Department of Health and Human Services November 15, 2016 – Federal Register Recent Federal Regulation Documents

Medicare Program; Medicare Part B Monthly Actuarial Rates, Premium Rate, and Annual Deductible Beginning January 1, 2017
Document Number: 2016-27425
Type: Notice
Date: 2016-11-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the monthly actuarial rates for aged (age 65 and over) and disabled (under age 65) beneficiaries enrolled in Part B of the Medicare Supplementary Medical Insurance (SMI) program beginning January 1, 2017. In addition, this notice announces the monthly premium for aged and disabled beneficiaries, the deductible for 2017, and the income-related monthly adjustment amounts to be paid by beneficiaries with modified adjusted gross income above certain threshold amounts. The monthly actuarial rates for 2017 are $261.90 for aged enrollees and $254.20 for disabled enrollees. The standard monthly Part B premium rate for all enrollees for 2017 is $134.00, which is equal to 50 percent of the monthly actuarial rate for aged enrollees (or approximately 25 percent of the expected average total cost of Part B coverage for aged enrollees) plus $3.00. (The 2016 standard premium rate was $121.80, which includes the $3.00 repayment amount.) The Part B deductible for 2017 is $183.00 for all Part B beneficiaries. If a beneficiary has to pay an income-related monthly adjustment, they will have to pay a total monthly premium of about 35, 50, 65, or 80 percent of the total cost of Part B coverage plus $4.20, $6.00, $7.80, or $9.60.
Federal Financial Participation in State Assistance Expenditures; Federal Matching Shares for Medicaid, the Children's Health Insurance Program, and Aid to Needy Aged, Blind, or Disabled Persons for October 1, 2017 Through September 30, 2018
Document Number: 2016-27424
Type: Notice
Date: 2016-11-15
Agency: Department of Health and Human Services
The Federal Medical Assistance Percentages (FMAP), Enhanced Federal Medical Assistance Percentages (eFMAP), and disaster-recovery FMAP adjustments for Fiscal Year 2018 have been calculated pursuant to the Social Security Act (the Act). These percentages will be effective from October 1, 2017 through September 30, 2018. This notice announces the calculated FMAP rates, in accordance with sections 1101(a)(8) and 1905(b) of the Act, that the U.S. Department of Health and Human Services (HHS) will use in determining the amount of federal matching for state medical assistance (Medicaid), Temporary Assistance for Needy Families (TANF) Contingency Funds, Child Support Enforcement collections, Child Care Mandatory and Matching Funds of the Child Care and Development Fund, Title IV-E Foster Care Maintenance payments, Adoption Assistance payments and Guardianship Assistance payments, and the eFMAP rates for the Children's Health Insurance Program (CHIP) expenditures. Table 1 gives figures for each of the 50 states, the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands. This notice reminds states of available disaster-recovery FMAP adjustments for qualifying states, and adjustments available for states meeting requirements for negative growth in total state personal income. At this time, no states qualify for such adjustments. This notice also contains the increased eFMAPs for CHIP as authorized under the Patient Protection and Affordable Care Act (Affordable Care Act) for fiscal years 2016 through 2019 (October 1, 2015 through September 30, 2019). Programs under title XIX of the Act exist in each jurisdiction. Programs under titles I, X, and XIV operate only in Guam and the Virgin Islands. The percentages in this notice apply to state expenditures for most medical assistance and child health assistance, and assistance payments for certain social services. The Act provides separately for federal matching of administrative costs. Sections 1905(b) and 1101(a)(8)(B) of the Social Security Act (the Act) require the Secretary of HHS to publish the FMAP rates each year. The Secretary calculates the percentages, using formulas in sections 1905(b) and 1101(a)(8), and calculations by the Department of Commerce of average income per person in each state and for the Nation as a whole. The percentages must fall within the upper and lower limits specified in section 1905(b) of the Act. The percentages for the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands are specified in statute, and thus are not based on the statutory formula that determines the percentages for the 50 states.
