Relatedly, now comes word of the release of a Congressional "discussion draft" (pdf) of the "21st Century Cures Act."
The partisan bickering ensued before the toner was dry.
Dems balk on medical technology billBelow, I've stripped out the topical headings and sub-headings to give you a sense of where all of this might be headed.
By Darius Tahir, January 28, 2015
Democrats on the House Energy & Commerce Committee have withdrawn support from legislation that would loosen regulatory requirements on a broad range of new healthcare technologies, sources close to the legislative discussions say.
The sprawling 21st Century Cures Act, whose 393-page first draft was released on Jan. 27, is aimed at speeding up the adoption of next generation medical technologies. It seeks to foster drug development, including of antibiotics, by requiring the Food and Drug Administration to allow more “flexible” clinical trial design and gives medical-device makers more “innovative device review pathways.”
It also incorporates the Sensible Oversight for Technology which Advances Regulatory Efficiency (Software) Act sponsored by Rep. Marsha Blackburn (R-Tenn.), which would allow the FDA to take a risk-based regulatory approach to new healthcare information technologies. Its goal is to foster faster adoption of mobile medical applications, clinical decision-support tools and other healthcare-related software.
Rep. Frank Pallone (D-N.J.), the ranking member of the committee, said the draft legislation disappointed him because it “does not reflect true bipartisan collaboration.”
“In its current form, I am concerned that the nearly 400-page draft could create more problems for our healthcare system than it solves,” he said. “Further, the draft does not include any real dollars to fund additional basic research at the National Institutes of Health.”...
TITLE I—PUTTING PATIENTS FIRST BY INCORPORATING THEIR PERSPECTIVES INTO THE REGULATORY PROCESS AND ADDRESSING UNMET NEEDSThe legislative sausage-making process. Thus far only miniscule and vague references therein alluding to "health information technology" and "interoperability."
Subtitle A—Patient-Focused Drug Development
Sec. 1001. Development and use of patient experience data To enhance structured risk-Benefit assessment framework.
Subtitle B—Surrogate Endpoint Qualification and Utilization
Sec. 1021. Evidentiary standards for the review of requests for the qualification of surrogate endpoints; Biomarkers partnership.
Sec. 1022. Enhancing the process for qualification of surrogate endpoints.
Sec. 1023. Transitional provisions for previous submissions for qualification of biomarkers as surrogate endpoints.
Sec. 1024. Biannual reports to Congress.
Subtitle C—Approval of Breakthrough Therapies
Sec. 1041. Approval of breakthrough therapies.
Subtitle D—Antibiotic Drug Development
Sec. 1061. Approval of certain drugs for use in a limited population of patients.
Sec. 1062. Susceptibility test interpretive criteria for microbial organisms.
Sec. 1063. Election to convey a portion of extended exclusivity period applicable to qualified infectious disease products.
Sec. 1064. Encouraging the development and use of new antimicrobial drugs.
Subtitle E—Priority Review for Breakthrough Devices
Sec. 1081. Priority review for breakthrough devices.
Sec. 1082. CMS coverage of breakthrough devices to be supplied.
Subtitle F—Accelerated Approval for Breakthrough Devices
Sec. 1101. Accelerated approval for breakthrough devices.
Subtitle G—Expanded Access
Sec. 1121. Expanded access policy as condition of expedited approval.
Sec. 1122. Notification of submitters of expanded access requests.
Sec. 1123. GAO qualitative analysis on individual patient access to unapproved therapies and diagnostics.
Sec. 1124. Expanded Access Task Force.
Sec. 1125. Finalizing draft guidance on expanded access.
Subtitle H—Facilitating Responsible Communication of Scientific and Medical Developments
Sec. 1141. to be supplied.
Subtitle I—Modernizing the Regulation of Social Media
Sec. 1161. Dissemination of information about medical products using the Internet.
Subtitle J—Streamlined Data Review
Sec. 1181. Streamlined data review program.
Subtitle K—Cures Acceleration Network
Sec. 1201. Flexible research authority.
Sec. 1202. Repurposing drugs.
Subtitle L—Dormant Therapies
Sec. 1221. Definitions.
Sec. 1222. Capturing lost opportunities and creating new cures for patients.
