Federal Register
Week of May 13, 2013 - May 17, 2013

May 17

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CMS

Notices:

  • CMS is seeking comments on an extension of a currently approved collection entitled: Detailed Notice of Discharge (DND). When a Medicare beneficiary requests a Quality Improvement Organization review of his/her inpatient hospital discharge, hospitals and Medicare plans have used the DND to provide the beneficiary with a detailed explanation regarding the reason for discharge. FR, Pages 29135-29137

  • CMS is seeking comments on an extension of a currently approved collection entitled: Important Message from Medicare (IM). Hospitals have used the Important Message from Medicare (IM) to inform original Medicare, Medicare Advantage, and other Medicare plan beneficiaries who are hospital inpatients about their hospital rights and discharge rights. In particular, the IM provides information about when a beneficiary will and will not be liable for charges for a continued stay in a hospital and offers a detailed description of the Quality Improvement Organization review process. FR, Pages 29135-29137

  • CMS is seeking comments on a new collection entitled: Broker Data Collection in Federally-facilitated Health Insurance Exchanges. Both section 1312(e) of the Affordable Care Act and 45 CFR 155.220 permit states to allow agents and brokers to enroll qualified individuals, employers, and employees in QHPs, including through the Exchange; and assist individuals in applying for advance payments of the premium tax credit and cost-sharing reductions. Agents and brokers will serve as additional access points to the Exchange for individuals, SHOP employers or SHOP employees requiring or desiring agent and broker assistance. In order to interface with the Federally-facilitated Exchange (FFE), agents and brokers must establish an account and obtain a user ID through the CMS Enterprise Portal. Additionally, agents and brokers must register for, and successfully complete, Exchange-specific training, which enforces their understanding of eligibility and enrollment requirements in Exchanges. Agents and brokers must also apply this understanding to the use or development of any non-Exchange Web site, such as an issuer's or web broker's Web site, used as a tool for enrollment. At the conclusion of training, agents and brokers will attest to adhere to FFE standards and requirements. Web-brokers will sign and submit a similar agreement. FR, Pages 29135-29137

  • CMS is seeking comments an extension without change of a currently approved collection entitled: Notification of Fiscal Intermediaries (FIs) and CMS of Co-located Medicare Providers and Supporting Regulations in 42 CFR 412.22 and 412.532. Many long-term care hospitals (LTCHs) are co-located with other Medicare providers (acute care hospitals, inpatient rehabilitation facilities (IRFs), skilled nursing facilities (SNFs), and psychiatric facilities), which leads to potential gaming of the Medicare system based on patient shifting. We are requiring LTCHs to notify fiscal intermediaries (FIs), Medicare administrative contractors (MACs), and CMS of co-located providers and establish policies to limit payment abuse that will be based on FIs and MACs tracking patient movement among these co-located providers 42 CFR 412.22(e)(6) and (h)(5). Based upon being able to identify co-located providers, FIs, MACs, and CMS will be able to track patient shifting between LTCHs and other in-patient providers which will lead to appropriate payments under Sec. 412.532. That section limits payments to LTCHs where over 5 percent of admissions represent patients who had been sequentially discharged by the LTCH, admitted to an on-site provider, and subsequently readmitted to the LTCH. Since each discharge triggers a Medicare payment, we implemented this policy to discourage payment abuse. FR, Pages 29137-29139

  • CMS is seeking comments a reinstatement with a change of a previously approved collection entitled: Mandatory Insurer Reporting Requirements of Section 111 of the Medicare, Medicaid and SCHIP Act of 2007. Section 111 of the Medicare, Medicaid and SCHIP Extension Act of 2007 (Pub. L. 110-173) (MMSEA) amends the Medicare Secondary Payer (MSP) provisions of the Social Security Act (42 U.S.C. 1395y(b)) to provide for mandatory reporting by group health plan arrangements and by liability insurance (including self-insurance), no-fault insurance, and workers' compensation laws and plans. The law provides that, notwithstanding any other provision of law, the Secretary of Health and Human Services may implement this provision by program instruction or otherwise. The Secretary has elected not to implement the provision through rulemaking and will implement by publishing instructions on a publicly available Web site and submitting an information collection request to OMB for review and approval of the associated information collection requirements. FR, Pages 29137-29139

FDA

Notices:

  • The FDA is announcing the availability of the draft guidance entitled: “Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A.'' This draft document provides CDRH's proposed interpretation of key provisions of the Federal Food Drug and Cosmetic Act (FD&C Act), which were added by the FDA Safety and Innovation Act (FDASIA), as those provisions pertain to requests for documentation of rationales for significant decisions and requests for supervisory review of regulatory decisions and actions taken by CDRH. This draft guidance is not final nor is it in effect at this time. Comments on the draft guidance are due by August 15, 2013. FR, Pages 29140-29141

May 16

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FDA

Notices:

  • The FDA is seeking comments on extending a collection entitled: Postmarket Surveillance.

    Section 522 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 360l) authorizes the FDA to require a manufacturers to conduct postmarket surveillance (PS) of any device that meets the criteria set forth in the statute. The PS regulation establishes procedures that FDA uses to approve and disapprove PS plans. The regulation provides instructions to manufacturers so they know what information is required in a PS plan submission. FDA reviews PS plan submissions in accordance with part 822 (21 CFR part 822) in Sec. Sec. 822.15 through 822.19 of the regulation, which describe the grounds for approving or disapproving a PS plan. In addition, the PS regulation provides instructions to manufacturers to submit interim and final reports in accordance with Sec. 822.38. Respondents to this collection of information are those manufacturers who require postmarket surveillance of their products. FR, Pages 28853-28854

  • The FDA is seeking comments on extending a collection entitled: Bar Code Label Requirement for Human Drug and Biological Products.

