{"description":"Documents matching '\"calcitonin-salmon\"'","count":61,"total_pages":4,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bterm%5D=%22calcitonin-salmon%22&format=json&page=2","results":[{"title":"Product-Specific Guidances; Revised Draft Guidances for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of additional revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled \"Bioequivalence Recommendations for Specific Products\" that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The draft guidances identified in this notice were developed using the process described in that guidance.","document_number":"2026-15285","html_url":"https://www.federalregister.gov/documents/2026/07/29/2026-15285/product-specific-guidances-revised-draft-guidances-for-industry-availability","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-29/pdf/2026-15285.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-15285.pdf?1785242713","publication_date":"2026-07-29","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Available \n FDA is announcing the availability of revised draft product-specific guidances for industry for drug products containing the following active ingredients: \n \n Table 1—Revised Draft Product-Specific Guidances for Drug Products \n \n Active ingredient(s) \n \n \n <span class=\"match\">Calcitonin salmon</span> (multiple reference listed drugs). \n \n \n Dasiglucagon hydrochloride. \n \n \n Glucagon (multiple reference listed drugs). \n \n \n Liraglutide (multiple reference listed drugs). \n \n \n Pegcetacoplan (multiple reference listed drugs). \n \n \n Semaglutide (multiple reference listed"},{"title":"Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of additional draft and revised draft product-specific guidances. The draft guidances provide product- specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled \"Bioequivalence Recommendations for Specific Products\" that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The draft guidances identified in this notice were developed using the process described in that guidance.","document_number":"2025-22131","html_url":"https://www.federalregister.gov/documents/2025/12/05/2025-22131/product-specific-guidances-draft-and-revised-draft-guidances-for-industry-availability","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-12-05/pdf/2025-22131.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-22131.pdf?1764855937","publication_date":"2025-12-05","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"for drug products containing the following active ingredients: \n \n Table 2—Revised Draft Product-Specific Guidances for Drug Products \n \n Active ingredient(s) \n \n \n Baclofen \n \n \n Baricitinib \n \n \n Brigatinib \n \n \n Budesonide (multiple reference listed drugs) \n \n \n <span class=\"match\">Calcitonin salmon</span> \n \n \n Carbinoxamine maleate \n \n \n Carvedilol phosphate \n \n \n Cenobamate \n \n \n Dabrafenib mesylate \n \n \n Dasiglucagon hydrochloride \n \n \n Diltiazem hydrochloride \n \n \n Epinephrine (multiple reference listed drugs) \n \n \n Etodolac \n \n \n Fluticasone propionate \n \n \n Glucagon"},{"title":"Determination That MIACALCIN (Calcitonin Salmon) Injection, 100 USP Units/Milliliter (mL), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness","type":"Notice","abstract":"The Food and Drug Administration (FDA, Agency, or we) has determined that MIACALCIN (calcitonin salmon) injection, 100 USP Units/ milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for calcitonin salmon injection, 100 USP Units/mL, if all other legal and regulatory requirements are met.","document_number":"2023-03389","html_url":"https://www.federalregister.gov/documents/2023/02/17/2023-03389/determination-that-miacalcin-calcitonin-salmon-injection-100-usp-unitsmilliliter-ml-was-not","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-02-17/pdf/2023-03389.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-03389.pdf?1676555134","publication_date":"2023-02-17","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"information we have at this time, FDA has determined under § 314.161 that MIACALCIN (<span class=\"match\">calcitonin salmon</span>) injection, 100 USP Units/mL, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that MIACALCIN (<span class=\"match\">calcitonin salmon</span>) injection, 100 USP Units/mL, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of MIACALCIN (<span class=\"match\">calcitonin salmon</span>) injection, 100 USP Units/mL, from sale. We have also independently evaluated"},{"title":"Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled \"Bioequivalence Recommendations for Specific Products\" that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.","document_number":"2022-25210","html_url":"https://www.federalregister.gov/documents/2022/11/18/2022-25210/product-specific-guidances-draft-and-revised-draft-guidances-for-industry-availability","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-11-18/pdf/2022-25210.