SURVEY OF STATE SALES AND MARKETING COMPLIANCE REQUIREMENTS

SURVEY OF STATE SALES AND MARKETING COMPLIANCE REQUIREMENTS
12-STATE ANALYSIS
Prepared for Solstice Biomedical Devices Ltd. and Solstice Biomedical Inc.
PRIVILEGED & CONFIDENTIAL — ATTORNEY-CLIENT COMMUNICATION / ATTORNEY WORK PRODUCT This memorandum is a privileged and confidential attorney-client communication and constitutes attorney work product prepared in anticipation of litigation or for the purpose of providing legal advice. This memorandum should not be disclosed to any third party without the prior written consent of Calderwood & Harkness LLP.
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I. Executive Summary
A. Purpose
This memorandum presents a comprehensive survey of state-level sales and marketing compliance laws applicable to Solstice Biomedical Inc. ("SBI"), a Delaware corporation (EIN 93-4718206), with principal offices located at 200 Harborview Drive, Suite 1100, Boston, Massachusetts 02210, in connection with the planned United States commercial launch of the Pulsar™ Cardiac Rhythm Management System (the "Pulsar™ CRM System" or the "Product") on October 1, 2024. SBI is a wholly owned subsidiary of Solstice Biomedical Devices Ltd. ("SBD" or the "Parent"), an Irish limited company headquartered in Dublin, Ireland.
The purpose of this survey is to identify, analyze, and catalog affirmative compliance obligations arising under state law that SBI must satisfy in order to lawfully conduct sales and marketing activities throughout the United States. This survey is intended to serve as a practical compliance guide for SBI's US management team and the Parent's global compliance function, and to facilitate the development of state-specific compliance protocols in advance of the October 1, 2024 commercial launch date.
B. Scope of Survey
This survey analyzes twelve (12) jurisdictions identified as having specific medical device or pharmaceutical marketing compliance statutes, regulations, or disclosure requirements that may apply to SBI's US commercial activities. The jurisdictions surveyed are:
1.  California
2.  Colorado
3.  Connecticut
4.  Louisiana
5.  Maine
6.  Massachusetts
7.  Minnesota
8.  Nevada
9.  New Jersey
10.  Oregon
11.  Vermont
12.  Washington, D.C. (treated as a state-equivalent jurisdiction)
These jurisdictions were selected based on a comprehensive review of the US legislative landscape as of the second quarter of 2024, with a focus on states that impose affirmative obligations — including registration, reporting, code adoption, and gift restrictions — on medical device manufacturers or, more broadly, on manufacturers of healthcare products. This survey does not constitute a fifty-state analysis, and SBI should be aware that additional jurisdictions may enact or have enacted provisions of potential applicability that fall outside the scope of this survey.
C. Product Context
The Pulsar™ CRM System is a subcutaneous implantable cardiac monitor with an integrated cloud-based remote telemetry platform. The system consists of two primary components: (i) the Pulsar™ implantable cardiac monitor (the "Monitor"), and (ii) the Pulsar™ remote telemetry transmitter (the "Transmitter"). The Monitor is implanted subcutaneously by a qualified physician and continuously records cardiac rhythm data, which is transmitted via the Transmitter to a secure cloud-based platform accessible by the patient's healthcare team.
The Pulsar™ CRM System received FDA 510(k) clearance on February 9, 2024, under clearance number K232847. The system is classified as a Class II medical device under FDA product code MHX. The US list prices for the system components are as follows:
•  Implantable Monitor: $4,950 per unit (wholesale acquisition cost)
•  Remote Telemetry Transmitter: $1,200 per unit (wholesale acquisition cost)
SBI projects Year-1 US revenue of approximately $26 million from the Pulsar™ CRM System, comprising sales of both the Monitor and Transmitter components along with associated service and support revenues.
D. Key Findings Overview
The survey has identified the following key findings, each of which is discussed in detail in the state-by-state analysis presented in Section III and the cross-jurisdictional compliance matrix presented in Section IV:
Registration and Pre-Launch Requirements. Three jurisdictions require manufacturer registration, fee payment, or similar affirmative action prior to the commencement of commercial marketing activities:
•  Vermont requires annual manufacturer registration with the Vermont Attorney General's Office and payment of an annual registration fee of $500. Registration must be completed prior to commencing commercial marketing activities in Vermont and therefore must be filed in advance of the October 1, 2024 launch.
•  Massachusetts requires annual registration with the Massachusetts Department of Public Health and payment of an annual fee of $2,000, plus an annual attestation of adoption of either the PhRMA Code on Interactions with Healthcare Professionals or the AdvaMed Code of Ethics. Registration and attestation must be completed prior to commencing commercial marketing activities in Massachusetts.
•  Minnesota requires annual reporting of marketing expenditures directed at Minnesota healthcare professionals. While Minnesota does not impose a pre-launch registration fee, SBI must establish reporting processes in advance of the launch to ensure timely compliance with annual reporting deadlines.
California Fair Pricing Act Disclosure. The Pulsar™ implantable monitor has a wholesale acquisition cost ("WAC") of $4,950, which exceeds the $2,500 threshold that triggers disclosure requirements under the California Fair Pricing Act (Health & Safety Code § 127685 et seq.). SBI must complete the required disclosure filing with the relevant California state agency prior to or contemporaneous with the commercial launch. The Transmitter's WAC of $1,200 does not independently trigger disclosure.
Aggregate Spend Reporting and Gift Bans. Multiple jurisdictions impose aggregate spend reporting requirements, gift bans, and marketing code adoption requirements of varying scope and stringency. The survey identifies the specific obligations in each jurisdiction and assesses their applicability to SBI as a medical device manufacturer. Vermont and Massachusetts impose the most stringent gift ban provisions among the surveyed jurisdictions.
Applicability Determinations. A critical threshold issue in each jurisdiction is whether the state's marketing compliance statutes apply to medical device manufacturers, pharmaceutical manufacturers only, or some broader category of healthcare product manufacturers. Several of the surveyed jurisdictions' statutes were enacted primarily targeting pharmaceutical manufacturers, and the applicability of those statutes to medical device companies is in some cases ambiguous. The survey provides an applicability determination for each jurisdiction, distinguishing between statutes that definitively apply to medical device manufacturers, those that likely apply, and those that do not apply or are of uncertain applicability.
