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Regulatory Intelligence

Compliance Updates & Regulatory News

Auto-fed daily from GuardWell's regulatory intelligence engine — Federal Register agency feeds, OCR enforcement, CMS rules, OSHA, DEA, FDA, and more. Below: the most recent items the engine flagged as relevant to small medical practices.

September 2026

September 24, 2026CMSLive

Request for Information; Medicare Part D Reasonable and Relevant Pharmacy Contracting Standards

This request for information (RFI) solicits input from interested parties for purposes of establishing standards for reasonable and relevant pharmacy contract terms and conditions under the Medicare prescription drug benefit. Section 6223(a) of the Consolidated Appropriations Ac…

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Source: Federal Register — Department of Health and Human Services
September 23, 2026CMSLive

Patient Protection and Affordable Care Act; Temporary Moratoria on Certain Agent and Broker Registration To Participate in the Exchanges

This interim final rule with comment period (IFC) codifies the Department of Health and Human Services' (HHS) authority to impose a temporary moratorium pausing the registration of agents and brokers that do not have a current Plan Year registration with the Federally- facilitat…

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Source: Federal Register — Department of Health and Human Services
September 21, 2026HIPAALive

Data Intermediaries and Approaches To Strengthen Public Health Data Exchange

The Centers for Disease Control and Prevention (CDC) seeks broad public input on how data intermediaries can be used to support secure, scalable, standards-based public health data exchange. CDC invites public comment to inform the evaluation and to explore how data intermediari…

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Source: Federal Register — Department of Health and Human Services
September 16, 2026CMSLive

Medicare Program; Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2027

This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ…

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Source: Federal Register — Department of Health and Human Services
September 16, 2026CMSLive

Medicare Program; Public Meeting for New Revisions to the Healthcare Common Procedure Coding System (HCPCS) Level II Coding

This notice announces the second biannual Healthcare Common Procedure Coding System (HCPCS) Level II public meeting of 2026 to discuss the CMS preliminary coding, Medicare benefit category, and Medicare payment determinations, if applicable, for new revisions to the HCPCS Level…

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Source: Federal Register — Department of Health and Human Services
September 11, 2026ALLERGYLive

Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information; Aminobenzoic Acid (PABA) and Trolamine Salicylate

The Food and Drug Administration (FDA or Agency) is announcing the availability on its website of the final administrative order (final order) (OTC000008-1) titled "Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Info…

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Source: Federal Register — Department of Health and Human Services
September 10, 2026CLIALive

Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Anti-Tumor Necrosis Factor Alpha Monoclonal Antibody Test System for Inflammatory Bowel Disease

The Food and Drug Administration (FDA) is classifying the anti-tumor necrosis factor alpha monoclonal antibody test system for inflammatory bowel disease into class II (special controls). The special controls that apply to the device type are identified in this order and will be…

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Source: Federal Register — Department of Health and Human Services
September 3, 2026DEALive

Determination That PHENAPHEN WITH CODEINE NO. 3 (Acetaminophen; Codeine Phosphate) Oral Capsules, 325 Milligrams and 30 Milligrams, and PHENAPHEN WITH CODEINE NO. 4 (Acetaminophen; Codeine Phosphate) Oral Capsules, 325 Milligrams and 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA or Agency) has determined that PHENAPHEN WITH CODEINE NO. 3 (acetaminophen; codeine phosphate) oral capsules, 325 milligrams (mg) and 30 mg, and PHENAPHEN WITH CODEINE NO. 4 (acetaminophen; codeine phosphate) oral capsules, 325 mg and 60 mg,…

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Source: Federal Register — Department of Health and Human Services

August 2026

August 27, 2026DEALive

Schedules of Controlled Substances: Placement of Cipepofol in Schedule IV

On May 29, 2026, the United States Food and Drug Administration (FDA) approved a new drug application for Cypsedo (cipepofol) for induction of general anesthesia in adults undergoing surgery. The Department of Health and Human Services provided the Drug Enforcement Administratio…

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Source: Federal Register — Drug Enforcement Administration
August 26, 2026DEALive

Schedules of Controlled Substances: Temporary Placement of Mitragynine Pseudoindoxyl, MGM-15, and MGM-16 in Schedule I

The Drug Enforcement Administration (DEA) is issuing this temporary order to schedule three 7-hydroxymitragynine-related substances (mitragynine pseudoindoxyl, MGM-15, and MGM-16), including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever…

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Source: Federal Register — Drug Enforcement Administration
August 21, 2026OSHALive

Cadmium in General Industry Standard; Extension of the Office of Management and Budget's (OMB) Approval of Information Collection (Paperwork) Requirements

OSHA solicits public comments concerning the proposal to extend Office of Management and Budget's (OMB) approval of the information collection requirements specified in the Cadmium in General Industry Standard.

