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FORT MYERS, FL – An investigation by the U.S renova online in canada. Department of Labor’s Wage and Hour Division has recovered more than $36,000 in back wages for workers at a grocery store that denied them overtime pay required by the Fair Labor Standards Act. At Pica Italian Deli Inc renova online in canada. €“ operating as Mario’s Italian Meat Market – investigators found the employer paid two deli clerks, one cook and one stocker, flat salaries regardless of the number of hours they worked each workweek. By doing renova online in canada so, the employer violated FLSA overtime requirements when these employees worked more than 40 hours in a workweek, yet they failed to pay them overtime.

As a result, the division recovered $36,279 in overtime back wages for the four workers. The employer also violated FLSA recordkeeping requirements by failing to track the number renova online in canada of hours these employees worked each workweek. €œSome employers believe incorrectly that simply paying an employee a flat salary automatically means they don’t have to pay those workers overtime. That is not true,” said Wage and Hour Division District Director Nicolas Ratmiroff in Tampa, renova online in canada Florida. €œAny exemptions from the law’s overtime provisions require that very specific criteria be met.

We hope this investigation’s outcome encourages other employers to review their own pay practices to ensure they avoid similar violations and comply with the law.” For more information about the FLSA and other laws enforced by the division, contact the agency’s toll-free renova online in canada helpline at 866-4US-WAGE (487-9243). Learn more about the Wage and Hour Division, including a search tool to use if you think you may be owed back wages collected by the division.WASHINGTON, DC – U.S. Secretary of Labor Marty Walsh issued the following statement on the April 2021 Employment Situation Report:“Today, the Bureau of Labor Statistics reported that the American economy added 266,000 jobs in the month of April, and the unemployment rate was 6.1 percent, renova online in canada up marginally from 6.0 percent in March. Labor force participation is at its highest point since last August and the number of people expressing hesitancy about returning to work due to the skin care is at its lowest point in the renova. “However, the renova online in canada numbers also show we have a steep climb ahead of us.

We have yet to recover roughly eight million jobs that existed prior to the renova. Racial inequities in the unemployment picture persist, as the Black unemployment rate increased slightly to 9.7 percent, the Hispanic rate held level at 7.9 percent, the Asian rate dropped renova online in canada to 5.7 percent and the white rate fell to 5.3 percent. “These figures underscore how the American Rescue Plan puts us on the path to recovery. It’s increased the speed and access of vaccinations, it’s bringing needed relief to families, it’s enabling daycare centers and schools to reopen, and it’s supporting small businesses. It’s going to take time and effort to heal this economy.”.

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The Henry J renova zero wraps. Kaiser Family renova zero wraps Foundation Headquarters. 185 Berry St., Suite 2000, San Francisco, CA 94107 | Phone 650-854-9400 Washington Offices and Barbara Jordan Conference Center. 1330 G Street, NW, Washington, DC 20005 | Phone 202-347-5270 www.kff.org | Email Alerts renova zero wraps.

Kff.org/email | facebook.com/KaiserFamilyFoundation | twitter.com/kff Filling the need for trusted information on national health issues, the Kaiser Family Foundation is a nonprofit organization based in San Francisco, California.The Henry J. Kaiser Family renova zero wraps Foundation Headquarters. 185 Berry St., Suite 2000, San Francisco, CA 94107 | Phone 650-854-9400 Washington Offices and Barbara Jordan Conference Center. 1330 G Street, NW, Washington, DC 20005 renova zero wraps | Phone 202-347-5270 www.kff.org | Email Alerts.

Kff.org/email | facebook.com/KaiserFamilyFoundation | twitter.com/kff Filling the need for trusted information on national health issues, the Kaiser Family Foundation is a nonprofit organization based in San Francisco, California..

The Henry J renova online in canada. Kaiser Family renova online in canada Foundation Headquarters. 185 Berry St., Suite 2000, San Francisco, CA 94107 | Phone 650-854-9400 Washington Offices and Barbara Jordan Conference Center.

1330 G Street, NW, Washington, DC 20005 | Phone 202-347-5270 www.kff.org | Email Alerts renova online in canada. Kff.org/email | facebook.com/KaiserFamilyFoundation | twitter.com/kff Filling the need for trusted information on national health issues, the Kaiser Family Foundation is a nonprofit organization based in San Francisco, California.The Henry J. Kaiser Family renova online in canada Foundation Headquarters.

185 Berry St., Suite 2000, San Francisco, CA 94107 | Phone 650-854-9400 Washington Offices and Barbara Jordan Conference Center. 1330 G Street, NW, Washington, DC 20005 | Phone renova online in canada 202-347-5270 www.kff.org | Email Alerts. Kff.org/email | facebook.com/KaiserFamilyFoundation | twitter.com/kff Filling the need for trusted information on national health issues, the Kaiser Family Foundation is a nonprofit organization based in San Francisco, California..