E. Distribution Context
SBI has entered into an exclusive US distribution agreement with Ascendant Distribution Solutions LLC ("ADS") (ADS Distribution Agreement Ref. SBD-ADS-2024-0315, dated March 15, 2024). Under the terms of the ADS Distribution Agreement, ADS serves as SBI's exclusive distributor for the Pulsar™ CRM System throughout the United States, with the right to engage up to five (5) authorized sub-distributors. State-level compliance obligations applicable to SBI may flow through to ADS and its authorized sub-distributors, and this survey addresses distributor compliance implications in Section V.
F. Relationship to Federal Compliance
This state-level survey is intended to complement, not replace, the separate analyses of federal compliance requirements that have been or are being prepared by this firm for SBI, including analyses of the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the federal False Claims Act (31 U.S.C. §§ 3729–3733), the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), and FDA promotional compliance requirements. Where state requirements are identified that exceed federal standards in scope or stringency, this survey identifies the more stringent state standard and recommends that SBI adopt compliance protocols that satisfy both federal and state requirements.
II. Methodology and Legal Framework
A. Scope and Approach
The twelve jurisdictions analyzed in this survey were selected based on a systematic review of the US legislative landscape as of the second quarter of 2024. The selection process focused on identifying jurisdictions that impose affirmative obligations on medical device manufacturers — or, more broadly, on manufacturers of healthcare products — in the areas of registration, reporting, code adoption, gift restrictions, and promotional conduct. Jurisdictions were identified through a combination of primary statutory research, review of secondary sources including the Health Industry Group Purchasing Association (HIGPA) and AdvaMed regulatory affairs guidance, review of state attorney general publications and enforcement actions, and consultation with Calderwood & Harkness's network of state regulatory contacts.
Each of the twelve jurisdictions was analyzed across eight (8) dimensions:
1.  Applicability to Medical Device Manufacturers: Whether the jurisdiction's marketing compliance statutes apply to medical device manufacturers, pharmaceutical manufacturers only, or a broader category of healthcare product manufacturers.
2.  Registration or Licensure Requirements: Whether the jurisdiction requires manufacturers to register or obtain licensure before engaging in commercial marketing activities within the jurisdiction.
3.  Fee Payment Obligations: Whether the jurisdiction requires payment of registration fees, annual renewal fees, or other monetary obligations as a condition of engaging in commercial marketing activities.
4.  Aggregate Spend or Transfer-of-Value Reporting: Whether the jurisdiction requires periodic reporting of expenditures made by manufacturers to healthcare professionals, including consulting fees, speaker honoraria, meals, travel, gifts, and other transfers of value.
5.  Gift Bans or Limitations: Whether the jurisdiction prohibits or restricts gifts, entertainment, meals, or other transfers of value from manufacturers to healthcare professionals, and the nature and scope of any applicable restrictions and exceptions.
6.  Marketing Code Adoption or Certification: Whether the jurisdiction requires manufacturers to adopt and certify compliance with an industry-recognized marketing code of conduct, such as the PhRMA Code on Interactions with Healthcare Professionals or the AdvaMed Code of Ethics.
7.  Promotional Restrictions Specific to the Jurisdiction: Whether the jurisdiction imposes restrictions on promotional activities beyond those applicable under federal law, including restrictions on specific types of promotional claims, detailing practices, or use of particular marketing channels.
8.  Enforcement Mechanisms and Penalties: The enforcement mechanisms available to state regulators and the nature and magnitude of penalties for non-compliance.
For each jurisdiction, the analysis includes a compliance action checklist that identifies the specific actions SBI must take to comply with the jurisdiction's requirements, the responsible parties for each action, and the recommended deadlines for completion.
B. Federal Baseline
The state-level requirements analyzed in this survey operate against the backdrop of a well-established federal regulatory framework governing manufacturer interactions with healthcare professionals. The principal federal requirements forming this baseline are summarized below.
Physician Payments Sunshine Act. The federal Physician Payments Sunshine Act, codified at 42 U.S.C. § 1320a-7h and implemented through CMS regulations at 42 C.F.R. Part 403, Subpart I, requires applicable manufacturers of drugs, devices, biologics, and medical supplies covered under Medicare, Medicaid, or the Children's Health Insurance Program to report to CMS all payments or other transfers of value made to covered recipients (physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, anesthesiologist assistants, and certified nurse midwives) and to teaching hospitals. CMS publishes this data annually on its Open Payments platform. For calendar year 2024, the applicable reporting thresholds are $12.49 per individual payment or transfer of value, or $100 in the aggregate per covered recipient per calendar year.
SBI submitted its CMS Manufacturer ID application in June 2024 and anticipates receiving its manufacturer identification number in advance of the October 1, 2024 launch date. Based on SBI's commercial launch plan and projected marketing activities, the estimated Year-1 reportable transfers of value under the Sunshine Act total approximately $650,000, comprising consulting fees, speaker honoraria, meals and beverages, travel and lodging, educational grants, and other categories of reportable payments. Calendar year 2024 data (October through December) is due to CMS by March 31, 2025; full calendar year 2025 data will be due by March 31, 2026.
AdvaMed Code of Ethics. SBI has adopted the AdvaMed Code of Ethics on Interactions with Health Care Professionals (2020 Revision) (the "AdvaMed Code") as its baseline voluntary code of conduct governing interactions with healthcare professionals in the United States. The AdvaMed Code establishes standards for consulting arrangements, speaker programs, educational grants, product training, meals and hospitality, gifts, and other interactions. Under the AdvaMed Code, SBI has established a per-person meal and hospitality cap of $150 per attendee per event, which is consistent with current industry practice and, as discussed below, meets or exceeds the most restrictive state-level meal limitations identified in this survey.
