On May 21, 2015, the House Energy and Commerce Committee approved by a unanimous vote H.R. 6, the 21st Century Cures Act.1 House Energy and Commerce Committee Chairman Fred Upton (R-MI), Oversight and Investigations Subcommittee Ranking Member Diana DeGette (D-CO), Energy and Commerce Ranking Member Frank Pallone, Jr. (D-NJ), Health Subcommittee Chairman Joe Pitts (R-PA), and Health Subcommittee Ranking Member Gene Green (D-TX) reached an agreement on an overall framework for the legislation in April, significantly narrowing its scope relative to the version first released in January. Over the past month, a bewildering series of adjustments have been made to many provisions of the legislation, reflecting debate amongst stakeholders, the Executive Branch, and the Congress about the appropriate scope and legislative vehicle for each provision (Cures vs. an upcoming reauthorization of FDA user fee laws), and the trade-offs associated with accelerating the development of new precision medicines.
Now that the dust has settled, at least temporarily, the legislation will give the Food and Drug Administration (FDA) additional resources and regulatory flexibility to address precision medicine, and includes a variety of proposals to modernize research, development, and delivery of medical innovations. The resulting legislation does not include most of the expanded periods of exclusivity sought by industry, but includes additional funding for the National Institutes of Health (NIH), a key priority for Democrats.
Lawmakers scrambled to agree on ways to cut federal spending to offset the additional funds for NIH and FDA. The total amount of offsets needed declined from a reported ~$30 billion in the days leading up to the markup, to $13.2 billion in the final version. Although most health-related legislation is fully offset with cuts in health programs, the offsets for Cures include $5.2 billion from selling off crude oil from the Strategic Petroleum Reserve.2 Other health-related cuts include Medicaid payments for durable medical
1 The 21st Century Cures Act passed by the Energy & Commerce Committee on May 21, 2015, is available here, along with the Manager’s Amendment, available here. We previously provided a summary of the January 2015 Discussion Draft of the 21st Century Cures Act, available here.
2 See Section 4061, as added by the Manager’s Amendment.
equipment (-$2.8 billion)3 and changes in the timing of federal reinsurance payments to Part D plans (-$5 to $7 billion according to press reports).4
According to sponsors, the 21st Century Cures legislation will go to the floor of the House of Representatives for a vote this summer. Some policy priorities for stakeholders in the pharmaceutical and medical device industries may be deferred to the user fee agreements and associated legislation that must be reauthorized by 2017. The January draft also included a placeholder for alternatives to the Food and Drug Administration’s (FDA) proposal for oversight of laboratory-developed tests (LDTs), but the version passed by the Committee is silent on this controversial issue. Although the new draft includes some reforms to increase the transparency of the local Medicare coverage process, they are less consequential than those in the January draft.
I. Highlights of New Provisions in the May 2015 Discussion Draft
As approved by the Committee, the 21st Century Cures Act includes a number of new provisions that would impose changes in areas such as development of precision medicine products, the use of evidence from clinical experience, and the dissemination of health care economic information. Highlights of the legislation are found below.
A. Sections 1001-1002: NIH reauthorization; NIH Innovation Fund
The updated 21st Century Cures Act authorizes specific levels of funding for the National Institutes of Health (NIH) for 2016 through 2018—$31.8billion in 2016; $33.3billion in 2017; and $34.9billion in 2018—although, if the legislation is enacted, these amounts will still need to be appropriated by Congress each year. It also establishes a new NIH Innovation Fund for fiscal years 2016 through 2020 ($2 billion each year).
B. Section 1123: Data on Natural History of Diseases
Section 1123 would allows the Secretary to participate in public-private partnerships to “facilitate the collection, maintenance, analysis, and interpretation of data regarding the natural history of disease, with
3 See Section 4001, as added by the Managers Amendment.
4 See Section 4003, as added by the Managers Amendment.
a particular focus on rare diseases.”5 This section specifies that such partnerships may include sponsoring or maintaining disease registries, developing or enhancing IT systems for disease study data, and providing advice on disease studies. Data obtained under this section must be made available, consistent with privacy laws, “to help facilitate and expedite medical product development programs.” This section authorizes a yearly appropriation of $5million for FYs 2016 through 2020.
C. Section 2021: Qualification of Drug Development Tools
Section 2021 would require FDA to establish a process for the qualification of drug development tools, initiated by request, for use in supporting or obtaining FDA approval for or investigational use of a drug or biologic. Drug development tools are defined broadly to include biomarkers, clinical outcomes assessments, and “any other method, material, or measure that the Secretary determines aid[s] drug development and regulatory review for purposes of this section.” Like its predecessor provisions in the original discussion draft, this section would require FDA to issue guidance, in consultation with stakeholders, to assist in implementation. The language in the new version, however, provides more details about the qualification process, including factors that the Secretary may consider in determining whether to accept a submission and prioritization of qualification review.
D. Section 2022: Accelerated Approval Development Plan
This section would amend Section 506 of the FDCA (21 U.S.C. § 356) to allow the sponsor of a drug that FDA determines is eligible for accelerated approval to request, at any time after the submission of an IND, that the Secretary agree to an accelerated approval development plan.6 The accelerated approval development plan would be required to include an agreement on: (A) the surrogate endpoint to be assessed under such plan; (B) the design of the study that will utilize the surrogate endpoint; and (C) the magnitude of the effect of the drug on the surrogate endpoint that is the subject of the agreement that would be sufficient to form the primary basis of a claim that the drug is effective. The Secretary would have the authority to require the sponsor of such drug to modify or terminate the plan if additional data or
5 Note that Section 1001 of the January Discussion Draft would have provided for “the establishment and maintenance of registries designed to increase understanding of the natural history of disease.”
6 This section defines “accelerated approval development plan” to mean “a development plan agreed upon by the Secretary and the sponsor submitting the plan that contains study parameters for the use of a surrogate endpoint that: (A) is reasonably likely to predict clinical benefit; (B) is intended to be the basis of the accelerated approval of a drug.”
information indicates that the plan originally agreed upon is no longer sufficient to demonstrate the safety and effectiveness of the drug involved; or the drug is no longer eligible for accelerated approval.
E. Section 2041: FDA Precision Medicine Guidance
Section 2041 would require FDA to issue guidance, no later than eighteen months after enactment, to “assist sponsors in the development of a precision drug or biological product.” FDA would develop a definition for the term “precision drug or biological product” and would be required to a provide information to assist sponsors in development of such products." The draft legislation provides that this guidance could address:
1. The evidence needed to support the use of biomarkers that identify subsets of patients as likely respondents to therapies to streamline the conduct of clinical trials;
2. Recommendations for the design of studies to validate biomarkers as predictors of response to a drug or biologic;
3. The extent to which using biomarkers to subset patient populations affects the benefit-risk assessment;
4. The development of companion diagnostics in the context of a drug development program; and
5. Considerations for developing biomarkers that predict response to therapy and the timing of when such information may be included in a drug or biologic’s labeling.