    In the Federal Register of February 26, 2004 (69 FR 9120), we issued regulations that required human drug product and biological product labels to have bar codes. The rule required bar codes on most human prescription drug products and on over-the-counter (OTC) drug products that are dispensed under an order and commonly used in health care facilities. The rule also required machine-readable information on blood and blood components. For human prescription drug products and OTC drug products that are dispensed under an order and commonly used in health care facilities, the bar code must contain the National Drug Code number for the product. For blood and blood components, the rule specifies the minimum contents of the machine-readable information in a format approved by the Center for Biologics Evaluation and Research Director as blood centers have generally agreed upon the information to be encoded on the label. The rule is intended to help reduce the number of medication errors in hospitals and other health care settings by allowing health care professionals to use bar code scanning equipment to verify that the right drug (in the right dose and right route of administration) is being given to the right patient at the right time. FR, Pages 28856-28857

Final Order:

  • The FDA is classifying the ingestible event marker into class II (special controls). The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. This order is effective June 17, 2013. FR, Pages 28733-28735

May 15

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HHS

Proposed Rule:

  • HHS issued a proposed rule entitled: Medicaid Program; State Disproportionate Share Hospital Allotment Reductions. The statute, as amended by the Affordable Care Act, requires aggregate reductions to state Medicaid Disproportionate Share Hospital (DSH) allotments annually from fiscal year (FY) 2014 through FY 2020. This proposed rule delineates a methodology to implement the annual reductions for FY 2014 and FY 2015. The rule also proposes to add additional DSH reporting requirements for use in implementing the DSH health reform methodology. Comments are due by July 12, 2013. FR, Pages 28551-28569

May 14

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CMS

Notice:

  • CMS is seeking comments on revisions of a currently approved collection entitled: Reporting Requirements for Grants to Support States in Health Insurance Rate Review and Pricing Transparency--Cycles I, II, and III. Under the Section 1003 of the Affordable Care Act (ACA) (Section 2794 of the Public Health Service Act), the Secretary, in conjunction with the states and territories, is required to establish a process for the annual review, beginning with the 2010 plan year, of unreasonable increases in premiums for health insurance coverage. Section 2794(c) requires the Secretary to establish the Rate Review Grant Program to States to assist states to implement this provision. In addition, Section 2794(c) requires the Rate Review Grant Program to assist states in the establishment and enhancement of “Data Centers'' that collect, analyze, and disseminate health care pricing data to the public. The U.S. Department of Health and Human Services (HHS) released the Rate Review Grants Cycle I funding opportunity twice; first to states (and the District of Columbia) in June 2010 and then to the territories and the five states that did not apply during the first release, (http://www.hhs.gov/ociio/initiative/final_premium_review_grant_solicitat...). The second release was due to the decision that the territories were subject to provisions of the ACA and hence eligible for the Rate Review Grants. Forty-five (45) states and 5 U.S. territories plus the District of Columbia were awarded grants. On February 24, 2011, HHS released the Funding Opportunity Award (FOA) for Cycle II Rate Review Grants. On December 21, 2012, Cycle II of the Rate Review Grant Program was amended in order to include an additional application date. Thirty (30) states, the District of Columbia, and three territories were awarded grants in Cycle II. The CMS is seeking to publish the Cycle III Funding Opportunity Announcement, “Grants to Support States in Health Insurance Rate Review and Pricing Transparency'', and associated grantee reporting requirements consisting of: (4) quarterly reports, (5) rate review transaction data reports (quarterly and annual), (1) Annual report, and (1) final report from all grantees. This information collection is required for effective monitoring of grantees and to fulfill statutory requirements under section 2794(b)(1)(A) of the ACA that requires grantees, as a condition of receiving a grant authorized under section 2794(c) of the ACA, to report to the Secretary information about premium increases. FR, Page 28222

FDA

Notice:

  • The FDA has submitted a proposed collection entitled: Communicating Composite Scores in Direct-to-Consumer (DTC) Advertising to OMB for review and clearance.

To market their products, pharmaceutical companies must demonstrate to FDA the efficacy and safety of their drugs, typically through well-controlled clinical trials (Ref. 1) (see section 505 of the FD&C Act; 21 U.S.C. 355). In some cases, drug efficacy can be measured by a single endpoint, such as high blood pressure (Ref. 2). Often, however, efficacy is measured by multiple endpoints that are sometimes combined into an overall score called a composite score (Ref. 3). For example, nasal allergy relief is measured by examining individual symptoms such as runny nose, congestion, nasal itchiness, and sneezing. Each symptom is measured on its own. An overall score is computed from the individual symptom measurements; if a drug has a significantly better overall score than the comparison group (e.g., placebo), it can be marketed for the relief of allergy symptoms. However, although a drug may have a significantly better score overall, it may not have a significantly better score on a particular aspect (e.g., runny nose). Scientists and medical professionals have had training to understand the difference between composite score endpoints and single endpoints, but members of the general public may not understand the difference. FR, Pages 28224-28227

May 13

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FDA

Notice:

  • The FDA has determined that REV-EYES (dapiprazole hydrochloride ophthalmic solution), 0.5%, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for dapiprazole hydrochloride ophthalmic solution, 0.5%, if all other legal and regulatory requirements are met. FR, Page 27971

NIH

Notice:

  • The NIH Office of Biotechnology Activities (NIH OBA) proposes to revise the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) to streamline review of certain human gene transfer trials that present a low biosafety risk. Specifically, the NIH OBA proposes to remove the requirement that institutional biosafety committees (IBCs) review and approve certain human gene transfer clinical trials that use plasmids and certain attenuated, non-integrating viral vectors, provided the clinical trial follows an initial study in humans that was previously approved by an IBC registered with the OBA. This initial trial will have established the safety of the proposed dose of the gene transfer product (vector and transgene) in a comparable population (adults or children). The initial study should have been conducted in the same country as the proposed study to control for potential variability in infectious disease backgrounds of the participants. FR, Pages 27977-27980
Week of May 6, 2013 - May 10, 2013

May 10

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CMS

Notices:

  • CMS is seeking comments on the reinstatement of a previously approved collection entitled: Indirect Medical Education (IME) and Supporting Regulations at 42 CFR 412.105; Direct Graduate Medical Education (GME) and Supporting Regulations at 412 CFR 413.75 through 83. Section 1886(d)(5)(B) of the Social Security Act (the Act) requires additional payments to be made under the Medicare Prospective Payment System (PPS) for the indirect medical educational costs a hospital incurs in connection with interns and residents (IRs) in approved teaching programs. In addition, Title 42, Part 413, sections 75 through 83 implement section 1886(d) of the Act by establishing the methodology for Medicare payment of the cost of direct graduate medical educational activities. These payments, which are adjustments (add-ons) to other payments made to a hospital under PPS, are largely determined by the number of full-time equivalent (FTE) IRs that work at a hospital during its cost reporting period. In Federal fiscal year (FY) 2011, the estimated Medicare program payments for indirect medical education (IME) costs amounted to $6.59 billion. Medicare program payments for direct graduate medical education (GME) are also based upon the number of FTE-IRs that work at a hospital. In FY 2011, the estimated Medicare program payments for GME costs amounted to $2.57 billion. FR, Pages 27399-27400