OIG Compliance Program Guidance. SBI's US compliance program is being developed with reference to the OIG's General Compliance Program Guidance issued in November 2023, as well as the OIG's earlier Compliance Program Guidance for Pharmaceutical Manufacturers issued in April 2003, which has been adapted by SBI for application to the medical device context. These guidance documents inform the structure and content of SBI's compliance program, including the establishment of compliance policies, training programs, internal monitoring and auditing protocols, and mechanisms for reporting and investigating compliance concerns.
Federal Anti-Kickback Statute. The federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b), prohibits the knowing and willful offer, payment, solicitation, or receipt of remuneration to induce or reward referrals of items or services payable by federal healthcare programs. The statute and its implementing safe harbor regulations (42 C.F.R. § 1001.952) are addressed in a separate memorandum and are referenced in this survey only where state-level anti-kickback or marketing compliance provisions impose additional or differing requirements.
C. Applicability Considerations for Medical Devices vs. Pharmaceuticals
A recurring threshold issue in the state-by-state analysis is the applicability of state marketing compliance statutes to medical device manufacturers. Many of the state statutes analyzed in this survey were enacted during the period from approximately 2002 to 2012, at a time when legislative attention was focused primarily on pharmaceutical industry marketing practices. As a result, several of these statutes are drafted in terms that refer specifically to "pharmaceutical manufacturers," "drug manufacturers," or "manufacturers of prescription drugs," and do not expressly reference medical device manufacturers.
In analyzing each jurisdiction, this survey considers the following factors in determining whether a statute applies to SBI:
•  The statutory definition of "manufacturer" or "applicable manufacturer" and whether it includes, excludes, or is ambiguous with respect to medical device companies.
•  The statutory definition of the products covered (e.g., "prescription drugs," "pharmaceutical products," "prescribed products," "medical products," "healthcare products") and whether medical devices fall within the definition.
•  Regulatory interpretations, guidance documents, or advisory opinions issued by the jurisdiction's enforcement agencies addressing the statute's applicability to medical device manufacturers.
•  Enforcement history, including any enforcement actions brought against medical device manufacturers under the statute.
•  The overall statutory scheme and legislative intent, including whether the statute was enacted as part of a broader healthcare reform initiative that may be construed to encompass medical devices.
SBI's position as a cardiac rhythm management device manufacturer — marketing a Class II device cleared under the FDA's 510(k) pathway — is considered in each jurisdictional analysis. The Pulsar™ CRM System requires physician implantation and is prescribed or ordered by a licensed healthcare professional, which may bring it within the scope of statutes that apply to "prescribed products" or "products requiring a prescription or order."
Where a statute is determined not to apply definitively to medical device manufacturers, this survey nevertheless identifies precautionary compliance measures that SBI may wish to adopt and recommends ongoing monitoring of legislative and regulatory developments that could extend the statute's coverage to device manufacturers.
III. State-by-State Analysis
A. California
1. Applicable Statutes and Regulations
The following California statutes and regulations are relevant to SBI's marketing compliance obligations in connection with the Pulsar™ CRM System:
•  California Health & Safety Code §§ 119400–119402 — Comprehensive Compliance Program Requirements for pharmaceutical companies, requiring adoption of a compliance program consistent with industry codes of conduct and Office of Inspector General guidance.
•  California Fair Pricing Act, Health & Safety Code § 127685 et seq. — Requires manufacturers of prescription drugs and medical devices to provide specified disclosures to the Office of Statewide Health Planning and Development (OSHPD) and its successor agency, the Department of Health Care Access and Information (HCAI), regarding wholesale acquisition costs, price increases, and related information for products whose WAC exceeds specified thresholds.
•  California Business and Professions Code §§ 17200, 17500 — Unfair Competition Law and False Advertising Law, which prohibit unlawful, unfair, or fraudulent business acts or practices, and false or misleading advertising, respectively. These provisions apply broadly to all businesses operating in California, including medical device manufacturers.
2. Applicability to Medical Device Manufacturers
California Health & Safety Code § 119400 applies by its terms to "pharmaceutical companies," defined to include entities engaged in the production, preparation, propagation, compounding, conversion, or processing of prescription drugs. The statute does not expressly include medical device manufacturers within its scope. However, the California Legislature has on multiple occasions signaled an interest in extending healthcare transparency requirements to the medical device sector, and regulatory guidance from the California Department of Justice has suggested that medical device companies operating in California should, as a matter of best practice, implement compliance programs consistent with the standards set forth in § 119402.
The California Fair Pricing Act, by contrast, applies explicitly to medical devices. Health & Safety Code § 127685.1 defines "health care product" to include prescription drugs and medical devices with a wholesale acquisition cost exceeding specified thresholds. The Pulsar™ implantable monitor, with a WAC of $4,950, clearly falls within the scope of the Fair Pricing Act. The Transmitter, with a WAC of $1,200, does not independently trigger the Act's disclosure requirements.
California Business and Professions Code §§ 17200 and 17500 apply broadly to all businesses engaged in commerce within California, including medical device manufacturers, and do not present an applicability question.
3. Registration and Fee Requirements
California does not impose a separate manufacturer registration requirement or registration fee on medical device companies under Health & Safety Code §§ 119400–119402 or under the Fair Pricing Act. SBI is not required to register as a medical device manufacturer with any California agency solely for purposes of marketing compliance (separate FDA establishment registration and California device listing requirements, if applicable, are addressed by SBI's US Regulatory Affairs team and are outside the scope of this survey).
4. Compliance Program Mandate
California Health & Safety Code § 119402 requires pharmaceutical companies to adopt a comprehensive compliance program that is consistent with the PhRMA Code on Interactions with Healthcare Professionals, the OIG Compliance Program Guidance for Pharmaceutical Manufacturers, or a substantially similar industry code. While this requirement applies by its terms to pharmaceutical companies rather than medical device manufacturers, SBI's adoption of the AdvaMed Code of Ethics (2020 Revision) and its development of a comprehensive compliance program consistent with OIG guidance positions SBI well to satisfy the standards contemplated by § 119402, should the statute's scope be extended to device manufacturers through legislative amendment or regulatory interpretation.
We recommend that SBI adopt a compliance program that is demonstrably consistent with § 119402 standards as a precautionary measure and as a reflection of SBI's commitment to industry best practices. This approach will also facilitate compliance with Massachusetts's mandatory code adoption requirement, discussed in Section III.F below.
