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How Prescription Drugs are Obtained through Managed Care plans can you buy viagra No - Until April 2020 HOW DO MANAGED CARE PLANS DEFINE THE PHARMACY BENEFIT FOR CONSUMERS?. The Medicaid pharmacy benefit includes all FDA approved prescription drugs, as well as some over-the-counter drugs and medical supplies. Under Medicaid managed care.

Plan can you buy viagra formularies will be comparable to but not the same as the Medicaid formulary. Managed care plans are required to have drug formularies that are “comparable” to the Medicaid fee for service formulary. Plan formularies do not have to include all drugs covered listed on the fee for service formulary, but they must include generic or therapeutic equivalents of all Medicaid covered drugs.

The Pharmacy can you buy viagra Benefit will vary by plan. Each plan will have its own formulary and drug coverage policies like prior authorization and step therapy. Pharmacy networks can also differ from plan to plan.

Prescriber Prevails applies in certain drug classes can you buy viagra. Prescriber prevails applys to medically necessary precription drugs in the following classes. atypical antipsychotics, anti-depressants, anti-retrovirals, anti-rejection, seizure, epilepsy, endocrine, hemotologic and immunologic therapeutics.

Prescribers will can you buy viagra need to demonstrate reasonable profession judgment and supply plans witht requested information and/or clinical documentation. Pharmacy Benefit Information Website -- http://mmcdruginformation.nysdoh.suny.edu/-- This website provides very helpful information on a plan by plan basis regarding pharmacy networks and drug formularies. The Department of Health plans to build capacity for interactive searches allowing for comparison of coverage across plans in the near future.

Standardized Prior Autorization (PA) Form -- The Department of Health worked with managed care plans, provider organizations and other state agencies to develop a standard prior authorization form for can you buy viagra the pharmacy benefit in Medicaid managed care. The form will be posted on the Pharmacy Information Website in July of 2013. Mail Order Drugs -- Medicaid managed care members can obtain mail order/specialty drugs at any retail network pharmacy, as long as that retail network pharmacy agrees to a price that is comparable to the mail order/specialty pharmacy price.

CAN CONSUMERS SWITCH PLANS IN ORDER TO GAIN ACCESS TO can you buy viagra DRUGS?. Changing plans is often an effective strategy for consumers eligible for both Medicaid and Medicare (dual eligibles) who receive their pharmacy service through Medicare Part D, because dual eligibles are allowed to switch plans at any time. Medicaid consumers will have this option only in the limited circumstances during the first year of enrollment in managed care.

Medicaid managed care enrollees can only leave can you buy viagra and join another plan within the first 90 days of joining a health plan. After the 90 days has expired, enrollees are “locked in” to the plan for the rest of the year. Consumers can switch plans during the “lock in” period only for good cause.

The can you buy viagra pharmacy benefit changes are not considered good cause. After the first 12 months of enrollment, Medicaid managed care enrollees can switch plans at any time. STEPS CONSUMERS CAN TAKE WHEN A MANAGED CARE PLAM DENIES ACCESS TO A NECESSARY DRUG As a first step, consumers should try to work with their providers to satisfy plan requirements for prior authorization or step therapy or any other utilization control requirements.

If the plan still denies access, consumers can pursue review processes specific to managed care while can you buy viagra at the same time pursuing a fair hearing. All plans are required to maintain an internal and external review process for complaints and appeals of service denials. Some plans may develop special procedures for drug denials.

Information can you buy viagra on these procedures should be provided in member handbooks. Beginning April 1, 2018, Medicaid managed care enrollees whose plan denies prior approval of a prescription drug, or discontinues a drug that had been approved, will receive an Initial Adverse Determination notice from the plan - See Model Denial IAD Notice and IAD Notice to Reduce, Suspend or Stop Services The enrollee must first request an internal Plan Appeal and wait for the Plan's decision. An adverse decision is called a 'FInal Adverse Determination" or FAD.

See model Denial FAD Notice and can you buy viagra FAD Notice to Reduce, Suspend or Stop Services. The enroll has the right to request a fair hearing to appeal an FAD. The enrollee may only request a fair hearing BEFORE receiving the FAD if the plan fails to send the FAD in the required time limit, which is 30 calendar days in standard appeals, and 72 hours in expedited appeals.