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Renova is for external use only. Do not take by mouth. Gently wash the skin with a mild, non-medicated soap before use. Pat the skin dry. Wait 20 to 30 minutes for your skin to dry before use in order to minimize the possibility of skin irritation. Apply enough medicine to cover the affected area and rub in gently. Avoid applying Renova to your eyes, ears, nostrils, angles of the nose, and mouth. Do not use more often than your doctor or health care professional has recommended. Using too much of Renova may irritate or increase the irritation of your skin, and will not give faster or better results.

Contact your pediatrician or health care professional regarding the use of this medication in children. While this drug may be prescribed for children as young as 12 years of age for selected conditions, precautions do apply.

Overdosage: If you think you have applied too much of Renova contact a poison control center or emergency room at once.

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CMS must also respond to inquiries related to a PHE from providers renova papier and Low cost zithromax beneficiaries. CMS is not collecting information from these inquiries. We are merely responding to them.

Prior to this request, CMS did not renova papier have a standard process or OMB approval for providers/suppliers impacted to submit 1135 waiver/flexibility requests or inquiries, as these were generally seen on a smaller scale (natural disasters) prior to the skin care products public health emergency. CMS has provided general guidance to Medicare-participating facilities which can be viewed at https://www.cms.gov/​Medicare/​Provider-Enrollment-and-Certification/​SurveyCertEmergPrep/​1135-Waivers. The requests and inquiries would be sent directly, via email, to the Survey Operations Group in each CMS Location (previously known as CMS Regional Offices) and the entity would provide a brief summary to CMS for a waiver/flexibility request or an answer to an inquiry.

We are now developing a streamlined, automated process to standardize the 1135 waiver requests and inquiries submitted based on lessons learned during skin care products PHE, primarily based on the volume of requests to ensure renova papier timely response to facility needs. The waiver request form was approved under an Emergency information collection request on October 15, 2020. Furthermore, the normal operations of a healthcare provider are disrupted by emergencies or disasters occasionally.

When this occurs, State Survey Agencies renova papier (SA) deliver a provider/beneficiary tracking report regarding the current status of all affected healthcare providers and their beneficiaries. This report includes demographic information about the provider, their operational status, beneficiary status, and planned resumption of normal operations. This information is provided whether or not a PHE has been declared.

We are now developing a streamlined, automated process to standardize submission of this information directly by the provider during emergencies and eliminating the need for SA renova papier to provide it. It will consist of a public facing web form. This information will be used by CMS to receive, triage, respond to and report on requests and/or inquiries for Medicare, Medicaid, and CHIP beneficiaries.

This information will be renova papier Start Printed Page 66992used to make decisions about approving or denying waiver and flexibility requests and may be used to identify trends that inform CMS Conditions for Coverage or Conditions for Participation policies during public health emergencies, when declared by the President and the HHS Secretary. Subsequent to the Emergency information collection request, we are revising the package to include a second form, Healthcare Facility Status Workflow, which is for operational status information which will be used to assist providers in delivering critical care to beneficiaries during emergencies. Form Number.

CMS-10752 (OMB renova papier control number. 0938-1384). Frequency.

Occasionally. Affected Public. Private Sector.

Business or other for-profits and Not-for-profit institutions and State, Local or Tribal Governments. Number of Respondents. 3,730.

Total Annual Responses. 3,730. Total Annual Hours.

3,730. (For policy questions regarding this collection, contact Adriane Saunders at 404-562-7484.) 2. Type of Information Collection Request.

Revision of a currently approved collection. Title of Information Collection. Solicitation for Applications for Medicare Prescription Drug Plan 2022 Contracts.

Use. Coverage for the prescription drug benefit is provided through contracted prescription drug plans (PDPs) or through Medicare Advantage (MA) plans that offer integrated prescription drug and health care coverage (MA-PD plans). Cost Plans that are regulated under Section 1876 of the Social Security Act, and Employer Group Waiver Plans (EGWP) may also provide a Part D benefit.

Organizations wishing to provide services under the Prescription Drug Benefit Program must complete an application, negotiate rates, and receive final approval from CMS. Existing Part D Sponsors may also expand their contracted service area by completing the Service Area Expansion (SAE) application. Collection of this information is mandated in Part D of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) in Subpart 3.

The application requirements are codified in Subpart K of 42 CFR 423 entitled “Application Procedures and Contracts with PDP Sponsors.” The information will be collected under the solicitation of proposals from PDP, MA-PD, Cost Plan, Program of All Inclusive Care for the Elderly (PACE), and EGWP applicants. The collected information will be used by CMS to. (1) Ensure that applicants meet CMS requirements for offering Part D plans (including network adequacy, contracting requirements, and compliance program requirements, as described in the application), (2) support the determination of contract awards.

Form Number. CMS-10137 (OMB control number. 0938-0936).

Private Sector. Business or other for-profits and Not-for-profit institutions and State, Local or Tribal Governments. Number of Respondents.