5. California Fair Pricing Act Disclosure
This is a critical compliance item requiring pre-launch action.
The California Fair Pricing Act (Health & Safety Code § 127685 et seq.) requires manufacturers of healthcare products, including medical devices, to provide specified disclosures to the Department of Health Care Access and Information ("HCAI") when a product's wholesale acquisition cost exceeds certain thresholds. For medical devices, the relevant threshold is a WAC exceeding $2,500.
The Pulsar™ CRM System implantable monitor has a WAC of $4,950, which exceeds the $2,500 threshold by a substantial margin. Accordingly, SBI is required to file with HCAI a disclosure that includes, at minimum, the following information:
(a) The wholesale acquisition cost of the Pulsar™ implantable monitor at the time of its initial commercial introduction in California.
(b) A description of the factors that contributed to the establishment of the product's WAC, including manufacturing costs, research and development costs, and other relevant factors.
(c) Information regarding the product's clinical utility and the patient population for which the product is indicated.
(d) Such additional information as may be required by HCAI regulations or guidance.
The Transmitter component of the Pulsar™ CRM System has a WAC of $1,200, which does not independently trigger the Fair Pricing Act's disclosure requirements. However, if the Monitor and Transmitter are sold as a bundled system with a combined WAC exceeding $2,500, the bundled product may be subject to disclosure. SBI should ensure that its pricing structure and invoicing practices clearly distinguish between the Monitor and Transmitter components.
In addition to initial disclosure, the Fair Pricing Act requires ongoing reporting of price increases that exceed specified annual thresholds. SBI must monitor the WAC of the Pulsar™ implantable monitor on an ongoing basis and file supplemental disclosures if and when price increases trigger additional reporting obligations.
The required disclosure must be filed with HCAI in advance of or contemporaneously with the commercial launch of the Pulsar™ CRM System in California. Given the October 1, 2024 launch date, SBI should prepare and submit the Fair Pricing Act disclosure no later than September 15, 2024, to allow sufficient time for processing and to avoid any delays in the California launch.
6. Gift and Aggregate Spend Reporting
California does not currently have a standalone aggregate spend reporting statute specific to medical device manufacturers. The transparency objectives underlying aggregate spend reporting are addressed at the federal level through the Physician Payments Sunshine Act, and SBI's compliance with federal Open Payments reporting requirements will satisfy California's transparency expectations in this area.
California has not enacted a state-level gift ban statute applicable to medical device manufacturers, although the general prohibition on unfair business practices under Business and Professions Code § 17200 may be implicated by egregious or systematic gift-giving practices that create conflicts of interest or distort clinical decision-making. SBI's adoption of the AdvaMed Code's meal and hospitality standards, including the $150 per-person per-event cap, provides a robust compliance framework in this area.
7. Promotional Restrictions
California Business and Professions Code § 17500 prohibits false or misleading advertising in connection with the sale of goods or services. Section 17200 prohibits unlawful, unfair, or fraudulent business acts or practices. Both provisions apply to SBI's promotional activities in California, including advertising, sales materials, physician detailing, and digital marketing.
SBI's promotional materials for the Pulsar™ CRM System are subject to FDA regulatory review under 21 C.F.R. Part 801 (medical device labeling) and Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 352). Promotional claims that are consistent with FDA requirements — i.e., claims that are truthful, not misleading, supported by substantial evidence, and consistent with the product's cleared indications for use — will generally satisfy California's false advertising standards. SBI should ensure that all promotional materials disseminated in California are reviewed and approved through its Medical, Legal, and Regulatory ("MLR") review process prior to use.
8. Enforcement and Penalties
The California Attorney General has enforcement authority over violations of Health & Safety Code §§ 119400–119402, the Fair Pricing Act, and Business and Professions Code §§ 17200 and 17500. Enforcement may take the form of civil actions seeking injunctive relief, civil penalties, and disgorgement of profits. Penalties under the Fair Pricing Act may include fines for failure to file required disclosures or for filing materially inaccurate or incomplete disclosures.
In addition, private plaintiffs may bring actions under Business and Professions Code §§ 17200 and 17500 seeking injunctive relief, restitution, and, in certain circumstances, treble damages. California's robust private enforcement tradition means that SBI's promotional practices in California will be subject to scrutiny not only by state regulators but also by private plaintiffs' attorneys and advocacy organizations.
9. Compliance Action Checklist — California
•  [ ] Complete California Fair Pricing Act disclosure filing for the Pulsar™ implantable monitor (WAC $4,950 exceeds $2,500 threshold). Target deadline: September 15, 2024. Responsible: Theresa Brennan / Patrick Dunne.
•  [ ] Adopt a comprehensive compliance program that satisfies the standards of Cal. H&S Code § 119402, even though the statute is primarily pharmaceutical-directed. SBI's adoption of the AdvaMed Code and development of a comprehensive compliance program consistent with OIG guidance should satisfy this standard.
•  [ ] Ensure all promotional materials for the Pulsar™ CRM System are reviewed through the MLR review process for compliance with California false advertising statutes (B&P Code §§ 17200, 17500) prior to dissemination in California.
•  [ ] Monitor California legislative developments for any proposed legislation extending device-specific marketing compliance requirements to medical device manufacturers.
•  [ ] Establish monitoring protocol for WAC price increases on the Pulsar™ implantable monitor to ensure timely supplemental Fair Pricing Act disclosures if required.
B. Colorado
1. Applicable Statutes and Regulations
The following Colorado statutes and regulations were analyzed for potential applicability to SBI's marketing activities in connection with the Pulsar™ CRM System:
•  Colorado Consumer Protection Act, C.R.S. § 6-1-101 et seq. — Prohibits deceptive trade practices in connection with the sale or advertisement of goods or services. Applies broadly to all businesses operating in Colorado, including medical device manufacturers.
•  Colorado Prescription Drug Transparency and Disclosure Provisions — Colorado has enacted various provisions addressing prescription drug pricing transparency, including requirements for pharmaceutical manufacturers to disclose pricing information and justify price increases. These provisions are codified in various sections of C.R.S. Title 25 and Title 10.