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-25210.pdf?1668692741","publication_date":"2022-11-18","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"product-specific guidances for industry for drug products containing the following active ingredients: \n \n Table 1—New Draft Product-Specific Guidances for Drug Products \n \n Active ingredient(s) \n \n \n Ammonium lactate (multiple reference listed drugs). \n \n \n Budesonide. \n \n \n <span class=\"match\">Calcitonin salmon</span>. \n \n \n Clindamycin phosphate. \n \n \n Deferiprone. \n \n \n Drospirenone; Estetrol. \n \n \n Eteplirsen. \n \n \n Fidaxomicin. \n \n \n Fosdenopterin hydrobromide. \n \n \n Hydrocortisone. \n \n \n Hydroxyurea. \n \n \n Inotersen sodium. \n \n \n Ketotifen fumarate. \n \n \n Magnesium sulfate; Potassium"},{"title":"Hikma Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 29 New Drug Applications","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is withdrawing approval of 29 new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.","document_number":"2022-02059","html_url":"https://www.federalregister.gov/documents/2022/02/02/2022-02059/hikma-pharmaceuticals-usa-inc-et-al-withdrawal-of-approval-of-29-new-drug-applications","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-02-02/pdf/2022-02059.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-02059.pdf?1643723118","publication_date":"2022-02-02","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"4 mg base, EQ 8 mg base, and EQ 12 mg base \n Janssen Research &amp; Development, LLC, 1125 Trenton-Harbourton Rd., Titusville, NJ 08560. \n \n \n NDA 021204 \n Starlix (nateglinide) Tablets, 60 mg, and 120 mg \n Novartis Pharmaceuticals Corp. \n \n \n NDA 021406 \n Fortical (<span class=\"match\">calcitonin-salmon</span> recombinant) Nasal Spray, 200 International Units/Spray \n Upsher-Smith Laboratories, LLC, 6701 Evenstad Dr., Maple Grove, MN 55369. \n \n \n NDA 021860 \n Sarafem (fluoxetine HCl) Tablets, EQ 10 mg base, EQ 15 mg base, and EQ 20 mg base \n Allergan Pharmaceuticals International"},{"title":"Determination That BUTISOL SODIUM (Butabarbital Sodium) Oral Tablets, 15 Milligrams, 50 Milligrams, and 100 Milligrams, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products if they meet relevant legal and regulatory requirements.","document_number":"2020-23300","html_url":"https://www.federalregister.gov/documents/2020/10/21/2020-23300/determination-that-butisol-sodium-butabarbital-sodium-oral-tablets-15-milligrams-50-milligrams-and","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-10-21/pdf/2020-23300.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-23300.pdf?1603197934","publication_date":"2020-10-21","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":" \n \n \n NDA 019716 \n DIPROLENE \n Betamethasone Dipropionate \n EQ 0.05% Base \n Lotion, Augmented; Topical \n Merck Sharp &amp; Dohme Corp. \n \n \n NDA 019964 \n TERAZOL 3 \n Terconazole \n 0.8% \n Cream; Vaginal \n Janssen Pharmaceuticals, Inc. \n \n \n NDA 020313 \n MIACALCIN \n <span class=\"match\">Calcitonin Salmon</span> \n 200 International Units/Spray \n Metered Spray; Nasal \n Mylan Ireland Limited. \n \n \n NDA 020388 \n NAVELBINE \n Vinorelbine Tartrate \n EQ 10 mg Base/mL \n Injectable; Injection \n Pierre Fabre Medicament. \n \n \n NDA 020413 \n ZERIT \n Stavudine \n 1 mg/mL \n For Solution; Oral"},{"title":"Determination That CALCIMAR (calcitonin salmon) Injection, 200 International Units Per Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) has determined that CALCIMAR (calcitonin salmon) Injection, 200 International Units per milliliter (IU/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for CALCIMAR (calcitonin salmon) Injection, 200 IU/mL, if all other legal and regulatory requirements are met.","document_number":"2019-19347","html_url":"https://www.federalregister.gov/documents/2019/09/09/2019-19347/determination-that-calcimar-calcitonin-salmon-injection-200-international-units-per-milliliter-was","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-09-09/pdf/2019-19347.