Sec. 1223. Implementation and effect.
Subtitle M—New Therapeutic Entities
Sec. 1241. Extended exclusivity period for certain new drug applications and abbreviated new drug applications.
Subtitle N—Orphan Product Extensions Now
Sec. 1261. Extension of exclusivity periods for a drug approved for a new indi- cation for a rare disease or condition.
TITLE II—BUILDING THE FOUNDATION FOR 21ST CENTURY MEDICINE, INCLUDING HELPING YOUNG SCIENTISTS
Subtitle A—21st Century Cures Consortium Act
Sec. 2001. Innovative Cures Consortium.
Subtitle B—Medical Product Innovation Advisory Commission
Sec. 2021. Medical Product Innovation Advisory Commission.
Subtitle C—Regenerative Medicine
Sec. 2041. Issuance of guidance on surrogate and intermediate endpoints for accelerated approval of regenerative medicine products.
Subtitle D—Genetically Targeted Platform Technologies for Rare Diseases
Sec. 2051. Genetically targeted platform technologies for rare diseases.
Subtitle E—Sensible Oversight for Technology Which Advances Regulatory Efficiency
Sec. 2061. Medical and health software defined.
Sec. 2062. Applicability and inapplicability of regulation.
Sec. 2063. Exclusion from definition of device.
Subtitle F—Building a 21st Century Data Sharing Framework
PART 1—IMPROVING CLINICAL TRIAL DATA OPPORTUNITIES FOR PATIENTS
Sec. 2081. Standardization of data in Clinical Trial Registry Data Bank on eli- gibility for clinical trials.
Sec. 2082. Clinical Trial Data System.
PART 2—IMPROVING CLINICAL OUTCOMES FOR PATIENTS AND PROGRAM INTEGRITY THROUGH CMS DATA
Sec. 2085. Expanding availability of Medicare data.
Sec. 2086. Empowering patient research and better outcomes through CMS data.
Sec. 2087. Allowing clinical data registries To comply with HIPAA privacy and security law in lieu of complying with the privacy and security provisions of the Common Rule.
Sec. 2088. Access to CMS claims data for purposes of fraud analytics.
PART 3—BUILDING A 21ST CENTURY CLINICAL DATA SHARING SYSTEM
Sec. 2091. Commission on Data Sharing for Research and Development.
Sec. 2092. Recommendations for development and use of clinical data registries.
Subtitle G—Utilizing Real-World Evidence
Sec. 2101. Utilizing real-World evidence.
Subtitle H—Coverage With Evidence Development
Sec. 2121. Authority for coverage with evidence development for medical de- vices under the Medicare program.
Subtitle I—Combination Products
Sec. 2141. Regulation of combination products by the Food and Drug Administration.
Sec. 2142. GAO report on FDA regulation of combination products. Subtitle J—Modernizing Regulation of Diagnostics
Sec. 2161. to be supplied.
Sec. 2181. to be supplied.
Subtitle L—NIH–Federal Data Sharing
Sec. 2201. Sharing of data generated through NIH-funded research.
Subtitle M—Accessing, Sharing, and Using Health Data for Research Purposes
Sec. 2221. Accessing, sharing, and using health data for research purposes.
Subtitle N—21st Century Chronic Disease Initiative Act
Sec. 2241. Plan for longitudinal study on outcomes of patients with a chronic disease.
Subtitle O—Helping Young Emerging Scientists
Sec. 2261. Funding research by emerging scientists through Common Fund.
Sec. 2262. Report on trends in age of recipients of NIH-funded major research grants.
Subtitle P—Fostering High-Risk, High-Reward Science
High-risk, high-reward research program.
Subtitle Q—Precision Medicine to be supplied.
TITLE III—MODERNIZING CLINICAL TRIALS
Subtitle A—Clinical Research Modernization
Protection of human subjects in research; applicability of rules. Use of institutional review boards for review of investigational device exemptions.
Subtitle B—Broader Application of Bayesian Statistics and Adaptive Trial Designs
Sec. 3021. Clinical trial modernization.
Subtitle C—Postapproval Studies and Clinical Trials
Sec. 3031. Evaluations of required postapproval studies and clinical trials.
Subtitle D—Pediatric Research Network Improvement
Sec. 3041. National Pediatric Research Network.