Total Annual Hours. 1,550. (For policy questions regarding this collection, contact Arianne Spaccarelli at 410-786-5715.) 3.

Type of Information Collection Request. Revision of a currently approved collection. Title of Information Collection.

CMS Plan Benefit Package (PBP) and Formulary CY 2022. Use. Under the Medicare Modernization Act (MMA), Medicare Advantage (MA) and Prescription Drug Plan (PDP) organizations are required to submit plan benefit packages for all Medicare beneficiaries residing in their service area.

The plan benefit package submission consists of the Plan Benefit Package (PBP) software, formulary file, and supporting documentation, as necessary. MA and PDP organizations use the PBP software to describe their organization's plan benefit packages, including information on premiums, cost sharing, authorization rules, and supplemental benefits. They also generate a formulary to describe their list of drugs, including information on prior authorization, step therapy, tiering, and quantity limits.

CMS requires that MA and PDP organizations submit a completed PBP and formulary as part of the annual bidding process. During this process, organizations prepare their proposed plan benefit packages for the upcoming contract year and submit them to CMS for review and approval. CMS uses this data to review and approve the benefit packages that the plans will offer to Medicare beneficiaries.

This allows CMS to review the benefit packages in a consistent way across all submitted bids during with incredibly tight timeframes. This data is also used to populate data on Medicare Plan Finder, which allows beneficiaries to access and compare Medicare Advantage and Prescription Drug plans. Form Number.

CMS-R-262 (OMB control number. 0938-0763). Frequency.

Business or other for-profits and Not-for-profit institutions and State, Local or Tribal Governments. Number of Respondents. 753.

Total Annual Responses. 8,090. Total Annual Hours.

74,038. (For policy questions regarding this collection, contact Kristy Holtje at 410-786-2209.) 4. Type of Information Collection Request.

Revision of a currently approved collection. Title of Information Collection. Generic Clearance.

Questionnaire Testing and Methodological Research for the Medicare Current Beneficiary Survey (MCBS). Use. The current generic clearance for MCBS Questionnaire Testing and Methodological Research encompasses development and testing of MCBS questionnaires, instrumentation, and data collection protocols, as well as a mechanism for conducting methodological experiments.

The current clearance includes conducting field tests and experiments, including split ballot experiments, within the MCBS production environment, and conducting usability tests. The purpose of this OMB clearance package is to revise the current clearance to expand the methods to allow for field tests outside of MCBS production Field tests conducted within production do not incur any additional burden on respondents whereas tests conducted outside production must account for additional respondent burden. The MCBS is a continuous, multipurpose survey of a nationally representative sample of aged, disabled, and institutionalized Medicare beneficiaries.

The MCBS, which is sponsored by the Centers for Medicare &. Medicaid Services (CMS), is the only comprehensive source of information on the health status, health care use and expenditures, health insurance coverage, and socioeconomic and demographic characteristics of the entire spectrum of Medicare beneficiaries. The core of the MCBS is a series of interviews with a stratified random sample of the Medicare population, including aged and disabled enrollees, residing in the community or in institutions.

Questions are asked about enrollees' patterns of health care use, charges, insurance coverage, and payments over time. Respondents are asked about their sources of health care coverage and payment, their demographic characteristics, their health and work history, and their family living circumstances. In addition to collecting information through the core questionnaire, the MCBS collects information on special topics.

Form Number. CMS-10549 (OMB control number. 0938-1275).

Individuals or Households. Number of Respondents. 11,655.

Total Annual Responses. 11,655. Total Annual Hours.

Start Printed Page 669933,947. (For policy questions regarding this collection, contact William Long at 410-786-7927.) Start Signature Dated. October 16, 2020.

William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. End Signature End Supplemental Information [FR Doc.

2020-23335 Filed 10-20-20. 8:45 am]BILLING CODE 4120-01-PStart Preamble Start Printed Page 66989 Centers for Medicare &. Medicaid Services (CMS), HHS.

Final notice. This final notice announces our decision to approve The Joint Commission for continued recognition as a national accrediting organization for Ambulatory Surgical Centers that wish to participate in the Medicare or Medicaid programs. The decision announced in this notice is effective on December 20, 2020 through December 20, 2024.

Joy Webb (410) 786-1667. Erin Imhoff (410) 786-2337. I.

Background Ambulatory Surgical Centers (ASCs) are distinct entities that operate exclusively for the purpose of furnishing outpatient surgical services to patients. Under the Medicare program, eligible beneficiaries may receive covered services from an ASC provided certain requirements are met. Section 1832(a)(2)(F)(i) of the Social Security Act (the Act) establishes distinct criteria for a facility seeking designation as an ASC.