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-19347.pdf?1567773918","publication_date":"2019-09-09","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"the Agency determine whether CALCIMAR (<span class=\"match\">calcitonin salmon</span>) injection, 200 IU/mL, was withdrawn from sale for reasons of safety or effectiveness. \n After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that CALCIMAR (<span class=\"match\">calcitonin salmon</span>) injection, 200 IU/mL, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that CALCIMAR (<span class=\"match\">calcitonin salmon</span>) injection, 200 IU/mL, was withdrawn"},{"title":"Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled \"Bioequivalence Recommendations for Specific Products\" that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.","document_number":"2020-04320","html_url":"https://www.federalregister.gov/documents/2020/03/03/2020-04320/product-specific-guidances-draft-and-revised-draft-guidances-for-industry-availability","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-03-03/pdf/2020-04320.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-04320.pdf?1583156728","publication_date":"2020-03-03","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"industry for drug products containing the following active ingredients: \n \n Table 2—Revised Draft Product-Specific Guidances for Drug Products \n \n Active ingredient(s) \n \n \n Albuterol sulfate (multiple reference listed drugs). \n \n \n Beclomethasone dipropionate. \n \n \n <span class=\"match\">Calcitonin salmon</span>. \n \n \n Dapagliflozin; Metformin hydrochloride. \n \n \n Edoxaban tosylate. \n \n \n Ibrutinib. \n \n \n Levalbuterol tartrate. \n \n \n Olsalazine sodium. \n \n \n Selexipag. \n \n \n \n For a complete history of previously published \n Federal Register \n notices related to product-specific"},{"title":"Determination That REGITINE (Phentolamine Mesylate) Injection, 5 Milligrams/Vial, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.","document_number":"2018-25187","html_url":"https://www.federalregister.gov/documents/2018/11/19/2018-25187/determination-that-regitine-phentolamine-mesylate-injection-5-milligramsvial-and-other-drug-products","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-11-19/pdf/2018-25187.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-25187.pdf?1542375934","publication_date":"2018-11-19","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"5 mg/500 mg; 5 mg/500 mg \n Tablet; Oral \n Bristol-Myers Squibb Co. \n \n \n NDA 21277 \n AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER \n Moxifloxacin HCl \n 400 mg/250 mL \n Solution; IV Infusion \n Bayer HealthCare Pharmaceuticals, Inc. \n \n \n NDA 021406 \n FORTICAL \n <span class=\"match\">Calcitonin Salmon</span> Recombinant \n 200 international units/spray \n Metered Spray; Nasal \n Upsher-Smith Laboratories, LLC. \n \n \n NDA 021530 \n MOBIC \n Meloxicam \n 7.5 mg/5 mL \n Suspension; Oral \n Boehringer Ingelheim Pharmaceuticals, Inc. \n \n \n NDA 021689 \n NEXIUM IV \n Esomeprazole Sodium"},{"title":"Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Short Inpatient Hospital Stays; Transition for Certain Medicare-Dependent, Small Rural Hospitals Under the Hospital Inpatient Prospective Payment System; Provider Administrative Appeals and Judicial Review","type":"Rule","abstract":"This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2016 to implement applicable statutory requirements and changes arising from our continuing experience with these systems. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. Further, this document includes certain finalized policies relating to the hospital inpatient prospective payment system: Changes to the 2- midnight rule under the short inpatient hospital stay policy; and a payment transition for hospitals that lost their status as a Medicare- dependent, small rural hospital (MDH) because they are no longer in a rural area due to the implementation of the new Office of Management and Budget delineations in FY 2015 and have not reclassified from urban to rural before January 1, 2016. In addition, this document contains a final rule that finalizes certain 2015 proposals, and addresses public comments received, relating to the changes in the Medicare regulations governing provider administrative appeals and judicial review relating to appropriate claims in provider cost reports.","document_number":"2015-27943","html_url":"https://www.federalregister.gov/documents/2015/11/13/2015-27943/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-11-13/pdf/2015-27943.