Department of Health and Human Services November 12, 2020 – Federal Register Recent Federal Regulation Documents

National Institute Of Allergy And Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-25051
Type: Notice
Date: 2020-11-12
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission to OMB for Review and Approval: Public Comment Request; Information Collection Request Title: Title V Maternal and Child Health Services Block Grant to States Program: Guidance and Forms for the Title V Application/Annual Report OMB No. 0915-0172-Revision
Document Number: 2020-25031
Type: Notice
Date: 2020-11-12
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30 day comment period for this notice has closed.
Medicare Program; Medicare Part B Monthly Actuarial Rates, Premium Rates, and Annual Deductible Beginning January 1, 2021
Document Number: 2020-25029
Type: Notice
Date: 2020-11-12
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, 2021. In addition, this notice announces the monthly premium for aged and disabled beneficiaries, the deductible for 2021, 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 2021 are $291.00 for aged enrollees and $349.90 for disabled enrollees. The standard monthly Part B premium rate for all enrollees for 2021 is $148.50, 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 the $3.00 repayment amount required under current law. (The 2020 standard premium rate was $144.60, which included the $3.00 repayment amount.) The Part B deductible for 2021 is $203.00 for all Part B beneficiaries. If a beneficiary has to pay an income-related monthly adjustment, he or she will have to pay a total monthly premium of about 35, 50, 65, 80 or 85 percent of the total cost of Part B coverage plus a repayment amount of $4.20, $6.00, $7.80, $9.60 or $10.20, respectively.
Medicare Program; CY 2021 Part A Premiums for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement
Document Number: 2020-25028
Type: Notice
Date: 2020-11-12
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces Medicare's Hospital Insurance (Part A) premium for uninsured enrollees in calendar year 2021. 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 individuals with disabilities who have exhausted other entitlement. The monthly Part A premium for the 12 months beginning January 1, 2021 for these individuals will be $471. The premium for certain other individuals as described in this notice will be $259.
Medicare Program; CY 2021 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts
Document Number: 2020-25024
Type: Notice
Date: 2020-11-12
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) 2021 under Medicare's Hospital Insurance Program (Medicare Part A). The Medicare statute specifies the formulae used to determine these amounts. For CY 2021, the inpatient hospital deductible will be $1,484. The daily coinsurance amounts for CY 2021 will be: $371 for the 61st through 90th day of hospitalization in a benefit period; $742 for lifetime reserve days; and $185.50 for the 21st through 100th day of extended care services in a skilled nursing facility in a benefit period.
Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring
Document Number: 2020-25023
Type: Notice
Date: 2020-11-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collections of information in the regulations for in vivo radiopharmaceuticals used for diagnosis and monitoring.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2020-25022
Type: Notice
Date: 2020-11-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2020-25019
Type: Notice
Date: 2020-11-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2020-24985
Type: Notice
Date: 2020-11-12
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-24981
Type: Notice
Date: 2020-11-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2020-24980
Type: Notice
Date: 2020-11-12
Agency: Department of Health and Human Services, National Institutes of Health
Supplemental Evidence and Data Request on Malnutrition in Hospitalized Adults
Document Number: 2020-24968
Type: Notice
Date: 2020-11-12
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Malnutrition in Hospitalized Adults, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
Voluntary Disclosure of Sesame as an Allergen: Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
Document Number: 2020-24727
Type: Notice
Date: 2020-11-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Voluntary Disclosure of Sesame as an Allergen.'' The draft guidance, when finalized, will provide food manufacturers with FDA's current views on sesame as an allergen and will provide recommendations to voluntarily disclose sesame in certain circumstances where such disclosure is not currently required. The guidance is intended to help individuals who are allergic to sesame identify those foods that may contain sesame as an ingredient. This draft guidance is not final nor is it in effect at this time.
Transparency in Coverage
Document Number: 2020-24591
Type: Rule
Date: 2020-11-12
Agency: Employee Benefits Security Administration, Department of Labor, Department of Health and Human Services, Internal Revenue Service, Department of Treasury, Department of the Treasury
The final rules set forth requirements for group health plans and health insurance issuers in the individual and group markets to disclose cost-sharing information upon request to a participant, beneficiary, or enrollee (or his or her authorized representative), including an estimate of the individual's cost-sharing liability for covered items or services furnished by a particular provider. Under the final rules, plans and issuers are required to make this information available on an internet website and, if requested, in paper form, thereby allowing a participant, beneficiary, or enrollee (or his or her authorized representative) to obtain an estimate and understanding of the individual's out-of-pocket expenses and effectively shop for items and services. The final rules also require plans and issuers to disclose in-network provider negotiated rates, historical out-of- network allowed amounts, and drug pricing information through three machine-readable files posted on an internet website, thereby allowing the public to have access to health coverage information that can be used to understand health care pricing and potentially dampen the rise in health care spending. The Department of Health and Human Services (HHS) also finalizes amendments to its medical loss ratio (MLR) program rules to allow issuers offering group or individual health insurance coverage to receive credit in their MLR calculations for savings they share with enrollees that result from the enrollees shopping for, and receiving care from, lower-cost, higher-value providers.
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