Regulations concerning provider agreements are at 42 CFR part 489 and those pertaining to activities relating to the survey and certification of facilities are at 42 CFR part 488. The regulations at 42 CFR part 416 specify the conditions that an ASC must meet in order to participate in the Medicare program, the scope of covered services, and the conditions for Medicare payment for ASCs. Generally, to enter into an agreement, an ASC must first be certified by a State survey agency (SA) as complying with the conditions or requirements set forth in part 416 of our Medicare regulations.

Thereafter, the ASC is subject to regular surveys by an SA to determine whether it continues to meet these requirements. Section 1865(a)(1) of the Act provides that, if a provider entity demonstrates through accreditation by a Centers for Medicare &. Medicaid Services (CMS) approved national accrediting organization (AO) that all applicable Medicare conditions are met or exceeded, we may deem that provider entity as having met the requirements.

Accreditation by an AO is voluntary and is not required for Medicare participation. If an AO is recognized by the Secretary of the Department of Health and Human Services as having standards for accreditation that meet or exceed Medicare requirements, any provider entity accredited by the national accrediting body's approved program may be deemed to meet the Medicare conditions. The AO applying for approval of its accreditation program under part 488, subpart A, must provide CMS with reasonable assurance that the AO requires the accredited provider entities to meet requirements that are at least as stringent as the Medicare conditions.

Our regulations concerning the approval of AOs are set forth at § 488.5. The Joint Commission's (TJC's) current term of approval for its ASC program expires December 20, 2020. II.

Application Approval Process Section 1865(a)(3)(A) of the Act provides a statutory timetable to ensure that our review of applications for CMS-approval of an accreditation program is conducted in a timely manner. The Act provides us 210 days after the date of receipt of a complete application, with any documentation necessary to make the determination, to complete our survey activities and application process. Within 60 days after receiving a complete application, we must publish a notice in the Federal Register that identifies the national accrediting body making the request, describes the request, and provides no less than a 30-day public comment period.

At the end of the 210-day period, we must publish a notice in the Federal Register approving or denying the application. III. Provisions of the Proposed Notice On May 26, 2020 we published a proposed notice in the Federal Register (85 FR 31511), announcing TJC's request for continued approval of its Medicare ASC accreditation program.

In the May 26, 2020 proposed notice, we detailed our evaluation criteria. Under section 1865(a)(2) of the Act and in our regulations at § 488.5, we conducted a review of TJC's Medicare ASC accreditation application in accordance with the criteria specified by our regulations, which include, but are not limited to the following. An administrative review of TJC's.

(1) Corporate policies. (2) financial and human resources available to accomplish the proposed surveys. (3) procedures for training, monitoring, and evaluation of its ASC surveyors.

(4) ability to investigate and respond appropriately to complaints against accredited ASCs. And (5) survey review and decision-making process for accreditation. The comparison of TJC's Medicare ASC accreditation program standards to our current Medicare ASC conditions for coverage (CfCs).

A documentation review of TJC's survey process to do the following. ++ Determine the composition of the survey team, surveyor qualifications, and TJC's ability to provide continuing surveyor training. ++ Compare TJC's processes to those we require of state survey agencies, including periodic resurvey and the ability to investigate and respond appropriately to complaints against TJC-accredited ASCs.

++ Evaluate TJC's procedures for monitoring accredited ASCs it has found to be out of compliance with TJC's program requirements. (This pertains only to monitoring procedures when TJC identifies non-compliance. If noncompliance is identified by a SA through a validation survey, the SA monitors corrections as specified at § 488.9(c)).

++ Assess TJC's ability to report deficiencies to the surveyed ASCs and respond to the ASCs' plans of correction in a timely manner. ++ Establish TJC's ability to provide CMS with electronic data and reports necessary for effective validation and assessment of the organization's survey process. ++ Determine the adequacy of TJC's staff and other resources.

++ Confirm TJC's ability to provide adequate funding for performing required surveys. ++ Confirm TJC's policies with respect to surveys being unannounced. ++ Confirm TJC's policies and procedures to avoid conflicts of interest, including the appearance of conflicts of interest, involving individuals who conduct surveys or participate in accreditation decisions.

++ Obtain TJC's agreement to provide CMS with a copy of the most current accreditation survey together with any other information related to the survey as we may require, including corrective action plans.Start Printed Page 66990 IV. Analysis of and Responses to Public Comments on the Proposed Notice In accordance with section 1865(a)(3)(A) of the Act, the May 26, 2020 proposed notice also solicited public comments regarding whether TJC's requirements met or exceeded the Medicare CfCs for ASCs. No comments were received in response to our proposed notice.

V. Provisions of the Final Notice A. Differences Between TJC's Standards and Requirements for Accreditation and Medicare Conditions and Survey Requirements We compared TJC's ASC accreditation requirements and survey process with the Medicare CfCs of parts 416, and the survey and certification process requirements of parts 488 and 489.

Our review and evaluation of TJC's ASC application, which were conducted as described in section III of this final notice, yielded the following areas where, as of the date of this notice, TJC has completed revising its standards and certification processes in order to do all of the following. Meet the standard's requirements of all of the following regulations. ++ Section 416.2, to include the regulatory definition of an ASC as a comparable TJC standard instead of a glossary definition.