Further, Section 2041 would make certain changes for drugs designated for rare diseases. Specifically, in the case of an application for a precision drug or biologic for the treatment of a serious or life-threatening disease or condition, and has been designated under section 526 as a drug for a rare disease or condition, the Secretary may, consistent with applicable standards for approval, rely upon data or information previously developed by the sponsor of a prior approved drug or indication (or another sponsor that has provided the sponsor with a contractual right of reference to such data and information) for such drug or indication in order to expedite clinical development for a precision drug or indication that
is using the same or similar precision medicine approach as that of the prior approved drug or indication. In addition, the Secretary may, as appropriate, consider the application for approval of such precision drug to be eligible for expedited review. Although not mandatory in nature, this provision could have an impact on FDA thinking and flexibility in the development and approval of applications for precision medicines, particularly with respect to use of data from prior applications to support extrapolation across genetic subsets of patients.
F. Section 2062: Utilizing Evidence from Clinical Experience
Section 2062 would require FDA to establish a program to evaluate the potential use of evidence from clinical experience to help support the approval of a new indication for a drug and to help support or satisfy post-approval study requirements.7 In parallel, FDA would identify and execute pilot demonstrations to extend existing use of the Sentinel System to support these efforts. This section would define “evidence from clinical experience” to mean “data regarding the usage, or potential benefits or risks, of a drug derived from sources other than randomized clinical trials, including from observational studies, registries, and therapeutic use.”
Within 18 months of enactment, the FDA would be required to establish a draft framework for implementing the program. The draft framework is required to include information describing: (A) the current sources of data developed through clinical experience, including ongoing safety surveillance, registry, claims, and patient-centered outcomes research activities; (B) the gaps in current data collection activities; (C) the current standards and methodologies for collection and analysis of data generated through clinical experience; and (D) the priority areas, remaining challenges, and potential pilot opportunities that the program established under this section will address. In creating the framework, the FDA would be required to consult with stakeholders (e.g., industry, academia, medical professional organizations, and patient advocacy groups) and may engage a public-private entity or independent research organization to facilitate stakeholder engagement. The FDA would be required to implement the program evaluating the potential use of evidence from clinical experience within 24 months of enactment.
7 This provision is likely a replacement to the prior Section 2101: Real World Evidence; however, the language in the new Section 2062 is different from the prior language, as noted in this section.
This section also would require the Secretary to issue a guidance for industry which would address: (A) the circumstances under which sponsors of drugs and the Secretary may rely on evidence from clinical experience for the purposes described above; and (B) the appropriate standards and methodologies for collection and analysis of evidence from clinical experience submitted for such purposes. The Secretary would be required to issue the guidance within three years after enactment and to finalize the guidance within 48 months, after an opportunity for public comment.
Nothing in this section would prohibit the Secretary from using evidence from clinical experience for purposes not specified in this section, provided the Secretary determines that sufficient basis exists for any such non-specified use. Further, this provision would not otherwise alter any existing standards of approval (e.g., substantial evidence) or the Secretary’s authority to require post-approval studies or clinical trials or the standards of evidence under which studies or trials are evaluated.
In addition to implementing the evidence from clinical experience program noted above, the FDA also would be required to identify and execute pilot demonstrations using data captured within the Sentinel System surveillance infrastructure, as appropriate, to generate evidence from clinical experience to improve assessment of risks and benefits for drugs approved under Section 505 (c), protect public health, or advance patient-centered care. The Secretary would be able, but not required, to make strategic linkages between such data captured through the Sentinel System surveillance infrastructure and sources of complementary public health data and infrastructure the Secretary deems appropriate and necessary. The Secretary would be required to consult with relevant stakeholders in developing the pilot demonstrations and would be able to contract with qualified entities to carry out such pilots. The Secretary would have the flexibility to deem such pilot demonstrations as public health activities, and deem safety surveillance performed at the request of FDA in connection with such pilots as public health activities, permitting the use and disclosure of protected health information. The bill authorizes $3 million per year in 2016 through 2020 to implement the program.
G. Section 2101: Health Care Economic Information
Section 2101 would amend FDAMA 114 (21 U.S.C. § 352(a)) to help clarify and facilitate the dissemination of health care economic information to payers, formulary committees, or other similar entities. Under current FDAMA 114, the dissemination of health care economic information to formulary committees (or other similar entities) in the course of carrying out their duties to select drugs for managed
care or other similar organizations does not constitute false or misleading advertising or promotion if the healthcare economic information directly relates to an FDA-approved indication and is based on competent and reliable scientific evidence.
The Cures provision would broaden the definition of health care economic information, which is presently vague and somewhat ambiguous. FDAMA 114 presently defines health care economic information to mean “any analysis that identifies, measures, or compares the economic consequences, including the costs of the represented health outcomes.” Section 2101 would clarify and expand the meaning of this term by defining “health care economic information” to mean “any analysis (including the clinical data, inputs, clinical or other assumptions, methods, results, and other components underlying or comprising the analysis) that identifies, measures, or describes the economic consequences, which may be based on the separate or aggregated clinical consequences of the represented health outcomes, of the use of a drug. Such analyses may be comparative to the use of another drug, to another health care intervention, or to no intervention.” This definition likely would expand the types of health care economic materials and analyses firms could prepare and use with payors or formulary committees. This provision also would extend the dissemination of health economic information explicitly to “payors” as well as formulary committees or other similar entities with knowledge and expertise in the area of health care economic analysis select drugs for coverage or reimbursement.
Further, this provision would require only that the information “relate” (rather than “directly relate”) to an FDA-approved indication, and the health care economic information would be required to include, where applicable, “a conspicuous and prominent statement describing any material differences between the health care economic information and the labeling approved for the drug.” The May 21 version of this section also added subsection B which clarifies that health care economic information “does not include any analysis that relates only to an indication that is not approved under section 505 or under section 351 of the Public Health Service Act for such drug.” Read together, this language would allow on-label-focused health economic outcomes research claims that have off-label aspects (e.g., a database broader than just on-label patients, or an analysis focused on a patient subgroup that was not specifically studied as part of the clinical trials supporting FDA approval), but manufacturers could not disseminate or communicate health care economic information with a primary focus on an unapproved indication.