An analysis was conducted to determine whether Colorado's pharmaceutical marketing provisions extend to medical device manufacturers.
2. Applicability to Medical Device Manufacturers
Colorado's pharmaceutical marketing and pricing transparency provisions are drafted in terms that apply to "pharmaceutical manufacturers," "manufacturers of prescription drugs," or similar terminology that does not expressly encompass medical device manufacturers. A review of the relevant statutory definitions, regulatory guidance, and enforcement history reveals no indication that the Colorado Attorney General or other state regulators have interpreted or applied these provisions to medical device companies.
The Colorado Consumer Protection Act, C.R.S. § 6-1-101 et seq., applies broadly to all businesses engaged in trade or commerce in Colorado, including medical device manufacturers. SBI's promotional activities in Colorado must comply with the Act's prohibitions on deceptive trade practices, including false or misleading representations regarding the Pulsar™ CRM System's performance, safety, efficacy, or indications for use.
Based on the foregoing analysis, Colorado does not currently impose specific marketing compliance obligations — beyond general consumer protection requirements — on medical device manufacturers such as SBI. However, Colorado has been an active state in the healthcare regulation space, and SBI should monitor legislative developments for potential expansion of pharmaceutical marketing requirements to the device sector.
3. Registration and Fee Requirements
No manufacturer registration or fee requirement applicable to medical device companies has been identified under Colorado law. SBI is not required to register with any Colorado state agency for purposes of marketing compliance.
4. Aggregate Spend Reporting
No aggregate spend reporting requirement applicable to medical device manufacturers has been identified under Colorado law. SBI's compliance with federal Sunshine Act reporting will provide transparency with respect to transfers of value to Colorado healthcare professionals.
5. Gift Restrictions
Colorado has not enacted a standalone gift ban or gift limitation statute applicable to medical device manufacturers or pharmaceutical manufacturers. The general consumer protection prohibitions on deceptive trade practices apply broadly and may be implicated by promotional practices that involve excessive or improper inducements to healthcare professionals, but Colorado does not impose specific dollar limits on gifts, meals, or other transfers of value.
SBI's adherence to the AdvaMed Code's standards for interactions with healthcare professionals, including the $150 per-person meal cap, provides appropriate safeguards in the Colorado market.
6. Enforcement and Penalties
The Colorado Attorney General has primary enforcement authority under the Consumer Protection Act, with the ability to bring civil actions seeking injunctive relief, civil penalties of up to $20,000 per violation, and restitution. Private actions for damages and injunctive relief are also available under certain circumstances.
7. Compliance Action Checklist — Colorado
•  [ ] Monitor Colorado legislative developments for any proposed expansion of pharmaceutical marketing laws to the medical device sector.
•  [ ] Ensure compliance with the Colorado Consumer Protection Act in all promotional activities conducted in Colorado.
•  [ ] No affirmative registration, fee payment, or reporting obligations identified for medical device manufacturers at this time.
C. Connecticut
1. Applicable Statutes and Regulations
The following Connecticut statutes are relevant to SBI's marketing compliance obligations:
•  Connecticut General Statutes § 21a-70c et seq. — Pharmaceutical and Medical Device Marketing Disclosure Requirements. This statute requires manufacturers of pharmaceutical products and medical devices to report specified marketing expenditures and transfers of value to healthcare professionals.
•  Connecticut General Statutes § 53-395 et seq. — Connecticut's anti-kickback provisions, which prohibit the offer, payment, solicitation, or receipt of remuneration to induce referrals of patients or healthcare services. These provisions have broad applicability to healthcare transactions, including interactions between medical device manufacturers and healthcare professionals.
2. Applicability to Medical Device Manufacturers
Connecticut General Statutes § 21a-70c is one of a limited number of state marketing compliance statutes that expressly applies to both pharmaceutical and medical device manufacturers. The statute defines "manufacturer" to include entities engaged in the production, preparation, propagation, compounding, conversion, or processing of pharmaceutical products or medical devices. SBI, as a manufacturer of the Pulsar™ CRM System (a Class II medical device), falls squarely within the statute's scope.
Connecticut's anti-kickback provisions at CGS § 53-395 et seq. have broad healthcare applicability and are not limited to pharmaceutical manufacturers. These provisions apply to any person or entity that offers, pays, solicits, or receives remuneration to induce or reward referrals of healthcare services or products. SBI's interactions with healthcare professionals in Connecticut, including consulting arrangements, speaker programs, and educational grant-making, must be structured to comply with these provisions.
3. Registration and Fee Requirements
Connecticut does not impose a separate registration or fee payment requirement on medical device manufacturers under CGS § 21a-70c. SBI is not required to register with the Connecticut Department of Consumer Protection or any other Connecticut state agency for purposes of marketing compliance. However, SBI must comply with the reporting requirements described below.
4. Aggregate Spend and Gift Reporting
Connecticut General Statutes § 21a-70c requires manufacturers of pharmaceutical products and medical devices to report gifts, compensation, and other transfers of value made to healthcare professionals licensed in Connecticut. The statute defines reportable transfers broadly to include:
(a) Gifts of any kind, including promotional items, product samples (to the extent not otherwise exempt), and items provided at conferences or events;
(b) Compensation for consulting services, speaker engagements, advisory board participation, and similar professional services;
(c) Meals, beverages, and hospitality provided in connection with promotional or educational activities;
(d) Travel and lodging expenses incurred on behalf of healthcare professionals in connection with manufacturer-sponsored events;
(e) Grants for research, education, or other purposes made to healthcare professionals or institutions;
(f) Honoraria and other forms of compensation not captured by the foregoing categories.
The reporting thresholds and format are established by the Department of Consumer Protection through regulation. SBI must collect and report data on all transfers of value to Connecticut-licensed healthcare professionals that meet or exceed the applicable de minimis thresholds. Reports are due annually, and SBI should coordinate its Connecticut reporting with its federal Sunshine Act data collection to minimize duplication of effort and ensure consistency of reported data.