  • CMS is seeking comments on the reinstatement of a previously approved collection entitled: Social Security Office (SSO) Report of State Buy-in Problem. Under Section 1843 of the Social Security Act, states may enter into an agreement with the Department of Health and Human Services to enroll eligible individuals in Medicare and pay their premiums. The purpose of the State Buy-in program is to assure that Medicaid is the payer of last resort by permitting a state to provide Medicare protection to certain groups of needy individuals, as part of the state's total assistance plan. State Buy-in also has the effect of transferring some medical costs for this population from the Medicaid program, which is partially state funded to the Medicare program, which is funded by the federal government and individual premiums. Generally, the States Buy-in for individuals who meet the eligibility requirements for Medicare and are cash recipients or deemed cash recipients or categorically needy under Medicaid. In some cases, states may also include individuals who are not cash assistance recipients under the Medical Assistance Only group. The day-to-day operations of the State Buy-in program is accomplished through an automated data exchange process. The automated data exchange process is used to exchange Medicare and Buy-in entitlement information between the Social Security District Offices, Medicaid State Agencies and the Centers for Medicare & Medicaid Services. When problems arise however that cannot be resolved though the normal data exchange process, clerical actions are required. The CMS-1957, ``SSO Report of State Buy-In Problem'' is used to report Buy-in problems cases. The CMS-1957 is the only standardized form available for communications between the aforementioned agencies for the resolution of beneficiary complaints and inquiries regarding State Buy-in eligibility. FR, Pages 27399-27400

  • CMS is seeking comments on a revision of a currently approved collection entitled: Medicare Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program. Since 1989, Medicare has been paying for durable medical equipment (DME) and supplies (other than customized items) using fee schedule amounts that are calculated for each item or category of DME identified by a Healthcare Common Procedure Coding System code. Payments are based on the average supplier charges on Medicare claims from 1986 and 1987 and are updated annually on a factor legislated by Congress. For many years, the Government Accountability Office and the Office of Inspector General of the U.S. Department of Health and Human Services have reported that these fees are often highly inflated and that Medicare has paid higher than market rates for several different types of DME. Due to reports of Medicare overpayment of DME and supplies, Congress required that CMS conduct a competitive bidding demonstration project for these items. Accordingly, CMS implemented a demonstration project for this program from 1999-2002 which produced significant savings for beneficiaries and taxpayers without hindering access to DMEPOS and related services. Shortly after a successful demonstration of the competitive bidding program, Congress passed the Medicare Prescription Drug, Improvement and Modernization Act of 2003 and mandated a phased-in approach to implement this program over the course of several years beginning in 2007 in 10 metropolitan statistical areas (MSAs). The statute specifically required the Secretary to establish and implement programs under which competitive bidding areas are established throughout the United States for contract award purposes for the furnishing of certain competitively priced items and services for which payment is made under Medicare Part B. This program is commonly known as the ``Medicare DMEPOS Competitive Bidding Program.'' FR, Pages 27399-27400

  • CMS is seeking comments on a reinstatement with a change of a previously approved collection entitled: Information Collection Requirements in HSQ-110, Acquisition, Protection and Disclosure of Peer review Organization Information and Supporting Regulations in 42 CFR, Sections 480.104, 480.105, 480.116, and 480.134; Use: The Peer Review Improvement Act of 1982 authorizes quality improvement organizations(QIOs), formally known as peer review organizations (PROs), to acquire information necessary to fulfill their duties and functions and places limits on disclosure of the information. The QIOs are required to provide notices to the affected parties when disclosing information about them. These requirements serve to protect the rights of the affected parties. The information provided in these notices is used by the patients, practitioners and providers to: obtain access to the data maintained and collected on them by the QIOs; add additional data or make changes to existing QIO data; and reflect in the QIO's record the reasons for the QIO's disagreeing with an individual's or provider's request for amendment. FR, Pages 27400-27402

  • CMS is seeking comments on a reinstatement without change of a previously approved collection entitled: Information Collection Requirements in 42 CFR 478.18, 478.34, 478.36, 478.42, QIO Reconsiderations and Appeals. In the event that a beneficiary, provider, physician, or other practitioner does not agree with the initial determination of a Quality Improvement Organization (QIO) or a QIO subcontractor, it is within that party's rights to request reconsideration. The information collection requirements at 42 CFR 478.18, 478.34, 478.36, and 478.42, contain procedures for QIOs to use in reconsideration of initial determinations. The information requirements contained in these regulations are imposed on QIOs to provide information to parties requesting the reconsideration. These parties will use the information as guidelines for appeal rights in instances where issues are actively being disputed. FR, Pages 27400-27402

  • CMS is seeking comments on a new collection entitled: Annual Report of Physician-Owned Hospital Ownership and/or Investment Interest. Section 6001 of the Affordable Care Act (ACA) requires Medicare hospitals to report whether they have any physician owners including immediately family members of the physician. Currently the CMS 855A captures basic ownership/managerial information on providers. The CMS 855A was revised in July 2011 and a specific attachment designed to capture physician-owned hospital ownership and investment interest data was added to the form. The attachment is being removed from the CMS 855A application because the annual reporting requirement for physician-owned hospitals is not required for Medicare enrollment processing. This physician-owned hospital data collection is mandated to be reported on an annual basis. Additionally, the ACA prohibits the expansion of current physician-owned hospitals and banned the establishment of new ones making the CMS 855A the improper method to collect this required annual report. CMS is requesting the physician-owned hospital ownership information, investment information or both, previously collected in Attachment 1 of the CMS 855A enrollment application to become a stand-alone form with a unique OMB number for the following reasons: The physician-owned data collection has a small targeted audience of approximately 140 physician-owned hospitals nationwide. The physician-owned data collection is required annually, as noted above. The data required under section 6001 is more specific than the data currently collected on the CMS-855A provider enrollment application. The data is not required for Medicare provider enrollment purposes. FR, Pages 27400-27402

