Create a health passport
Service Introduction：
Obtain a personal health passport, connect the "My Health Bank" with one click, and avoid complicated login procedures, so that when you see a doctor in various hospitals and clinics, you can quickly view medical treatment and medication information on the medical terminal with one click, avoiding repeated communication of medical records and symptoms .
Program features：
If you want to access the medical records of patients, you need to go to the hospital to apply for it. Even your own medical records may require additional administrative processing fees. However, the medical treatment and medication information services help people obtain their own health passports. Keys connected to "Keep Savings SDK" to avoid complicated login process The program allows you to quickly check the medical treatment and medication information on the medical terminal with one click when you see a doctor in various hospitals and clinics, so as to avoid repeated communication of medical records and symptoms. "One phone in hand, medical records and passports are unimpeded", you only need to download "Yibingtong", and activate "My Data" through simple two steps, help People connect their medical records to their mobile phones, and can confirm their medical records with one click anytime, anywhere. No matter if there is a special disease or medication, they need to remind the medical staff of the medical record status, which can be clearly used for communication between doctors and patients. Step 1: Register and open "Yieyitong" Step 2: Click "My Data" and connect "Health Passbook" with one click (Follow the steps on the phone screen to complete the authorization, and you can open your exclusive medical record passport!)
Service Details：
"Yieyitong" connects the health insurance SDK with blockchain technology to solve the problem of patient identity authentication, protect the rights and interests of health passbook owners to obtain medical records, and then quickly confirm the patient support plans and welfare resources that can be applied for. The service description is as follows:
1)"My Data" to download medical records: online authorization to serialize and preserve the passbook, download medical records, and save the time and fees for hospitals to apply for medical records
2)"My data" creates a health passport: cross-diagnosis consultation and troubleshooting, one-click sharing of medical records and medication details.
3)"Health Plan" Welfare Resources: Just like a health supermarket, it provides members with a series of health and welfare plan information.
4)The "Health Plan" application is very simple: one-click review to apply for a health plan, and identity authentication through "My Data", eliminating the need for repeated administrative procedures for submitting patient identity documents.
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Private Policy Benefit Trial Calculation Service
Service Introduction：
Provide the public with one-stop collection and one-click matching of eligible and applicable health welfare plans, so that the benefits of patients are not missed.
Program features：
At the same time as health management, what health welfare plans can be applied for, but the public does not know anything about it? health plan benefits package to help people According to their own medical records, one-click matching of health welfare plans that can be applied for helps the public save a lot of time and eliminates the need to understand health information one by one and exclude unqualified health plans. It only needs one-click to join the plan, which will be reviewed by the background Confirm that the conditions are met, you can get Comprehensive Health Benefits Program. The health and welfare consultation plan provides you with a mobile phone, a comprehensive grasp of various health and welfare plans, and only two steps to help the public get a qualified health and welfare plan with one-click matching: Step 1: Connect the health passbook and open "My Data" (for the first login, you need to prepare the health passbook registration password and the health insurance card number) Step 2: Click "Health Plan", join the relevant plan with one click, and wait for the review result to get the relevant information Health benefits!
Service Details：
"Yieyitong" connects the health insurance SDK with blockchain technology to solve the problem of patient identity authentication, protect the rights and interests of health passbook owners to obtain medical records, and then quickly confirm the patient support plans and welfare resources that can be applied for. The service description is as follows:
1) "My data" to download medical records: online authorization to serialize and preserve passbooks, download medical records, and save the time and fees for hospitals to apply for medical records.
2)"My data" creates a health passport: cross-diagnosis consultation and troubleshooting, one-click sharing of medical records and medication details.
3) "Health Plan" Welfare Resources: Just like a health supermarket, it provides members with a series of health and welfare plan information.
4) The "Health Plan" application is very simple: one-click review to apply for a health plan, and identity authentication through "My Data", eliminating the need for repeated administrative procedures for submitting patient identity documents.