There is significant overlap between Connecticut's reporting requirements and federal Sunshine Act reporting. In general, any transfer of value that is reportable under the Sunshine Act will also be reportable under Connecticut law, although the converse is not necessarily true — Connecticut may require reporting of transfers that fall below the Sunshine Act's de minimis thresholds or that are made to categories of recipients not covered by the federal statute. SBI should analyze the specific differences between Connecticut's reporting requirements and the Sunshine Act and ensure that its data collection protocols capture all Connecticut-specific data points.
5. Gift Bans and Limitations
Connecticut imposes restrictions on gifts to prescribers, including physicians and other healthcare professionals who have prescribing authority or who make purchasing decisions regarding medical devices. The statute prohibits the provision of gifts that are intended to influence or could reasonably be perceived as influencing clinical decision-making or purchasing decisions.
Key provisions of the Connecticut gift restriction framework include:
•  Prohibition on gifts of substantial value that are not associated with a legitimate business purpose or bona fide professional service.
•  Exemption for fair market value compensation paid to healthcare professionals for bona fide consulting, speaking, or advisory services, provided that (i) the compensation is set at fair market value, (ii) the services are legitimately needed, (iii) the selection of the consultant or speaker is based on qualifications, and (iv) the arrangement is documented in a written agreement.
•  Exemption for product training and education reasonably necessary for the safe and effective use of the Pulsar™ CRM System.
•  Exemption for modest meals provided in connection with educational or informational presentations, subject to the standards established by the adopted industry code.
SBI's planned key opinion leader ("KOL") consulting program ($350–$500 per hour, with an annual per-consultant cap of $12,000) and speaker program ($1,500 per engagement for national-level speakers, $750 per engagement for regional speakers, with an annual per-speaker cap of $18,000) appear to fall within the bona fide services exemption, provided that each arrangement is properly documented, supported by a fair market value assessment, and subject to appropriate compliance review and approval.
6. Marketing Code Requirements
Connecticut does not impose a mandatory marketing code adoption requirement on pharmaceutical or medical device manufacturers. However, SBI's voluntary adoption of the AdvaMed Code of Ethics demonstrates good faith commitment to industry standards and provides a compliance framework that satisfies Connecticut's substantive requirements.
7. Enforcement and Penalties
The Connecticut Department of Consumer Protection has primary enforcement authority over violations of CGS § 21a-70c. Enforcement actions may result in civil penalties, including fines for failure to report or for providing inaccurate or incomplete reports. The Connecticut Attorney General also has authority to bring enforcement actions under the state's consumer protection statutes and anti-kickback provisions. Criminal penalties may apply to willful violations of the anti-kickback provisions at CGS § 53-395 et seq.
8. Compliance Action Checklist — Connecticut
•  [ ] Ensure aggregate spend reporting protocols capture all Connecticut-specific categories of reportable transfers of value, including categories that may exceed federal Sunshine Act requirements.
•  [ ] Verify that physician consulting and speaker program honoraria comply with Connecticut's gift restrictions, including documentation of fair market value, legitimate need, and qualification-based selection.
•  [ ] Coordinate Connecticut reporting data collection with federal Sunshine Act data collection to ensure consistency and completeness.
•  [ ] Train territory managers assigned to Connecticut territories on Connecticut-specific gift restrictions and reporting requirements.
•  [ ] Establish compliance review protocols for all physician engagement arrangements involving Connecticut-licensed healthcare professionals.
D. Louisiana
1. Applicable Statutes and Regulations
The following Louisiana statutes were analyzed for potential applicability to SBI's marketing activities:
•  Louisiana Revised Statutes § 40:1237.1 et seq. — Louisiana healthcare-related provisions addressing relationships between manufacturers and healthcare providers, including provisions related to inducements and referral arrangements.
•  Louisiana Unfair Trade Practices and Consumer Protection Law, La. R.S. § 51:1401 et seq. — Broadly applicable statute prohibiting unfair or deceptive trade practices in the conduct of any trade or commerce within Louisiana.
2. Applicability to Medical Device Manufacturers
Louisiana's healthcare marketing-related provisions at La. R.S. § 40:1237.1 et seq. are primarily focused on pharmaceutical manufacturers and the marketing of prescription drugs. A review of the statutory definitions reveals that the term "manufacturer" as used in these provisions is generally defined by reference to pharmaceutical products and does not expressly include medical device manufacturers. There is no published regulatory guidance from the Louisiana Board of Pharmacy, the Louisiana Department of Health, or the Louisiana Attorney General extending these provisions to medical device companies.
The Louisiana Unfair Trade Practices and Consumer Protection Law at La. R.S. § 51:1401 et seq. applies broadly to all businesses engaged in trade or commerce in Louisiana, including medical device manufacturers. This statute prohibits unfair methods of competition and unfair or deceptive acts or practices, and it provides both public enforcement authority (through the Attorney General) and private rights of action. SBI's promotional activities in Louisiana must comply with the general prohibitions on deceptive practices embodied in this statute.
Based on the foregoing analysis, Louisiana does not currently impose specific marketing compliance obligations — beyond general consumer protection requirements — on medical device manufacturers. However, the broad language of the unfair trade practices statute, combined with Louisiana's history of active enforcement in the healthcare sector, counsels in favor of conservative compliance practices.
3. Registration and Fee Requirements
No manufacturer registration or fee requirement applicable to medical device companies has been identified under Louisiana law.
4. Aggregate Spend Reporting
No aggregate spend reporting requirement applicable to medical device manufacturers has been identified under Louisiana law. SBI's compliance with federal Sunshine Act reporting will provide transparency with respect to transfers of value to Louisiana healthcare professionals.
5. Gift Restrictions
Louisiana has not enacted a standalone gift ban or gift limitation statute applicable to medical device manufacturers. General prohibitions on inducements that may constitute kickbacks or improper referral arrangements are addressed by Louisiana's healthcare fraud statutes, which are analyzed in SBI's separate federal/state anti-kickback compliance memorandum. SBI's adherence to the AdvaMed Code's standards for interactions with healthcare professionals provides an appropriate compliance framework.
6. Enforcement and Penalties
The Louisiana Attorney General and relevant state licensing boards have enforcement authority over healthcare-related marketing practices. The Attorney General may bring actions under the Unfair Trade Practices and Consumer Protection Law seeking injunctive relief, civil penalties, and attorney's fees. Violations of healthcare fraud provisions may result in criminal prosecution.