Proposed Rules:

  • CMS is proposing to revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems. Some of the proposed changes implement certain statutory provisions contained in the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively known as the Affordable Care Act) and other legislation. These proposed changes would be applicable to discharges occurring on or after October 1, 2013, unless otherwise specified in this proposed rule. We also are proposing to update the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits. The proposed updated rate-of-increase limits would be effective for cost reporting periods beginning on or after October 1, 2013. We are proposing to update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) and implement certain statutory changes made by the Affordable Care Act. Generally, these proposed changes would be applicable to discharges occurring on or after October 1, 2013, unless otherwise specified in this proposed rule. In addition, we are proposing a number of changes relating to direct graduate medical education (GME) and indirect medical education (IME) payments. We are proposing to establish new requirements or revised requirements for quality reporting by specific providers (acute care hospitals, PPS-exempt cancer hospitals, LTCHs, and inpatient psychiatric facilities (IPFs)) that are participating in Medicare. We are proposing to update policies relating to the Hospital Value-Based Purchasing (VBP) Program and the Hospital Readmissions Reduction Program. In addition, we are proposing to revise the conditions of participation (CoPs) for hospitals relating to the administration of vaccines by nursing staff as well as the CoPs for critical access hospitals relating to the provision of acute care inpatient services. Comments are due by June 25, 2013. FR, Pages 27485-27823

  • This proposed rule would update the hospice payment rates and the wage index for fiscal year (FY) 2014, and continue the phase out of the wage index budget neutrality adjustment factor (BNAF). Including the FY 2014 15 percent BNAF reduction, the total BNAF reduction in FY 2014 will be 70 percent. The BNAF phase-out will continue with successive 15 percent reductions in FY 2015 and FY 2016. This proposed rule would also clarify how hospices are to report diagnoses on hospice claims, and proposes changes in the requirements for the hospice quality reporting program. Comments are due by June 28, 2013. FR, Pages 27823-27852

May 9

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FDA

Notice:

  • The FDA is announcing the availability of a draft guidance for industry entitled: Expanded Access to Investigational Drugs for Treatment Use--Qs & As.” This guidance is intended to provide information for industry, researchers, physicians, and patients about certain aspects of FDA's implementation of its regulations on expanded access to investigational drugs for treatment use. FDA has received a number of questions about implementation of its expanded access regulations. Therefore, FDA is providing this draft guidance in a question and answer format, addressing the most frequently asked questions.

Comments on the draft guidance are due by July 8, 2013. FR, Pages 27115-27116

  • The FDA is announcing the availability of a draft guidance for industry entitled: “Charging for Investigational Drugs Under an IND--Qs & As.'' This guidance is intended to provide information for industry, researchers, and physicians on how FDA is implementing its regulation on charging for an investigational drug under an investigational new drug (IND) application. FDA has received a number of questions about how it is implementing the charging regulation. Therefore, FDA is providing this draft guidance in a question and answer format, addressing the most frequently asked questions and answers, including questions about charging for investigational drugs made available under expanded access programs.

Comments on the draft guidance are due by July 8, 2013. FR, Pages 27116-27117

May 8

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FDA

Notice:

  • The FDA is announcing that a proposed collection of information entitled: Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Act has been submitted to OMB for review and clearance.

As part of its commitments in PDUFA V. FDA has established a new review Program to promote greater transparency and increased communication between the FDA review team and the applicant on the most innovative products reviewed by the Agency. The Program applies to all New Molecular Entities (NMEs), New Drug Applications (NDAs), and original Biologics License Applications (BLAs) that are received from October 1, 2012, through September 30, 2017. The Program is described in detail in section II.B of the document entitled "PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2013 through 2017'' (the "Commitment Letter'') (available at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf. FR, Pages 26782-26783

HHS

Proposed Rules:

  • This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2014 (for discharges occurring on or after October 1, 2013 and on or before September 30, 2014) as required by the statute. We are also proposing to revise the list of diagnosis codes that are used to determine presumptive compliance under the ``60 percent rule,'' update the IRF facility-level adjustment factors, revise sections of the Inpatient Rehabilitation Facility-Patient Assessment Instrument, revise requirements for acute care hospitals that have IRF units, clarify the IRF regulation text regarding limitation of review, update references to previously changed sections in the regulations text, and revise and update quality measures and reporting requirements under the IRF quality reporting program.

To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on July 1, 2013. FR, Pages 26879-26933

May 7

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  • No health-related actions were published.

May 6

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CMS

Notice:

  • CMS is publishing a new information collection, “Transparency Reports and Reporting of Physician Ownership or Investment Interests.” Regulations require direct and indirect payments or other transfers of value provided by an applicable manufacturer to a covered recipient, and that direct and indirect payments or other transfers of value provided to a third party at the request of (or designated by) the applicable manufacturer on behalf of a covered recipient, be reported by the applicable manufacturer to CMS on an annual basis. Regulations also require each applicable manufacturer and applicable group purchasing organization to report to CMS on an annual basis all ownership and investment interests that were held by a physician or an immediate family member of a physician during the preceding calendar year. FR, Pages 26370-26371

Proposed Rule:

  • CMS has proposed a rule that would update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2014, would revise and rebase the SNF market basket, and would make certain technical and conforming revisions in the regulations text. This proposed rule also includes a proposed policy for reporting the SNF market basket forecast error correction in certain limited circumstances and a proposed new item for the Minimum Data Set (MDS), Version 3.0. FR, Pages 26437-26480

FDA

Notice:

  • FDA is announcing an opportunity for public comment on an assessment of the Prescription Drug User Fee Act (PDUFA) Workload Adjuster conducted by an independent consulting firm. This assessment was conducted to fulfill FDA performance commitments made as part of the fifth authorization of PDUFA in Section XV, “Improving FDA Performance Management,’’ subsection B, which was reauthorized by the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012. The assessment will be conducted by an independent consultant in two phases. This is the first assessment of two during PDUFA V to evaluate whether the adjustment reasonably represents actual changes in workload volume and complexity in the human drug review program and present options to discontinue, retain, or modify any elements of the adjustment. After review of the report and receipt of public comment, FDA can adopt appropriate change to the workload adjustment methodology, if warranted. FR, Pages 26374-26375
Week of April 29, 2013 - May 3, 2013

