Official Testifies About HRSA’s Health Workforce Investments, Goals, Successes

On April 9, 2014, Rebecca Spitzgo, Associate Administrator of the Bureau of Health Professions in the Health Resources and Services Administration (HRSA), testified before a Senate Subcommittee on Primary Health and Aging regarding the nation’s primary care workforce needs and HRSA’s activities and in this area. In light of recent investments from the American Reinvestment Recovery Act of 2009 (ARRA) (P.L. 111-5) and the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148), Spitzgo’s testimony focused on: (1) recent investments to strengthen the primary care workforce; (2) new efforts to build a primary care workforce; (3) diversity programs; and (4) training for comprehensive primary care.

HRSA’s Mission and Focus

An agency of HHS, HRSA is the primary federal agency for improving access to health care services for people who are uninsured, isolated or medically vulnerable. HRSA was created in 1982, when the Health Resources Administration and the Health Services Administration were merged. Its stated mission is to improve health and achieve health equity through access to quality services, a skilled health workforce, and innovative programs. In its efforts to strengthen the health care workforce, HRSA’s workforce programs emphasize the training of the next generation of primary care providers, strengthening up the primary care training and development infrastructure, providing incentives for students to choose primary care and to practice where the Nation needs them most, and repaying loans for primary care providers willing to work in some of the Nation’s most underserved areas.

Recent Investments to Strengthen the Primary Care Workforce

In her testimony, Spitzgo stated that, to date, ACA and ARRA investments have resulted in:

  • the training of an additional 1,700 primary care providers, including physicians, advanced practice nurses, and physician assistants, as well as 200 behavioral health providers;
  • the doubling of the numbers of clinicians in the National Health Service Corps (NHSC) from 3,600 in 2008 to nearly 8,900 in 2013; and
  • nearly 1,600 advanced practice nurses in the NHSC and nearly 2,600 nurses in the NURSE Corps working in high need communities.

Spitzgo also noted that the ACA provides $230 million over five years to fund the Teaching Health Center Graduate Medical Education (GME) program, which has expanded residency training for primary care residents and dentists in community-based ambulatory patient care settings, including HRSA-funded health centers. According to Spitzgo, this program supported more than 300 primary care resident full-time equivalents (FTEs) in 21 states in academic year 2013-2014, and is expected to support nearly 600 FTEs in academic year 2014-2015.

New Efforts to Build a Primary Care Workforce

Spitzgo testified as to the several new programs and initiatives to build a better primary care workforce contained in the President’s FY 2015 Budget, including:

  • A workforce initiative to support the training of 13,000 new physicians by 2024 and grow NHSC clinicians from 8,900 in 2013 to 15,000 in by FY 2015.
  • A new residency program, the Targeted Support for GME program, will build on the Teaching Health Center GME program, focusing on residency training in ambulatory, preventive care delivered in team-based settings. This new program includes a $100 million set aside for children’s hospitals in FYs 2015-2016, to be distributed via formula that will continue to support the same types of disciplines currently funded through the Children’s Hospitals GME Payment program.
  • Continued support of the NHSC.
  • A new $10 million Clinical Training in Interprofessional Practice program, which will support community-based clinical training in interprofessional, team-based care setting.
  • $4 million for the Rural Physician Training Grant program to provide support for medical schools to recruit and train students interested in rural practice.

Diversity Programs

In her testimony, Spitzgo stressed HRSA’s success in facilitating a diverse healthcare workforce. She offered the following statistics:

  • Underrepresented minorities and individuals from disadvantaged backgrounds accounted for approximately 45 percent of those who completed HRSA’s health professions training and education programs during 2012-2013.
  • More than half of the nearly 1,100 NHSC scholars and residents in the pipeline are minorities.
  • In FY 2013, African American physicians represented 17.8 percent of the Corps physicians, which exceeds their 6.3 percent representation within the national physician workforce.
  • In FY 2013, Hispanic physicians represented 15.7 percent of the Corps physicians, exceeding their 5.5 percent representation in the national physician workforce.

Training for Comprehensive Primary Care

Spitzgo’s testimony focused on HRSA investments to support the behavioral health disciplines and the integration of oral health into primary care. With regard to behavioral health, she noted that:

  • NHSC providers (including health service psychologists, licensed clinical social workers, licensed professional counselors, marriage and family therapists, and psychiatric nurse specialists) have increased from 700 in 2008 to 2,440 in 2013.
  • If they count psychiatrists, psychiatric physician assistants, and psychiatric nurse practitioners, more than 2,800 out of nearly 8,900 clinicians in NHSC (as of September 30, 2013) provide behavioral health services.
  • A partnership between HRSA and the Substance Abuse and Mental Health Services Administration (SAMHSA) will train and provide placement assistance for approximately 1,800 additional behavioral health professionals and 1,700 behavioral health paraprofessionals.