The plan may extend the time to decide both standard and expedited appeals by up to 14 days can you buy viagra if more information is needed and it is in the enrollee's interest. AID CONTINUING -- If an enrollee requests a Plan Appeal and then a fair hearing because access to a drug has been reduced or terminated, the enrollee has the right to aid continuing (continued access to the drug in question) while waiting for the Plan Appeal and then the fair hearing. The enrollee must request the Plan Appeal and then the Fair Hearing before the effective date of the IAD and FAD notices, which is a very short time - only 10 days including mailing time.

See more about can you buy viagra the changes in Managed Care appeals here. Even though that article is focused on Managed Long Term Care, the new appeals requirements also apply to Mainstream Medicaid managed care. Enrollees who are in the first 90 days of enrollment, or past the first 12 months of enrollment also have the option of switching plans to improve access to their medications.

Consumers who experience problems with access to prescription drugs should always file a complaint with the State Department of Health’s Managed can you buy viagra Care Hotline, number listed below. ACCESSING MEDICAID'S PHARMACY BENEFIT IN FEE FOR SERVICE MEDICAID For those Medicaid recipients who are not yet in a Medicaid Managed Care program, and who do not have Medicare Part D, the Medicaid Pharmacy program covers most of their prescription drugs and select non-prescription drugs and medical supplies for Family Health Plus enrollees. Certain drugs/drug categories require the prescribers to obtain prior authorization.

These include brand name drugs that have a generic alternative under New York's mandatory generic drug program or prescribed drugs that are not on New York's preferred drug list can you buy viagra. The full Medicaid formulary can be searched on the eMedNY website. Even in fee for service Medicaid, prescribers must obtain prior authorization before prescribing non-preferred drugs unless otherwise indicated.

Prior authorization is required for original prescriptions, can you buy viagra not refills. A prior authorization is effective for the original dispensing and up to five refills of that prescription within the next six months. Click here for more information on NY's prior authorization process.

The New York State Board of Pharmacy publishes an annual list of the 150 most frequently prescribed drugs, in the most can you buy viagra common quantities. The State Department of Health collects retail price information on these drugs from pharmacies that participate in the Medicaid program. Click here to search for a specific drug from the most frequently prescribed drug list and this site can also provide you with the locations of pharmacies that provide this drug as well as their costs.

Click here can you buy viagra to view New York State Medicaid’s Pharmacy Provider Manual. WHO YOU CAN CALL FOR HELP Community Health Advocates Hotline. 1-888-614-5400 NY State Department of Health's Managed Care Hotline.

1-800-206-8125 can you buy viagra (Mon. - Fri. 8:30 am - 4:30 pm) NY State Department of Insurance.

1-800-400-8882 NY State Attorney General's Health Care can you buy viagra Bureau. 1-800-771-7755Haitian individuals and immigrants from some other countries who have applied for Temporary Protected Status (TPS) may be eligible for public health insurance in New York State. 2019 updates - The Trump administration has taken steps to end TPS status.

Two courts have temporarily enjoined can you buy viagra the termination of TPS, one in New York State in April 2019 and one in California in October 2018. The California case was argued in an appeals court on August 14, 2019, which the LA Times reported looked likely to uphold the federal action ending TPS. See US Immigration Website on TPS - General TPS website with links to status in all countries, including HAITI.

See can you buy viagra also Pew Research March 2019 article. Courts Block Changes in Public charge rule- See updates on the Public Charge rule here, blocked by federal court injunctions in October 2019. Read more about this change in public charge rules here.

What is Temporary can you buy viagra Protected Status?. TPS is a temporary immigration status granted to eligible individuals of a certain country designated by the Department of Homeland Security because serious temporary conditions in that country, such as armed conflict or environmental disaster, prevents people from that country to return safely. On January 21, 2010 the United States determined that individuals from Haiti warranted TPS because of the devastating earthquake that occurred there on January 12.

TPS gives can you buy viagra undocumented Haitian residents, who were living in the U.S. On January 12, 2010, protection from forcible deportation and allows them to work legally. It is important to note that the U.S.

Grants TPS to individuals from other countries, as well, can you buy viagra including individuals from El Salvador, Honduras, Nicaragua, Somalia and Sudan. TPS and Public Health Insurance TPS applicants residing in New York are eligible for Medicaid and Family Health Plus as long as they also meet the income requirements for these programs. In New York, applicants for TPS are considered PRUCOL immigrants (Permanently Residing Under Color of Law) for purposes of medical assistance eligibility and thus meet the immigration status requirements for Medicaid, Family Health Plus, and the Family Planning Benefit Program.