May 3

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CMS

Notices:

  • CMS is seeking comments on reinstating with change of a previously approved collection entitled: Prepaid Health Plan Cost Report. Health Maintenance Organizations and Competitive Medical Plans contracting with the Secretary under section 1876 of the Social Security Act are required to submit a budget and enrollment forecast, semi-annual interim report, interim final cost report, and a final certified cost report in accordance with 42 CFR 417.572 through 417.576. Health Care Prepayment Plans contracting with the Secretary under section 1833 of the Social Security Act are required to submit a budget and enrollment forecast, semi-annual interim report, and final cost report in accordance with 42 CFR 417.808 and 417.810. CMS is requesting approval for the reinstatement with change of form CMS-276. The Cost Report outlines the provisions for implementing sections 1876(h) and 1833(a)(1)(A) of the Act. The purposes of the revisions are to implement certain changes associated with the Affordable Care Act, clarify instructions, and update outdated issues within the Cost Report and the Budget Report. FR, Pages 26034-26035

  • CMS is seeking comments on reinstating with change of a previously approved collection entitled: Medicare Provider Cost Report Reimbursement Questionnaire. The purpose of form CMS-339 is to assist the provider in preparing an acceptable cost report and to minimize subsequent contact between the provider and its Medicare Administrative Contractor (MAC). The form provides the basic data necessary to support the information in the cost report. Exhibit 1 of form CMS-339 contains a series of reimbursement-oriented questions which serve to update information on the operations of the provider. It is arranged topically regarding financial activities such as independent audits, provider organization and operation, etc. The MAC is responsible for the settlement of the Medicare cost report and must determine the reasonableness and the accuracy of the reimbursement claimed. This process includes performing both a desk review of the cost report and an analysis leading to a decision to settle the cost report with or without further audit. The form provides essential information to enable the MAC to make the audit or no audit decision, scope of the audit if one is necessary, and to update the provider documentation (i.e., documentation to support the financial profile of the provider). If the information is not collected, the MAC will have to go onsite to each provider to get this information. Consequently, it is far less burdensome and extremely cost effective to capture this information through the form CMS-339. Exhibit 2 of form CMS-339 is a listing of bad debts pertaining to uncollectible Medicare deductible and coinsurance amounts. Preparation of the listing is a convenient way for providers to supply the MAC with information needed to determine the allowability of the bad debts for reimbursement. Some items required to determine allowability that are included on this exhibit are patient's name, dates of service, date first bill sent to beneficiary, and date the collection effort ceased. Supplying the MAC with this information may be all that is required for the MAC to determine whether or not the bad debt is allowable. This too may eliminate a visit to the provider to gather this needed data. FR, Pages 26034-26035

  • CMS is seeking comments on extending a collection entitled: Medicare Advantage Appeals and Grievance Data Disclosure Requirements (42 CFR 422.111). Section 1852(c)(2)(C) of the Social Security Act and 42 CFR 422.111(c)(3) require that Medicare Advantage (MA) organizations and demonstrations disclose information pertaining to the number of disputes, and their disposition in the aggregate, with the categories of grievances and appeals to any individual eligible to elect an MA organization who requests this information. MA organizations and demonstrations remain under a requirement to collect and provide this information to individuals eligible to elect an MA organization, we continue to need the same format and form for reporting. FR, Pages 26034-26035

  • CMS is seeking comments on revisions of a currently approved collection entitled: Notice of Denial of Medicare Prescription Drug Coverage. Section 1860D-4(g)(1) of the Social Security Act, requires that Part D plan sponsors who deny prescription drug coverage must provide a written notice of the denial to the enrollee. The written notice must include a statement, in understandable language, of the reasons for the denial and a description of the appeals process. The Part D denial notice has been revised for clarity and includes new optional language for Part D plan sponsors to use when explaining their denial rationale. Specifically, CMS has added optional language in the denial rationale section of the notice to allow plans to populate text explaining that a drug denied under Part D may be (or is) covered under a different benefit, such as Part B. The instructions have also been changed to guide plans on when to use this optional text. CMS solicits feedback on this new addition as well as other situations where another benefit may cover a drug (i.e. employer group benefits) and what changes to the denial notice may be helpful in addressing those situations. CMS also seeks comment regarding the potential viability and usefulness of developing a combined notice for Part C and Part D, which would allow MA-PD plans that deny a drug under Part D to simultaneously issue an approval letter under Part B. FR, Pages 26035-26036

  • CMS is seeking comments on revisions of a currently approved collection entitled Parts C and D Complaints Resolution Performance Measures. CMS seeks to conduct a survey as part of the Part C and D Complaints Resolution Performance Measure project. The purpose of the project is to develop and support implementation of internal monitoring tools for the Medicare Advantage (Part C) and Prescription Drug (Part D) program that represents, from the beneficiary's perspective, the way in which plans handle complaints. The data collection is necessary because a survey is the only way to collect information about the resolution process from the beneficiary's perspective. Currently, there is no other data source that collects such information for Part C and Part D Medicare plans. FR, Pages 26035-26036

  • CMS is seeking comments on revisions of a currently approved collection entitled: Pre-Existing Health Insurance Plan and Supporting Regulations. On March 23, 2010, the President signed into law H.R. 3590, the Patient Protection and Affordable Care Act (Affordable Care Act), Public Law 111-148. Section 1101 of the law establishes a ``temporary high risk health insurance pool program'' (which has been named the Pre-Existing Condition Insurance Plan, or PCIP) to provide health insurance coverage to currently uninsured individuals with pre-existing conditions. The law authorizes HHS to carry out the program directly or through contracts with states or private, non-profit entities. We are requesting an extension of this package because this information is needed to assure that PCIP programs are established timely and effectively. This request is being made based on regulations and guidance that have been issued and contracts which have been executed by HHS with states or an entity on their behalf participating in the PCIP program. PCIP is also referred to as the temporary qualified high risk insurance pool program, as it is called in the Affordable Care Act, but we have adopted the term PCIP to better describe the program and avoid confusion with the existing state high risk pool programs. FR, Pages 26035-26036