++ Section 416.43(c)(2), to address the broad requirement under the quality improvement program to track adverse patient events. ++ Section 416.44(c), to include reference to the Health Care Facilities Code (HCFC) of the National Fire Protection Association (NFPA) 99 (2012 edition). ++ Section 416.45(a), to include adequate review of credential and personnel files during survey activity.

++ Section 416.48(a), to include policies regarding the administration of drugs be in accordance with acceptable standards of practice. ++ Section 416.50(a), to provide the correct regulatory citation reference to the CMS standard, “Condition for Coverage—Patient Rights. Notice of Rights.” ++ Section 488.5(a)(4)(iv), to include the requirement that all comparable Medicare CfC citations be included in the findings sections of TJC's survey reports.

CMS also reviewed TJC's comparable survey processes, which were conducted as described in section III. Of this final notice, and yielded the following areas where, as of the date of this notice, TJC has completed revising its survey processes in order to demonstrate that it uses survey processes that are comparable to state survey agency processes by. ++ Modifying TJC's accreditation award letter to facilities to remove the term “lengthen” to eliminate potential conflict as it relates to survey cycle length not to exceed 36 months, as survey cycles for deeming purposes do not exceed this timeframe.

++ Adding references to the HCFC of the NFPA 99 (2012 edition). (NFPA 99) within its Accreditation Process and Surveyor Activity Guide. ++ Providing clarification to its Surveyor Activity Guide indicating that the 2012 edition of the NFPA Life Safety Code and NFPA 99 applies to ASCs, regardless of the number of patients served.

++ Clarifying the process for TJC's performance of on-site Evidence of Standard Compliance (ESC) processes, including what it means to provide coaching and guidance as part of TJC's ESC survey activities. B. Term of Approval Based on our review described in section III.

And section V. Of this final notice, we approve TJC as a national accreditation organization for ASCs that request participation in the Medicare program. The decision announced in this final notice is effective December 20, 2020 through December 20, 2024.

In accordance with § 488.5(e)(2)(i) the term of the approval will not exceed 6 years. Due to travel restrictions and the reprioritization of survey activities brought on by the 2019 Novel skin care Disease (skin care products) Public Health Emergency (PHE), CMS was unable to observe an ASC survey completed by TJC surveyors as part of the application review process, which is one component of the comparability evaluation. Therefore, we are providing TJC with a shorter period of approval.

Based on our discussions with TJC and the information provided in its application, we are confident that TJC will continue to ensure that its accredited ASCs will continue to meet or exceed Medicare standards. While TJC has taken actions based on the findings annotated in section V.A., of this final notice, (Differences Between TJC's Standards and Requirements for Accreditation and Medicare Conditions and Survey Requirements) as authorized under § 488.8, we will continue ongoing review of TJC's ASC survey processes and will conduct a survey observation once the skin care products PHE has expired.

Revision of a currently renova online in canada approved collection. Title of Information Collection. Submissions of 1135 Waiver Request Automated Process.

Use. Waivers under Section 1135 of the Social Security Act (the Act) and certain flexibilities allow the CMS to relax certain requirements, known as the Conditions of Participation (CoPs) or Conditions of Coverage to promote the health and safety of beneficiaries. Under Section 1135 of the Act, the Secretary may temporarily waive or modify certain Medicare, Medicaid, and Children's Health Insurance Program (CHIP) requirements to ensure that sufficient health care services are available to meet the needs of individuals enrolled in Social Security Act programs in the emergency area and time periods.

These waivers ensure that providers who provide such services in good faith can be reimbursed and exempted from sanctions. During emergencies, such as the current skin care products public health emergency (PHE), CMS must be able to apply program waivers and flexibilities under section 1135 of the Social Security Act, in a timely manner to respond quickly to unfolding events. In a disaster or emergency, waivers and flexibilities assist health care providers/suppliers in providing timely healthcare and services to people who have been affected and enables states, Federal districts, and U.S.

Territories to ensure Medicare and/or Medicaid beneficiaries have continued access to care. During disasters and emergencies, it is not uncommon to evacuate Medicare-participating facilities and relocate patients/residents to other provider settings or across state lines, especially, during hurricane and tornado events. CMS must collect relevant information for which a provider is requesting a waiver or flexibility to make proper decisions about approving or denying such requests.

Collection of this data aids in the prevention of gaps in access to care and services before, during, and after an emergency. CMS must also respond to inquiries related to a PHE from providers and beneficiaries. CMS is not collecting information from these inquiries.

We are merely responding to them. Prior to this request, CMS did not have a standard process or OMB approval for providers/suppliers impacted to submit 1135 waiver/flexibility requests or inquiries, as these were generally seen on a smaller scale (natural disasters) prior to the skin care products public health emergency. CMS has provided general guidance to Medicare-participating facilities which can be viewed at https://www.cms.gov/​Medicare/​Provider-Enrollment-and-Certification/​SurveyCertEmergPrep/​1135-Waivers.