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Drug trial calculation service
Service Introduction：
The drug cost trial calculation service provides you with simple input of indications and estimated prescription drug information, and will assist you in evaluating the trial cost of the overall course of treatment according to the standard treatment,helping you to properly plan and prepare for drug costs, and evaluate whether to start the course of treatment.
Program features：
Service Details：
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Private Policy Benefit Trial Calculation Service
Service Introduction：
Easily log in to the insurance policy you already own, and you can grasp the rights and interests of multiple insurance policies at one hand, and you can grasp the relevant medical benefits such as the daily hospitalization amount, the amount of major injury and disease compensation, etc. with one-click trial calculation.
Program features：
Buying an insurance policy was a matter of decades ago. Now I only remember when to pay the premium, but I don’t know the detailed policy benefits? Even if you know that there may be a need for treatment in the future, but you don’t know the amount of insurance that you can apply for without applying for a claim? There are too many insurance companies' policies, but it is difficult to collect and understand themselves Integrity interest assessment? Private insurance rights consultation plan does not need to enter personal information, only need to enter the policy name, no matter one, three, or even five or more different insurance companies, as long as you log in your policy name, you can compile your own personal policy in one stop rights, allowing you to actually develop Before starting the course of treatment, you can know the amount of benefits you can get if you stay in the hospital for one day, or receive chemotherapy once. (Note: The actual claim amount should still be paid according to the actual application status of the insurance company, and the calculation and evaluation amount is for reference only.)
Service Details：
People only know their own insurance rights when they buy and use them, and when they get sick, it is also the time when they will use their insurance rights with a high probability in the future. This plan provides private Insurance benefits assist in overall assessment, help the public review your policy benefits, and help the public discuss with doctors the resource evaluation of follow-up treatment plans. Private insurance is like a fast food package. In each primary contract, Different meals (riders) can be matched according to needs, and the choice of each rider will affect the policy benefits, so by correctly registering your policy name, no matter which insurance company’s product can help you according to your own benefit category , Assist you in calculating the relevant benefit items and amounts that may be used during treatment, such as how much is a day of hospitalization? Fixed payment or real payment? How much is the amount of miscellaneous expenses, and the amount needs to be reaccumulated every few days.
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Social resource matching service
Service Introduction：
Provide the public with fast matching and matching of social resources that can be applied for, so that the public can avoid spending extra time and effort in searching and screening social resources that can be applied for.
Program features：
In the event of an emergency, is it difficult to afford the shortfall in medical expenses? This program provides the public with a one-stop collection of emergency resources that can be applied for. According to their own special identities, including low-middle income, low-middle-income households, cold certificates, major injury cards, or children in school, etc., one-stop Quickly match and query available social resources.
Service Details：
Social resources are grasped, one-stop links to various resource links for emergency medical applications, and help the public to include and link relevant social resource application information with one click. People will apply for social resources according to their special status and obtain relevant social resources.
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medical payment installment service (BNPL)
Service Introduction：
How to find appropriate medical funds for the sudden self-paid drug demand? Provide everyone with medical and financial consulting services. According to your drug needs, after evaluation, we recommend you installment payment plans or loan information.
Program features：
"The purpose of seeking to extend the payment period is to take into account the quality of life of myself and my family!" When there are better options for treatment, but you have to face the dilemma of economic decision, should you pay for family living expenses or medical expenses first? Limited by medical ethics and legal restrictions, excessive medical consumption is not encouraged. Medical financial services are different from consumer finance, starting from compliance with medical professional decisions, taking into account medical risks, evaluating clinical evidence models, and providing installment payment plans or loan introductions for patients' financial support based on patients' affordability.
Service Details：
Under the health insurance system, many people who want to receive new treatments encounter the dilemma of having to pay for their own expenses. Faced with the sudden demand for funds for medical expenses, they do not want to borrow money from relatives and friends. Affecting the quality of life of the family? In order to allow the public to have more time to raise funds, Medical Financial Consulting provides the public with treatment first and payment plan evaluation. Through the project-based installment payment plan or medical loan, it helps patients start the course of treatment first, and strives for More time to raise funds for drug expenses and extend the time to pay medical expenses.
