Reimbursement is a major challenge for many of the new digital health solutions whose importance, value and expansion have been highlighted and expanded due to the current COVID-19 pandemic. Germany's new digital health law (Digitale - Versorgung - Gesetz or DVG) gives all legal health insurance people the right to reimburse some digital health applications (for example, insurance companies will pay for their use). Given that Germany, like the United States (US), is a multi-payer healthcare system, the new law provides a particularly interesting case study for American lawmakers. First, we provide an overview of the new German DVG and outline the landscape for reimbursement for digital health solutions in the United States, including recent policy changes governing telehealth during the COVID-19 pandemic. Then we discuss the challenges and unanswered questions from DVG, ranging from the limited scope of the law to privacy issues. Finally, we highlight the first lessons and opportunities for other countries.
A recent survey of 284 health, life science and digital health professionals in the United States (US) revealed that 42% of respondents felt they were "likely" or "somewhat likely" to be partners or contracted with an AI company during the next day of the year. However, a large portion of respondents also believe that digital health associations face unique obstacles with respect to key issues such as price and reimbursement (26%) and data privacy and security (19%). Consequently, they have been reluctant to collaborate with digital health companies for various reasons. Of note is the fact that 60% of respondents believe that “established business models and reimbursement make it difficult to commercialize digital health products,” highlighting reimbursement as a major challenge for many new digital health solutions. The ongoing COVID-19 pandemic has emphasized and expanded the importance of digital health technologies, from the rapid transition to telehealth services to the development of alerting and contact tracing applications.
Despite the many differences, Germany, like the United States, has a multi-pay healthcare system with more than 100 independent insurers, making it a particularly interesting case study for American policy makers. On November 7, 2019, the German Parliament (Bundestag) adopted the Digital Healthcare Act (Digitale-Versorgung-Gesetz or DVG) 5, which was subsequently approved by the Federal Council (Bundesrat) and promulgated by the German President. In addition to improving the use of remote health services and ensuring better usability of health data for research purposes, the new law gives everyone covered by legal health insurance the right to benefit from some digital health applications (that is, insurance companies will pay for its use).
While DVG is seen by many as a breakthrough in stimulating and promoting the diagnosis, management and treatment of patients using digital health tools, the new law has also drawn criticism and faces a number of challenges in the future. In this article, we explain the relevant changes to the new German DVG and provide an overview of reimbursement for digital health solutions in the United States, including changes to the provision of telehealth and compensation during the COVID-19 pandemic. We then discuss the challenges and unanswered questions from DVG and highlight early lessons and opportunities for other countries.
New German digital health law
The German legal health insurance system is one of the largest health insurance systems in the world. Almost 90% of the population (that is, almost 75 million people) in Germany is covered by compulsory state-funded health insurance, while the remaining 10% are privately insured. First of all, by making amendments to the Social Security Act V (Sozialgesetzbuch V - SGB V), the DVG entitles those insured by an independent legal medical insurance provider in Germany to take advantage of coverage benefits for some health applications digital. This means that insurers will have to pay for eligible applications, making these digital health solutions widely available.
In general, policyholders are entitled to coverage benefits for digital health applications if these applications meet the following criteria:
- They are less dangerous medical devices;
- Its main function is mainly based on digital technologies;
- Its purpose is to support the monitoring, detection, relief, treatment of illness, compensation, detection, relief, treatment of injury or disability in the case of injured persons or in the care provided by service providers;
- They are included in the newly created official register of digital health applications maintained by the German Federal Institute for Medicine and Health Products (Bundesinstitut für Arzneimittel und Medizinprodukte - BfArM).
- It is used with the approval of the health insurance company or with the prescription of the treating physician or psychotherapist (SGB V, § 33a (1)).
Low risk medical devices, as defined in the first requirement, are those classified as Class I or Class IIa medical devices according to the European Union Medical Device Regulation (MDR) 2017/745 or the Medical Device Directive of the European Union 93/42 / CEE (MDD).
To meet the fourth requirement, each digital health application must be listed in a newly created registry maintained by BfArM. At the manufacturer's request, BfArM will assess whether the manufacturer has provided evidence that its digital health application meets the following requirements: security, functionality, medical device quality, data protection, state-of-the-art data security, and positive impacts on care. (SGB) V, § (2)). BfArM will make a decision on the manufacturer's application within 3 months after receipt of the complete application documents (SGB V, § 139e (3)).