The requests and inquiries would be sent directly, via email, to the Survey Operations Group in each CMS Location (previously known as CMS Regional Offices) and the entity would provide a brief summary to CMS for a waiver/flexibility request or an answer to an inquiry. We are now developing a streamlined, automated process to standardize the 1135 waiver requests and inquiries submitted based on lessons learned during skin care products PHE, primarily based on the volume of requests to ensure timely response to facility needs. The waiver request form was approved under an Emergency information collection request on October 15, 2020.

Furthermore, the normal operations of a healthcare provider are disrupted by emergencies or disasters occasionally. When this occurs, State Survey Agencies (SA) deliver a provider/beneficiary tracking report regarding the current status of all affected healthcare providers and their beneficiaries. This report includes demographic information about the provider, their operational status, beneficiary status, and planned resumption of normal operations.

This information is provided whether or not a PHE has been declared. We are now developing a streamlined, automated process to standardize submission of this information directly by the provider during emergencies and eliminating the need for SA to provide it. It will consist of a public facing web form.

This information will be used by CMS to receive, triage, respond to and report on requests and/or inquiries for Medicare, Medicaid, and CHIP beneficiaries. This information will be Start Printed Page 66992used to make decisions about approving or denying waiver and flexibility requests and may be used to identify trends that inform CMS Conditions for Coverage or Conditions for Participation policies during public health emergencies, when declared by the President and the HHS Secretary. Subsequent to the Emergency information collection request, we are revising the package to include a second form, Healthcare Facility Status Workflow, which is for operational status information which will be used to assist providers in delivering critical care to beneficiaries during emergencies.

Form Number. CMS-10752 (OMB control number. 0938-1384).

Private Sector. Business or other for-profits and Not-for-profit institutions and State, Local or Tribal Governments. Number of Respondents.

Total Annual Hours. 3,730. (For policy questions regarding this collection, contact Adriane Saunders at 404-562-7484.) 2.

Type of Information Collection Request. Revision of a currently approved collection. Title of Information Collection.

Solicitation for Applications for Medicare Prescription Drug Plan 2022 Contracts. Use. Coverage for the prescription drug benefit is provided through contracted prescription drug plans (PDPs) or through Medicare Advantage (MA) plans that offer integrated prescription drug and health care coverage (MA-PD plans).

Cost Plans that are regulated under Section 1876 of the Social Security Act, and Employer Group Waiver Plans (EGWP) may also provide a Part D benefit. Organizations wishing to provide services under the Prescription Drug Benefit Program must complete an application, negotiate rates, and receive final approval from CMS. Existing Part D Sponsors may also expand their contracted service area by completing the Service Area Expansion (SAE) application.

Collection of this information is mandated in Part D of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) in Subpart 3. The application requirements are codified in Subpart K of 42 CFR 423 entitled “Application Procedures and Contracts with PDP Sponsors.” The information will be collected under the solicitation of proposals from PDP, MA-PD, Cost Plan, Program of All Inclusive Care for the Elderly (PACE), and EGWP applicants. The collected information will be used by CMS to.

(1) Ensure that applicants meet CMS requirements for offering Part D plans (including network adequacy, contracting requirements, and compliance program requirements, as described in the application), (2) support the determination of contract awards. Form Number. CMS-10137 (OMB control number.

Affected Public. Private Sector. Business or other for-profits and Not-for-profit institutions and State, Local or Tribal Governments.

Number of Respondents. 658. Total Annual Responses.

(For policy questions regarding this collection, contact Arianne Spaccarelli at 410-786-5715.) 3. Type of Information Collection Request. Revision of a currently approved collection.

Title of Information Collection. CMS Plan Benefit Package (PBP) and Formulary CY 2022. Use.

Under the Medicare Modernization Act (MMA), Medicare Advantage (MA) and Prescription Drug Plan (PDP) organizations are required to submit plan benefit packages for all Medicare beneficiaries residing in their service area. The plan benefit package submission consists of the Plan Benefit Package (PBP) software, formulary file, and supporting documentation, as necessary. MA and PDP organizations use the PBP software to describe their organization's plan benefit packages, including information on premiums, cost sharing, authorization rules, and supplemental benefits.

They also generate a formulary to describe their list of drugs, including information on prior authorization, step therapy, tiering, and quantity limits. CMS requires that MA and PDP organizations submit a completed PBP and formulary as part of the annual bidding process. During this process, organizations prepare their proposed plan benefit packages for the upcoming contract year and submit them to CMS for review and approval.

CMS uses this data to review and approve the benefit packages that the plans will offer to Medicare beneficiaries. This allows CMS to review the benefit packages in a consistent way across all submitted bids during with incredibly tight timeframes. This data is also used to populate data on Medicare Plan Finder, which allows beneficiaries to access and compare Medicare Advantage and Prescription Drug plans.