H. Section 2102 - Facilitating Responsible Communication of Scientific and Medical Developments.
The January discussion draft included a Section 1141 with this title, with a placeholder for legislative language. The May version includes new language that would require FDA, within 18 months of
enactment, to issue draft guidance on facilitating the dissemination of responsible, truthful, and non-misleading scientific and medical information not included in the approved drug label. Essentially this provision punts -- for now -- on attempting a legislative fix to the fundamental problem of FDA’s onerous controls over pharmaceutical company speech, simply mandating a draft guidance that FDA had already promised to produce.
I. Section 2152: Reauthorization of Rare Pediatric Disease Priority Review Voucher Program
This provision reauthorizes, through December 31, 2018, the priority review voucher program for rare pediatric diseases and requires the Government Accountability Office (GAO) to conduct a study of the impact of the program on drugs for rare pediatric diseases that would not otherwise have been developed.
J. Section 2225—Eases the regulatory submission burden for certain Class I and Class II medical devices.
Section 2225 would require FDA to identify types of Class I devices for which a 510(k) submission is no longer necessary to assure safety and effectiveness and to publish a list of such devices in the Federal Register within 120 days of enactment. With respect to Class II devices, FDA would be required to publish in the Federal Register within 60 days of enactment a list of the types of devices for which the Secretary believes a 510(k) submission is no longer required to assure safety and effectiveness, and publish a final list of such devices within 180 days of enactment after collecting public comments for at least 60 days. The applicable classification regulations would be deemed amended to incorporate those exemptions following publication of a final list.
K. Section 2228: CLIA Waiver Study Design Guidance for In Vitro Diagnostics
Section 2228 would require FDA to issue draft guidance, no later than 12 months after enactment of the legislation, revising its guidance Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices (Jan. 30, 2008) to include guidance on the appropriate use of comparable performance tests between a CLIA waived and moderate complexity (non-waived) users to demonstrate device accuracy. In its current form, this guidance explains that the term “accurate” is used to “refer to those tests that are comparable to tests whose results of measurements are traceable to designated references of higher order.” To demonstrate accuracy in the hands of the intended operator, the guidance recommends performing “prospective clinical studies of the device proposed for waiver using patient samples collected in the intended testing
environment.” FDA would be required to finalize the revised guidance not later than 12 months after the draft’s comment period closes.
L. Section 2263: Alteration of Waiver of Informed Consent for Clinical Investigations
Section 2263 would amend Section 520(g)(3)(21 U.S.C. § 360j(g)(3)) of the FDCA to exempt from certain current requirements that human research subjects provide informed consent to participate in medical device or drug trials where the research poses no more than minimal risk to the subjects and includes safeguards to protect the subjects’ rights, safety, and welfare. This section would also make a similar amendment to Section 505(i)(4) of the FDCA (21 U.S.C. § 355(i)(4)).
M. Section 3001: Interoperability
Section 3001 of May Cures includes the long-awaited interoperability provisions, intended to reduce economic and technical barriers to clinical datasharing. Portions of Section 3001 appear substantially similar to the interoperability bill released by Rep. Burgess in March 2015.
Section 3001 would provide that for health information technology (HIT) to be considered interoperable,8 it must: (1) allow for secure records transfer, (2) allow access to the entirety of the patient’s data, and (3) not engage in “information blocking.” The extent to which interoperability is met would be measured using 1) standards for vocabulary and terminology, 2) standards for content and structure, 3) standards for transport of information, 4) security standards, and 5) service standards. The bill would require the Secretary to issue guidance on implementing this definition of interoperability by January 1, 2017.
Section 3001 would require the HHS Secretary to contract standards development organizations to recommend standards for interoperability, which the Secretary must decide to adopt (or state reasons not to adopt) within 90 days; those standards, if adopted, will be effective one year after the Secretary decides to adopt them. The draft legislation no longer includes the “Charter Organization,” a feature of the previous interoperability provision in Cures and of a draft interoperability bill floated in March by Representative Burgess; the Charter Organization would have been an advisory committee (but one with unusually broad authority for an advisory committee) made up of standards development organization representatives. Section 3001 would authorize an appropriation of $10million for HHS’s contract. The HIT Standards Committee of the Office of the National Coordinator for HIT would terminate 90 days after enactment of the 21st Century Cures legislation.
8 In the prior discussion draft this was “EHR / HIT”; HIT is broader.
After consultation with stakeholders and not later than July 1, 2017,9 this section would require the Secretary to submit to Congress and make publicly available a report on the methods adopted for measuring interoperability and also findings including how much interoperability has been achieved to date, strategies for achieving widespread interoperability, barriers preventing interoperability, and a plan and milestones—with specific steps—to achieve widespread interoperability.
Penalties for noncompliance with interoperability criteria would begin in 2018. Section 3001 would require, beginning January 1, 2018, that EHR vendors attest to compliance with interoperability as a condition for certification or maintenance of certification in the government’s EHR incentive program. Vendors who do not meet interoperability criteria could face decertification. This provision also would authorize HHS OIG to investigate and penalize vendor violations of interoperability attestations and the prohibition against information blocking and provider engagement in information blocking, unless for a “legitimate purpose.” The definition of information provides some insight into legitimate purposes for information blocking, defining it as practices that interfere with exchange of electronic health information and “do not serve to protect patient safety, maintain the privacy and security of individuals’ health information or promote competition and consumer welfare.” Section 3001 would, however, provide for a “significant hardship” exemption for certain providers, to be granted at the Secretary’s discretion, for use of decertified technology. Exemptions would be no less than one year in duration, and could last up to five years.
N. Section 3021: Telehealth Services Under Medicare
The telehealth provision in the first Cures draft would have expanded Medicare coverage of telehealth services (though the provision was confusing and the precise degree to which it would have expanded telehealth coverage was therefore difficult to judge). The new provision does not expand telehealth coverage.10 The new provision simply provides for CMS and MedPAC to submit certain information on telehealth to Congress (which Congress presumably would use to evaluate the need for future legislation expanding Medicare coverage of telehealth), and expresses the sense of Congress on certain issues relevant to telehealth.
9 Earlier versions required this report by 2016.
10 Medicare coverage of telehealth services is limited in several ways. Most importantly, telehealth services can only be furnished to beneficiaries in certain rural or underserved areas. In addition, the beneficiary must be at an eligible “originating site” (various specified medical facilities) when receiving the services, the services must be on a list of telehealth services maintained and annually updated by CMS, and to qualify as “telehealth” the services must be furnished via real-time audio and video conferencing.