The medical financial consultation plan provides the public with their own financial experience to evaluate the appropriate medical financial plan, including the project-based medical payment installment service (BNPL) or medical loan plan.
[Project-type drug payment installment plan] Cooperate with special pharmacies to design a project-based drug payment installment plan for specific project drug treatment courses to help patients start treatment as soon as possible and extend drug expenditure (dividing the entire drug fee amount into Multi-payment method, regular payment of drug fees and period payment method, so as to strive for more time to raise funds for drug fees).
【Medical Credit Program】Referring banks provide Unily Medical Credit Program for patients or family members who have a funding gap due to medical expenses, assist the public to evaluate and apply for affordable loan programs, and help start the treatment process
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Free-Drug inventory and flow management system
Service Introduction：
The introduction of the drug gifted management system helps the cooperative pharmacy to manage the drug inventory and approval list, and it can immediately grasp the flow of drugs.
Program features：
The donated medicine management system helps to integrate the donated medicines of various pharmaceutical companies and products, and approves and distributes medicines according to different plans, so that cooperative pharmacies can more efficiently assist patients in supporting plans.
Service Details：
The free medicine management system can easily manage the subsidy schemes of different products, monitor the inventory and track the flow in real time, and can query the information of the approved patients for the approval and issuance of medicines, and leave the medicine receiving records for future inspection.
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HCP e-shop
Service Introduction：
Sales of medicines/medical materials/consumer goods, e-commerce platforms for exclusive medical staff.
Program features：
Want to easily place an order for medical and health care products? The quality of the international pharmaceutical factory makes people feel at ease, easy to click online, diversified payment methods, and the most important thing is OPEN 24 hours at any time, so you can order at any time without waiting!
Service Details：
The pharmaceutical e-commerce sales platform provides an exclusive order service system for pharmacies, medical service units, and medical staff to assist in easy order placement and related order progress tracking and customer service.
Portal APP 下載
Medical expert social media management training service
Service Introduction：
Provide medical teams for training strategy training, hardware operation teaching, and coaching medical/ hospital to create a high -volume net red team.
Program features：
Want to become an online celebrity medical team, want to build your own channel but don't know where to start? Shooting, scripting, recording, live broadcasting, etc., every link is knowledge, provide you with a series of courses and training courses for the Internet celebrity medical team, and help you successfully establish your own channel and build a famous Internet celebrity team!
Service Details：
A qualified Internet celebrity team, in addition to being able to complete independent operations and complete live broadcast or video channel material preparation, on-site shooting quality control and long-term operation management of channels and fans, including script planning, on-site layout and professional equipment understanding and use, during the live broadcast Mastering the atmosphere of the host and the editor, the long-term operation and setting of the channel, etc., each link is a knowledge, so this plan assists in providing one-stop training courses, and assists in planning and providing according to your Internet celebrity goals. Course content that suits you.
Portal APP 下載
MediBiz
Service Introduction：
Provide the industry's various professional cooperation invitations to cooperate opportunities, such as the health promotion lectures of enterprise employees.
Program features：
Assist match-matching medical experts to undertake relevant appointment and cooperation opportunities, including arranging manpower to go to the hospital for marketing and publicity of health education activities with brand owners in medical institutions, or to cooperate with relevant associations, pharmaceutical companies and other health education lecturers, and will further media To meet the needs of lecture topics in joint enterprise occupational care, and provide a variety of expert cooperation opportunities.
Service Details：
Help medical experts including physicians, nurses, health teachers, nutritionists, pharmacists, etc., assist in matching brand owners, drug dealers, occupational care and other related units to see if there are suitable appointment cooperation opportunities, including marketing endorsements, public health education ambassadors, Corporate health education lecturer, etc.