Spitzgo further testified that HRSA funds several programs that support training and education necessary to improve the integration of dental care into primary care. Sptizgo also noted that approximately 75 percent of the more than 1,300 dentists and dental hygienists in NHSC work at health centers or health center look-alikes.

Sponge-Filled Syringe to Treat Gunshot Wounds Approved for Military Use

The FDA has approved a first-of-a-kind hemostatic dressing to control bleeding from battlefield wounds in the pre-hospital setting. The XStat™, manufactured by RevMedx, Inc., of Wilsonville, Oregon, is a temporary dressing for wounds in areas that a tourniquet cannot be placed, such as in the pelvis/groin or shoulder/armpit regions. The dressing can be used up to four hours, which could allow time for the patient to receive surgical care.

Necessity

According to the U.S. Army Medical Department, Medical Research and Materiel Command, since mid-World War II, nearly 50 percent of combat deaths have been due to bleeding out. Of those, half could likely have been saved if timely, appropriate care had been available. At the present time, military field medics have to pack layers of gauze into a wound to stop the bleeding, a time-consuming process that does not always work. Moreover, medics are taught that if the bleeding does not stop within three minutes, to go through the extremely painful process of pulling out the gauze and starting the process again.

The Device

According to the FDA, the XStat consists of three, syringe-style applicators containing 92 compressed, cellulose sponges that have an absorbent coating. RevMedx’s XStat syringe injects these hemostatic sponges into deep wounds. After approximately 20 seconds of contact with water from blood or bodily fluid, the sponges expand to fill the wound cavity, creating a temporary physical barrier to blood flow. No direct manual pressure is required. The number of sponges needed for effective hemorrhage control will vary depending on the size and depth of the wound. Up to three applicators may be used on a patient.

The Sponges

The tablet-shaped sponges are each 9.8 millimeters in diameter and 4 to 5 millimeters in height. They can absorb 3 milliliters of blood or body fluid. An applicator filled with 92 sponges can absorb about 300 milliliters of fluid.The sponges cannot be absorbed by the body and all sponges must be removed from the body before a wound is closed. For ease of visualization and to confirm removal of every sponge, each sponge contains a marker visible via X-ray.

FDA Review

The FDA reviewed XStat through its de novo classification process, a regulatory pathway for novel, low- to moderate-risk medical devices that are first-of-a-kind. In a preclinical model with aggressive non-compressible hemorrhaging, Xstat provided statistically significant improvement in hemostasis and survival 60 minutes after injury with a large reduction in blood loss, resuscitation fluid requirement, and medic treatment time compared to conventional hemorrhage control dressings.

The FDA’s review of XStat included animal studies demonstrating its effectiveness at stopping bleeding and the absorption capacity of the device. Non-clinical biocompatibility data and human factors testing were also provided to demonstrate the safety and usability of the device.

Interview with Co-Developers

On March 5, 2014, RevMedx’s Chief Executive Officer, Andrew Barofsky, and Director of Strategic Development, John Steinbaugh (a former special forces medic), appeared on Fox Business Channel’s Opening Bell and explained how their device can be used both on the battlefield to seal wounds and in civilian application by first responders.

Senate Agrees to Another Temporary “Doc Fix,” Delays ICD-10

The Senate voted to approve a House bill (H.R. 4302) that will create another temporary “doc fix” to the Medicare sustainable growth rate (SGR) and delay the implementation of the International Classification of Diseases, 10th Edition, Clinical Modification/Procedure Coding System (ICD-10-CM/PCS) until at least October 1, 2015. The healthcare industry had been preparing to switch to the ICD-10 code set on October 1, 2014. The House bill passed 64-35 in the Senate and by voice vote in the House. The president signed the bill on April 1. A separate Senate bill that would have permanently fixed the SGR failed to come to a vote.

Senate Bill Fails

The last “doc fix” bill was set to expire at midnight on March 31, 2014, so a permanent or temporary doc fix was needed. A permanent fix was offered in S. 2110 by Senate Finance Committee Chairman Ron Wyden (D-Ore.), but his measure never came to a vote.  Wyden’s bill, to repeal and replace the SGR, would have been paid for by using savings from winding down military operations in Afghanistan, known as Overseas Contingency Operations (OCO) funding. However, when Wyden asked for unanimous consent to move his bill, Sen. Jeff Sessions (R-Ala.) objected, characterizing this OCO funding mechanism as a gimmick. Sessions then moved for the Senate to pass a Republican alternative that would fund the SGR replacement by repealing the individual mandate required by the Affordable Care Act (ACA). Wyden objected to Session’s motion, which lead to consideration of the House alternative, H.R. 4302, Protecting Access to Medicare Act of 2014.