CMS would be required to provide information to Congress on the beneficiary populations whose care could be improved the most by expanding telehealth, on initiatives by the Center for Medicare and Medicaid Innovation related to telehealth, on the high-volume procedures or diagnoses for which telehealth services might be suitable, and on barriers (under the current legal framework) that might prevent expanding telehealth coverage further. MedPAC would be required to provide information on telehealth services that could not currently be covered under fee-for-service Medicare for which MedPAC recommends coverage, and on barriers to telehealth under existing law and “solutions to address such barriers.”
The sense of Congress language provides that: (1) States should cooperate to create common licensure requirements for providers furnishing telehealth services, to facilitate multi-state practices; (2) “eligible originating sites” under Medicare should be expanded; and (3) any expansion of Medicare telehealth coverage should recognize that telehealth services must be safe, effective, quality services that meet the ordinary standards for Medicare coverage and payment and are furnished by “clinically appropriate means.”
O. Additional New Provisions
Additional new provisions in the May version include:
A. Section 1025—Expressing Congress’ position of the importance of NIH participation in or sponsorship of scientific conferences and meetings
B. Section 1026—Other transactions authority
C. Section 1029—Expressing Congress’ position that the National Institute on Minority Health and Health Disparities (NIMHD) should include within its strategic plan ways to increase representation of underrepresented communities in clinical trials.
D. Section 1041—Improving loan repayment assistance for qualified health professionals who engage in research for the Federal government
E. Section 1042—Requiring the NIH Director to submit to Congress a report on efforts of NIH to attract, retain, and develop emerging scientists
F. Section 1061—Creating Capstone Award for outstanding scientists who have been funded by the NIH
G. Section 1083—Requires NIH to convene workshops of experts on pediatrics and geriatrics concerning appropriate age groupings to be included in human clinical studies and post on its website data on the number of children included in NIH-funded research, disaggregated by developmentally appropriate age group, race, and gender.
H. Section 2081—Congress’ general sense of support for FDA’s expedited approval of breakthrough therapies
I. Section 2161—Allowing FDA to award grants to higher education and non-profit organizations to study and recommend improvements to the process of continuous manufacturing of drugs and biologic
J. Section 2181—Requiring FDA to issue guidance describing each agency center’s responsibilities with regard to review of combination products and update it periodically
K. Section 2221—Third-Party Quality System Assessment11
L. Section 2281—Silvio Conte Senior Biomedical Research Service
M. Section 2282—Enabling FDA scientific engagement
N. Section 2284—Exempting FDA from the Paperwork Reduction Act with respect to the collection of voluntary information (through voluntary surveys/questionnaires) from patients, industry, academia, and other stakeholders.
O. Section 2285—Hiring authority for scientific, technical and professional personnel at FDA centers12
P. Section 2301—Exempting from Sequestration Certain User Fees of FDA13
Q. Section 4001—Limiting Federal Medicaid Reimbursement to States for Durable Medical Equipment (DME) to Medicare Payment Rates14
R. Section 4002—Medicare Payment Incentive for the Transition from Traditional X-Ray Imaging to Digital Radiography15
S. Section 4003—Implementation of Office of Inspector General Recommendation to Delay Certain Medicare Prescription Drug Plan Prepayments16
T. Section 4041—Cures Innovation Fund17
U. Section 4061—Strategic Petroleum Reserve Drawdown18
11 A prior version of this section was included in the January 2015 Discussion Draft, but Congress had left placeholders and comments at the time. This section was included in the 21st Century Cures Act as passed on May 21, 2015; however, a revised section was included in the Manager’s Amendment.
12 Added by the Manager’s Amendment.
13 Added by the Manager’s Amendment.
14 Added by the Manager’s Amendment.
15 Added by the Manager’s Amendment.
16 Added by the Manager’s Amendment.
17 Added by the Manager’s Amendment.
18 Added by the Manager’s Amendment.
V. Section 4071—Lyme Disease and Other Tick-Borne Diseases19
II. Significant Changes to Previous Provisions in the 21st Century Cures Act Discussion Draft
A. Section 2121-2123: Antibiotic Drug Development
Section 2121 builds on the progress Congress made with the passage of the Generating Antibiotic Incentives Now (GAIN) Act as a part of the FDA Safety and Innovation Act (FDASIA) in 2012, by facilitating the development of certain new antibacterial or antifungal drugs for limited patient populations through a tailored FDA approval pathway. The revised section replaces the term “systemic antibacterial or antifungal drug” with “antimicrobial drug,” which the legislation defines as “a systemic antibacterial or antifungal drug that: (i) is intended for human use in the treatment of a disease or condition caused by a bacterium or fungus; (ii) may include a qualified infectious disease product designated under section 505E(d); and (iii) is subject to section 503(b)(1). If provided by the Secretary through regulations, this section also provides that “antimicrobial drug” may include (i) drugs other than systemic antibacterial and antifungal drugs; and (ii) biological products (as such term is defined in section 351 of the Public Health Service Act) to the extent such products exhibit antimicrobial activity.
In addition, Section 2122 streamlines the process by which FDA can clear or approve updates to antimicrobial susceptibility testing devices. The new legislation would make certain revisions to the Interpretive Criteria Website that FDA would be required to create and maintain, which would include a list of recognized susceptibility test interpretive criteria to characterize the in vitro susceptibility of particular bacteria, fungi, or other microorganisms to antimicrobial drugs. The website would be required to include a list of appropriate interpretive criteria, as well as criteria where the Secretary: (i) does not recognize, in whole or in part, an interpretive criteria standard otherwise applicable to such a drug; (ii) the Secretary withdraws recognition of a standard, in whole or in part, otherwise applicable to such a drug; (iii) the Secretary approves an application under section 505 of this Act or section 351 of the PHSA, as applicable, with respect to marketing of such a drug for which there are no relevant interpretive criteria included in a standard recognized by the Secretary; or (iv) because the characteristics of such a drug product differ from other drug products with the same active ingredient, the interpretive criteria with
respect to such drug: (I) differ from otherwise applicable interpretive criteria included in a listed standard or interpretive criteria otherwise listed under this subparagraph; and (II) are determined to be appropriate for the drug.
