The HCMC Resources page is a living reference library. Content changes as regulations, guidance, and research are updated. A printed copy may be out of date within days.
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HCMC RESOURCES
A curated library of regulatory authority, policy updates, and peer-reviewed publications relevant to medical device and biologics distribution, wound care, and advanced tissue therapeutics. Reviewed periodically as policy and literature evolve.
This page links to publicly available government, regulatory, industry-association, and peer-reviewed sources. HCMC is not the author or publisher of any linked material, is not affiliated with or endorsed by any government agency or third-party organization, and makes no representation that linked information is current, complete, accurate, or applicable to any specific clinical, reimbursement, or business situation.
This page is not legal, clinical, reimbursement, or insurance advice. Consult your own qualified counsel, treating clinician, payer, and insurance carrier for guidance specific to your circumstances. You are responsible for verifying you are accessing the current version of any information before relying on it — external content can change without notice.
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Comprehensive regulatory framework for medical devices, including 510(k), PMA, and De Novo pathways, classification, labeling, and post-market obligations.
The FDA regulation governing Human Cells, Tissues, and Cellular & Tissue-Based Products — the framework underlying 361 HCT/P registration vs. 351 biologic classification.
Office of Inspector General guidance on Anti-Kickback Statute (AKS) safe harbors, Stark Law physician self-referral rules, and fraud-and-abuse enforcement priorities for the medical-device industry.
Required elements for every commercial email: accurate sender identity, clear opt-out mechanism, physical postal address, honored unsubscribe requests within 10 business days.
The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and Security Rule — applies when handling Protected Health Information (PHI). Business Associate Agreement (BAA) requirements included.
National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and coverage articles — the authoritative source for Medicare Part B coverage of devices, biologics, and clinical procedures.
Physician Fee Schedule (MPFS), Ambulatory Surgical Center (ASC) payment system, Hospital Outpatient Prospective Payment System (OPPS), and DMEPOS fee schedules — including annual updates and coding changes. HCMC does not publish, endorse, or guarantee any fee-schedule figure; verify directly with CMS and your payer.
Healthcare Common Procedure Coding System — quarterly HCPCS updates governing how devices, biologics, and supplies are billed to Medicare and most other payers.
The CY 2026 Hospital Outpatient Prospective Payment System (OPPS) Final Rule and its implementation of a flat per-square-centimeter payment for Cellular and Tissue-based Products (CTPs) — a material reimbursement change for wound care distributors.
The National Library of Medicine's bibliographic database of biomedical literature — the primary index for peer-reviewed publications cited in any HCMC product or clinical content.
NIH registry and results database of publicly and privately supported clinical studies — the source to verify a trial's status, eligibility, endpoints, and investigators when reviewing claims based on registered research.
FDA's publicly available guidance for industry — searchable by product area, document type (draft/final), and date. The authoritative source for FDA's current thinking on regulatory interpretation and expectations.
Preprint servers for life-science and health-science research. Valuable for tracking emerging science, but preprints are not peer-reviewed — verify publication in a peer-reviewed journal before relying on findings.
The federal authority on research misconduct for HHS-funded work. Publishes findings on individual researchers, administrative actions, and debarment notices. Authoritative for any citation tied to NIH-funded research.
NIH/NLM's authoritative index of papers officially tagged as retracted. Direct lookup to verify a cited article has not been withdrawn. Use this first for any evidence check; federal sources carry more weight than private databases.
Public archive of FDA enforcement correspondence. Searchable by product, company, and area. Useful for confirming whether a manufacturer, product, or claim has been the subject of prior enforcement action — a critical check before citing competitor evidence.
The Committee on Publication Ethics (COPE) and Retraction Watch database — independent, non-profit sources tracking retractions and publishing-integrity concerns. Used alongside federal sources because they cover investigations in progress and non-HHS-funded work that the federal system does not reach.
The voluntary industry code governing medical-device company interactions with U.S. healthcare professionals — gifts, meals, research grants, speaker payments, consulting arrangements. Adherence is industry-standard.
The CMS National Plan and Provider Enumeration System — public lookup for any U.S. healthcare provider's National Provider Identifier, taxonomy, and practice location. Useful for verification before outreach or contracts.
The Department of Veterans Affairs Federal Supply Schedule program — the primary procurement pathway for medical devices, biologics, and pharmacy products purchased by VA Medical Centers and other federal healthcare facilities.
The Joint Trauma System and Committee on Tactical Combat Casualty Care portal — current TCCC guidelines, clinical practice guidelines, and deployed-medicine education. The authoritative source for combat-medicine doctrine.