Nearly all children in New York remain eligible for Child Health Plus including TPS applicants and children who lack immigration can you buy viagra status. For more information on immigrant eligibility for public health insurance in New York see 08 GIS MA/009 and the attached chart. Where to Apply What to BringIndividuals who have applied for TPS will need to bring several documents to prove their eligibility for public health insurance.

Individuals will need to bring can you buy viagra. 1) Proof of identity. 2) Proof of residence in New York.

3) Proof of can you buy viagra income. 4) Proof of application for TPS. 5) Proof that U.S.

Citizenship and can you buy viagra Immigration Services (USCIS) has received the application for TPS. Free Communication Assistance All applicants for public health insurance, including Haitian Creole speakers, have a right to get help in a language they can understand. All Medicaid offices and enrollers are required to offer free translation and interpretation services to anyone who cannot communicate effectively in English.

A bilingual worker or an interpreter, whether in-person or over the telephone, must be provided in all interactions with the office. Important documents, such as Medicaid applications, should be translated either orally or in writing. Interpreter services must be offered free of charge, and applicants requiring interpreter services must not be made to wait unreasonably longer than English speaking applicants.

An applicant must never be asked to bring their own interpreter. Related Resources on TPS and Public Health Insurance o The New York Immigration Coalition (NYIC) has compiled a list of agencies, law firms, and law schools responding to the tragedy in Haiti and the designation of Haiti for Temporary Protected Status. A copy of the list is posted at the NYIC’s website at http://www.thenyic.org.

o USCIS TPS website with links to status in all countries, including HAITI. O For information on eligibility for public health insurance programs call The Legal Aid Society’s Benefits Hotline 1-888-663-6880 Tuesdays, Wednesdays and Thursdays. 9:30 am - 12:30 pm FOR IMMIGRATION HELP.

CONTACT THE New York State New Americans Hotline for a referral to an organization to advise you. 212-419-3737 Monday-Friday, from 9:00 a.m. To 8:00 p.m.Saturday-Sunday, from 9:00 a.m.

To 5:00 p.m. Or call toll-free in New York State at 1-800-566-7636 Please see these fact sheets and web sites of national organizations for more information about the new PUBLIC CHARGE rules. Printable Fact Sheets for Distribution This article was co-authored by the New York Immigration Coalition, Empire Justice Center and the Health Law Unit of the Legal Aid Society.

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Start Preamble can women use viagra Centers buy generic viagra for Medicare &. Medicaid Services (CMS), HHS. Notice. This notice announces a $631.00 calendar year (CY) 2022 application fee for institutional providers that are initially enrolling in the Medicare or Medicaid program or the Children's Health Insurance Program (CHIP). Revalidating their Medicare, Medicaid, or CHIP enrollment.

Or adding a new Medicare practice location. This fee is required with any enrollment application submitted on or after January 1, 2022 and on or before December 31, 2022. The application fee announced in this notice is effective on January 1, 2022. Start Further Info Frank Whelan, (410) 786-1302. End Further Info End Preamble Start Supplemental Information I.

Background In the February 2, 2011 Federal Register (76 FR 5862), we published a final rule with comment period titled “Medicare, Medicaid, and Children's Health Insurance Programs. Additional Screening Requirements, Application Fees, Temporary Enrollment Moratoria, Payment Suspensions and Compliance Plans for Providers and Suppliers.” This rule finalized, among other things, provisions related to the submission of application fees as part of the Medicare, Medicaid, and CHIP provider enrollment processes. As provided in section 1866(j)(2)(C)(i) of the Social Security Act (the Act) and in 42 CFR 424.514, “institutional providers” that are initially enrolling in the Medicare or Medicaid programs or CHIP, revalidating their enrollment, or adding a new Medicare practice location are required to submit a fee with their enrollment application. An “institutional provider” for purposes of Medicare is defined at § 424.502 as “any provider or supplier that submits a paper Medicare enrollment application using the CMS-855A, CMS-855B (not including physician and non-physician practitioner organizations), CMS-855S, CMS-20134, or associated internet-based PECOS enrollment application.” As we explained in the February 2, 2011 final rule (76 FR 5914), in addition to the providers and suppliers subject to the application fee under Medicare, Medicaid-only and CHIP-only institutional providers would include nursing facilities, intermediate care facilities for persons with intellectual disabilities (ICF/IID), psychiatric residential treatment facilities. They may also include other institutional provider types designated by a state in accordance with their approved state plan.