19 Added by the Manager’s Amendment.
This section would also require additional language on the Interpretive Criteria Website, noting that the website provides information about susceptibility of bacteria, fungi, or other microorganisms to a certain drug (or drugs). Further, this section clarifies that the inclusion in the approved labeling of an antimicrobial drug of a reference or hyperlink to the Interpretive Criteria Website, in and of itself, shall not cause the drug to be misbranded in violation of section 502, or the regulations promulgated thereunder. Additionally, the new section would permit the Secretary to authorize the marketing of an antimicrobial susceptibility testing device20 under the following conditions:
(A) The device is used to make a determination of susceptibility using susceptibility test interpretive criteria that are: (i) included in a standard recognized by the Secretary under subsection (c); or (ii) otherwise listed on the Interpretive Criteria Website under subsection (b)(2);
(B) The labeling of such device prominently and conspicuously:
(i) includes a statement that: (I) the device provides information about the susceptibility of bacteria and fungi to certain drugs; and (II) the safety and efficacy of such drugs in treating clinical infections due to such bacteria or fungi may not have been established in adequate and well-controlled clinical trials and the clinical significance of such susceptibility information in those instances is unknown;
(ii) includes a statement directing health care practitioners to consult the approved labeling for drugs tested using such a device, to determine the uses for which FDA has approved such drugs; and
(iii) includes any other statement the Secretary determines appropriate to adequately convey the limitations of the data supporting the interpretive criteria described in subparagraph (A).
The legislation would clarify that nothing in this section could be construed to alter the substantial evidence standards or any applicable standards with respect to marketing authorization. Further, the legislation expressly states that nothing in the subtitle can be construed to restrict in any manner the
prescribing or administering of antibiotics or other products by health care practitioners or to limit the practice of health care. The legislation removes the prior Section 1063, which would have allowed sponsors to elect to convey a portion of extended exclusivity period applicable to a qualified infectious disease product.
20 Defined as “a device that utilizes susceptibility test interpretive criteria to determine and report the in vitro susceptibility of certain microorganisms to a drug (or drugs).”
Section 2123, “encouraging the development and use of new antimicrobial drugs,” provides an additional Medicare payment for certain antibiotics -- those meeting the definition of a “new antimicrobial drug” -- used in an inpatient hospital stay. This section would require that CMS publish a list annually (beginning for fiscal year 2018) of designated “new antimicrobial drugs” and provide additional payments to “eligible hospitals” for discharges of Medicare patients who received those drugs. “Eligible hospital” would be defined as a subsection (d) hospital (meaning a hospital participating in the Medicare Inpatient Prospective Payment System, or IPPS) that participates in the CDC’s National Health Safety Network (or a similar surveillance system).
“New antimicrobial drug” would mean a product first approved (or approved for a new indication) after December 1, 2014 that FDA determines is:
(1) is intended to treat an infection caused by (or likely to be caused by) a qualifying pathogen (as defined under FDCA 505E(f), part of the GAIN Act); or
(2) meets the definition of a “qualified infectious disease product” under FDCA 505E(g) (also part of GAIN), and is intended to treat an infection for which there is a “unmet medical need” and that is associated with high rates of mortality or significant morbidity (as determined in consultation with CDC and the infectious disease professional community).
The Secretary could revoke a new antimicrobial drug designation “only upon a finding that the request for such designation contained an untrue statement.” The drug could not have received New Technology Add-On Payments (nor could it receive NTAP payments after having received additional payments as a new antimicrobial drug). The additional payments could only be made “during the 5 fiscal year period in which the drug is first included [on the CMS new antimicrobial drug list].”
Additional payments would be made under Social Security Act 1847A (which usually would mean 106% of Average Sales Price), subject to a potential cap on annual additional payments. CMS would be required, through rulemaking, to estimate the total additional payments and total IPPS payments for each
upcoming fiscal year; if the total additional payments exceeded 0.03% of the estimated total IPPS payments, then CMS would make a pro rata cut in the amount of each additional payment to satisfy the cap. (This is similar to the procedure CMS carries out each year to ensure that estimated OPPS pass-through payments do not exceed a set percentage of estimated OPPS spending for the upcoming year.)
The provision also would require the GAO to study (consulting with NIH and CDC) and report to Congress on barriers to developing new antimicrobial drugs and recommendations for overcoming these barriers.
B. Section 2141-2143: Vaccines
Sections 2141 through 2143 make several technical and conforming changes to the process for the making of vaccination scheduling recommendations to the expert group that makes recommendation on how to use vaccines in the United States, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC).
First, these sections would clarify that upon the licensure of any vaccine (or any new indication for a vaccine), the CDC Director must direct the ACIP to consider the use of the vaccine at its next regularly scheduled meeting. If the ACIP does not make recommendations on the vaccine, it would be required, at the request of the vaccine sponsor, to make recommendations on an expedited basis. The ACIP also would then be required to issue a report to Congress on vaccination scheduling within 18 months of legislative enactment.
The new provision also would clarify that “vaccine developers” could request meetings with CDC (instead of FDA and the National Vaccine Program). CDC would be required to schedule a meeting with a vaccine developer within 120 days after a request. Vaccine developer would be defined as a nongovernmental entity engaged in:
(i) the development of a vaccine with the intent to pursue licensing of the vaccine by FDA; or
(ii) the production of a vaccine licensed by FDA; and
(B) vaccine research.
CDC still would be able to include FDA and National Vaccine Program officials during meetings. Absent from the new version are January Draft Sections 4043 (requiring the Secretary to issue guidance to facilitate use of pathways for vaccine development and licensure) and 4045 (addressing modifications to the priority review voucher program for tropical diseases).
C. Section 2181: Enhancing Combination Products Review
This section would require the Secretary to issue guidance within 18 months of enactment that describes the responsibility of each agency center regarding its review of combination product. The Secretary
would also be required, after soliciting public comment, to review and update such guidance periodically.21
D. Section 2227: Humanitarian Device Exemption Application
An Humanitarian Use Device (HUD) is a device intended to treat or diagnose a disease or condition that affects fewer than 4,000 individuals in the United States per year. To obtain approval for a HUD, sponsors must submit a humanitarian device exemption application to FDA. This section would revise 21 U.S.C. § 360j(m)(1) such that the humanitarian device exemption application could apply if the relevant disease or condition affect not more than 8,000 individuals in the U.S. per year. FDA would be required to issue guidance within 18 months after enactment regarding this provision and such guidance would be the same as previously proposed.
