Blood Work
| Requirement | Primary source | How Blood Work meets it |
|---|---|---|
| Clinicians licensed in Texas | Tex. Occ. Code §155.001 (physicians), ch. 204 (physician assistants), §301.152 (nurse practitioners); §§157.001, 157.0512 (delegation); 22 TAC §175.1 | Every order is signed by a Texas-licensed physician, or by a nurse practitioner or physician assistant under the delegation and supervision of a Passion Health physician. Blood Work serves only people in Texas. |
| Remote ordering treated as telemedicine | Tex. Occ. Code §§111.001(4), 111.002, 111.005, 111.007; 22 TAC §175.2 | A clinician reviews each request for a patient at another location, so Blood Work treats every order as a telemedicine medical service. The relationship rests on an existing Passion Health relationship or on the clinician's review of the patient's relevant clinical records (the patient's own voice or written account of their health, the records they upload, and their medication history when they allow it), with a phone or video call with the clinician whenever the standard of care needs one. Informed consent is recorded before the order, the in-person standard of care applies, and, when the patient agrees, a report goes to the patient's outside primary care physician within 72 hours. |
| Tests only on an authorized clinician's order | 42 C.F.R. §493.1241 | Patients never order directly from the laboratory. A Passion Health clinician reviews each request and signs the lab order, which is sent electronically to CPL. |
| Blood Work is self-pay; insurance is used through a visit | 42 C.F.R. §410.32(a) (Medicare); each health plan's medical-necessity rules | Blood Work sends no claims to any health plan. A patient who wants to use insurance, Medicare or Medicaid sends an online check-up request and is seen at a check-up, in a clinic or by video. The clinician orders the tests that fit the patient's documented symptoms, conditions and risk factors and records the diagnosis that truthfully describes the patient; Passion Health bills the plan for the visit and CPL bills it for covered tests. A test that may not be covered is priced in writing before the draw, and the patient decides. A patient with a commercial plan may choose to pay Blood Work prices instead. |
| Certified laboratory | 42 U.S.C. §263a; 42 C.F.R. Part 493 (CLIA) | Samples are collected and tested by Clinical Pathology Laboratories (CPL), a CLIA-certified laboratory, at its Texas patient service centers or at Passion Health clinics. |
| Critical results reach the clinician | 42 C.F.R. §493.1291(g) | CPL alerts Passion Health right away to a result that may be life-threatening; a clinician tries to reach the patient right away, the same day whenever possible, and keeps trying. |
| Results released without delay | 45 C.F.R. Part 171 (information blocking); §171.202(e) (honoring a patient's own request) | Patients are told when results are ready and can have them as soon as they arrive, before the clinician's review; results are held only if the patient asks. Positive HIV results follow the Texas counseling rule below. |
| Patients' access to their records | 45 C.F.R. §164.524; Tex. Health & Safety Code §181.102; 42 C.F.R. §493.1291(l) | Copies of results and records on request; electronic records within 15 business days of a written request. Patients may also ask CPL directly. |
| Informed consent for HIV testing; confidentiality | Tex. Health & Safety Code §§81.103, 81.105, 81.106 | The HIV test is explained on the screen before payment, and the patient consents by ticking a separate box that is kept in the medical record; the patient can remove it before the draw. Results are confidential and released only as the statute allows. |
| Positive HIV results given with counseling | Tex. Health & Safety Code §81.109 | Positive HIV results are not posted to the portal or sent by text or email. A clinician gives the result personally with an immediate opportunity for individual, face-to-face counseling on what the result means, further testing, preventing transmission, health care and support services, and partner notification. |
| Reportable conditions | Tex. Health & Safety Code ch. 81; 25 TAC ch. 97 | CPL and Passion Health report notifiable results, such as HIV and hepatitis B and C, to public health authorities as required. Reports are confidential. |
| Confidentiality and electronic disclosure | 45 C.F.R. Parts 160 and 164; Tex. Health & Safety Code ch. 181 (§181.154); Tex. Occ. Code ch. 159 | Orders and results move through the practice's electronic health record (under its vendor's business associate agreement) and CPL's laboratory interface; CPL is itself a HIPAA covered entity. Blood Work pages use no advertising pixels or tools that share what people view with advertisers or social media. Patients are told about electronic disclosure in the consent and the Notice of Privacy Practices. |
| Privacy notice on the website and given to patients | 45 C.F.R. §164.520(c)(2), (c)(3)(i) | The practice's joint Notice of Privacy Practices is linked from every Blood Work page and shown to each patient before payment, with a box to confirm receipt; the confirmation is kept in the medical record. |
| Good Faith Estimates for self-pay patients | 45 C.F.R. §149.610 | The notice of the right to a Good Faith Estimate is on the prices page, in the cart and in the terms, and patients are told again before they pay. A written estimate is due within 3 business days of a request (asking about cost counts as a request); Blood Work sends one with every self-pay order confirmation, before the draw. |
| Billing policies, estimates, itemized statements and refunds | Tex. Occ. Code §101.352 | Written billing policies cover discounts for patients without insurance, interest and billing complaints. An estimate or an itemized statement is sent within 10 business days of a request, every charge comes with an itemized receipt, and an overpayment is refunded within 30 days of being found. |
| Self-pay restriction from health plans | 45 C.F.R. §164.522(a)(1)(vi) | Blood Work orders are paid in full by the patient. Nothing is sent to a health plan, and a request not to share the order with the plan is honored. |