May 2

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FDA

Notices:

  • The FDA is seeking comments on a proposed extension of an existing collection of information entitled Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications. This regulation relates to Agency management and organization and has two purposes. The first is to implement section 503(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(g)), as added by the Safe Medical Devices Act of 1990 (Pub. L. 101-629), and amended by the Medical Device User Fee and Modernization Act of 2002 (Pub. L. 107-250), by specifying how FDA will determine the organizational component within FDA assigned to have primary jurisdiction for the premarket review and regulation of products that are comprised of any combination of: (1) A drug and a device; (2) a device and a biological product; (3) a biological product and a drug; or (4) a drug, a device, and a biological product. The second purpose of this regulation is to enhance the efficiency of Agency management and operations by providing procedures for classifying and determining which Agency component is designated to have primary jurisdiction for any drug, device, or biological product where such jurisdiction is unclear or in dispute.

    The regulation establishes a procedure by which an applicant may obtain an assignment or designation determination. The regulation requires that the request include the identity of the applicant, a comprehensive description of the product and its proposed use, and the applicant's recommendation as to which Agency component should have primary jurisdiction, with an accompanying statement of reasons. The information submitted would be used by FDA as the basis for making the assignment or designation decision. Most information required by the regulation is already required for premarket applications affecting drugs, devices, biological products and combination products. The respondents will be businesses or other for-profit organizations. FR, Pages 25746-25747

  • The FDA is announcing a pilot program to test an XML (extensible markup language)-enabled Adobe PDF form, Form FDA 3331--Automated to submit new drug application (NDA) and abbreviated new drug application (ANDA) Field Alert Reports (FARs) as required by FDA regulations. This pilot program is intended to provide FDA with information to allow the Agency to modernize the FAR submission and review pathway and will permit integration with electronic archive filing systems.

The XML-enabled Adobe PDF form, Form FDA 3331--Automated, will be available for piloting between May 1, 2013, and January 1, 2014. FR, Page 25749

May 1

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FDA

Notices:

  • The FDA announced that a collection of information entitled: “Emergency Use Authorization of Medical Products” has been approved by OMB under the Paperwork Reduction Act of 1995. FR, Page 25456

  • The FDA announced that a collection of information entitled: “Medical Devices; Inspection by Accredited Persons Program” has been approved by OMB under the Paperwork Reduction Act of 1995. FR, Page 25456

HHS

Notices:

  • This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that OMB approve the proposed information collection project: “Patient-Reported Health Information Technology and Workflow.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.

    This proposed information collection was previously published in the Federal Register on Feb. 13, 2013 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment. Comments on this notice must be received by May 31, 2013. FR, Pages 25450-25454

April 30

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HHS

Notices:

  • HHS is issuing this notice pursuant to section 564(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act, 21 U.S.C. 360bbb-3(b)(4). On April 19, 2013, the HHS Secretary determined that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves the avian influenza A (H7N9) virus.

    On the basis of this determination, she also declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of the avian influenza A (H7N9) virus pursuant to section 564(b)(1) of the FD&C Act, 21 U.S.C. Sec. 360bbb-3(b)(1), subject to the terms of any authorization issued under that section. The Secretary also specified that this declaration is a declaration of an emergency with respect to in vitro diagnostics as defined under the Public Readiness and Emergency Preparedness (PREP) Act Declaration for Pandemic Influenza Diagnostics, Personal Respiratory Protection Devices, and Respiratory Support Devices signed by then Secretary Michael Leavitt on December 17, 2008.\1. The determination and declaration are effective April 19, 2013. FR, Pages 25273-25274

April 29

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CMS

Notices:

  • CMS is seeking comments on a revision of a currently approved collection entitled: Hospice Facility Cost Report. In accordance with sections 1815(a), 1833(e) and 1861(v)(1)(A) of the Social Security Act (the Act), providers of service in the Medicare program are required to submit annual information to achieve reimbursement for health care services rendered to Medicare beneficiaries. In addition, 42 CFR 413.20(b) specifies that cost reports are required from providers on an annual basis. Such cost reports are required to be filed with the provider's Medicare contractor. The functions of the Medicare contractor are described in section 1816 of the Act. Section 3132 of the Affordable Care Act requires that CMS collect appropriate data and information to facilitate hospice payment reform. FR, Pages 25089-25090

  • CMS is seeking comments on a reinstatement with change of a previously approved collection entitled: Federal Reimbursement of Emergency Health Services Furnished to Undocumented Aliens, Section 1011 of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA). Section 1011 of the MMA provides that the Secretary will establish a process (i.e., enrollment and claims payment) for eligible providers to request payment. The Secretary must directly pay hospitals, physicians and ambulance providers (including Indian Health Service, Indian Tribe and Tribal organizations) for their otherwise un-reimbursed costs of providing services required by section 1867 of the Social Security Act and related hospital inpatient, outpatient and ambulance services. CMS will use the application information to administer this health services program and establish an audit process. FR, Pages 25089-25090

  • CMS is seeking comments on a new collection entitled: Evaluation of the Multi-Payer Advanced Primary Care Practice (MAPCP) Demonstration Focus Group Protocols. On September 16, 2009, the Department of Health and Human Services announced the establishment of the Multi-payer Advanced Primary Care Practice (MAPCP) Demonstration, under which Medicare joined Medicaid and private insurers as a payer participant in state-sponsored patient-centered medical home (PCMH) initiatives. CMS selected eight states to participate in this demonstration: Maine, Vermont, Rhode Island, New York, Pennsylvania, North Carolina, Michigan, and Minnesota. CMS is proposing to conduct in-person focus groups with Medicare and Medicaid beneficiaries and their caregivers to more thoroughly understand patients' experiences with their PCMHs and how well their PCMHs are serving their needs. The focus groups will provide CMS with answers to fundamental “what, how, and why'' questions about beneficiaries' experiences with care and access to and coordination of care. The information obtained via in-person, focus groups will be utilized by CMS for the evaluation of the MAPCP Demonstration. The focus group data will be collected to supplement other qualitative and quantitative analyses from primary and secondary data sources by providing data on context, structure, and process, as well as select aspects of the key outcomes. The data gathered from the interviews will allow for more complete interpretation of the quantitative claims and other data analysis by taking into account the unique perspectives of beneficiaries. FR, Pages 25089-25090