E. Sections 2241-2243: Sensible Oversight for Technology Which Advances Regulatory Efficiency
The revised Sections would make several significant changes to the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act. As noted in our prior advisory, the SOFTWARE Act is designed to provide regulatory certainty to manufacturers and developers of medical apps and health software by amending the FDCA to exclude certain types of software from FDA regulation as medical devices. First, the revised legislation would only define “health software;” the legislation no longer defines or makes a distinction between “software” and “medical software.” Second, the legislation makes significant changes to the definition of “health software.” The revised language would define “health software” as
software that does not, through use of an in vitro diagnostic device or signal acquisition system, acquire, process, or analyze an image or physiological signal, is not an accessory, is not an integral part of a device necessary to the support the use of the device, and:
(A) is intended for use for administrative or operational support or the processing and maintenance of financial records;
(B) is intended for use for clinical, laboratory, or administrative workflow and related record-keeping;
21 Sections 2141-2142 of the January 2015 Discussion Draft also addressed combination products.
(C)(i) is intended for use solely in the transfer, aggregation, conversion (in accordance with a present specification), storage, management, retrieval, or transmission of data or information; (ii) is not intended for use--(I) in active patient monitoring; or (II) in controlling or altering the functions or parameters of a device that is connected to such software;
(D) is intended for use to organize and present information for health or wellness education for use in maintaining a healthy lifestyle, including medication reminders and health management tools;
(E) Is intended for use to analyze information to provide general health information that does not include patient-specific recommended options to consider in the prevention, diagnosis, treatment, cure, or mitigation of a particular disease or condition;22
(F) is intended to analyze information to provide patient-specific recommended options to consider in the prevention, diagnosis, treatment, cure or mitigation of a particular disease or condition
Third, the new section would change the proposed definition of “accessory” to mean a “product that: (A) is intended for use with one or more parent devices; (B) is intended to support, supplement, or augment the performance of one or more parent devices; and (C) shall be classified by the Secretary--(i) according to its intended use; and (ii) independently of any classification of any parent device with which it is used.” Fourth, the revised section does not define “component.” Authority over health software would continue to be delegated to FDA’s Center for Device and Radiological Health (CDRH). The Secretary would no longer be required to issue final regulations within two years. Instead, the Secretary would be required to review existing regulations and guidance regarding regulation of software. This review could include topics such as classification of software, development standards, manufacturing, modifications, labeling, etc. Based on this review, the Secretary would have the discretion to implement a new framework for the regulation of software and would be required, as appropriate, to modify such regulations and guidance or issue new regulations or guidance. The Secretary would also have the authority to modify or issue regulations for the regulation of software by administrative order published in the Federal Register. FDA would be required to hold public workshops regarding health software within 18 months to solicit input.
Similar to the provision in the January 2015 Discussion Draft, “health software” would be excluded from the definition of a “medical device” under 21 U.S.C. § 321. Certain health software, however, may be subject to FDA regulation under the proposed new Section 524B of the FDCA. Specifically, a product could be subject to FDA regulation if the Secretary determined that the software product is of a type described in subparagraph (F) of section 201(ss)(1) that the Secretary determines poses a significant risk
22 This provision was modified from the prior version issued in April version.
to patient safety. In making such a determination, the Secretary would be required to consider the following: (1) The likelihood and severity of patient harm if the product were to not perform as intended; (2) The extent to which the product is intended to support the clinical judgment of a medical professional; (3) Whether there is a reasonable opportunity for a medical professional to review the basis of the information or treatment recommendation provided by the product; and (4) The intended use of the product, including the intended user and user environment, such as whether a medical professional will use a software product of a type described in subparagraph (F) of section 201(ss)(1).
The revised sections would remove the previous January 2015 language in Section 2062 regarding prior submissions of medical software to FDA, as well as the language on adulteration and misbranding of medical software.
F. Section 3041: Exemption From Manufacturer Transparency Reporting Certain Transfers Used for Education Purposes
The updated language would continue to exclude from reporting peer-reviewed journals, journal reprints, journal supplements, medical conference reports, and medical textbooks under the current educational materials exemption of the Sunshine Act, 42 U.S.C. § 1320a-7h(e)(10)(B)(iii). The revised section would still create a new exclusion from reporting under the Sunshine Act for certain educational events, although the bill text is revised. The new language would explicitly exclude from reporting the following interactions: Indirect payments or transfers of value to a covered recipient—
A. for speaking at, or preparing educational materials for, an educational event for physicians or other health care professionals that does not commercially promote a covered drug, device, biological, or medical supply; and
B. that serves the sole purpose of providing the covered recipient with medical education, such as by providing the covered recipient with the tuition required to attend an educational event or with materials provided to physicians at an educational event.
Stakeholders expect that these provisions will apply to continuing education events and similar educational programs, which Congress demonstrated by re-titling the subtitle “Encouraging Continuing Medical Education for Physicians.”
G. Section 3061: Treatment of Certain Items and Devices (Disposable Medical Technologies)23
This provision is the successor to a significantly different provision in the original Cures draft; the new provision has a narrow focus that covers two discrete items, whereas the original provision would have provided somewhat broader coverage for a class of disposable medical equipment meeting certain criteria. The new provision provides Medicare coverage for a “durable medical item” (DMI), meaning an item that administers insulin and that includes a disposable component and at least one durable component (plus associated supplies and the insulin). The DMI and supplies would be paid under a methodology whereby the average total payment (over a set period of time, for an individual beneficiary) should not exceed what Medicare would otherwise have paid “for the durable medical item for which the [DMI] is a substitute” plus its associated supplies. The insulin would be paid separately. The insulin could be included in the DME competitive bidding program, in which event it would be paid under that program; otherwise the insulin would be paid under the provision on Part B payment for DME infusion drugs -- a provision recently criticized by the HHS Office of Inspector General that pays 95% of the October 1, 2003 AWP.
The provision also would provide a separate payment for a device when that device is furnished to a Medicare beneficiary receiving home health benefits (a small group of beneficiaries who are homebound). The device in question is a disposable device that satisfies two tests as of January 1, 2015, i.e., (1) a CPT code exists “for which the description for a professional service includes the furnishing of such device”; and (2) a separate CPT code exists “for a professional service that uses [DME] instead of such device.” This may describe a disposable negative pressure wound therapy device.
H. Section 3081: Local Coverage Decision Reforms
This provision marks a retreat from the provision on LCDs in the first Cures draft. The original provision required Medicare Administrative Contractors (MACs) to develop LCDs through a notice-and-comment process with strong requirements concerning transparency and stakeholder input; among other things, it explicitly required MACs to follow the full notice-and-comment procedure when proposing to adopt an LCD from another MAC jurisdiction.
Whether the new provision requires a notice-and-comment process is unclear. The new provision requires MACs to post certain information on their websites at least 45 days before a new or revised LCD takes effect. Specifically, MACs must post: (1) the LCD, (2) “[w]here and when the proposed [LCD] was
23 Previously Section 4141.
first made public”; (3) “[l]inks to the proposed [LCD] and a response to comments submitted to the [MAC]” concerning the proposed LCD; and (4) a summary of the evidence the MAC considered in developing the LCD. This language suggests that the MAC was required to post the proposed LCD and seek comments on it. But at least arguably, this language could instead be read as only requiring that (at least 45 days before the LCD takes effect) the MAC must post information on “where and when the proposed [LCD] was first made public” if the proposed LCD was previously made public, and as permitting a MAC to post “links to the proposed [LCD]” at a point when comments would be futile (after the final LCD has been adopted and will soon take effect). This seems a strained reading, but it is also difficult to understand why the bill language does not explicitly state that MACs must post a proposed LCD and consider comments on the proposed LCD before adopting a final LCD, if that was intended.
