• On July 13, 2015, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule entitled “Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities.” This proposed rule would revise the requirements that Long-Term Care facilities must meet to participate in the Medicare and Medicaid programs. According to CMS’ summary, these proposed changes “are necessary to reflect the substantial advances that have been made over the past several years in the theory and practice of service delivery and safety.” Comments on the proposed rule are due September 11, 2015.
  • On July 13, 2015, CMS submitted an information collection request to the Office of Management and Budget (OMB) for review, entitled “Agent/Broker Data Collection in Federally-Facilitated Health Insurance Exchanges”. CMS collects personally identifiable information from agents/brokers to register them with the Federally Facilitated Marketplace (FFM) and permit them to assist individuals and employers in enrolling in the FFM. Agents/brokers will use CMS or third-party systems to enter identifying information and register with the FFM. As a component of registration, agents/ brokers are required to complete online training courses through a CMS or third-party Learning Management System (LMS). Upon completion of their applications and training requirements, agents/brokers will be required to attest to their agreement to adhere to FFM standards and requirements through a CMS or third-party LMS. Comments are due August 12, 2015.
  • On July 14, 2015, the Food and Drug Administration (FDA) announced the availability of a draft guidance entitled ‘‘Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices.’’ This draft guidance provides a detailed description of the information that should be included in a premarket notification for a magnetic resonance diagnostic device (MRDD). Comments on draft guidance should be submitted by October 13, 2015.
  • On July 14, 2015, the FDA announced an opportunity for public comment on a proposed information collection activity entitled “Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach To Monitoring”. The guidance is intended to assist sponsors of clinical investigations in developing strategies for risk-based monitoring and plans for clinical investigations of human drug and biological products, medical devices, and combinations thereof. Section IV.D ‘‘Monitoring Plan’’ of the guidance recommends that sponsors develop a prospective, detailed monitoring plan that describes the monitoring methods, responsibilities, and requirements for each clinical trial. Comments are due September 14, 2015.
  • On July 15, 2015, CMMS announced an extension of the Medicare Prior Authorization for Power Mobility Devices (PMDs) demonstration, which is now scheduled end on August 31, 2018. More information on the announcement may be found here.
  • On July 16, 2015, the Centers for Disease Control and Prevention (CDC) issued a notice of proposed rulemaking and request for comments entitled “Possession, Use, and Transfer of Select Agents and Toxins; Addition of Certain Influenza Virus Strains to the List of Select Agents and Toxins”. CDC is proposing to add certain influenza virus strains to the list of Department of Health and Human Services (HHS) select agents and toxins. Specifically, CDC is proposing to add the influenza viruses that contain the hemagglutinin (HA) from the Goose Guangdong/1/96 lineage (the influenza viruses that contain the hemagglutinin (HA) from the A/Gs/Gd/1/96 lineage), including wild-type viruses, as a non-Tier 1 select agent. We are also proposing to add any influenza viruses that contain the HA from the A/Gs/Gd/ 1/96 lineage that were made transmissible among mammals by respiratory droplets in a laboratory as a Tier 1 select agent. CDC has determined that these influenza viruses have the potential to pose a severe threat to public health and safety. Comments should be received on or before September 14, 2015.
  • On July 16, 2015, the Department of Veterans Affairs (VA) published interpretive guidance entitled “Agency Interpretation of Prosthetic Replacement of a Joint”. VA is publishing interpretive guidance for diagnostic codes (DC) 5051 through 5056, which establish rating criteria for prosthetic implant replacements of joints of the musculoskeletal system. The Schedule for Rating Disabilities under these DCs allows for a 1-year, 100-percent disability evaluation upon prosthetic replacement of a joint. This final rule clarifies that VA’s longstanding interpretation of DCs 5051 through 5056 is that a 100-percent evaluation will be in place for a period of one year when the total joint, rather than the partial joint, has been replaced by a prosthetic implant. This final rule is effective July 16, 2015.
  • On July 17, 2015, FDA released an information collection activity, entitled “Guidance for Industry on Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act”, for public comment. Comments are due September 15, 2015.
  • On July 17, 2015, FDA announced the availability of a draft guidance for industry entitled “Testicular Toxicity: Evaluation During Drug Development; Draft Guidance for Industry”. The draft guidance addresses nonclinical findings that may raise concerns of a drug-related adverse effect on the testes, clinical monitoring of adverse testicular effects early in clinical development, and the design and conduct of a safety clinical trial assessing drug-related testicular toxicity. The draft guidance is intended to assist sponsors developing drugs to identify nonclinical signals of testicular toxicity and to evaluate the potential for such toxicity in humans. Comments are due October 15, 2015.
  • On July 17, 2015, HHS released an interim final rule entitled “Health Resources Priority and Allocations System (HRPAS)”. This interim final rule establishes standards and procedures by which HHS may require that certain contracts or orders that promote the national defense be given priority over other contracts or orders. This rule also sets new standards and procedures by which HHS may allocate materials, services, and facilities to promote the national defense. This rule will implement HHS’s administration of priorities and allocations actions, and establish the Health Resources Priorities and Allocation System (HRPAS). The HRPAS will cover health resources pursuant to the authority under Section 101(c) of the Defense Production Act as delegated to HHS by Executive Order 13603. Priorities authorities (and other authorities delegated to the Secretary in E.O. 13603, but not covered by this regulation) may be re-delegated by the Secretary. The Secretary retains the authority for allocations. Effective July 17, 2015. Comments must be received by September 15, 2015.
  • On July 17, 2015, FDA issued a notice entitled “Market Claims in Direct-to-Consumer Prescription Drug Print Ads”. The Office of Prescription Drug Promotion plans to investigate, through empirical research, the impact of market claims on prescription drug product perceptions with and without quantitative information about product efficacy. This will be investigated in direct-to-consumer (DTC) print advertising for prescription drugs. Comments are due within 60 days.
  • On July 17, 2015, FDA announced the availability of a revised draft guidance for industry on lubiprostone capsules entitled "Bioequivalence Recommendations for Lubiprostone." The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for lubiprostone capsules.

Event Notices

  • September 22, 2015: FDA is announcing a public meeting and an opportunity for public comment on Patient-Focused Drug Development for Huntington’s disease and Parkinson’s disease. Patient-Focused Drug Development is part of FDA’s performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patient perspectives on the impact of Huntington’s disease and Parkinson’s disease on daily life and patient views on treatment approaches. Although these are both neurological diseases, since they are quite distinct, FDA will structure this public meeting into two distinct sessions. The morning session, scheduled from 9 a.m. to 1 p.m., will be devoted to hearing patient perspectives on the impact of Huntington’s disease on daily life and their views on currently available treatment approaches. The afternoon session, scheduled from 1 p.m. to 5 p.m., will be devoted to obtaining patient perspectives on the impact of Parkinson’s disease on daily life and patient views on currently available treatment approaches. The meetings will take place at FDA’s White Oak Campus in Silver Spring, Maryland. More information may be found here.