Proposed Rule:

  • This proposed rule would revise the Incentive Reward Program provisions in Sec. 420.405 and certain provider enrollment requirements in part 424, subpart P. The most significant of these revisions include: changing the Incentive Reward Program potential reward amount for information on individuals and entities who are or have engaged in acts or omissions which resulted in the imposition of a sanction from 10 percent of the overpayments recovered in the case or $1,000, whichever is less, to 15 percent of the final amount collected applied to the first $66,000,000 for the sanctionable conduct; expanding the instances in which a felony conviction can serve as a basis for denial or revocation of a provider or supplier's enrollment; if certain criteria are met, enabling us to deny enrollment if the enrolling provider, supplier, or owner thereof had an ownership relationship with a previously enrolled provider or supplier that had a Medicare debt; enabling us to revoke Medicare billing privileges if we determine that the provider or supplier has a pattern or practice of submitting claims for services that fail to meet Medicare requirements; and limiting the ability of ambulance suppliers to “backbill” for services performed prior to enrollment. We believe this proposed rule would--increase the incentive for individuals to report information on individuals and entities that have or are engaged in sanctionable conduct; improve our ability to detect new fraud schemes; and help us ensure that fraudulent entities and individuals do not enroll in or maintain their enrollment in the Medicare program.

Comments are due on June 28, 2013. FR, Pages 25013-25033

Week of April 22, 2013 - April 26, 2013

April 26

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CMS

Notices:

  • CMS is seeking comments on a revision of a previously approved collection entitled: End Stage Renal Disease (ESRD) Network Semi-Annual Cost Report Forms and Supporting Regulations in 42 CFR section 405.2110 and 42 CFR 405.2112. Section 1881(c) of the Social Security Act establishes End Stage Renal Disease (ESRD) Network contracts. The regulations found at 42 CFR 405.2110 and 405.2112 designated 18 ESRD Networks which are funded by renewable contracts. These contracts are on 3-year cycles. To better administer the program, CMS is requiring contractors to submit semi-annual cost reports. The purpose of the cost reports is to enable the ESRD Networks to report costs in a standardized manner. This will allow CMS to review, compare and project ESRD Network costs during the life of the contract. Since the last collection, the survey instrument has been revised. The burden has not changed. FR, Pages 24752-24754

  • CMS is seeking comments on a new collection entitled: Evaluation of the Multi-Payer Advanced Primary Care Practice Demonstration. On Sept. 16, 2009, the Department of Health and Human Services announced the establishment of the Multi-Payer Advanced Primary Care Practice (MAPCP) Demonstration, under which Medicare joined Medicaid and private insurers as a payer participant in state-sponsored initiatives to promote the principles that characterize advanced primary care, often referred to as the ``patient-centered medical home'' (PCMH). The CMS selected eight states to participate in this demonstration: Maine, Vermont, Rhode Island, New York, Pennsylvania, North Carolina, Michigan, and Minnesota. These states vary on a number of important dimensions, such as features of their public (Medicaid) and private insurance markets, delivery system, prior experience with medical home initiatives, and nature of their state-sponsored multi-payer initiative. CMS is conducting an evaluation of the demonstration to assess the effects of advanced primary care practice when supported by Medicare, Medicaid, and private health plans. As part of this evaluation, qualitative and quantitative data will be collected and analyzed to answer research questions focused on: (1) State initiative features and implementation, including various payment models; (2) practice characteristics, particularly medical home transformation; and (3) outcomes, including access to and coordination of care, clinical quality of care and patient safety, beneficiary experience with care, patterns of utilization, Medicare and Medicaid expenditures, and budget neutrality. FR, Pages 24752-24754

  • CMS is seeking comments on a new collection entitled: CMS Enterprise Identity Management System. The Enterprise Identity Management (EIDM) solution will provide an enterprise-wide solution that will also support CMS' senior management goal to improve the Provider and Health Information Exchange experience by providing an enterprise-wide set of credentials and single sign-on capability for multiple CMS applications. In order to prove the identity of an individual requesting electronic access to CMS protected information or services, CMS will collect a core set of attributes about that individual. These core attributes will be used to:

    1. Provide the identity proofing service sufficient data to establish that the individual's identity is provable to a NIST assurance level;
    2. Store the approval information returned by the identity proofing service;
    3. Provide CMS with additional data for multi-factor identification (personal questions and answers);
    4. Provide the user a single sign-on, federated CMS EIDM ID and Password;
    5. Authenticate the user; and
    6. Authorize the user for application access.

The information collected will be gathered and used solely by CMS and approved contractor(s) and state health insurance exchanges. Information confidentiality will conform to HIPAA and FISMA requirements. FR, Pages 24752-24754

FDA

Notices:

  • The FDA is announcing the availability of a guidance for industry entitled: “Regulatory Classification of Pharmaceutical Co-Crystals.” This guidance provides applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) with the Center for Drug Evaluation and Research's (CDER's) current thinking on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms. This guidance also provides information about the data the applicant should submit to support the appropriate classification of a co-crystal, as well as the regulatory implications of the classification.

    The recommendations in this guidance apply to materials that the Agency has not previously evaluated and determined to be pharmaceutical co-crystals. The recommendations do not apply to materials that the Agency has previously designated as salts, complexes, or other non-co-crystalline forms. FR, Pages 24754-24755

April 25

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FDA

Notices:

  • The FDA is announcing the availability of the guidance entitled: Assay Migration Studies for In Vitro Diagnostic Devices. This guidance presents a least burdensome regulatory approach to gain FDA approval of Class III or certain licensed in vitro diagnostic devices in cases when a previously approved assay is migrating (i.e., transitioning) to a new system for which the assay has not been previously approved, licensed, or cleared. FR, Pages 24425-24426

April 24

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HHS

Notices:

  • The FDA is seeking comments on a new collection entitled: Protection of Human Subjects; Informed Consent; Institutional Review Boards -- 21 CFR Parts 50 and 56.