Portal APP 下載
Patient assistance programs (PAPs)
Service Introduction：
To solve patients at their own expense, through the control of drug -gift compliance management systems, help patients support the implementation of the plan, and provide effective and instant service and records.
Program features：
The patient drug donation compliance management system-MediPASS is the first digital solution service system for patient support plans, and won the 2021 National Medical Quality Award Industry Label. Improve the application process of patient support programs in a digital way, and provide a convenient, safe and compliant service platform for clinical and patients. At the same time, it has obtained the certifications of ISO9001 quality management system, ISO27001 information security management system and ISO27701 personal data privacy information management system.
Service Details：
Assist patients to increase medical accessibility and help patients obtain complete treatment. Through the drug donation compliance management system, the patient support plan is implemented and managed digitally, helping medical staff, patients and caregivers to obtain the services and assistance of the support plan in a timely manner.
According to different disease areas and patient needs, we will assist in planning patient medication assistance programs:
【early stage】
1) Demand Discussion and Planning
2) Related material design and preparation
3) Standard workflow document formulation
4) Integrated communication across departments
5) Project Promotion and Adjustment
【mid stage】
1) Project Quality Management
2) Document review and control
3) Communication with relevant units
4) special event handling
【Late stage】
1) Compliance retention and archiving of documents and materials
2) Summary and analysis of execution results
Portal APP 下載
Patient Medication Assistance Program
Service Introduction：
Solve the plight of patients for self-financed treatment, assist patients to support the implementation of the plan through the drug donation compliance management system, and provide effective and real-time services and records.
Program features：
The patient drug donation compliance management system-MediPASS is the first digital solution service system for patient support plans, and won the 2021 National Medical Quality Award Industry Label. Improve the application process of patient support programs in a digital way, and provide a convenient, safe and compliant service platform for clinical and patients. At the same time, it has obtained the certifications of ISO9001 quality management system, ISO27001 information security management system and ISO27701 personal data privacy information management system.
Service Details：
Assist patients to increase medical accessibility and help patients obtain complete treatment. Through the drug donation compliance management system, the patient support plan is implemented and managed digitally, helping medical staff, patients and caregivers to obtain the services and assistance of the support plan in a timely manner.
According to different disease areas and patient needs, we will assist in planning patient medication assistance programs:
【early stage】
1) Demand Discussion and Planning
2) Related material design and preparation
3) Standard workflow document formulation
4) Integrated communication across departments
5) Project Promotion and Adjustment
【mid stage】
1) Project Quality Management
2) Document review and control
3) Communication with relevant units
4) special event handling
【Late stage】
1) Compliance retention and archiving of documents and materials
2) Summary and analysis of execution results
Portal APP 下載
Case treatment treatment expert service(PSP)
Service Introduction：
In accordance with the needs of individual diseases and planning, assist qualified experts, including experts, nutritionists, and health teachers, etc., and use the positive circulation expert cooperation and management mechanism to assist patients to improve their advice compliance and health education knowledge Improve target settings.
Program features：
In accordance with the needs of individual diseases and planning, assist qualified experts, including experts, nutritionists, and health teachers, etc., and use the positive circulation expert cooperation and management mechanism to assist patients to improve their advice compliance and health education knowledge Improve target settings.
Service Details：
MEDIA-WIND HEALTH STRATEGIES provided by the License Strategy Consulting Co., Ltd. helps to formulate detailed planning specifications in response to the development of disease needs and market strategies, including experts and their care settings, projects and personnel performance indicators, services, services Projects, etc., from the recruitment, interview evaluation, education and training, performance management, and the performance implementation progress and compliance management of the overall project.
【early stage】
1) Drawing of project specifications (SOW/SOP)
2) Project settings and standard documents and assistive material table designs
3) Related internal and external management system frame connection and settings
4) Recruitment, interview evaluation, education and training, etc.