If the manufacturer meets all the requirements except the last one (that is, the positive effects on care - "Versorgungseffekte Positive"), the digital health application can be included in the registry for an initial (trial) period of 12 months ( SGB V, § 139e (4)), and during these Period The manufacturer must provide evidence of its effect on care. The explanatory memorandum clarifies that these effects constitute one of two things: medical benefit (that is, therapeutic improvement through a positive effect on patient-related end points, such as quality of life), or structural and procedural improvements of medical care, for example, improvement of patient information and patient sovereignty, better coordination of care processes. , Etc. The memo also states that medicinal benefit can be demonstrated through expert opinions, case reports, application notes, studies, or other valid results. If the manufacturer cannot provide sufficient evidence during the first year, BfArM may extend the term for another 12 months if there is a high probability of subsequent verification based on the preliminary information provided (SGB V, § 139e (4)).
Recently, on April 9, 2020, the Digital Health Applications Decree (Digitale Gesundheitsanwendungen-Verordnung-DiGAV) came into force. DiGAV regulates the procedures and requirements for reviewing payment eligibility for digital health applications by legal insurers. In particular, the decree specifies the details of the inclusion of digital health applications in the registry, including the means to demonstrate evidence of positive effects on care. In the meantime, BfArM has also published a guide for manufacturers who interpret DiGAV and provide additional details on record listing procedures (SGB V, § 139e (8)).
Once a digital health application is included in the registry, the National Association of Statutory Health Insurance Funds (“GKV-Spitzenverband”) begins the process of negotiating a standard repayment rate (“negotiated price”) with the manufacturer (SGB V). This rate is then applied to all statutory health insurers 12 months after entering the digital health application in the registry (SGB V, § 134 (1)). During the first year, the manufacturer's price list applies SGB V, § 134. In the event that the manufacturer and the National Association of Statutory Health Insurance Funds cannot reach an agreement on a negotiated price within one year, the jury will determine the reimbursement price within three months of SGB V, § 134.
DVG also aims to accelerate the adoption and use of telehealth services. In particular, with DVG, the patient can more easily benefit from video consultations. During this counseling, the patient may be informed of the circumstances necessary to consent to a medical procedure, including its nature, scope and implementation, and the expected risks and consequences (SGB V, § 291g (4); BGB 14, § 630e) 6. Previously this was only possible after a consultation in the doctor's office prior to a video consultation 6. Furthermore, doctors in Germany can now announce video consultations whenever appropriate treatment and advice is possible, based on a state of recognized medical knowledge (HWG 15, paragraph 9) 6.
The use and value of remote healthcare tools, such as video consultations, have increased during the COVID-19 pandemic. Due to the spread of the virus, the National Association of Statutory Health Insurance Physicians (“Kassenärztliche Bundesvereinigung”) and the National Association of Statutory Health Insurance Funds have lifted restrictions on the number of cases and the amount of services to be can be provided through video consultations 16. Previously, one in five patients could only be treated by a physician or psychotherapist through video counseling and these consultations were limited to 20% of the total of 16 services provided. While now clinicians can use video counseling flexibly in all therapeutically relevant cases, Psychotherapists are limited to videoconferencing for some services and can practice telehealth only after personal consultation including preliminary diagnosis, indication and provision of relevant information 16. For telehealth visits, physicians and psychotherapists must use one of more than 30 certified video service providers 17 and generally must notify the Association of Statutory Health Insurance Physicians ("Kassenärztliche Vereinigung") They are using an approved provider to be eligible for 17 utility bills.
The DVG also contains provisions to make demographic data from health insurance companies more usable for research purposes (SGB V, § 303a to 303f). In particular, according to the General Data Protection Regulation of the European Union 2016/679 (GDPR), DVG allows some beneficiaries, such as universities and research institutions funded with public funds (for example, the Max Planck Association) to process certain demographic data of health insurance companies for specific purposes. Research purposes, especially to analyze treatment or care processes or longitudinal analysis for longer periods (SGB V, § 303b, 303e (1) and (2)) 6. These data may include information on the patient's sex, age, place of residence, vital status, date of death, and billing information such as Hospital Treatment Bills (SGB V, § 303b (1)). If researchers can clearly explain the relevance and necessity of the required data scope and structure, then the responsible research data center will send the data to them in an anonymous and aggregated format (SGB V, § 303e (3)). In certain circumstances, individual data records may also be provided in the form of aliases (SGB V, § 303e (4)). Researchers can only use this data for the agreed purposes and the data generally cannot be passed on to third parties (SGB V, § 303e (5)). The details of these data sharing research agreements will be further regulated by a new decree of the German Federal Ministry of Health (SGB V, § 303a).