As indicated in § 424.514 and § 455.460, the application fee is not required for either of the following. A Medicare physician or non-physician practitioner submitting a CMS-855I. A prospective or revalidating Medicaid or CHIP provider— ++ Who is an individual physician or non-physician practitioner. Or ++ That is enrolled as an institutional provider in Title XVIII of the Act or another state's Title XIX or XXI plan and has paid the application fee to a Medicare contractor or another state. II.

Provisions of the Notice Section 1866(j)(2)(C)(i)(I) of the Act established a $500 application fee for institutional providers in calendar year (CY) 2010. Consistent with section 1866(j)(2)(C)(i)(II) of the Act, § 424.514(d)(2) states that for CY 2011 and subsequent years, the preceding year's fee will be adjusted by the percentage change in the consumer price index (CPI) for all urban consumers (all items. United States city average, CPI-U) for the 12-month period ending on June 30 of the previous year. Each year since 2011, accordingly, we have published in the Federal Register an announcement of the application fee amount for the forthcoming CY based on the formula noted previously. Most recently, in the November 23, 2020 Federal Register (85 FR 74724), we published a notice announcing a fee amount for the period of January 1, 2021 through December 31, 2021 of $599.00.

The $599.00 fee amount for CY 2021 was used to calculate the fee amount for 2022 as specified in § 424.514(d)(2). According to Bureau of Labor Statistics (BLS) data, the CPU-U increase for the period of July 1, 2020 through June 30, 2021 was 5.4 percent. As required by § 424.514(d)(2), the preceding year's fee of $599 will be adjusted by 5.4 percent. This results in a CY 2022 application fee amount of $631.35 ($599 × 1.054). As we must round this to the nearest whole dollar amount, the resultant application fee amount for CY 2022 is $631.00.

III. Collection of Information Requirements This document does not impose information collection requirements, that is, reporting, recordkeeping, or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995. However, it does reference previously approved information collections. The Forms CMS-855A, CMS-855B, and CMS-855I are approved under OMB control number 0938-0685.

The Form CMS-855S is approved under OMB control number 0938-1056. IV. Regulatory Impact Statement A. Background and Review Requirements We have examined the impact of this notice as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L.

96-354), section 1102(b) of the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995. Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C. 804(2)).

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits, including potential economic, environmental, public health and safety effects, distributive impacts, and equity. A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). As explained in this section of the notice, we estimate that the total cost of the increase in the application fee will not exceed $100 million. Therefore, this notice does not reach the $100 million Start Printed Page 58918 economic threshold and is not considered a major notice. The RFA requires agencies to analyze options for regulatory relief of small businesses.

For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of less than $7.5 million to $38.5 million in any 1 year. Individuals and states are not included in the definition of a small entity. As we stated in the RIA for the February 2, 2011 final rule with comment period (76 FR 5952), we do not believe that the application fee will have a significant impact on small entities. In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals.

This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment regulations and has fewer than 100 beds. We are not preparing an analysis for section 1102(b) of the Act because we have determined, and the Secretary certifies, that this notice would not have a significant impact on the operations of a substantial number of small rural hospitals. Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2021, that threshold was approximately $158 million.

The Agency has determined that there will be minimal impact from the costs of this notice, as the threshold is not met under the UMRA. Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has federalism implications. Since this notice does not impose substantial direct costs on state or local governments, the requirements of Executive Order 13132 are not applicable. B. Costs The costs associated with this notice involve the increase in the application fee amount that certain providers and suppliers must pay in CY 2022.

The CY 2022 cost estimates are as follows. 1. Medicare Based on CMS data, we estimate that in CY 2022 approximately— 10,214 newly enrolling institutional providers will be subject to and pay an application fee. And 42,117 revalidating institutional providers will be subject to and pay an application fee. Using a figure of 52,331 (10,214 newly enrolling + 42,117 revalidating) institutional providers, we estimate an increase in the cost of the Medicare application fee requirement in CY 2022 of $1,674,592 (or 52,331 × $32 (or $631 minus $599)) from our CY 2021 projections.