Note that the Medicare Program Integrity Manual currently requires that MACs follow a basic notice-and-comment process in developing LCDs. But this requirement could be eliminated via a Manual change unless established in statute or regulation.
Also dropped were related requirements that would have improved transparency and opportunities for stakeholder input (i.e., requirements for longer comment periods for proposed LCDs that would restrict coverage, and requirements for MACs to meet with affected stakeholders upon request and to hold public meetings of their Carrier Advisory Committees). Further, MACs have other ways to set coverage and payment policy, including publishing local coverage articles, implementing correct coding edits, or creating an “improper payment outreach and education program” as required by the recently enacted Medicare and CHIP Access and Reauthorization Act of 2015 (MACRA.) Arnold & Porter has published a summary of the MACRA legislation.
I. Section 3121: Medicare Site-of-Service Transparency
Section 3121 requires the Secretary to post information, starting in 2017, on the estimated costs, to Medicare and to its beneficiaries, for items and services provided in hospital outpatient departments (HOPDs) compared to ambulatory surgical centers (ASCs). Under its predecessor version (January Draft Section 4421), this provision would have required transparency in Medicare payments and beneficiary coinsurance for selected items and services applied to “each site of service.” Sites of service were to be specified by the Secretary, but presumably would have included the physician office setting as well as HOPDs and ASCs. The new text is limited to information on costs incurred by Medicare and beneficiaries in the HOPD and ASC settings.
Medicare pays lower amounts in ASCs for some services that are also delivered in HOPDs. Acquisition of ASCs by hospitals and conversion to HOPDs results in higher Medicare spending. This provision aims to
drive volume to ASCs (paid at the lower rate) rather than to HOPDs by making beneficiaries aware of the differences in cost. Another acquisition related shift that may be increasing Medicare costs is hospitals’ acquiring formerly independent physician practices and converting them to HOPDs for Medicare billing purposes. CMS has noted previously that generally Medicare’s total payment for a service in the HOPD setting (i.e., payment to the HOPD plus payment to the physician) is higher than its payment for the same item or service in the physician office setting; as noted, the new draft would not capture information comparing costs to Medicare and beneficiaries in the physician office setting versus the HOPD or ASC setting.
Importantly, the legislation permits the Secretary to display the estimated out-of-pocket cost for a beneficiary with no supplemental insurance coverage for Part B cost-sharing — even though the vast majority of beneficiaries have supplemental insurance that pays some or all of that amount.
J. Section 3141: Medicare Parts C and D Drug Abuse Prevention Program
Section 3141, “Programs to prevent prescription drug abuse under Medicare Parts C and D,” replaces sections 4281-4284 in the first Cures draft. Section 4284 in the previous draft, on “Requiring e-prescribing for coverage of covered Part D Controlled Substances,” has been deleted as a separate provision but its substance has been moved to new section 3141. Section 3141 generally seeks to prevent “at-risk” Medicare Part D beneficiaries from abusing controlled substances covered by Part D, through a “drug management program” (more commonly known as a lock-in program).
The new text is similar to the lock-in provision in the Protecting the Integrity of Medicare Act (HR 1021), and differs significantly from the lock-in provision in the first Cures draft. Some of the new language would create more safeguards to protect beneficiaries compared to the original Cures draft, whereas other new language would broaden the scope of the lock-in mechanism. Some of the key differences between the Cures lock-in provisions include the following:
The new language would lock an “at-risk” beneficiary into a specified physician (or physicians) as well as a specified pharmacy (or pharmacies).
The new language permits Part D plans to operate lock-in programs (as long as they have certain safeguards) but does not require plans to operate lock-in programs.
The new language would not automatically impose lock-in restrictions on a beneficiary merely because he or she had a prescription for a controlled substance that was considered “frequently abused” (as the original Cures provision would have done); instead, “clinical guidelines” will be used in determining whether a beneficiary is an “at-risk” (lock-in) beneficiary.
Under the new language a lock-in program apparently would cover the prescribing and dispensing of all controlled substances (not just a subset).
The new language expresses the “sense of Congress” that plans should use e-prescribing to combat fraud, but does not require e-prescribing of controlled substances.
The new language requires regulations on lock-in programs. CMS is directed to “convene stakeholders” to gather input on specified topics, and then to “promulgate regulations based on the input gathered.”
III. Provisions that Are Largely Identical to Counterparts in the January Discussion Draft
Section 1021—NIH Research Strategic Plan24
Section 1022—Increasing NIH Accountability25
Section 1024—Exemptions for NIH from Paperwork Reduction Act Requirements
Section 1027—NCATS Phase IIB Restriction
Section 1028—High Risk, High Reward Research
Section 1081—National Pediatric Research Network
Section 1082—Global Pediatric Clinical Trial Network Sense of Congress
Section 1101—Sharing of Data Through NIH-Funded Research
Section 1102—Standardization of Data in Clinical Trial Registry Data Bank on Eligibility for Clinical Trials
Section 1121—Clinical Trial Data System
Section 1122—National Neurological Diseases Surveillance System
Section 1124—Accessing, Sharing and Using Health Data for Research Purposes26
Section 1141—Council for 21st Century Cures27
24 The new legislative language would require NIH in creating strategic focus areas to consider the return on investment to the United States public through the investments of NIH in biomedical research and whether the area contributes to expanding knowledge to improve the United States public’s health through biomedical research.
25 NIH Director would be appointed for 5 years; study on duplication in federal biomedical research would be issued by the IOM instead of GAO.
26 This section, which previously was Section 2221 in the January 2015 Discussion Draft, has been amended principally for clarification purposes, but also omits language that would have permitted the disclosure by an entity regulated under the HIPAA privacy regulations of a “limited data set” containing patient information for research purposes, without requiring, as the HIPAA privacy regulations currently require, that the recipient of such data enter into a “data use agreement” with the disclosing entity.
Section 2001—Development and Use of Patient Experience Data to Enhance Structured Risk-Benefit Assessment Framework28
Section 2061—Broader Application of Bayesian Statistics and Adaptive Trial Designs29
Section 2063—Streamlined Data Review Program30
Section 2082-2083—Expanded Access31
Section 2151—Orphan Product Exclusivity Period Extensions.32
Section 2162—Re-Exportation Among Members for the European Economic Area33
Section 2201—Priority Review for Breakthrough Devices34
Section 2222—Valid Scientific Evidence35
Section 2223—Training and Oversight in Least-Burdensome Means Concept36
Section 2224—Recognition of Standards37 Footnote continued from previous page
27 This section modified Section 2001 in the January 2015 Discussion Draft, which would have established the 21st Century Cures Consortium.