【mid stage】
1) Instructions for the patients who have collected cases
2) Project execution progress and performance management
3) Regular staff education and training and performance management
4) Regular report delivery and comparison project implementation progress and performance
【Late stage】
1) Compliance retain and archiving of the data of the project document
2) Confirmation of related reconciliation and request information
Portal APP 下載
PAPPAY installment service (PAP)
Service Introduction：
Provide a installment plan for first treatment and then payment, and use compliance risk assessment methods to assist specific prescription patients at the same time as a medical and disease common decision -making treatment plan. At the same time, there may be other payment methods to facilitate the initiation of the drug purchase treatment.
Program features：
Help patients face the sudden medicinal costs, which can extend the payment time and soothe the pressure of drug purchase. Therefore, it provides a "self -funded installment project". Through cooperation with the Special Pharmacy, the financial risk model evaluation is conducted for the purchase amount of specific drugs, and Patients with one more payment plan, through multiple periods of allocation, to strive for patients to raise drug costs and do not affect the start time of treatment.
The characteristic description is as follows:
1. Extend the payment period and strive to raise funds time: "Medicine Installation" is aimed at specific project -type drugs, providing the funds for the early stage of medical purchase, and the time for you to raise the cost of treatment. "Pharmaceutical" allows you to extend the payment of payment and reduce the pressure of one payment.
2. Easily handle, speed processing: special person service, online explanation, solve the problems you encountered in your application, and complete the "medicinal stage" application. Quickly review, let you know the results of the audit within three working days.
3. Apply before payment: There is no charge during the application period. After you obtain the drug through the review, pay the payment conditions and time.
4. Online entity, good service: North, Central and South has a special pharmacy bureau for cooperation, so that you can apply at ease and rest assured to buy medicine.
Service Details：
The PAPPAY installment service (PAP) provided by Medi-Loan Fintech, Ltd., in order to help the implementation of the vision of paying before treatment, helping patients plan medical funds, can also start treatment at the same time at the same time. In addition, the treatment of the original family life is kept at the same time. Therefore
【early stage】
1) Cooperation content negotiation
2) Related process design
3) Form file formulation
4) Disting and communication between the Special Pharmaceutical Bureau
【mid stage】
1) Project commentary
2) Credit review review of patients (applicants) who received the case
3) Resource subsidy execution and related connections and communication
【Late stage】
1) Compliance retain and archiving of the data approved case
2) Confirmation of related account information
Portal APP 下載
Self-media brand planning and public relations services
Service Introduction：
Assist pharmaceutical factories to plan information with medical staff, establish the best platform for communication with medical staff, and use data to obtain ins -decision -making decisions to achieve business goals.
Program features：
To meet the digital transformation, you need a smarter digital strategy -Medicine! Medical Communication Medi+KNOW service to establish a medical staff exclusive channel, diverse planning marketing contacts to communicate with medical staff, and comprehensively track digital footprints. Use data to understand users' attention information, formulate future trends and achieve business goals!
Service Details：
Establish an official channel, connect medical channels that are dedicated to the brand, and make various promotions (Tuka, Video, LANDINGPAGE, Customized Web Page ...) to transmit professional medical knowledge according to the marketing period. And the article archives system can divide all medical information in the same class to become a knowledge platform with away. Through the system recorded user digital footprint, comprehensively analyzes user habits, and uses data to formulate future trends and achieve business goals!
Portal APP 下載
Medical activities support service
Service Introduction：
Provide traditional media or new media topics strategies to maintain a good interaction with government departments, media relations, medical and disease communities and market systems.
Program features：
Assist public relations services such as online and offline pharmaceutical activities and public health publicity, and assist in consulting and suggestions for consulting and suggestions of providing demand, providing medical public relations consultants and strategic communication services, assisting in maintaining relationships with the media, and training special press issues.
Service Details：
Since 2006, Caifu integrated marketing specializes in medical media and public issues in pharmaceutical/biotechnology/science education. According to the news planning goals, formulate professional topic strategies and exposure channels, create sound volume, and improve topic exposure.