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-27943.pdf?1446236131","publication_date":"2015-11-13","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"status \n indicator \n \n CY 2016 APC \n \n \n 90581 \n Anthrax vaccine, for subcutaneous or intramuscular use \n 1 \n N \n N/A \n \n \n C9293 \n Injection, glucarpidase, 10 units \n 400 \n K \n 9293 \n \n \n J0215 \n Injection, alefacept, 0.5 mg \n 29 \n K \n 1633 \n \n \n J0630 \n Injection, <span class=\"match\">calcitonin salmon</span>, up to 400 units \n 2 \n K \n 1433 \n \n \n J1324 \n Injection, enfuvirtide, 1 mg \n 169 \n K \n 1361 \n \n \n J1556 \n Inj, Imm Glob Bivigam, 500mg \n 78 \n K \n 9130 \n \n \n J2670 \n Tolazoline hcl injection \n 1 \n K \n 1457 \n \n \n J3060 \n Inj, Taliglucerace Alfa 10 u \n 479 \n K \n 9294 \n"},{"title":"Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Short Inpatient Hospital Stays; Transition for Certain Medicare-Dependent, Small Rural Hospitals Under the Hospital Inpatient Prospective Payment System","type":"Proposed Rule","abstract":"This proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2016 to implement applicable statutory requirements and changes arising from our continuing experience with these systems. In this proposed rule, we describe the proposed changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this proposed rule would update and refine the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. Further, this proposed rule includes certain proposals relating to the hospital inpatient prospective payment system: proposed changes to the 2-midnight rule under the short inpatient hospital stay policy, as well as a discussion of the related -0.2 percent payment adjustment; and a proposed transition for Medicare-dependent, small rural hospitals located in all-urban States.","document_number":"2015-16577","html_url":"https://www.federalregister.gov/documents/2015/07/08/2015-16577/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-07-08/pdf/2015-16577.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-16577.pdf?1435781725","publication_date":"2015-07-08","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"2016 SI \n Proposed New CY 2016 APC * \n \n \n 90581 \n Anthrax vaccine, for subcutaneous or intramuscular use \n 1 \n N \n N/A \n \n \n C9293 \n Injection, glucarpidase, 10 units \n 400 \n K \n 9293 \n \n \n J0215 \n Injection, alefacept, 0.5 mg \n 29 \n K \n 1633 \n \n \n J0630 \n Injection, <span class=\"match\">calcitonin salmon</span>, up to 400 units \n 2 \n K \n 1433 \n \n \n J0717 \n Injection, certolizumab pegol, 1 mg \n 361 \n K \n 1474 \n \n \n J1324 \n Injection, enfuvirtide, 1 mg \n 169 \n K \n 1361 \n \n \n J3355 \n Injection, urofollitropin, 75 IU \n 2 \n K \n 1741 \n \n \n J3489 \n Injection, Zoledronic Acid, 1 mg"},{"title":"Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Physician-Owned Hospitals: Data Sources for Expansion Exception; Physician Certification of Inpatient Hospital Services; Medicare Advantage Organizations and Part D Sponsors: CMS-Identified Overpayments Associated with Submitted Payment Data","type":"Rule","abstract":"This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2015 to implement applicable statutory requirements and changes arising from our continuing experience with these systems. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. In this document, we also are making changes to the data sources permitted for expansion requests for physician-owned hospitals under the physician self-referral regulations; changes to the underlying authority for the requirement of an admission order for all hospital inpatient admissions and changes to require physician certification for hospital inpatient admissions only for long-stay cases and outlier cases; and changes to establish a formal process, including a three- level appeals process, to recoup overpayments that result from the submission of erroneous payment data by Medicare Advantage (MA) organizations and Part D sponsors in the limited circumstances in which the organization or sponsor fails to correct these data.","document_number":"2014-26146","html_url":"https://www.federalregister.gov/documents/2014/11/10/2014-26146/medicare-and-medicaid-programs-hospital-outpatient-prospective-payment-and-ambulatory-surgical","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-11-10/pdf/2014-26146.