Subtitle E—Global Pediatric Clinical Trial
Sec. 3061. Sense of Congress.
TITLE IV—ACCELERATING THE DISCOVERY, DEVELOPMENT, AND DELIVERY CYCLE AND CONTINUING 21ST CENTURY INNOVATION AT NIH, FDA, CDC, AND CMS
Subtitle A—National Institutes of Health
Sec. 4001. NIH research strategic investment plan.
Sec. 4002. Biomedical research working group to reduce administrative burden on researchers.
Sec. 4003. NIH travel.
Sec. 4004. Increasing accountability at the National Institutes of Health.
Sec. 4005. GAO report on Common Fund.
Sec. 4006. Exemption for the National Institutes of Health from the Paperwork Reduction Act requirements.
Sec. 4007. Additional funding for NIH Common Fund.
Sec. 4008. Additional funding for NIH brain research.
Sec. 4009. NCATS Phase IIB Restriction.
Subtitle B—Advancing Research for Neurological Diseases
Sec. 4021. National neurological diseases surveillance system.
Subtitle C—Vaccine Access, Certainty, and Innovation PART 1—DEVELOPMENT, LICENSURE, AND RECOMMENDATIONS
Sec. 4041. Prompt review of vaccines by the Advisory Committee on Immuniza- tion Practices.
Sec. 4042. Review of transparency and consistency of ACIP recommendation process.
Sec. 4043. Guidance on vaccine development.
Sec. 4044. Meetings between CDC and vaccine developers.
Sec. 4045. Modifications to priority review voucher program for tropical diseases.
Sec. 4046. Guidance on changes to an approved application for biological products.
Sec. 4047. Expediting the process for export certifications for vaccines.
Sec. 4048. NIH vaccine research.
PART 2—MEDICARE, MEDICAID, AND OTHER PROVISIONS
Sec. 4061. Requiring prompt updates to Medicare program upon issuance of ACIP recommendations.
Sec. 4062. Encouraging health plans to establish programs to increase adult immunization.
Subtitle D—Reagan-Udall Improvements Bill
Sec. 4081. Reagan-Udall Foundation for the Food and Drug Administration.
Subtitle E—FDA Hiring, Travel, and Training
Sec. 4101. TO BE SUPPLIED.
Subtitle F—FDA Succession Planning
Sec. 4121. Professional development of FDA staff.
Sec. 4122. FDA management succession planning.
Subtitle G—Disposable Medical Technologies
Sec. 4141. Coverage of certain disposable medical technologies under the Medicare program.
Subtitle H—Local and National Coverage Decision Reforms
Sec. 4161. Improvements in the Medicare local coverage determination (LCD) process.
Sec. 4181. Advancing telehealth opportunities in Medicare.
Subtitle J—Revise IPPS New Technology Add-On Payment (NTAP) Reimbursement Amounts
Sec. 4201. Coding and reimbursement reforms.
Subtitle K—Lowering Medicare Patients OOP Costs
Sec. 4221. Medicare site-of-service price transparency.
Subtitle L—Global Surgery Services Rule
Sec. 4241. Treatment of global surgery services rule.
Subtitle M—Providers Consolidation and Medicare Payments Examined Through Evaluation
Sec. 4261. Rulemaking that implements certain Medicare payment changes to consider effects on provider consolidation.
Subtitle N—Medicare Part D Patient Safety and Drug Abuse Prevention
Sec. 4281. Establishing PDP safety program to prevent fraud and abuse in Medicare prescription drug plans.
Sec. 4282. Part D suspension of claims payment.
Sec. 4283. Improving activities of Medicare Drug Integrity Contractors (MEDICs).
Sec. 4284. Requiring e-prescribing for coverage of covered part D controlled substances.
Subtitle O—Accelerating Innovation in Medicine
Sec. 4301. Establishment of manufacturer opt-out program for medical devices.
Subtitle P—Medicare Pharmaceutical and Technology Ombudsman
Sec. 4321. Medicare pharmaceutical and technology ombudsman.
Subtitle Q—Ensuring Local Medicare Administrative Contractors Evaluate Data Related to Category III Codes
Sec. 4341. Ensuring local medicare administrative contractors evaluate data re- lated to Category III codes.