Portal APP 下載
Pharmaceutical e-commerce distribution service
Service Introduction：
Provide pharmaceutical factories on health products, care products, medical materials management and e-commerce and marketing services, and provide professional medical channel sales solutions.
Program features：
MEDIA-WIND HEALTH E-COMMERCE has licenses for sales of drug dealers and medical equipment dealers, and can distribute professional products of pharmaceutical factories. From brand strategy formulation, marketing image formulation, planning execution to online and offline channel layout integrity planning .
Service Details：
International Pharmaceutical Factory Professional Products Brand Management: Brand Marketing Strategy Drawing and Practice, Brand Official Website Management, Members Deepening Management, AE Definition Report; E-commerce marketing operations: advertising, data analysis, sales strategy formulation, multi -channel layout; and line lines; and lines Lower Tong Road layout: Professional medical care institutions, closed -type community operations, corporate group purchase development.
Portal APP 下載
MediCom Health support program partner
Service Introduction：
Assist all kinds of institutional units to put the patient welfare plan on the healthy supermarket platform,For patients, check the relevant patient support plan information in one stop.
Program features：
The company has the well -being plan for the planning for specific patients, but does not know where to accurately put the plan information to the qualified patients? This plan helps the industry partners to quickly find out the disease that meets the indications that meet the indications that meet the indications that meet the indications that meet the indications that meet the indications. Patients, and accurately provide the plan information to the other party. In addition, through blockchain technology, in order to not expose the patient's personal capital, assist in the health and well -being designed for special patients. And through system settings, provide highly accurate marketing channels. Media and exposure provides the plan to provide relevant plan information to patients who meet the relevant indications, as follows: the following three steps:
1) The plan specifications are drafted, and the plan specifications include the plan name, the plan interval, the plan of the plan, the planning of the plan, the plan of the plan and the related icons and the addition, exit, review and the audit. Broadcast information and so on.
2) Receive relevant plan information in the project window will be checked with you (1) and assisted the plan on the shelves through the background.
3) After the patient's medical records obtained by the system assisted the background comparison, the promotion reminded the user to go to the meal and buy it.
Service Details：
"Medical and Diseases" uses blockchain technology to connect health insurance SDK, solve the problem of patient identity authentication, ensure the medical record information of the ownership of the ownership of the health passbook, and then quickly confirm the supporting plan and welfare resources that can be applied for. The service description is as follows:
1) "My Data" download medical record information: Online authorized series of health preservation, download medical record information, eliminates the hospital application time and cost
2) "My Data" creates a healthy passport: Cross -consultation is troublesome, sharing the medical records and medication details with one click.
3) "Health Plan" Welfare Resources: It is like a healthy supermarket and provides a series of health welfare plan information for members.
4) The application for "Health Plan" is simple: One -click censorship wants to apply for a health plan. Through "My Data", identity authentication is used to avoid repeatedly paying the administrative process of the identity document of patients.
Portal APP 下載
Precision sickness media joint marketing service
Service Introduction：
Assist patients with blockchain technology media to jointly produce relevant adaptive ethnic groups to provide precise marketing exposure to health plans.
Program features：
In addition to the health plan, there are focus marketing activities and precise push? Welcome to major brands or colleagues in the industry, such as banks and insurance operators to provide insurance or related marketing plans. And help provide relevant marketing activities to increase the proportion of accurate target groups to join the plan.
Service Details：
Precise marketing is a task that major operators hope to achieve. However, how to find the precise ethnic group has become the biggest dilemma in practice. This plan has been authorized by the blockchain technology to assist patients to help patients bring their relevant medical records information information. Authorized certification to mobile phones, and patients with background media -related adaptive ethnic groups provide precise marketing exposure to health plans.
Portal APP 下載
Pharmaceutical Bureau Card Road Campaign Cooperation (sample)
Service Introduction：
Provide marketing activities to discuss and match professional marketing consultant strategies.