Form Number. CMS-R-262 (OMB control number. 0938-0763).

Private Sector. Business or other for-profits and Not-for-profit institutions and State, Local or Tribal Governments. Number of Respondents.

Total Annual Hours. 74,038. (For policy questions regarding this collection, contact Kristy Holtje at 410-786-2209.) 4.

Type of Information Collection Request. Revision of a currently approved collection. Title of Information Collection.

Generic Clearance. Questionnaire Testing and Methodological Research for the Medicare Current Beneficiary Survey (MCBS). Use.

The current generic clearance for MCBS Questionnaire Testing and Methodological Research encompasses development and testing of MCBS questionnaires, instrumentation, and data collection protocols, as well as a mechanism for conducting methodological experiments. The current clearance includes conducting field tests and experiments, including split ballot experiments, within the MCBS production environment, and conducting usability tests. The purpose of this OMB clearance package is to revise the current clearance to expand the methods to allow for field tests outside of MCBS production Field tests conducted within production do not incur any additional burden on respondents whereas tests conducted outside production must account for additional respondent burden.

The MCBS is a continuous, multipurpose survey of a nationally representative sample of aged, disabled, and institutionalized Medicare beneficiaries. The MCBS, which is sponsored by the Centers for Medicare &. Medicaid Services (CMS), is the only comprehensive source of information on the health status, health care use and expenditures, health insurance coverage, and socioeconomic and demographic characteristics of the entire spectrum of Medicare beneficiaries.

The core of the MCBS is a series of interviews with a stratified random sample of the Medicare population, including aged and disabled enrollees, residing in the community or in institutions. Questions are asked about enrollees' patterns of health care use, charges, insurance coverage, and payments over time. Respondents are asked about their sources of health care coverage and payment, their demographic characteristics, their health and work history, and their family living circumstances.

In addition to collecting information through the core questionnaire, the MCBS collects information on special topics. Form Number. CMS-10549 (OMB control number.

Affected Public. Individuals or Households. Number of Respondents.

Total Annual Hours. Start Printed Page 669933,947. (For policy questions regarding this collection, contact William Long at 410-786-7927.) Start Signature Dated.

October 16, 2020. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.

End Signature End Supplemental Information [FR Doc. 2020-23335 Filed 10-20-20. 8:45 am]BILLING CODE 4120-01-PStart Preamble Start Printed Page 66989 Centers for Medicare &.

Medicaid Services (CMS), HHS. Final notice. This final notice announces our decision to approve The Joint Commission for continued recognition as a national accrediting organization for Ambulatory Surgical Centers that wish to participate in the Medicare or Medicaid programs.

The decision announced in this notice is effective on December 20, 2020 through December 20, 2024. Joy Webb (410) 786-1667. Erin Imhoff (410) 786-2337.

I. Background Ambulatory Surgical Centers (ASCs) are distinct entities that operate exclusively for the purpose of furnishing outpatient surgical services to patients. Under the Medicare program, eligible beneficiaries may receive covered services from an ASC provided certain requirements are met.

Section 1832(a)(2)(F)(i) of the Social Security Act (the Act) establishes distinct criteria for a facility seeking designation as an ASC. Regulations concerning provider agreements are at 42 CFR part 489 and those pertaining to activities relating to the survey and certification of facilities are at 42 CFR part 488. The regulations at 42 CFR part 416 specify the conditions that an ASC must meet in order to participate in the Medicare program, the scope of covered services, and the conditions for Medicare payment for ASCs.

Generally, to enter into an agreement, an ASC must first be certified by a State survey agency (SA) as complying with the conditions or requirements set forth in part 416 of our Medicare regulations. Thereafter, the ASC is subject to regular surveys by an SA to determine whether it continues to meet these requirements. Section 1865(a)(1) of the Act provides that, if a provider entity demonstrates through accreditation by a Centers for Medicare &.

Medicaid Services (CMS) approved national accrediting organization (AO) that all applicable Medicare conditions are met or exceeded, we may deem that provider entity as having met the requirements. Accreditation by an AO is voluntary and is not required for Medicare participation. If an AO is recognized by the Secretary of the Department of Health and Human Services as having standards for accreditation that meet or exceed Medicare requirements, any provider entity accredited by the national accrediting body's approved program may be deemed to meet the Medicare conditions.

The AO applying for approval of its accreditation program under part 488, subpart A, must provide CMS with reasonable assurance that the AO requires the accredited provider entities to meet requirements that are at least as stringent as the Medicare conditions. Our regulations concerning the approval of AOs are set forth at § 488.5. The Joint Commission's (TJC's) current term of approval for its ASC program expires December 20, 2020.

II. Application Approval Process Section 1865(a)(3)(A) of the Act provides a statutory timetable to ensure that our review of applications for CMS-approval of an accreditation program is conducted in a timely manner. The Act provides us 210 days after the date of receipt of a complete application, with any documentation necessary to make the determination, to complete our survey activities and application process.