Medicaid Program; Covered Outpatient Drug; Delay in Change in Definitions of States and United States
Document Number: 2016-27423
Type: Rule
Date: 2016-11-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Covered Outpatient Drug final rule with comment period was published in the February 1, 2016 Federal Register. As part of that final rule with comment, we amended the regulatory definitions of ``States'' and ``United States'' to include the U.S. territories (American Samoa, the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, and the Virgin Islands) beginning April 1, 2017. This interim final rule with comment period delays the inclusion of the territories in the definition of ``States'' and ``United States'' until April 1, 2020.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-27421
Type: Notice
Date: 2016-11-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Paul S. Singh: Debarment Order
Document Number: 2016-27418
Type: Notice
Date: 2016-11-15
Agency: Food and Drug Administration, Department of Health and Human Services
The U.S. Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Paul S. Singh from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Singh was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. Dr. Singh was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Singh failed to request a hearing. Dr. Singh's failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.
Louis Daniel Smith: Debarment Order
Document Number: 2016-27417
Type: Notice
Date: 2016-11-15
Agency: Food and Drug Administration, Department of Health and Human Services
The U.S. Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Louis Daniel Smith from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Smith was convicted of felonies under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product, or otherwise relating to the regulation of a drug product under the FD&C Act. Mr. Smith was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Mr. Smith failed to respond. Mr. Smith's failure to respond constitutes a waiver of his right to a hearing concerning this action.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-27395
Type: Notice
Date: 2016-11-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed project entitled ``Reframing How We Talk About Alcohol: Public Perceptions of Excessive Alcohol Use Among Multiple Audiences.'' CDC will seek a one-year approval for a new information collection request to assess the public's perceptions and frames regarding alcohol use and its related harms, gain insights on the language the public uses when talking about excessive alcohol use, examine patient-provider communication about alcohol use, and evaluate the influence of other sources of information on the public's understanding of excessive alcohol use.
Medicare Program; CY 2017 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts
Document Number: 2016-27389
Type: Notice
Date: 2016-11-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for services furnished in calendar year (CY) 2017 under Medicare's Hospital Insurance Program (Medicare Part A). The Medicare statute specifies the formulae used to determine these amounts. For CY 2017, the inpatient hospital deductible will be $1,316. The daily coinsurance amounts for CY 2017 will be: (1) $329 for the 61st through 90th day of hospitalization in a benefit period; (2) $658 for lifetime reserve days; and (3) $164.50 for the 21st through 100th day of extended care services in a skilled nursing facility in a benefit period.
Medicare Program; CY 2017 Part A Premiums for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement
Document Number: 2016-27388
Type: Notice
Date: 2016-11-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This annual notice announces Medicare's Hospital Insurance (Part A) premium for uninsured enrollees in calendar year (CY) 2017. This premium is paid by enrollees age 65 and over who are not otherwise eligible for benefits under Medicare Part A (hereafter known as the ``uninsured aged'') and by certain disabled individuals who have exhausted other entitlement. The monthly Part A premium for the 12 months beginning January 1, 2017, for these individuals will be $413. The premium for certain other individuals as described in this notice will be $227.
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2016-27342
Type: Notice
Date: 2016-11-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2016-27341
Type: Notice
Date: 2016-11-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2016-27340
Type: Notice
Date: 2016-11-15
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2016-27339
Type: Notice
Date: 2016-11-15
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2016-27337
Type: Notice
Date: 2016-11-15
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Center For Scientific Review; Notice of Closed Meeting
Document Number: 2016-27336
Type: Notice
Date: 2016-11-15
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Evaluation of the Food and Drug Administration's Education at the Point of Sale Campaign
Document Number: 2016-27330
Type: Notice
Date: 2016-11-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the creation of a cohort of cigarette smoking adults between the ages of 25 and 54 for the evaluation of FDA's point of sale tobacco education campaign.
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements
Document Number: 2016-26668
Type: Rule
Date: 2016-11-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This major final rule addresses changes to the physician fee schedule and other Medicare Part B payment policies, such as changes to the Value Modifier, to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. This final rule also includes changes related to the Medicare Shared Savings Program, requirements for Medicare Advantage Provider Networks, and provides for the release of certain pricing data from Medicare Advantage bids and of data from medical loss ratio reports submitted by Medicare health and drug plans. In addition, this final rule expands the Medicare Diabetes Prevention Program model.