7. Compliance Action Checklist — Louisiana
•  [ ] Monitor Louisiana statutory and regulatory developments for any expansion of pharmaceutical marketing provisions to the medical device sector.
•  [ ] Ensure promotional activities in Louisiana comply with the Louisiana Unfair Trade Practices and Consumer Protection Law.
•  [ ] No affirmative registration, fee payment, or reporting obligations currently identified for medical device manufacturers.
•  [ ] Maintain documentation of all transfers of value to Louisiana-licensed healthcare professionals through the federal Sunshine Act reporting infrastructure.
E. Maine
1. Applicable Statutes and Regulations
The following Maine statutes are relevant to SBI's marketing compliance obligations:
•  Maine Revised Statutes Title 22, § 2698-A et seq. — Prescription Drug Marketing Activities. This statute regulates certain marketing activities directed at healthcare professionals by manufacturers of prescription products and, depending on interpretation, medical devices.
•  Maine Revised Statutes Title 22, § 2700-A — Pharmaceutical and Medical Device Manufacturer Reporting. This statute requires manufacturers to report specified marketing expenditures to the Maine Attorney General.
2. Applicability to Medical Device Manufacturers
Maine law extends certain marketing and reporting requirements to medical device manufacturers. Title 22, § 2700-A specifically references "pharmaceutical and medical device manufacturer reporting," indicating legislative intent to include medical device companies within its scope. The term "manufacturer" as defined in the reporting statute includes entities that manufacture, prepare, propagate, compound, process, or distribute medical devices for sale in Maine.
SBI, as the manufacturer of the Pulsar™ CRM System, falls within the scope of Maine's reporting requirements. The Pulsar™ implantable monitor is a medical device that requires physician implantation and is prescribed or ordered by a licensed healthcare professional, further supporting its inclusion within Maine's regulatory framework.
The marketing activity provisions at Title 22, § 2698-A are drafted more narrowly and focus primarily on prescription drug marketing activities. However, the reporting statute at § 2700-A establishes an independent reporting obligation for medical device manufacturers that does not depend on the marketing activity provisions' scope.
3. Registration and Fee Requirements
Maine does not impose a separate manufacturer registration or fee requirement on medical device companies for purposes of marketing compliance. The compliance obligation takes the form of reporting rather than pre-launch registration. SBI is not required to register with any Maine state agency prior to commencing marketing activities in Maine, although it must be prepared to comply with reporting obligations from the outset of its commercial activities in the state.
4. Aggregate Spend Reporting
Maine requires manufacturers of pharmaceutical products and medical devices to file annual reports with the Maine Attorney General's Office disclosing aggregate expenditures on marketing activities directed at healthcare professionals licensed or practicing in Maine. The categories of reportable expenditures include:
(a) Fees paid for consulting services, advisory board participation, and other professional services;
(b) Speaker honoraria and related expenses;
(c) Meals, beverages, and hospitality provided in connection with promotional or educational activities;
(d) Travel and lodging expenses paid on behalf of healthcare professionals;
(e) Educational grants to healthcare professionals or institutions;
(f) Research funding provided to healthcare professionals or institutions;
(g) Gifts and promotional items of any value provided to healthcare professionals;
(h) Other transfers of value not captured by the foregoing categories.
Reports are filed annually on a calendar-year basis. SBI must establish data collection protocols that capture Maine-specific expenditure data beginning with the October 1, 2024 launch and must be prepared to file its first Maine report covering the period from October 1 through December 31, 2024 (or, if annual reporting is on a calendar-year basis, incorporated into the CY2024 report due in 2025). The specific filing deadline and format requirements should be confirmed with the Maine Attorney General's Office prior to the launch date.
SBI should coordinate its Maine reporting with its federal Sunshine Act data collection. While there is significant overlap between the two reporting regimes, Maine may require reporting of expenditures or categories of recipients not covered by the federal statute, and SBI's data collection systems must be designed to capture these additional data points.
5. Gift Bans and Limitations
Maine imposes restrictions on gifts to healthcare practitioners. The gift ban provisions prohibit manufacturers from providing gifts to healthcare professionals that are intended to influence or could reasonably be perceived as influencing prescribing or purchasing decisions. Key aspects of Maine's gift ban framework include:
•  Prohibition on gifts of entertainment, recreation, or leisure activities to healthcare professionals.
•  Prohibition on gifts of cash or cash equivalents to healthcare professionals (other than fair market value compensation for bona fide services).
•  Permitted exceptions include: (i) fair market value compensation for bona fide consulting services, speaking engagements, and advisory board participation; (ii) product samples provided in compliance with applicable federal and state regulations; (iii) educational items and materials of minimal value that are directly relevant to the healthcare professional's clinical practice; and (iv) modest meals provided in connection with bona fide educational or informational presentations.
SBI's planned KOL consulting program and speaker program are structured to comply with the bona fide services exception, provided that each arrangement satisfies the standard requirements of fair market value compensation, legitimate need, written agreement, and qualification-based selection. SBI's territory managers assigned to Maine territories must be trained on the specific parameters of Maine's gift ban provisions.
6. Marketing Code Adoption
Maine does not require manufacturers to adopt a specific marketing code of conduct. However, SBI's adoption of the AdvaMed Code of Ethics demonstrates compliance with industry best practices and may serve as evidence of good faith in the event of a regulatory inquiry or enforcement action.
7. Enforcement and Penalties
The Maine Attorney General has primary enforcement authority over violations of the reporting and gift ban provisions. The Maine Department of Health and Human Services may also have oversight authority over certain marketing practices. Enforcement actions may result in civil penalties, including fines for failure to report, filing inaccurate or incomplete reports, or violations of the gift ban.
8. Compliance Action Checklist — Maine
•  [ ] Establish data collection and reporting protocols for Maine-directed marketing expenditures, including categories that may exceed federal Sunshine Act requirements.
•  [ ] Confirm specific filing deadline and format requirements with the Maine Attorney General's Office.