Within 60 days after receiving a complete application, we must publish a notice in the Federal Register that identifies the national accrediting body making the request, describes the request, and provides no less than a 30-day public comment period. At the end of the 210-day period, we must publish a notice in the Federal Register approving or denying the application. III.

Provisions of the Proposed Notice On May 26, 2020 we published a proposed notice in the Federal Register (85 FR 31511), announcing TJC's request for continued approval of its Medicare ASC accreditation program. In the May 26, 2020 proposed notice, we detailed our evaluation criteria. Under section 1865(a)(2) of the Act and in our regulations at § 488.5, we conducted a review of TJC's Medicare ASC accreditation application in accordance with the criteria specified by our regulations, which include, but are not limited to the following.

An administrative review of TJC's. (1) Corporate policies. (2) financial and human resources available to accomplish the proposed surveys.

(3) procedures for training, monitoring, and evaluation of its ASC surveyors. (4) ability to investigate and respond appropriately to complaints against accredited ASCs. And (5) survey review and decision-making process for accreditation.

The comparison of TJC's Medicare ASC accreditation program standards to our current Medicare ASC conditions for coverage (CfCs). A documentation review of TJC's survey process to do the following. ++ Determine the composition of the survey team, surveyor qualifications, and TJC's ability to provide continuing surveyor training.

++ Compare TJC's processes to those we require of state survey agencies, including periodic resurvey and the ability to investigate and respond appropriately to complaints against TJC-accredited ASCs. ++ Evaluate TJC's procedures for monitoring accredited ASCs it has found to be out of compliance with TJC's program requirements. (This pertains only to monitoring procedures when TJC identifies non-compliance.

If noncompliance is identified by a SA through a validation survey, the SA monitors corrections as specified at § 488.9(c)). ++ Assess TJC's ability to report deficiencies to the surveyed ASCs and respond to the ASCs' plans of correction in a timely manner. ++ Establish TJC's ability to provide CMS with electronic data and reports necessary for effective validation and assessment of the organization's survey process.

++ Determine the adequacy of TJC's staff and other resources. ++ Confirm TJC's ability to provide adequate funding for performing required surveys. ++ Confirm TJC's policies with respect to surveys being unannounced.

++ Confirm TJC's policies and procedures to avoid conflicts of interest, including the appearance of conflicts of interest, involving individuals who conduct surveys or participate in accreditation decisions. ++ Obtain TJC's agreement to provide CMS with a copy of the most current accreditation survey together with any other information related to the survey as we may require, including corrective action plans.Start Printed Page 66990 IV. Analysis of and Responses to Public Comments on the Proposed Notice In accordance with section 1865(a)(3)(A) of the Act, the May 26, 2020 proposed notice also solicited public comments regarding whether TJC's requirements met or exceeded the Medicare CfCs for ASCs.

No comments were received in response to our proposed notice. V. Provisions of the Final Notice A.

Differences Between TJC's Standards and Requirements for Accreditation and Medicare Conditions and Survey Requirements We compared TJC's ASC accreditation requirements and survey process with the Medicare CfCs of parts 416, and the survey and certification process requirements of parts 488 and 489. Our review and evaluation of TJC's ASC application, which were conducted as described in section III of this final notice, yielded the following areas where, as of the date of this notice, TJC has completed revising its standards and certification processes in order to do all of the following. Meet the standard's requirements of all of the following regulations.

++ Section 416.2, to include the regulatory definition of an ASC as a comparable TJC standard instead of a glossary definition. ++ Section 416.43(c)(2), to address the broad requirement under the quality improvement program to track adverse patient events. ++ Section 416.44(c), to include reference to the Health Care Facilities Code (HCFC) of the National Fire Protection Association (NFPA) 99 (2012 edition).

++ Section 416.45(a), to include adequate review of credential and personnel files during survey activity. ++ Section 416.48(a), to include policies regarding the administration of drugs be in accordance with acceptable standards of practice. ++ Section 416.50(a), to provide the correct regulatory citation reference to the CMS standard, “Condition for Coverage—Patient Rights.

Notice of Rights.” ++ Section 488.5(a)(4)(iv), to include the requirement that all comparable Medicare CfC citations be included in the findings sections of TJC's survey reports. CMS also reviewed TJC's comparable survey processes, which were conducted as described in section III. Of this final notice, and yielded the following areas where, as of the date of this notice, TJC has completed revising its survey processes in order to demonstrate that it uses survey processes that are comparable to state survey agency processes by.

++ Modifying TJC's accreditation award letter to facilities to remove the term “lengthen” to eliminate potential conflict as it relates to survey cycle length not to exceed 36 months, as survey cycles for deeming purposes do not exceed this timeframe. ++ Adding references to the HCFC of the NFPA 99 (2012 edition).

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