Subtitle R—Advancing Care for Exceptional Kids
Sec. 4361. Findings.
Sec. 4362. Establishment of Medicaid and CHIP Care Coordination program for children with medically complex conditions as Medicaid State option.
Subtitle S—Continuing Medical Education Sunshine Exemption
Sec. 4381. Exempting from manufacturer transparency reporting certain transfers used for educational purposes.
Subtitle T—Medical Testing Availability
Sec. 4401. Clarification regarding research use only products.
TITLE V—MODERNIZING MEDICAL PRODUCT REGULATION
Subtitle A—Manufacturing Incentives
Sec. 5001. Extension of exclusivity period for American-manufactured generic drugs and biosimilars.
Subtitle B—21st Century Manufacturing
Sec. 5021. Updating regulations and guidance on current good manufacturing practice requirements.
Subtitle C—Controlled Substance Manufacturing and Exports
Sec. 5041. Re-exportation among members of the European Economic Area.
Subtitle D—Medical Device Reforms
Sec. 5061. Third-party quality system assessment.
Sec. 5062. Valid scientific evidence.
Sec. 5063. Training and oversight in least burdensome means concept.
Sec. 5064. Recognition of standards.
Sec. 5065. Notification of marketing of certain class I devices.
Sec. 5066. General and specific uses.
Sec. 5067. Humanitarian device exemption application to in vitro diagnostics. Sec. 5068. Advisory committee process.
Subtitle E—Supply Chain Security for Devices
Sec. 5081. Short title.
Sec. 5082. Device distribution supply chain.
Sec. 5083. Authorized trading partners.
Sec. 5084. National licensing standards for wholesale device distributors.
Sec. 5085. National licensing standards for third-party logistics providers.
Sec. 5086. Waivers and exemptions.
Sec. 5087. Uniform national policy.
Sec. 5088. Penalties.
SPEAKING OF DC
ONC Annual Meeting
Interoperable Health IT for a Healthy Nation
February 2 - 3, 2015
1919 Connecticut Avenue
Washington, D.C. 20009
The Office of the National Coordinator for Health IT (ONC) will hold the 2015 Annual Meeting February 2-3, 2015, at the Washington Hilton in Washington, D.C. The meeting will gather over 1,000 health IT partners for two days of plenaries and breakout sessions. Online registration has closed; however onsite registration will be available. The Annual Meeting will also be webcasted on February 2, 2015 and the morning plenary on February 3, 2015.
What has SHARP accomplished for EHRs?JAN 30th UPDATE
'I would say in general that the SHARP programs were successful, but some were more successful than others'
January 29, 2015
After four years and $60 million, the ONC's Strategic Health IT Advanced Research Projects program is essentially done, and each project has made strides in improving various elements of EHRs. Those involved in SHARP believe their work has advanced the health IT field, but it remains to be seen if any of their innovations find their way into widespread use.
"I would say in general that the SHARP programs were successful, but some were more successful than others," said Douglas Fridsma, MD, former ONC chief scientist who departed in September to become president and CEO of the American Medical Informatics Association. Fridsma was effectively the point person for SHARP while at ONC.
With money appropriated by the 2009 HITECH Act, ONC issued grants in 2010 to four major institutions, to "address well-documented problems that impede the adoption of health IT," according to the program's website...
Medscape Medical News___
President Requests $215M for 'Precision Medicine'
Alicia Ault, January 30, 2015
Washington, DC — Putting his money where his mouth is, President Obama will seek $215 million to finance the Precision Medicine Initiative he first mentioned in his State of the Union speech on January 20.
The funding request will be included in his fiscal 2016 budget, which will be sent to Congress on February 5.
"The time is right to unleash a new wave of advances in this area — precision medicine," said Obama at today at the East Wing of the White House. And he said he knew the time was right, in part, because "there is bipartisan support for the idea."
A centerpiece of the president's proposal is a million-patient research cohort that will depend largely on physicians and hospitals to help recruit participants and ensure there is continuous and long-term data collection and follow-up, Francis S. Collins, MD, PhD, director of the National Institutes of Health (NIH), told Medscape Medical News.
He likened the Precision Medicine Initiative to the Human Genome Project...
More to come...