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-26146.pdf?1414787533","publication_date":"2014-11-10","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"units per day \n CY 2015 SI \n CY 2015 APC \n \n \n 90581 \n Anthrax vaccine, for subcutaneous or intramuscular use \n 1 \n K \n 1422 \n \n \n J0215 \n Injection, alefacept, 0.5 mg \n 29 \n K \n 1633 \n \n \n J0365 \n Injection, aprotonin, 10,000 kiu \n 1 \n N \n 1439 \n \n \n J0630 \n Injection, <span class=\"match\">calcitonin salmon</span>, up to 400 units \n 2 \n K \n 1433 \n \n \n J2670 \n Injection, tolazoline hcl, up to 25 mg \n 1 \n N \n 1457 \n \n \n J3355 \n Injection, urofollitropin, 75 iu \n 2 \n K \n 1741 \n \n \n J7196 \n Injection, antithrombin recombinant, 50 IU \n 268 \n K \n 1332 \n \n \n J7505 \n Muromonab-cd3, parenteral"},{"title":"Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Physician-Owned Hospitals: Data Sources for Expansion Exception; Physician Certification of Inpatient Hospital Services; Medicare Advantage Organizations and Part D Sponsors: Appeals Process for Overpayments Associated With Submitted Data","type":"Proposed Rule","abstract":"This proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2015 to implement applicable statutory requirements and changes arising from our continuing experience with these systems. In this proposed rule, we describe the proposed changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this proposed rule would update and refine the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. In this document, we also are proposing changes to the data sources used for expansion requests for physician owned hospitals under the physician self-referral regulations; changes to the underlying authority for the requirement of an admission order for all hospital inpatient admissions and changes to require physician certification for hospital inpatient admissions only for long-stay cases and outlier cases; and changes to establish a three-level appeals process for Medicare Advantage (MA) organizations and Part D sponsors that would be applicable to CMS-identified overpayments associated with data submitted by these organizations and sponsors.","document_number":"2014-15939","html_url":"https://www.federalregister.gov/documents/2014/07/14/2014-15939/medicare-and-medicaid-programs-hospital-outpatient-prospective-payment-and-ambulatory-surgical","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-07-14/pdf/2014-15939.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-15939.pdf?1404418332","publication_date":"2014-07-14","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"Proposed \n CY 2015 \n APC \n \n \n \n 90581 \n Anthrax vaccine, for subcutaneous or intramuscular use \n 1 \n K \n 1422 \n \n \n J0215 \n Injection, alefacept, 0.5 mg \n 29 \n K \n 1633 \n \n \n J0364 \n Injection, apomorphine hydrochloride, 1 mg \n 1 \n N \n N/A \n \n \n J0630 \n Injection, <span class=\"match\">calcitonin salmon</span>, up to 400 units \n 2 \n K \n 1433 \n \n \n J0638 \n Injection, canakinumab, 1 mg \n 180 \n K \n 1311 \n \n \n J3355 \n Injection, urofollitropin, 75 iu \n 2 \n K \n 1741 \n \n \n J7196 \n Injection, antithrombin recombinant, 50 i. U. \n 268 \n K \n 1332 \n \n \n J8650 \n Nabilone, oral, 1 mg "},{"title":"Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting","type":"Notice","abstract":null,"document_number":"2013-00507","html_url":"https://www.federalregister.gov/documents/2013/01/14/2013-00507/joint-meeting-of-the-advisory-committee-for-reproductive-health-drugs-and-the-drug-safety-and-risk","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-01-14/pdf/2013-00507.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-00507.pdf?1357912106","publication_date":"2013-01-14","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Agenda: \n On March 5, 2013, the committees will discuss whether the benefit of <span class=\"match\">calcitonin salmon</span> for the treatment of postmenopausal osteoporosis (thinning and weakening of bones that increase the chance of having a broken bone) outweighs a potential risk of cancer. <span class=\"match\">Calcitonin salmon</span> products approved for the treatment of osteoporosis include: Miacalcin (<span class=\"match\">calcitonin salmon</span>) injection and nasal spray, submitted by Novartis Pharmaceuticals Corporation; Fortical (<span class=\"match\">calcitonin salmon</span> recombinant) nasal spray, submitted by Upsher Smith Laboratories; and the"},{"title":"Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Hospital Value-Based Purchasing Program; Organ Procurement Organizations; Quality Improvement Organizations; Electronic Health Records (EHR) Incentive Program; Provider Reimbursement Determinations and Appeals","type":"Rule","abstract":"This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2014 to implement applicable statutory requirements and changes arising from our continuing experience with these systems. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program, the ASC Quality Reporting (ASCQR) Program, and the Hospital Value-Based Purchasing (VBP) Program. In the final rules in this document, we are finalizing changes to the conditions for coverage (CfCs) for organ procurement organizations (OPOs); revisions to the Quality Improvement Organization (QIO) regulations; changes to the Medicare fee-for-service Electronic Health Record (EHR) Incentive Program; and changes relating to provider reimbursement determinations and appeals.","document_number":"2013-28737","html_url":"https://www.federalregister.gov/documents/2013/12/10/2013-28737/medicare-and-medicaid-programs-hospital-outpatient-prospective-payment-and-ambulatory-surgical","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-12-10/pdf/2013-28737.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-28737.pdf?1385587633","publication_date":"2013-12-10","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"in CY 2013. Therefore, we are finalizing our proposal, without modification, for CY 2014. \n We note that we proposed to package HCPCS codes 90734 (Meningococcal conjugate vaccine, serogroups a, c, y and w-135 (tetravalent), for intramuscular use), J0630 (Injection, <span class=\"match\">calcitonin salmon</span>, up to 400 units), and J1570 (Injection, ganciclovir sodium, 500 mg) for CY 2014. Using updated ASPs and the CY 2012 hospital claims data available for this final rule with comment period, HCPCS codes 90734, J0630, and J1570 now have per day costs greater than $90. In"},{"title":"Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled \"Bioequivalence Recommendations for Specific Products,\" which explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.","document_number":"2012-22658","html_url":"https://www.federalregister.gov/documents/2012/09/14/2012-22658/draft-and-revised-draft-guidances-for-industry-describing-product-specific-bioequivalence","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2012-09-14/pdf/2012-22658.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2012-22658.pdf?1347540985","publication_date":"2012-09-14","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"active ingredients: \n \n A \n Amoxicillin \n Amoxicillin; clavulanate potassium \n Amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate \n B \n Budesonide \n Bupropion hydrochloride (multiple reference listed drugs (RLDs)) \n C \n <span class=\"match\">Calcitonin salmon</span> \n Carbidopa; levodopa \n Carglumic acid \n Ciclesonide \n Ciprofloxacin; dexamethasone \n Cyclophosphamide \n D \n Dalteparin sodium \n E \n Estramustine phosphate sodium \n F \n Fentanyl citrate \n K \n Ketoconazole \n L \n Linagliptin \n M \n Mesalamine (multiple RLDs and dosage forms)"},{"title":"Hospital Outpatient Prospective and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Electronic Reporting Pilot; Inpatient Rehabilitation Facilities Quality Reporting Program; Quality Improvement Organization Regulations","type":"Proposed Rule","abstract":"This proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2013 to implement applicable statutory requirements and changes arising from our continuing experience with these systems. In this proposed rule, we describe the proposed changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, we are proposing updates and refinements to the requirements for the Hospital Outpatient Quality Reporting (OQR) Program, the ASC Quality Reporting (ASCQR) Program, and the Inpatient Rehabilitation Facility (IRF) Quality Reporting Program. We also are proposing revisions to the electronic reporting pilot for the Electronic Health Record (EHR) Incentive Program, and the various regulations governing Quality Improvement Organizations (QIOs), including the secure transmittal of electronic medical information, beneficiary complaint resolution and notification processes, and technical changes.","document_number":"2012-16813","html_url":"https://www.federalregister.gov/documents/2012/07/30/2012-16813/hospital-outpatient-prospective-and-ambulatory-surgical-center-payment-systems-and-quality-reporting","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2012-07-30/pdf/2012-16813.