2. Medicaid and CHIP Based on CMS and state statistics, we estimate that approximately 30,000 (9,000 newly enrolling + 21,000 revalidating) Medicaid and CHIP institutional providers will be subject to an application fee in CY 2022. Using this figure, we project an increase in the cost of the Medicaid and CHIP application fee requirement in CY 2022 of $960,000 (or 30,000 × $32 (or $631 minus $599)) from our CY 2021 projections. 3. Total Based on the foregoing, we estimate the total increase in the cost of the application fee requirement for Medicare, Medicaid, and CHIP providers and suppliers in CY 2022 to be $2,634,592 ($1,674,592 + $960,000) from our CY 2021 projections.

In accordance with the provisions of Executive Order 12866, this notice was reviewed by the Office of Management and Budget. The Administrator of the Centers for Medicare &. Medicaid Services (CMS), Chiquita Brooks-LaSure, having reviewed and approved this document, authorizes Lynette Wilson, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register. Start Signature Dated. October 19, 2021.

Lynette Wilson, Federal Register Liaison, Centers for Medicare &. Medicaid Services. End Signature End Supplemental Information [FR Doc. 2021-23143 Filed 10-22-21. 8:45 am]BILLING CODE 4120-01-P.

Start Preamble Centers for see here now Medicare can you buy viagra &. Medicaid Services (CMS), HHS. Notice. This notice announces a $631.00 calendar year (CY) 2022 application fee for institutional providers that are initially enrolling in the Medicare or Medicaid program or the Children's Health Insurance Program (CHIP). Revalidating their Medicare, Medicaid, or CHIP enrollment.

Or adding a new Medicare practice location. This fee is required with any enrollment application submitted on or after January 1, 2022 and on or before December 31, 2022. The application fee announced in this notice is effective on January 1, 2022. Start Further Info Frank Whelan, (410) 786-1302. End Further Info End Preamble Start Supplemental Information I.

Background In the February 2, 2011 Federal Register (76 FR 5862), we published a final rule with comment period titled “Medicare, Medicaid, and Children's Health Insurance Programs. Additional Screening Requirements, Application Fees, Temporary Enrollment Moratoria, Payment Suspensions and Compliance Plans for Providers and Suppliers.” This rule finalized, among other things, provisions related to the submission of application fees as part of the Medicare, Medicaid, and CHIP provider enrollment processes. As provided in section 1866(j)(2)(C)(i) of the Social Security Act (the Act) and in 42 CFR 424.514, “institutional providers” that are initially enrolling in the Medicare or Medicaid programs or CHIP, revalidating their enrollment, or adding a new Medicare practice location are required to submit a fee with their enrollment application. An “institutional provider” for purposes of Medicare is defined at § 424.502 as “any provider or supplier that submits a paper Medicare enrollment application using the CMS-855A, CMS-855B (not including physician and non-physician practitioner organizations), CMS-855S, CMS-20134, or associated internet-based PECOS enrollment application.” As we explained in the February 2, 2011 final rule (76 FR 5914), in addition to the providers and suppliers subject to the application fee under Medicare, Medicaid-only and CHIP-only institutional providers would include nursing facilities, intermediate care facilities for persons with intellectual disabilities (ICF/IID), psychiatric residential treatment facilities. They may also include other institutional provider types designated by a state in accordance with their approved state plan.

As indicated in § 424.514 and § 455.460, the application fee is not required for either of the following. A Medicare physician or non-physician practitioner submitting a CMS-855I. A prospective or revalidating Medicaid or CHIP provider— ++ Who is an individual physician or non-physician practitioner. Or ++ That is enrolled as an institutional provider in Title XVIII of the Act or another state's Title XIX or XXI plan and has paid the application fee to a Medicare contractor or another state. II.

Provisions of the Notice Section 1866(j)(2)(C)(i)(I) of the Act established a $500 application fee for institutional providers in calendar year (CY) 2010. Consistent with section 1866(j)(2)(C)(i)(II) of the Act, § 424.514(d)(2) states that for CY 2011 and subsequent years, the preceding year's fee will be adjusted by the percentage change in the consumer price index (CPI) for all urban consumers (all items. United States city average, CPI-U) for the 12-month period ending on June 30 of the previous year. Each year since 2011, accordingly, we have published in the Federal Register an announcement of the application fee amount for the forthcoming CY based on the formula noted previously. Most recently, in the November 23, 2020 Federal Register (85 FR 74724), we published a notice announcing a fee amount for the period of January 1, 2021 through December 31, 2021 of $599.00.

