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
- 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
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
- 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
- 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
- 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
- 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
- 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
- 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