•  [ ] Ensure gift ban compliance for territory managers operating in Maine, including training on prohibited and permitted activities.
•  [ ] Document the legitimate business need, fair market value basis, and qualification-based selection rationale for all physician engagement payments involving Maine-licensed healthcare professionals.
•  [ ] Coordinate Maine reporting with federal Sunshine Act data collection.
F. Massachusetts
1. Applicable Statutes and Regulations
The following Massachusetts statutes and regulations are applicable to SBI's marketing compliance obligations:
•  Massachusetts General Laws Chapter 111N — Pharmaceutical and Medical Device Manufacturer Conduct. This is one of the most comprehensive state-level marketing compliance statutes in the United States, imposing registration, fee payment, code adoption, reporting, and gift restriction requirements on both pharmaceutical and medical device manufacturers.
•  105 CMR 970.000 — Pharmaceutical and Medical Device Manufacturer Code of Conduct Regulations. These regulations, promulgated by the Massachusetts Department of Public Health, implement the requirements of MGL c. 111N and establish detailed standards governing manufacturer interactions with healthcare professionals in Massachusetts.
2. Applicability to Medical Device Manufacturers
Massachusetts General Laws Chapter 111N expressly applies to medical device manufacturers. The statute defines "manufacturer" to include any entity engaged in the production, preparation, propagation, compounding, conversion, processing, or distribution of prescription drugs or medical devices for sale in Massachusetts. This definition unambiguously encompasses SBI as the manufacturer of the Pulsar™ CRM System, a Class II medical device cleared by the FDA under the 510(k) pathway.
Massachusetts's marketing compliance statute is one of the most comprehensive and clearly applicable state-level regulatory frameworks for medical device manufacturers in the United States. Unlike many other state statutes analyzed in this survey, which were drafted primarily with pharmaceutical manufacturers in mind and whose applicability to device companies is uncertain, MGL c. 111N was deliberately drafted to include medical device manufacturers within its scope. The implementing regulations at 105 CMR 970.000 similarly apply to both pharmaceutical and medical device manufacturers.
3. Registration and Fee Requirements
SBI is required to register annually with the Massachusetts Department of Public Health and to pay an annual registration fee of $2,000. This registration must be completed prior to commencing commercial marketing activities in Massachusetts, which means that SBI must file its registration and pay the fee in advance of the October 1, 2024 launch date.
In addition to the registration and fee payment, SBI must submit an annual attestation confirming its adoption of either the PhRMA Code on Interactions with Healthcare Professionals or the AdvaMed Code of Ethics. SBI will attest to its adoption of the AdvaMed Code of Ethics (2020 Revision), which is the appropriate industry code for a medical device manufacturer. The attestation must be filed simultaneously with the annual registration.
The registration process typically involves the submission of a registration form to the Massachusetts Department of Public Health, Division of Health Care Quality, along with payment of the $2,000 fee and the code adoption attestation. The form requires disclosure of the manufacturer's name, address, contact information, products marketed in Massachusetts, the identity of the adopted code of conduct, and the name and title of the individual responsible for compliance oversight.
This is a priority pre-launch action item. SBI's registration, fee payment, and AdvaMed Code attestation must be completed no later than September 15, 2024, to allow sufficient processing time before the October 1, 2024 launch.
4. Marketing Code of Conduct
Massachusetts requires mandatory adoption of an industry marketing code of conduct as a condition of engaging in commercial marketing activities in the state. The statute specifies that manufacturers must adopt either the PhRMA Code on Interactions with Healthcare Professionals or the AdvaMed Code of Ethics, or a substantially equivalent industry code approved by the Department of Public Health.
SBI will adopt and attest to the AdvaMed Code of Ethics (2020 Revision) as its governing code of conduct for interactions with healthcare professionals. The AdvaMed Code is the industry-standard code for medical device manufacturers and addresses the following areas:
•  Consulting arrangements with healthcare professionals, including fair market value standards, legitimate need requirements, and documentation requirements;
•  Speaker programs, including standards for speaker selection, compensation, and program content;
•  Educational grants, including standards for independence of educational content and prohibition on manufacturer control of program content;
•  Product training and education, including standards for training on the safe and effective use of medical devices;
•  Meals and hospitality, including the $150 per-person per-event cap and prohibition on entertainment;
•  Gifts, including the general prohibition on non-educational gifts;
•  Evaluation and demonstration equipment;
•  Charitable donations;
•  Other interactions with healthcare professionals.
SBI must annually certify to the Massachusetts Department of Public Health that it has adopted the AdvaMed Code, that its US marketing activities are conducted in compliance with the Code, and that it has implemented policies, procedures, and training programs to ensure ongoing compliance.
5. Aggregate Spend Reporting
Massachusetts requires annual reporting of aggregate expenditures on marketing activities, including all transfers of value to healthcare professionals licensed or practicing in Massachusetts. The reporting categories prescribed by the statute and implementing regulations include:
(a) Consulting fees paid to healthcare professionals for advisory, consulting, or professional services;
(b) Speaker honoraria and related expenses paid to healthcare professionals in connection with manufacturer-sponsored speaking engagements;
(c) Meals, beverages, and hospitality provided to healthcare professionals in connection with promotional or educational activities;
(d) Travel and lodging expenses paid on behalf of healthcare professionals in connection with manufacturer-sponsored events;
(e) Educational grants provided to healthcare professionals, educational institutions, or professional organizations;
(f) Research funding provided to healthcare professionals or research institutions;
(g) Gifts and promotional items provided to healthcare professionals;
(h) Product samples provided to healthcare professionals (to the extent reportable);
(i) Other transfers of value not captured by the foregoing categories.
Reports are filed annually on a calendar-year basis with the Massachusetts Department of Public Health. SBI should coordinate its Massachusetts reporting with its federal Sunshine Act data collection. While the Sunshine Act provides a comprehensive federal reporting framework, Massachusetts may require reporting of expenditures or categories of recipients not covered by the federal statute, and SBI's data collection systems must be designed to capture Massachusetts-specific data points.
SBI's estimated Year-1 reportable transfers under the federal Sunshine Act total approximately $650,000 nationwide. The Massachusetts-specific subset of these transfers will d