The $599.00 fee amount for CY 2021 was used to calculate the fee amount for 2022 as specified in § 424.514(d)(2). According to Bureau of Labor Statistics (BLS) data, the CPU-U increase for the period of July 1, 2020 through June 30, 2021 was 5.4 percent. As required by § 424.514(d)(2), the preceding year's fee of $599 will be adjusted by 5.4 percent. This results in a CY 2022 application fee amount of $631.35 ($599 × 1.054). As we must round this to the nearest whole dollar amount, the resultant application fee amount for CY 2022 is $631.00.

III. Collection of Information Requirements This document does not impose information collection requirements, that is, reporting, recordkeeping, or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995. However, it does reference previously approved information collections. The Forms CMS-855A, CMS-855B, and CMS-855I are approved under OMB control number 0938-0685.

The Form CMS-855S is approved under OMB control number 0938-1056. IV. Regulatory Impact Statement A. Background and Review Requirements We have examined the impact of this notice as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L.

96-354), section 1102(b) of the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995. Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C. 804(2)).

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits, including potential economic, environmental, public health and safety effects, distributive impacts, and equity. A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). As explained in this section of the notice, we estimate that the total cost of the increase in the application fee will not exceed $100 million. Therefore, this notice does not reach the $100 million Start Printed Page 58918 economic threshold and is not considered a major notice. The RFA requires agencies to analyze options for regulatory relief of small businesses.

For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of less than $7.5 million to $38.5 million in any 1 year. Individuals and states are not included in the definition of a small entity. As we stated in the RIA for the February 2, 2011 final rule with comment period (76 FR 5952), we do not believe that the application fee will have a significant impact on small entities. In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals.

This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment regulations and has fewer than 100 beds. We are not preparing an analysis for section 1102(b) of the Act because we have determined, and the Secretary certifies, that this notice would not have a significant impact on the operations of a substantial number of small rural hospitals. Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2021, that threshold was approximately $158 million.

The Agency has determined that there will be minimal impact from the costs of this notice, as the threshold is not met under the UMRA. Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has federalism implications. Since this notice does not impose substantial direct costs on state or local governments, the requirements of Executive Order 13132 are not applicable. B. Costs The costs associated with this notice involve the increase in the application fee amount that certain providers and suppliers must pay in CY 2022.

The CY 2022 cost estimates are as follows. 1. Medicare Based on CMS data, we estimate that in CY 2022 approximately— 10,214 newly enrolling institutional providers will be subject to and pay an application fee. And 42,117 revalidating institutional providers will be subject to and pay an application fee. Using a figure of 52,331 (10,214 newly enrolling + 42,117 revalidating) institutional providers, we estimate an increase in the cost of the Medicare application fee requirement in CY 2022 of $1,674,592 (or 52,331 × $32 (or $631 minus $599)) from our CY 2021 projections.

2. Medicaid and CHIP Based on CMS and state statistics, we estimate that approximately 30,000 (9,000 newly enrolling + 21,000 revalidating) Medicaid and CHIP institutional providers will be subject to an application fee in CY 2022. Using this figure, we project an increase in the cost of the Medicaid and CHIP application fee requirement in CY 2022 of $960,000 (or 30,000 × $32 (or $631 minus $599)) from our CY 2021 projections. 3. Total Based on the foregoing, we estimate the total increase in the cost of the application fee requirement for Medicare, Medicaid, and CHIP providers and suppliers in CY 2022 to be $2,634,592 ($1,674,592 + $960,000) from our CY 2021 projections.

In accordance with the provisions of Executive Order 12866, this notice was reviewed by the Office of Management and Budget. The Administrator of the Centers for Medicare &. Medicaid Services (CMS), Chiquita Brooks-LaSure, having reviewed and approved this document, authorizes Lynette Wilson, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register. Start Signature Dated. October 19, 2021.

Lynette Wilson, Federal Register Liaison, Centers for Medicare &. Medicaid Services. End Signature End Supplemental Information [FR Doc. 2021-23143 Filed 10-22-21. 8:45 am]BILLING CODE 4120-01-P.

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