a research project by that name was created by the president in 2015 but was not guaranteed consideration by the next administration. A new group, the Task Force on Research Specific to Pregnant Women and Lactating Women, will advise the HHS secretary; one of the goals is to improve the development of safe, effective therapies for pregnant or lactating women.
Development. FDA must issue guidance to the pharmaceutical industry on how to collect patient experience data. HHS must evaluate the use of so-called real-world evidence as possible support for FDA's approval of a new indication for a previously approved drug and as acceptable fulfillment of postmarketing study requirements. Pharmaceutical companies must make public their compassionate-use policies for drugs used to treat serious or life-threatening conditions. FDA may apply the accelerated approval process to regenerative therapeutic products, such as those based on gene therapy. The Centers for Disease Control and Prevention must distribute educational materials on antimicrobial stewardship programs or practices to healthcare facilities. FDA may approve antimicrobial drugs on the basis of tests of a limited population if the drugs are used to treat at least one life-threatening infection. To attract and retain employees, the FDA commissioner may set the annual pay rate at an amount up to but not exceeding that of the president of the United States.
Delivery. HHS must defer to health information technology standards developed in the private sector for the secure exchange of health information; the intention is to expedite interoperability among electronic health records. The department must educate healthcare providers on how they may legally use and share patient health information. The administrator of the Centers for Medicare and Medicaid Services must inform Congress on the types of high-volume Medicare-covered services that may be suitably furnished using telehealth methods.
Savings. Starting on January 1, 2017, the payment formula for Medicare Part B drugs infused through durable medical equipment will be average sales price plus 6% and not 95% of the average wholesale price. The HHS secretary will create a single, all-inclusive payment system for home infusion services; this payment system will go into use in 2012 and compensate providers for the professional and monitoring services associated with home infusion therapy.
Mental health, substance use disorders. Starting on October 1, 2017, health professional volunteers at federally supported community health centers have medical liability protections; this liability coverage for healthcare practitioners sunsets after five years. The director of the HHS Office for Civil Rights must clarify the circumstances when a healthcare provider or covered entity, without violating the Health Insurance Portability and Accountability Act of 1996, may use or disclose protected health information regarding the treatment of an adult with a mental or substance use disorder.
Medicare. The HHS secretary must adjust the Hospital Readmissions Reduction Program to account for patients' socioeconomic status. Implementation of the 25% limit for long-term care hospital admissions from the same inpatient acute care hospital is delayed to October 1, 2017. Hospitals with off-campus hospital outpatient departments under development have until February 12, 2017, to notify the HHS secretary of a department's status in order to receive Medicare payments under the outpatient prospective payment system rather than the physician fee schedule or ambulatory surgical center fee schedule.