    Part 50 (21 CFR part 50) applies to all clinical investigations regulated by FDA under sections 505(i) and 520(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i) and 360j(g), respectively), as well as clinical investigations that support applications for research or marketing permits for products regulated by FDA, including foods and dietary supplements that bear a nutrient content claim or a health claim, infant formulas, food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products. Compliance with part 50 is intended to protect the rights and safety of subjects involved in investigations filed with the FDA under sections 403, 406, 409, 412, 413, 502, 503, 505, 510, 513-516, 518-520, 721, and 801 of the FD&C Act (21 U.S.C. 343, 346, 348, 350a, 350b, 352, 353, 355, 360, 360c-360f, 360h-360j, 379e, and 381, respectively) and sections 351 and 354-360F of the Public Health Service Act.

    With few exceptions, no investigator may involve a human being as a subject in FDA-regulated research unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative (see 21 CFR 50.20). In seeking informed consent, each subject must be provided with certain elements of informed consent. Those elements are listed in Sec. 50.25. Informed consent shall be documented in writing as described in Sec. 50.27.Comments are due by June 24, 2013. FR, Pages 24208-24211

  • The FDA is announcing the availability of a draft guidance for industry entitled: “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.'' The draft guidance focuses on safety aspects of the container label and carton labeling design for prescription drug and biological products. The draft guidance provides sponsors of new drug applications (NDAs), biologics licensing applications (BLAs), abbreviated new drug applications (ANDAs), and prescription drugs marketed without an approved NDA or ANDA with a set of principles and recommendations for ensuring that critical elements of product container labels and carton labeling are designed to promote safe dispensing, administration, and use of the product to minimize medication errors. Comments are due by June 24, 2013. FR, Page 24211

April 23

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CMS

Notices:

  • This notice sets forth termination dates for several processes under the Early Retiree Reinsurance Program (ERRP) in preparation for the Jan. 1, 2014 program sunset date. These operational processes, which involve plan sponsors and other parties, include: the submission of changes to information in a plan sponsor's ERRP application; the reporting of plan sponsor change of ownership; the submission of reimbursement requests; the reporting and correction of data inaccuracies; and the request for reopenings of reimbursement determinations.

This notice is effective April 19, 2013. FR, Pages 23936-23938

  • In accordance with the requirements of the Privacy Act of 1974 (5 U.S.C. 552a), CMS is adding a new routine use for emergency preparedness and response to eight CMS systems of records. The new routine use will authorize CMS to disclose beneficiary-identifiable records to public health authorities and entities acting under a delegation of authority of a public health authority requesting such information for the purpose of identifying vulnerable individuals who may need health assistance in the event of an incident, emergency or disaster, and for purposes of planning and providing such assistance. Disclosures made pursuant to the new routine use will be limited to the minimum data necessary to carry out statutorily-authorized public health-related emergency preparedness and response activities, as provided in Section 1106 of the Social Security Act (42 U.S.C. 1306) and the HIPAA Privacy Rule at 45 CFR Sec. Sec. 154.502, 164.512(b), 164.502(b) and 164.514(d)(3)(iii)(A). Requests and disclosures made pursuant to the routine use will be coordinated through HHS' Office of the Assistant Secretary for Preparedness and Response (ASPR). The eight systems of records that will include the new routine use are: the National Claims History (NCH), System No. 09-70-0558; Medicare Integrated Data Repository (IDR), System No. 09-70-0571; Common Working Files (CWF), System No. 09-70-0526; Enrollment Database (EDB), System No. 09-70-0502; Medicare Beneficiary Database (MBD), System No. 09-70-0536; Medicare Drug Data Processing System (DDPS), System No. 09-70-0553; Long Term Care-Minimum Data Set (MDS), System No. 09-70-0528; and Home Health Agency (HHA) Outcome and Assessment Information Set (OASIS), System No. 09-70-0522. FR, Pages 23938-23939

FDA

Notices:

  • The FDA is announcing the availability of the draft guidance entitled: “Use of International Standard ISO-10993, `Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.''' FDA has developed this guidance document to assist industry in preparing premarket applications (PMAs), humanitarian device exemptions (HDEs), investigational device applications (IDEs), premarket notifications (510(k)s), and de novo requests for medical devices that come into direct or indirect contact with the human body in order to determine the potential toxicity resulting from contact of the component materials of the device with the body.

    The purpose of this guidance is to provide further clarification and updated information on the use of the Office of Device Evaluation (ODE) General Program Memorandum G95-1 entitled “Use of International Standard ISO-10993, `Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,''' dated May 1, 1995. When final, this guidance will therefore replace G95-1.

Comments on the draft guidance are due by July 22, 2013. FR, Pages 23940-23941

  • The FDA is announcing the extension of the Early Feasibility Study Investigational Device Exemption (IDE) Applications pilot program to May 8, 2014, for sponsors who have already been accepted for the program.

This notice is effective April 23, 2013. FR, Page 23941

April 22

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CMS

Notices:

  • CMS is seeking comments on reinstating with change of a previously approved collection entitled: Data Collection for Medicare Beneficiaries Receiving Implantable Cardioverter-Defibrillators for Primary Prevention of Sudden Cardiac Death. CMS provides coverage for implantable cardioverter-defibrillators (ICDs) for secondary prevention of sudden cardiac death based on extensive evidence showing that use of ICDs among patients with a certain set of physiologic conditions are effective. Accordingly, CMS considers coverage for ICDs reasonable and necessary under Section 1862(a)(1)(A) of the Social Security Act. However, evidence for use of ICDs for primary prevention of sudden cardiac death is less compelling for certain patients.

    To encourage responsible and appropriate use of ICDs, CMS issued a “Decision Memo for Implantable Defibrillators'' on January 27, 2005, indicating that ICDs will be covered for primary prevention of sudden cardiac death if the beneficiary is enrolled in either an FDA-approved category B IDE clinical trial (42 CFR 405.201), a trial under the CMS Clinical Trial Policy (NCD Manual Sec. 310.1) or a qualifying prospective data collection system (either a practical clinical trial or prospective systematic data collection, which is sometimes referred to as a registry). FR, Pages 23768-23769

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