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2012-16813.pdf?1341605829","publication_date":"2012-07-30","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"2013 \n HCPCS code \n \n CY 2013 long descriptor \n Estimated average number of units per day \n \n Proposed \n CY 2013 SI \n \n \n Proposed \n CY 2013 APC \n \n \n \n C9367 \n Skin substitute, Endoform Dermal Template, per square centimeter \n 55 \n K \n 9367 \n \n \n J0630 \n Injection, <span class=\"match\">calcitonin salmon</span>, up to 400 units \n 1.5 \n K \n 1433 \n \n \n J2793 \n Injection, Rilonacept \n 320 \n K \n 1291 \n \n \n J7196 \n Injection, antithrombin recombinant, 50 IU \n 268 \n K \n 1332 \n \n \n J8562 \n Fludarabine phosphate, oral, 10 mg \n 1 \n K \n 1339 \n \n \n J9065 \n Injection, cladribine, per 1"},{"title":"Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment; Ambulatory Surgical Center Payment; Hospital Value-Based Purchasing Program; Physician Self-Referral; and Patient Notification Requirements in Provider Agreements","type":"Rule","abstract":"This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) for CY 2012 to implement applicable statutory requirements and changes arising from our continuing experience with this system. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the OPPS. In addition, this final rule with comment period updates the revised Medicare ambulatory surgical center (ASC) payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. In this final rule with comment period, we set forth the relative payment weights and payment amounts for services furnished in ASCs, specific HCPCS codes to which these changes apply, and other ratesetting information for the CY 2012 ASC payment system. We are revising the requirements for the Hospital Outpatient Quality Reporting (OQR) Program, adding new requirements for ASC Quality Reporting System, and making additional changes to provisions of the Hospital Inpatient Value-Based Purchasing (VBP) Program. We also are allowing eligible hospitals and CAHs participating in the Medicare Electronic Health Record (EHR) Incentive Program to meet the clinical quality measure reporting requirement of the EHR Incentive Program for payment year 2012 by participating in the 2012 Medicare EHR Incentive Program Electronic Reporting Pilot. Finally, we are making changes to the rules governing the whole hospital and rural provider exceptions to the physician self-referral prohibition for expansion of facility capacity and changes to provider agreement regulations on patient notification requirements.","document_number":"2011-28612","html_url":"https://www.federalregister.gov/documents/2011/11/30/2011-28612/medicare-and-medicaid-programs-hospital-outpatient-prospective-payment-ambulatory-surgical-center","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2011-11-30/pdf/2011-28612.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2011-28612.pdf?1320178631","publication_date":"2011-11-30","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"use estimated per day costs for these drugs and biologicals or on the resulting packaging status of these drugs and biologicals. However, upon receiving updated CY 2011 claims data for HCPCS codes J0364 (Injection, apomorphine hydrochloride, 1 mg), J0630 (Injection, <span class=\"match\">calcitonin salmon</span>, up to 400 units), and J9216 (Injection, interferon, gamma 1-b, 3 million units) for this final rule with comment period, we determined that we no longer needed to calculate an estimated average number of units for these three items because we now have sufficient data"},{"title":"Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment; Ambulatory Surgical Center Payment; Hospital Value-Based Purchasing Program; Physician Self-Referral; and Provider Agreement Regulations on Patient Notification Requirements","type":"Proposed Rule","abstract":"This proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) to implement applicable statutory requirements and changes arising from our continuing experience with this system. In this proposed rule, we describe the proposed changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the OPPS. These proposed changes would be applicable to services furnished on or after January 1, 2012. In addition, this proposed rule would update the revised Medicare ambulatory surgical center (ASC) payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. In