Multiple bills championed by Isakson included in Senate-passed ‘21st Century Cures Act’

WASHINGTON – U.S. Senator Johnny Isakson, R-Ga., today applauded the Senate passage of the 21^st Century Cures Act, a comprehensive medical research and innovation bill that includes a number of healthcare priorities that Isakson has championed for Georgia.

“The 21st Century Cures Act is a bipartisan, bicameral bill that will spur the development of medical treatments and cures for American families as well as supporting the success of Georgia hospitals and research universities, including Emory, Georgia Tech and the University of Georgia, among others,” said Isakson. “There are a number of provisions in this bill that I have worked on very closely for several years that will benefit Georgians and all American families. This legislation will help find cures for the diseases of the 20th century to drastically improve lives in the 21st century.”

The 21^st Century Cures Act includes a three-year extension of the Food and Drug Administration (FDA) Priority Review Voucher program for rare pediatric diseases to continue to spur investment in the development of cures for these diseases. It will ultimately help make lifesaving treatments available more quickly through an expedited review timeline. Isakson introduced the Advancing Hope Act of 2015 with Sens. Bob Casey, D-Pa., Sherrod Brown, D-Ohio, and Mark Kirk, R-Ill.

Additional Isakson initiatives included in the 21^st Century Cures Act include a provision for Medicare coverage for home infusion therapy services, which are currently covered in hospital and physician office settings, but not the home; a Neurological Disease Registry to help advance research on neurological diseases such as multiple sclerosis and Parkinson’s disease; and a device-drug combination product provision that creates a much-needed clear and transparent regulatory pathway for innovative medical products to reach the patients who will benefit most.

The 21^st Century Cures Act passed the U.S. House of Representatives on Nov. 30, 2016, with a strong bipartisan vote. Following today’s 94-5 vote by the Senate, it will now head to the president’s desk for his signature.

Isakson spoke on the floor of the Senate in support of the legislation and to discuss the specific priorities that will benefit Georgians. Details for each are listed below:

• Sec. 3013 - Pediatric Rare Diseases- Priority Review Voucher:

• Extends the Priority Review Voucher Program for rare pediatric diseases at the Food and Drug Administration (FDA) until 2022.
• Enables new drug applications with rare pediatric disease designation to be reviewed in six months instead of 10.

• Sec. 3038 - Combination Products

• The 21st Century Cures Act includes a combination products section for device-led drugs, which will eliminate the high level of uncertainty in approval standards that currently exists for innovative companies, both small and large, when deciding to invest in a new product.
• It creates a much-needed clear regulatory pathway for new products that will directly translate to greater access and more innovative medical products for patients who will benefit most.
• It also assigns a center within the FDA to regulate products that constitute a combination of a drug, device, or biological product.
• If the product sponsor disagrees with the decision, it requires the secretary to provide a substantive rationale with scientific evidence for why the decision was made.
• Provides product sponsors the right to a meeting with the FDA.

• Sec. 2061 - Neurological Disease Registry

• Creates a registry at the Centers for Disease Control and Prevention (CDC) to enhance and expand infrastructure and activities to track the epidemiology of neurological diseases.
• This information will be gathered into an integrated surveillance system, which may include a registry, to be known as the National Neurological Conditions Surveillance System.
• The information gathered in this system must be available to the public, while also protecting patient privacy.
• Collection of this data will facilitate further research into finding cures for these debilitating diseases.

• Sec. 5012 - Home Infusion

• Provides Medicare coverage for home infusion therapy services, which are currently covered in hospital and physician office settings, but not the home.
• Applies to Part B Durable Medical Equipment (DME) drugs and provides additional coverage for training, monitoring, and education services as well as nursing services.

• Sec. 15009 - Shepherd Center Long-Term Care Hospital Fix

• Atlanta’s Shepherd Center and Craig Hospital in Englewood, Colo., are exempted from the new Medicare Long-Term Care Hospital (LTCH) payment model through fiscal year 2019.
• This exemption included in the 21^st Century Cures Act will allow Shepherd Center to continue to provide world class care for patients suffering from spinal cord and traumatic brain injuries.

• Sec. 16003 – Electronic Health Records Regulatory Fairness Act

• Physicians who conduct a majority of their practice in an ambulatory surgical center will not be subject to meaningful-use penalties until at least three years after the certification of an electronic health record for ambulatory surgical centers.

• Sec. 17006 - Lifting Prohibition on Medicare Advantage End Stage Renal Disease patients

• Allows patients suffering from End Stage Renal Disease to enroll in a Medicare Advantage plan if they want. Currently, the only End Stage Renal Disease patients enrolled in Medicare Advantage are those that developed the illness while already enrolled.

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