Digital Health Solutions Compensation in the United States
In the United States and other OECD countries, there are few large-scale formal mechanisms to pay for digital health solutions. However, recent developments, including COVID-19, have increased the coverage of other digitally delivered services, such as the use of "telehealth," a term that broadly refers to "providing health care, health education, and health information through technologies. remote ". 18.
The major player in the United States healthcare system is the Federal Medicare Program, which provides insurance coverage to more than 60 million Americans (19). Since 2019, Medicare Part B (Outpatient Health Insurance) has provided insurance coverage for some telehealth services, such as office visits, psychotherapy, and other counseling, and more telehealth benefits are expected for Medicare Advantage beneficiaries (plans that offer). Private companies certified by Medicare) in 2020 20.
During the COVID-19 pandemic, Medicare deliberately expanded telehealth coverage policies. For example, all Medicare beneficiaries can now receive telehealth services provided by physicians, regardless of whether they are new or established patients and where they are located 21. The (temporary) ability of physicians to provide care across state lines represents a dramatic departure from the regulations of American historical practice. Additionally, health care providers have also been given the option of waiving copayments for such services for Medicare Part B 21 beneficiaries. Additionally, a wide range of professionals can now provide telehealth services to patients; These include speech-language pathologists, occupational therapists, and physical therapists. 21. Medicare Advantage beneficiaries can also receive more telehealth benefits than before.
The US market is vast, and coverage for specific products and services, in addition to mandatory basic health benefits 22 and medically necessary ones, is determined by individual payers 23. However, Medicare coverage decisions generally play an important role. in shaping other payer coverage strategies and are a precursor to private coverage in many but not all contexts. As the nation's largest and most influential payer, it's interesting to explore the payment methods of Medicare and its parent agency, the American Center for Medicare and Medicare Services (CMS).
Historically, Medicare reimbursed for health care services on a fee-for-service basis, that is, "physicians and other health care providers are paid for each service rendered." billing, but may fail to drive quality of care or value, defined as health outcomes for every dollar spent 26. In a fee-for-service system, digital health solutions face an uphill battle to reimburse costs: Few of the existing billing codes apply to these tools, so manufacturers must seek alternative strategies to obtain funds, such as requiring physicians to pay for digital tools.
During the COVID-19 pandemic, the use of telehealth services has increased dramatically 28. This can be attributed to the multiple temporary changes in telehealth coverage policies described above 29. In particular, to boost the use of telehealth services. telehealth, Medicare announced that health care providers can now bill a telehealth visit at the same price as if it were a personal visit 30. Some private insurers have also introduced pay equity for telehealth 2. However, policy changes telehealth coverage will not be formally extended until the COVID 19 pandemic and, as such, new post-COVID-19 models will need to be developed to deliver care and reimbursement that maintain the widespread use of telehealth services where they are effective, but avoid the telehealth overpayments (generally) that are (generally) shorter compared to in-person visits two.
In addition to telehealth, in the absence of a broad set of standards for digital health cost reimbursement such as those introduced in Germany through DVG, even clinically proven digital health solutions are struggling to define a viable reimbursement strategy in the US market, where neither patients nor doctors believe they should bear the cost of these tools. Furthermore, payers, who benefit most from the widespread adoption of effective digital health solutions due to their ability to reduce overall costs, are not operationally equipped to ensure their clinically appropriate adoption and / or continued compatible use 31.
In the absence of coverage rules and guidelines, other payment strategies have been highlighted as a possible way forward for using and paying for digital healthcare solutions in the United States and other countries. An example of this payment strategy is the use of bulk payments. Unlike the fee-for-service payment, the combined payments include a price for all care necessary to treat a specific medical condition for a 32-year-old patient. In cases where the 'package' is used, any tool that has the potential to reduce the overall costs of care, for example through readmission to hospital, will be attractive to healthcare providers, even if some of the input costs increase. Over the past decade, CMS has experimented with using bundled bundles for Care Improvement Initiative 33. Eligible bundle adjustments include acute care episodes such as coronary artery bypass surgery and major joint replacement, as well as some chronic conditions like COPD and diabetes. All of these cases are likely to benefit from digital health solutions, with the greatest long-term potential likely to come from fees that facilitate chronic disease management, creating value on an ongoing basis.
National coverage rules, such as those created by the German company DVG, as well as the increasing use of value-based payment methods, such as batch payments, can spur the adoption of digital health solutions. However, the combination of the new payment approach and national coverage rules will go further to stimulate the development and adoption of innovative and beneficial digital healthcare solutions. Although both approaches encourage the use of proven solutions, not all medically beneficial solutions will be promoted through value-based payment models, only the subset of offerings that lead to lower costs of care associated with the overall condition. National coverage rules.
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