SECTION 1. SHORT TITLE
This Act may be cited as the “Pain Patient Protection and Clinical Autonomy Act of 2025.”
SECTION 2. CONGRESSIONAL FINDINGS AND PURPOSE
(a) Findings
Congress finds the following:
- Millions of patients in the United States suffer from acute and chronic pain arising from medical conditions including cardiovascular disease, cancer, neurological injury, post-surgical recovery, and congenital disorders.
- The practice of medicine requires individualized clinical judgment based on patient-specific risk–benefit analysis, informed consent, and evidence-based standards of care.
- In response to concerns regarding misuse of prescription opioids, healthcare institutions and regulatory bodies implemented broad, categorical restrictions that, in many cases:
- Supplanted individualized medical judgment;
- Resulted in undertreatment or denial of pain care; and
- Caused foreseeable harm to patients with legitimate medical need.
- Certain policies denied or restricted pain treatment based solely on lawful conduct, including participation in state-authorized medical cannabis programs.
- Cannabis has been recognized by the federal government as having accepted medical use and therapeutic value pursuant to its rescheduling under the Controlled Substances Act.
- Public health objectives related to substance misuse must be pursued without infringing upon patient rights, medical ethics, or the integrity of clinical decision-making.
- The conflation of law enforcement priorities with medical treatment decisions has undermined patient trust and physician autonomy.
(b) Purpose
The purposes of this Act are:
- To protect patients from categorical denial of pain treatment unrelated to individualized medical necessity;
- To restore and safeguard clinical discretion in pain management;
- To prohibit discrimination against patients based on lawful medical therapies;
- To separate healthcare delivery from criminal-law enforcement functions; and
- To establish enforceable patient protections consistent with federal law.
SECTION 3. DEFINITIONS
For purposes of this Act:
- “Pain patient” means an individual experiencing acute or chronic pain arising from a diagnosed medical condition.
- “Covered healthcare entity” means any hospital, integrated delivery system, insurer, pharmacy benefit manager, or healthcare organization receiving federal funds or participating in Medicare, Medicaid, or federally regulated insurance markets.
- “Clinician” means a physician or other licensed healthcare professional authorized to prescribe controlled substances under federal and state law.
- “Individualized clinical determination” means a documented, patient-specific medical decision based on:
- Medical history;
- Contraindications;
- Available treatment alternatives; and
- A reasoned risk–benefit analysis.
- “Lawful medical cannabis use” means the use of cannabis in compliance with applicable state or federal law.
- “Categorical exclusion” means any policy or practice that denies or restricts pain treatment solely on the basis of a non-clinical factor without individualized assessment.
SECTION 4. PROHIBITION ON CATEGORICAL DENIAL OF PAIN CARE
(a) General Rule
No covered healthcare entity may deny, restrict, or condition access to pain treatment through a categorical exclusion that is not based on an individualized clinical determination.
(b) Prohibited Bases for Categorical Exclusion
A covered healthcare entity shall not deny or restrict pain treatment solely on the basis of:
- A positive test for tetrahydrocannabinol (THC);
- Participation in a lawful medical cannabis program;
- The use of a lawful, non-impairing medical therapy unrelated to the prescribed treatment;
- Institutional risk-avoidance policies that override clinician judgment without individualized review.
SECTION 5. PRESERVATION OF CLINICAL DISCRETION
(a) Affirmation of Medical Judgment
Nothing in this Act shall be construed to require a clinician to prescribe any specific medication.
(b) Protection of Discretion
A clinician shall not be disciplined, penalized, or subject to adverse action solely for prescribing opioid analgesics or other pain treatments when:
- The prescription is medically indicated;
- An individualized clinical determination is documented; and
- Applicable monitoring and safety standards are followed.
SECTION 6. PAIN PATIENT BILL OF RIGHTS
Each pain patient receiving care from a covered healthcare entity shall have the right to:
- An individualized pain assessment;
- Access to evidence-based treatment options;
- Informed consent regarding risks and alternatives;
- A written explanation for any denial or limitation of pain treatment;
- A timely internal review of adverse decisions;
- Referral for an independent second opinion where clinically appropriate;
- Continuity of care without abrupt or non-consensual discontinuation absent medical necessity.
SECTION 7. TRANSPARENCY AND REVIEW REQUIREMENTS
(a) Policy Disclosure
Covered healthcare entities shall publicly disclose pain-management policies that affect access to care.
(b) Documentation
Any denial or restriction of pain treatment shall be documented with specific clinical justification.
(c) Appeals Process
Covered entities shall establish an internal appeals process and provide access to external review mechanisms.
SECTION 8. SEPARATION OF MEDICAL CARE AND LAW ENFORCEMENT
(a) Non-Delegation
Clinical decision-making shall not be delegated to, dictated by, or conditioned upon directives from law enforcement agencies.
(b) Limitation on Enforcement Influence
No federal agency may condition funding, enforcement discretion, or regulatory approval on the adoption of categorical pain-treatment exclusions.
SECTION 9. SAFE HARBOR FOR CLINICIANS
A clinician who complies with this Act shall be deemed to be acting within the scope of professional practice for purposes of federal law, including enforcement under the Controlled Substances Act.
SECTION 10. ENFORCEMENT
(a) Administrative Enforcement
The Secretary of Health and Human Services shall promulgate regulations to enforce this Act.
(b) Private Right of Action
Any person aggrieved by a violation of this Act may bring a civil action for:
- Declaratory relief;
- Injunctive relief; and
- Reasonable attorney’s fees.
SECTION 11. PREEMPTION AND CONSTRUCTION
(a) Minimum Federal Standard
This Act establishes minimum federal protections and does not preempt state laws providing greater patient protections.
(b) Rule of Construction
Nothing in this Act shall be construed to expand criminal liability or mandate prescribing.
SECTION 12. EFFECTIVE DATE
This Act shall take effect 30 days after enactment.