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Source: Federal Register — Occupational Safety and Health Administration
August 13, 2026CMSMACRALive

Medicare Program; Alternative Payment Model (APM) Incentive Payment Advisory for Clinicians-Request for Current Billing Information for Qualifying APM Participants

This advisory is to alert certain clinicians who are Qualifying Alternative Payment Model (APM) participants (QPs) and eligible to receive an APM Incentive Payment that the Centers for Medicare & Medicaid Services (CMS) does not have the current billing information needed to dis…

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Source: Federal Register — Centers for Medicare and Medicaid Services
August 13, 2026CMSHIPAAOIGLive

Medicaid Program; Prohibition on Federal Medicaid and Children's Health Insurance Program Funding for Sex-Rejecting Procedures Furnished to Children

This final rule requires that a State Medicaid plan must provide that the Medicaid agency will not make payment under the plan for sex-rejecting procedures for children under 18, and prohibits the use of Federal Medicaid dollars to fund sex-rejecting procedures for individuals u…

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Source: Federal Register — Centers for Medicare and Medicaid Services
August 11, 2026CMSLive

Medicare Program; Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway

This notice with comment period provides information to the public on the process CMS will use to provide accelerated Medicare coverage through the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway for new innovative technologies. The RAPID cover…

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Source: Federal Register — Centers for Medicare and Medicaid Services

July 2026

July 31, 2026CMSLive

Medicare Program; FY 2027 Inpatient Psychiatric Facilities Prospective Payment System-Rate Update

This final rule updates the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPFs), which include psychiatric hospitals and excluded psychiatric units of an acute care hosp…

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Source: Federal Register — Centers for Medicare and Medicaid Services
July 31, 2026CMSLive

Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program for Federal Fiscal Year 2027

This final rule finalizes changes and updates to the policies and payment rates used under the Skilled Nursing Facility (SNF) Prospective Payment System (PPS) for fiscal year (FY) 2027. This final rule also updates the requirements for the SNF Quality Reporting Program and the S…

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Source: Federal Register — Centers for Medicare and Medicaid Services
July 28, 2026OSHALive

Benzene

OSHA is providing an additional comment period to allow interested persons to comment on OSHA's proposal to revise the Benzene standard. Following consideration of the rulemaking by OSHA's Advisory Committee on Construction Safety and Health (ACCSH), OSHA is re-opening the recor…

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Source: Federal Register — Occupational Safety and Health Administration
July 22, 2026OSHALive

Formaldehyde

OSHA is providing an additional comment period to allow interested people to comment on OSHA's proposal to revise the Formaldehyde standard. Following consideration of the rulemaking by OSHA's Advisory Committee on Construction Safety and Health (ACCSH), OSHA is re-opening the r…

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Source: Federal Register — Occupational Safety and Health Administration
July 22, 2026OSHALive

Vinyl Chloride

OSHA is providing an additional comment period to allow interested people to comment on OSHA's proposal to revise the Vinyl Chloride standard. Following consideration of the rulemaking by OSHA's Advisory Committee on Construction Safety and Health (ACCSH), OSHA is re-opening the…

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Source: Federal Register — Occupational Safety and Health Administration
July 22, 2026OSHALive

Methylenedianiline

OSHA is providing an additional comment period to allow interested people to comment on OSHA's proposal to revise the Methylenedianiline standards. Following consideration of the rulemaking by OSHA's Advisory Committee on Construction Safety and Health (ACCSH), OSHA is re-openin…

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Source: Federal Register — Occupational Safety and Health Administration

February 2026

February 16, 2026HIPAA

42 CFR Part 2 Aligns with HIPAA — Substance Use Disorder Records

The final rule aligning 42 CFR Part 2 with HIPAA took effect February 16, 2026. Substance use disorder (SUD) treatment records can now be disclosed under the same framework as other protected health information, reducing the separate-consent burden for providers while maintaining patient protections against use in legal proceedings.

What this means for your practice

Practices that handle SUD records should update their Notice of Privacy Practices and train staff on the streamlined disclosure rules.

Source: SAMHSA / HHS

November 2025

November 1, 2025CMS

CMS Finalizes 2026 MIPS Performance Thresholds and MVPs

CMS released the 2026 Medicare Physician Fee Schedule final rule with updated MIPS performance thresholds. The performance threshold increased to 82 points (from 75), and additional MIPS Value Pathways (MVPs) are now available for specialty-focused reporting.

What this means for your practice

Review your MIPS reporting strategy, especially if you use traditional MIPS. Consider transitioning to an MVP that aligns with your specialty.

Source: Centers for Medicare & Medicaid Services

January 2025

January 15, 2025OIG

OIG Releases 2025 Work Plan: Healthcare Fraud Priorities

The HHS Office of Inspector General published its 2025 Work Plan highlighting enforcement priorities for healthcare providers — telehealth billing oversight, Medicare Advantage risk adjustment audits, opioid prescribing patterns, and laboratory test utilization reviews.

What this means for your practice

Review your billing practices for telehealth services and ensure documentation supports medical necessity. Audit high-risk CPT codes flagged in the plan.

Source: HHS Office of Inspector General
January 6, 2025HIPAA

HHS Proposes Major HIPAA Security Rule Overhaul

HHS published a Notice of Proposed Rulemaking to modernize the HIPAA Security Rule for the first time since 2013. Key proposals include mandatory encryption of ePHI at rest and in transit, required multi-factor authentication, annual compliance audits, and more prescriptive technical safeguard standards. The comment period has closed and a final rule is anticipated in 2026.

What this means for your practice

Start preparing now: assess current encryption practices, evaluate MFA readiness, and review your Security Risk Analysis process.

Source: HHS Office for Civil Rights

June 2024

June 25, 2024HIPAA

HIPAA Privacy Rule Update: Reproductive Health Information Protections

The final rule adding protections for reproductive health information under HIPAA took effect June 25, 2024. Covered entities and business associates are now prohibited from disclosing PHI related to lawful reproductive healthcare for non-healthcare purposes such as investigations or legal proceedings in states where the care was legally provided.

What this means for your practice

Update your Notice of Privacy Practices to reflect new reproductive health attestation requirements and train staff on permissible disclosures.

Source: HHS Office for Civil Rights

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