| Medicare: tests ordered by the treating clinician; only the laboratory bills; Advance Beneficiary Notices | 42 C.F.R. §410.32(a); Social Security Act §1833(h)(5)(A) (42 U.S.C. §1395l(h)(5)(A)); 42 C.F.R. §411.404; form CMS-R-131 | Medicare patients' tests are ordered at a visit, not through Blood Work, by the clinician who is treating the patient and uses the results. CPL, the laboratory that performs the test, bills Medicare for covered tests; Passion Health does not. An Advance Beneficiary Notice is signed before any test Original Medicare may not cover; Medicare Advantage coverage is checked with the plan. |
| Medicaid patients not billed for covered services | 42 C.F.R. §447.15; Texas Medicaid Provider Procedures Manual (billing clients) | Medicaid patients' tests are ordered at a visit, not through Blood Work. CPL bills Medicaid for covered tests and the patient is never charged for them. A test Medicaid doesn't cover is provided only after the patient is told and signs an acknowledgment of responsibility before the draw. |
| No payment for referrals | Tex. Occ. Code §102.001; 42 U.S.C. §1320a-7b(b); 42 U.S.C. §1395nn and 42 C.F.R. §411.357(i) | Passion Health pays CPL a client rate for self-pay tests (payments by a physician to a laboratory for laboratory services are an exception to the physician self-referral law) and accepts no referral fees, rebates or other payments from CPL or any laboratory. The client rate doesn't depend on Medicare or Medicaid referrals. Patients may use any laboratory. |
| Disclosure of artificial intelligence | Tex. Health & Safety Code §183.005; Tex. Bus. & Com. Code §552.051(f) | The order screen and the consent tell every patient, before the service starts, which AI tools Passion Health uses: an AI scribe, AI that suggests tests or flags results, and an AI chat or voice assistant. The assistant tells the patient it is an AI at the start of every call or chat. A clinician reviews and approves what these tools produce before it reaches the patient, and makes every diagnosis and treatment decision. |
| Video visits | Tex. Occ. Code ch. 111 (§§111.002, 111.005, 111.007) | Visits in Blood Work + Visit and Passion Direct Online follow the same standard of care as in person, with consent first, follow-up guidance after, and records to the patient's outside primary care physician within 72 hours when the patient agrees. |
| Memberships are not insurance; recurring charges need consent | Tex. Occ. Code §§162.253, 162.256; 15 U.S.C. §8403 | Passion Direct Online is a direct primary care agreement: patients are told in writing before they join that it is not insurance. The price, billing schedule and how to cancel are shown, and express consent is recorded, before any recurring charge. |
| Medical records kept, and stored in the United States | 22 TAC §163.2; Tex. Health & Safety Code §183.002 | Orders and results are part of the Passion Health medical record, stored in the United States and kept at least seven years after the last treatment. |
| Breach notification | 45 C.F.R. §§164.400–164.414; Tex. Bus. & Com. Code §521.053 | If unsecured health information is breached, affected patients are notified without unreasonable delay and no later than 60 days after discovery, and regulators are notified as the rules require. |
| Electronic consent, records and text messages | 15 U.S.C. §7001; Tex. Bus. & Com. Code ch. 322; 47 U.S.C. §227 | Consent is given by ticking boxes on the website and is recorded with the document version, date and time. Patients agree to electronic notices and can ask for paper at no charge. Texts, and calls from an automated or AI voice assistant, go only to patients who agreed and only to the number the patient gives; STOP is honored; marketing texts need separate written consent. |
| Card data handled safely | PCI DSS v4.0.1 (card-industry standard); Tex. Bus. & Com. Code §521.052 | Patients pay on Authorize.net's secure payment page, the same way Online Care payments are made. No card number reaches Passion Health staff, phones or systems, and staff never ask for one by phone, text or email. |
| Identity without immigration questions | Section 1557 (45 C.F.R. Part 92); Title VI; Tex. Bus. & Com. Code §521.052 | A photo of a government-issued photo ID is uploaded with every Blood Work order, and CPL checks the same ID at the draw; a check-up request also needs both sides of the insurance card. An ID from any country is accepted. Immigration and citizenship status are never asked. ID copies are protected in the medical record. |
| Nondiscrimination and language assistance | 45 C.F.R. §§92.10, 92.11 | The practice's nondiscrimination notice is linked from every page, and the consent and terms carry the notice of free language assistance in English and 16 other languages, with the full notice one link away. Interpreters and auxiliary aids are free; TTY 711. |
| Accessible website | Section 504, 45 C.F.R. §84.84 (WCAG 2.1 Level AA; compliance date May 11, 2027 for recipients with 15 or more employees) | Blood Work pages are designed to meet WCAG 2.1 Level AA and tested with automated checks, and anyone who cannot use the online form because of a disability can complete it with a team member by phone at the same price. See the accessibility statement. |
| Texas Medical Board complaint notice | Tex. Occ. Code §154.051; 22 TAC §§175.2, 177.2 | The required notice appears on the terms page in English and Spanish, and a prominently displayed link to it is in the footer of every Blood Work page. |
| Truthful advertising and prices | Tex. Occ. Code §101.201 | Prices shown are the full self-pay charge, with what is included and any added fee stated beside them. Pages make no promises about results and use no testimonials, and a physician reviews them before they are published. |
| Adults only | Passion Health policy | Blood Work is for patients 18 and older; children are seen at Passion Health clinics that see children. |
This summary explains how Blood Work is designed to meet Texas and federal law, as published at statutes.capitol.texas.gov, in the Texas Administrative Code and in the Code of Federal Regulations. It is not legal advice.