H.R. 4302

The bill repeals the current 24 percent cut in reimbursements for physicians treating Medicare patients set to take effect on April 1, 2014, and replaces it with a 0.5 percent update through December 31, 2014, and a zero percent update from January 1, 2015, through March 31, 2015. The bill also directs HHS to continue through June 2015 certain medical review activities related to the two-midnight rule; amends the ACA to repeal the limitation on cost-sharing (deductibles) for employer-sponsored health plans; directs HHS to specify a skilled nursing facility all-cause all-condition hospital readmission measure (or any successor) by October 1, 2015; revises requirements for the Medicare end state renal disease (ESRD) prospective payment system; authorizes HHS to collect and use certain information on physicians’ services in the determination of relative values in the formulae for setting physicians’ fees; and increases the amounts of reductions to Medicaid disproportionate share hospital (DSH) allotments for fiscal year (FY) 2017 through FY 2024.

Senators Urge FDA Not to Stifle Mobile Medical Apps Through Over-Regulation

On March 18, 2014, a bipartisan group of U.S. Senators, including Michael Bennet (D-Colo.), Orrin Hatch (R-Utah), Tom Harkin (D-Iowa), Lamar Alexander (R-Tenn.), Mark Warner (D-Va.), and Richard Burr (R-N.C.) sent a letter to FDA Commissioner Dr. Margaret Hamburg, urging the FDA to provide further clarity in its policies regarding medical mobile applications (MMAs).

In their joint letter, the senators stated their position on MMAs, “It is important for the FDA to be well-equipped with the proper tools to be able to advance public health while taking care that innovation is not stifled through uncertainty or over-regulation. While the FDA’s final guidance has provided clarity on the agency’s approach to regulation of mobile medical applications, we believe more transparency is needed to avoid stakeholder confusion over how a wider range of medical software might be appropriately regulated. … We urge the FDA to work with Congress to identify policies that will serve the best interests of patients and innovators alike.”

In 2013, the FDA issued final guidance for oversight of MMAs. The final guidance, entitled “Mobile Medical Applications: Guidance for Industry and FDA Staff,” uses a risk-based approach to define what the FDA considers to be a MMA, with the agency’s efforts concentrated on high-risk medical software.  The FDA has also provided the  MMA industry with the following examples: (1) MMAs the FDA regulates; (2) MMAs that are not medical devices; (3) MMAs the FDA has approved; and (4) MMAs for which the FDA will exercise enforcement discretion.

While the Senators appreciate the FDA’s decision to use a risk-based approach to regulation, they are still concerned about possible over-regulation. And they are not the only members of Congress to indicate their concern.

In fact, the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act of 2013, H.R. 3303, proposed October 22, 2013 in the House of Representatives by U.S. Rep. Marsha Blackburn (R-Tenn.), seeks to curb the FDA’s regulatory powers by deregulating less risky medical software.

Then on February 10, 2014, Sens. Deb Fischer (R-Neb.) and Angus King (I-Maine) introduced the Preventing Regulatory Overreach to Enhance Care Technology (PROTECT) Act of 2014, S. 2007, which seeks to clarify the extent to which the FDA can regulate clinical and health software.

In their letter, the senators also asked Dr. Hamburg to provide responses to the following questions about current policies and oversight of MMAs and other medical software within three weeks:

  • Compared to current FDA guidance, what impact would Congress establishing categories of medical software in legislation have on the FDA’s oversight of medical mobile applications?
  • We understand you have set up an e-mail address to answer questions about FDA’s regulation of specific mobile medical applications. How many e-mails have you received to date and what is FDA’s average response time in calendar days?
  • In addition to the dedicated e-mail address, what policies and practices has FDA established to further assist innovator companies that are not familiar with FDA’s regulations and requirements applicable to medical device manufacturers?
  • What role, if any, can statutory definitions play to clarify any uncertainty with respect to assigning risk level to medical software?
  • How is the FDA determining what types of medical software updates, even minor updates, change the function of or add a function to the medical software and would require FDA review?
  • When a medical mobile application presents a novel function that has never been classified by the FDA, what procedures are used to determine if and how that application should be regulated by the FDA?
  • How has the FDA been coordinating with the Office of the National Coordinator and Federal Communications Commission to address the recent FDA Safety and Innovation Act working group’s concerns over interoperability?
  • Are there additional legislative tools that the FDA needs to better oversee the regulation of medical mobile applications?
  • What approach does the FDA use to regulate complex medical software with multiple and separate functions?