this proposed rule, we set forth the proposed relative payment weights and payment amounts for services furnished in ASCs, specific HCPCS codes to which these proposed changes would apply, and other proposed ratesetting information for the CY 2012 ASC payment system. These proposed changes would be applicable to services furnished on or after January 1, 2012. We are proposing to revise the requirements for the Hospital Outpatient Quality Reporting (IQR) Program, add new requirements for ASC Quality Reporting System, and make additional changes to provisions of the Hospital Inpatient Value-Based Purchasing (VBP) Program. We also are proposing to allow eligible hospitals and CAHs participating in the Medicare Electronic Health Record (EHR) Incentive Program to meet the clinical quality measure reporting requirement of the EHR Incentive Program for payment year 2012 by participating in the 2012 Medicare EHR Incentive Program Electronic Reporting Pilot. In addition, we are proposing to make changes to the rules governing the whole hospital and rural provider exceptions to the physician self-referral prohibition for expansion of facility capacity and changes to provider agreement regulations on patient notification requirements.","document_number":"2011-16949","html_url":"https://www.federalregister.gov/documents/2011/07/18/2011-16949/medicare-and-medicaid-programs-hospital-outpatient-prospective-payment-ambulatory-surgical-center","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2011-07-18/pdf/2011-16949.pdf","public_inspection_pdf_url":null,"publication_date":"2011-07-18","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"Long descriptor \n Estimated average number of units per day \n Proposed CY 2012 SI \n Proposed CY 2012 APC \n \n \n J0205 \n Injection, alglucerase, per 10 units \n 420 \n K \n 0900 \n \n \n J0364 \n Injection, apomorphine hydrochloride, 1 mg \n 12 \n N \n N/A \n \n \n J0630 \n Injection, <span class=\"match\">calcitonin salmon</span>, up to 400 units \n 1.5 \n N \n N/A \n \n \n J1680 \n Injection, human fibrinogen concentrate, 100 mg \n 49 \n K \n 1290 \n \n \n J2513 \n Injection, pentastarch, 10% solution, 100 ml \n 4 \n K \n 1222 \n \n \n J2724 \n Injection, protein c concentrate, intravenous, human, 10 iu \n 1540 "},{"title":"Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2011","type":"Rule","abstract":"This final rule with comment period addresses changes to the physician fee schedule and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. It finalizes the calendar year (CY) 2010 interim relative value units (RVUs) and issues interim RVUs for new and revised procedure codes for CY 2011. It also addresses, implements, or discusses certain provisions of both the Affordable Care Act (ACA) and the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). In addition, this final rule with comment period discusses payments under the Ambulance Fee Schedule (AFS), the Ambulatory Surgical Center (ASC) payment system, and the Clinical Laboratory Fee Schedule (CLFS), payments to end-stage renal disease (ESRD) facilities, and payments for Part B drugs. Finally, this final rule with comment period also includes a discussion regarding the Chiropractic Services Demonstration program, the Competitive Bidding Program for durable medical equipment, prosthetics, orthotics, and supplies (CBP DMEPOS), and provider and supplier enrollment issues associated with air ambulances.","document_number":"2010-27969","html_url":"https://www.federalregister.gov/documents/2010/11/29/2010-27969/medicare-program-payment-policies-under-the-physician-fee-schedule-and-other-revisions-to-part-b-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2010-11-29/pdf/2010-27969.pdf","public_inspection_pdf_url":null,"publication_date":"2010-11-29","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"IMAGING SERVICES \n \n \n \n 76150 \n X-ray exam, dry process. \n \n \n 76880 \n Us exam, extremity. \n \n \n 77014 \n Ct scan for therapy guide. \n \n \n \n RADIATION THERAPY SERVICES AND SUPPLIES \n \n \n \n [No deletions]. \n \n \n \n DRUGS USED BY PATIENTS UNDERGOING DIALYSIS \n \n \n \n J0630 \n <span class=\"match\">Calcitonin salmon</span> injection. \n \n \n J0636 \n Inj calcitriol per 0.1 mcg. \n \n \n J0882 \n Darbepoetin alfa, esrd use. \n \n \n J0895 \n Deferoxamine mesylate inj. \n \n \n J1270 \n Injection, doxercalciferol. \n \n \n J1750 \n Inj iron dextran. \n \n \n J1756 \n Iron sucrose injection. \n \n \n J1955 \n Inj levocarnitine"}]}