Proposed Rule 16 Jul 2025 healthcare, regulation, administrative practice and procedure, reporting and recordkeeping requirements, medicare, intergovernmental relations, penalties, health professions, health care, health facilities, rural areas, medicaid, laboratories, privacy, health records, health insurance, medical devices, diseases, drugs, biologics, prescription drugs, reimbursement, health maintenance organizations (hmo), x-rays, emergency medical services, physician fee schedule, payment policies

💰Proposed Medicare and Medicaid Payment Policies for CY 2026

This major proposed rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; codification of establishment of new policies for: the Medicare Prescription Drug Inflation Rebate Program under the Inflation Reduction Act of 2022; the Ambulatory Specialty Model; updates to the Medicare Diabetes Prevention Program expanded model; updates to drugs and biological products paid under Part B; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; updates to policies for Rural Health Clinics and Federally Qualified Health Centers update to the Ambulance Fee Schedule regulations; codification of the Inflation Reduction Act and Consolidated Appropriations Act, 2023 provisions; updates to the Medicare Promoting Interoperability Program.

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Rule 15 Jul 2025 regulatory compliance, fda, manufacturing, medical devices, food industry, cosmetics, color additives, drugs, foods

🍏FDA Approves Gardenia (Genipin) Blue Color Additive for Foods

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of gardenia (genipin) blue in various foods, at levels consistent with good manufacturing practice (GMP). We are taking this action in response to a color additive petition (CAP) submitted by Exponent, Inc., on behalf of the Gardenia Blue Interest Group (GBIG).

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Proposed Rule 2 Jul 2025 administrative practice and procedure, reporting and recordkeeping requirements, medicare, health professions, health facilities, investigations, rural areas, medicaid, fraud, healthcare compliance, medical devices, grant programs-health, diseases, drugs, biologics, payment rates, quality reporting, x-rays, home health, emergency medical services, durable medical equipment

🏥Medicare and Medicaid Proposed Rule on Home Health Payment Updates

This proposed rule would set forth routine updates to the Medicare home health payment rates in accordance with existing statutory and regulatory requirements. In addition, this proposed rule proposes permanent and temporary behavior adjustments and proposes to recalibrate the case-mix weights and update the functional impairment levels; comorbidity subgroups; and low-utilization payment adjustment (LUPA) thresholds for CY 2026. Lastly, this proposed rule proposes policy changes to the face-to-face encounter policy. It also proposes changes to the Home Health Quality Reporting Program (HH QRP) and the expanded Health Value-Based Purchasing (HHVBP) Model requirements. In addition, it would update the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP). Lastly it proposes: a technical change to the HH conditions of participation; updates to DMEPOS supplier conditions of payment; updates to provider and supplier enrollment requirements; and changes to DMEPOS accreditation requirements.

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Rule 29 May 2025 compliance, food safety, fda regulations, medical devices, cosmetics, color additives, drugs, foods, myoglobin, food processing

🍖FDA Confirms Myoglobin Color Additive Regulations for 2025

The Food and Drug Administration (FDA or we) is confirming the effective date of February 19, 2025, for the final order that appeared in the Federal Register of January 17, 2025. The final order amends the color additive regulations to provide for the safe use of myoglobin as a color additive in ground meat and ground poultry analogue products.

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Rule 12 May 2025 manufacturing, food safety, fda regulations, medical devices, cosmetics, color additives, drugs, foods, butterfly pea flower extract

🌸FDA Expands Use of Butterfly Pea Flower Extract as Food Color Additive

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded safe use of butterfly pea flower extract as a color additive in ready-to-eat cereals, crackers, snack mixes, hard pretzels, plain potato chips (restructured or baked), and plain corn chips, tortilla chips, and multigrain chips at levels consistent with good manufacturing practice (GMP). This action is in response to a color additive petition (CAP) submitted by Sensient Colors, LLC (Sensient or petitioner).

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Rule 12 May 2025 compliance, fda, medical devices, cosmetics, color additives, drugs, foods, food regulation, calcium phosphate

🍗FDA Approves Calcium Phosphate as Safe Color Additive

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of calcium phosphate as a color additive in ready-to-eat chicken products, white candy melts, doughnut sugar, and sugar for coated candies. This action is in response to a color additive petition (CAP) filed by Innophos, Inc. (Innophos or petitioner).

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Rule 12 May 2025 compliance, regulation, fda, food, medical devices, cosmetics, color additives, drugs, foods, custody

🍉Galdieria Extract Blue Approved as Food Color Additive by FDA

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of galdieria extract blue, derived from unicellular red algae (Galdieria sulphuraria), in various food categories at levels consistent with good manufacturing practice (GMP). We are taking this action in response to a color additive petition (CAP) submitted by Fermentalg (Fermentalg or petitioner).

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Notice 11 Mar 2025 trade, automotive industry, homeland security, tariffs, canada, executive orders, border protection, customs, drugs

📦Amendment to Import Duties on Canadian Products Effective March 2025

In order to effectuate the President's Executive Order 14193, "Imposing Duties to Address the Flow of Illicit Drugs Across Our Northern Border," as amended by Executive Order 14197, "Progress on the Situation at Our Northern Border", and subsequently amended by Executive Order 14226, "Amendment to Duties to Address the Flow of Illicit Drugs Across Our Northern Border", which imposed specified rates of duty on imports of articles that are products of Canada, and further amended by the President's March 6, 2025 Executive order "Amendment to Duties to Address the Flow of Illicit Drugs Across Our Northern Border," the Secretary of Homeland Security has determined that appropriate action is needed to modify the Harmonized Tariff Schedule of the United States (HTSUS) as set out in the Annex to this notice.

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Compliance, Industry Regulation 17 Jan 2025 compliance, fda regulations, medical devices, food additives, cosmetics, color additives, drugs, meat alternatives, foods, myoglobin

🥩FDA Regulation on Myoglobin as Color Additive for Meat Alternatives

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of myoglobin as a color additive in ground meat and ground poultry analogue products. We are taking this action in response to a color additive petition (CAP) submitted by Motif FoodWorks, Inc. (Motif FoodWorks or petitioner).

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Compliance, Regulatory 16 Jan 2025 regulatory compliance, pharmaceuticals, fda, food safety, cosmetics, color additives, drugs

🚫FDA Revokes FD&C Red No. 3 for Food and Ingested Drugs

The Food and Drug Administration (FDA or we) is granting a color additive petition submitted by Center for Science in the Public Interest, et al., by repealing the color additive regulations that permit the use of FD&C Red No. 3 in foods (including dietary supplements) and in ingested drugs. The petitioners provided data demonstrating that this additive induces cancer in male rats. Therefore, FDA is revoking the authorized uses in food and ingested drugs of FD&C Red No. 3 in the color additive regulations.

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