28 Minor changes include adding “research sponsors” or other parties determined appropriate by the Secretary as someone who can provide FDA with patient experience data that is intended to facilitate or enhance the Secretary’s risk-benefit assessments, including information about the impact of a disease or a therapy on patients’ lives. Also, draft guidance would be issued in three years, instead of two, and no report to Congress would be required.
29 Previously Section 3021 in the January 2015 Discussion Draft.
30 Previously Section 1181 in the January 2015 Discussion Draft.
31 Previously Sections 1121-25 in the January 2015 Discussion Draft. The new provision requires companies to post their expanded access policies within 60 days instead of 30 days; it also states that the posting of such policies does not serve as a guarantee of access to any specific investigational drug and that a company that has made such a policy public as required under this section may revise it at any time. The new provision removes the prior proposal for an expanded access Task Force and requires FDA to issue guidance within 12 months instead of 6 months.
32 Previously Section 1261 in the January 2015 Discussion Draft. Section 2151 does not include a requirement that the Secretary adopt regulations implement the section within 2 years of enactment, unlike the previous Section 1261.
33 Previously Section 5041 in the January 2015 Discussion Draft.
34 Previously Section 1081 in the January 2015 Discussion Draft.
35 Previously Section 5041 in the January 2015 Discussion Draft. Under the new provision, the Secretary would have the authority to request data underlying the valid scientific evidence if the Secretary, in making such request, complies with the least burdensome appropriate means of evaluating device effectiveness or determining substantial equivalence; the Secretary furnishes a written rationale for so requesting the underlying data together with such request; and if the requested underlying data for such a study are unavailable, the Secretary shall consider such study to be part of the totality of the evidence with respect to the device, as the Secretary determines appropriate.
36 Previously Section 5063 in the January 2015 Discussion Draft.
37 Previously Section 5064 in the January 2015 Discussion Draft.
Section 2226—Advisory Committee Process38
Section 2261—Protection of Human Subjects in Research; Applicability of Rules
Section 2262—Use of Non-Local Institutional Review Boards for Review of Investigational Device Exemptions and Human Device Exemptions39
Section 2283—Reagan Udall Foundation for FDA
Section 3101—Medicare Pharmaceutical and Technology Ombudsman40
IV. Provisions in January Discussion Draft That Have Been Removed
The following provisions were originally included in the January 2015 initial 21st Century Cures Act Discussion Draft and not included in the May, 21, 2015 version.
Sections 1021-1024 - Surrogate Endpoint Qualification and Utilization
Section 1041 - Approval of Breakthrough Therapies
Section 2261 - Funding Research by Emerging Scientists
Section 1082 - CMS Coverage of Breakthrough Devices
Section 1101 - Accelerated Approval for Breakthrough Devices
Sections 1122-1124 - Notification of Submitters of Expanded Access Requests (1122); GAO Qualitative Analysis on Individual Patient Access to Unapproved Therapies and Diagnostics (1123); Expanded Access Task Force (1124)
Section 1161 - Dissemination of Information about Medical Products using the Internet
Sections 1201-1202 - Cures Acceleration Network
Sections 1221-1223 - Dormant Therapies
Section 1241 - New Therapeutic Entities
Section 1261 - Orphan Product Extensions Now
Section 2021 - Medical Product Innovation Advisory Commission
Section 2041 - Regenerative Medicine
Section 2051 - Genetically Targeted Platform Technologies for Rare Diseases
Sections 2085-2088 - Improving Clinical Outcomes for Patients and Program Integrity Through CMS Data
Sections 2091-2092 - Building a 21st Century Clinical Data Sharing System
Section 2101 - Utilizing Real-World Evidence
Section 2121 - Coverage With Evidence Development
38 Previously Section 5068 in the January 2015 Discussion Draft.
39 Previously Section 3002 in the January 2015 Discussion Draft.
40 The new draft eliminates an annual report to Congress on the activities of the Ombudsman.
Sections 2141-2142 - Combination Products
Section 2161 - Modernizing Regulation of Diagnostics
Section 2241 - 21st Century Chronic Disease Initiative Act
Section 3031 - Evaluations of Required Postapproval Studies and Clinical Trials
Section 4005 - GAO Report on NIH Common Fund
Section 4007 - Additional Funding for NIH Common Fund
Section 4008 - Additional funding for NIH Brain Research
Section 4043 - Guidance on Vaccine Development
Section 4045 - Modifications to Priority Review Voucher Program for Tropical Diseases
Section 4046 - Guidance on Changes to an Approved Application for Biological Products
Section 4047 - Expediting the Process for Export Certifications for Vaccines
Section 4048 - NIH Vaccine Research
Sections 4061-4062 - Requiring Prompt Updates to Medicare Program Upon Issuance of ACIP Recommendations; Encouraging Health Plans to Establish Programs to Increase Adult Immunization
Sections 4121-4122 - FDA Succession Planning
Section 4201 - Revise IPPS New Technology Add-On Payment (NTAP) Reimbursement Amounts: Coding and Reimbursement Reforms
Section 4241 - Treatment of Global Surgery Services Rule
Section 4261 - Providers Consolidation and Medicare Payments Examined Through Evaluation
Sections 4282-4284 - Part D Suspension of Claims (4282); Improving Activities of Medicare Drug Integrity Contractors (4283); and Requiring E-Prescribing for Coverage of Covered Part D Controlled Substances (4284)
Section 4301 - Establishment of Manufacturer Opt-Out Program for Medical Devices
Section 4341 - Ensuring Local Medicare Administrative Contractors Evaluate Data Related to Category III Codes
Sections 4361-4362 - Advancing Care for Exceptional Kids
Section 4401 - Clarification Regarding Research Use Only Products
Section 5001 - Extension of Exclusivity Period for American-Manufactured Generic Drugs and Biosimilars
Section 5021 - Updating Regulations and Guidance on cGMP Requirements
Section 5066 - General and Specific Uses (Devices)
Sections 5081-5088 - Supply Chain Security for Devices
If you have any questions about any of the topics discussed in this advisory, please contact any of the following Arnold & Porter professionals:
Daniel A. Kracov
Nancy L. Perkins
Jennifer B. Madsen MPH*
Lauren L Haertlein
*Not admitted to the practice of law
© 2015 Arnold & Porter LLP. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.