Program features：
Whether it is marketing questionnaire filling in, product test drinking and public education publicity, provide you with a one -stop consultation plan to assist you with the local pharmacy and clinics to assist in negotiating the arrangements of media related activities to assist your marketing activities implement.
Service Details：
Sandaron cooperation marketing channel service provides you with the most direct and local marketing service needs, help brands go deep into local clinics and pharmacy, and assist the media to cooperate with various types of medical care, health education, marketing and other opportunities, including various questionnaires to fill in , Product promotion, health education publicity services, etc.
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pLOG
"Regulatory Upgrade of Patient Assistance Programs (PAP) in the Pharmaceutical Industry: From Compliance Management to Digital Transformation"
Regulatory Upgrade of Patient Assistance Programs (PAP) in the Pharmaceutical Industry: From Compliance Management to Digital Transformation
Increasing Regulatory Scrutiny on PAPs with Nearly Two Decades of Medicare Part D
As Medicare Part D has been in effect for nearly 20 years, Patient Assistance Programs (PAPs) established by pharmaceutical companies have increasingly become a focal point of healthcare policy. In recent years, the federal government has intensified regulatory oversight through the Office of Inspector General (OIG) of the Department of Health and Human Services and the Centers for Medicare & Medicaid Services (CMS). In particular, regulations governing PAPs provided through charitable organizations have become stricter, with the establishment of a multi-layered compliance management framework and mandatory regular audits. These measures aim to ensure drug accessibility while preventing the misuse of healthcare resources.
From Direct Subsidies to Independent Charitable Models
In 2005, the OIG issued a Special Advisory Bulletin, explicitly stating that pharmaceutical company-operated PAPs could pose a regulatory risk of violating the Anti-Kickback Statute. Additionally, such programs were considered to have the potential to induce inappropriate prescribing behavior. The advisory clarified that PAPs operating through independent charitable organizations must be subject to regulatory oversight. Conditions for compliance included establishing an independent board of directors, ensuring diversified funding sources, and maintaining transparency in fund allocation.
From Transitional Policies to Strict Regulation
During the initial implementation of Medicare Part D, the OIG allowed pharmaceutical companies to transition beneficiaries to independent charitable organizations within a reasonable timeframe. However, in recent years, regulators have mandated that companies submit clear transition progress reports, explicitly prohibiting the use of transition periods as a means to evade long-term regulatory compliance.
Publicizing Operational Standards for Charitable Organizations
Recent policies emphasize that independent charitable organizations must establish multiple safeguards, including diversifying donation sources, standardizing disease classification, and implementing structured financial approval processes. In 2023, a new regulation was introduced specifically addressing biosimilar drugs, requiring PAPs to clearly label reference drug codes and distinguish financial assistance calculations. These measures aim to enhance transparency in patient support programs while mitigating potential misuse.
Strengthening Compliance Data Management
CMS has placed a strong emphasis on data protection and compliance in data usage, requiring PAPs to maintain strict separation from Medicare system information, with data usage limited solely to eligibility verification. Additionally, electronic auditing technologies have been introduced, including blockchain-based record-keeping and AI-driven anomaly detection, reflecting the increasing trend toward technological regulatory enforcement.
Rising Antitrust Risks and Regulation of Collaborative Agreements
Recently, joint PAP operations by multinational corporations have come under heightened scrutiny. One multinational pharmaceutical company was fined several hundred million dollars for engaging in collaborative behavior, underscoring the government's strict stance on antitrust risks in patient assistance programs.
Digital Regulation and Real-World Data
Starting in 2025, electronic auditing will become a mandatory standard, and PAPs that fail to integrate into the system in time will have their operating qualifications suspended. Industry experts recommend proactively adopting digital compliance solutions to cope with increasingly complex regulatory requirements. Additionally, Real-World Data (RWD) and AI-based approval systems are expected to emerge as new regulatory focal points, signaling a comprehensive shift toward digital transformation in the PAP landscape.
