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Remote patient monitoring (RPM) devices – fitness watches, blood pressure, cardio monitors – are growing in popularity as a way to gather and correlate data outside of a traditional clinical setting and share up-to-the-minute data with care providers. However, health tech entrepreneurs and developers must understand the revenue cycle management (RCM) aspects of the telehealth and RPM market and stay up-to-date about regulatory guidelines to ensure profitability. Some basics:

1. Medicare requires reimbursable telehealth technology to have an interactive audio-video component.

2. Telehealth technologies must be used in designated sites called “originating sites” – often not the home.

3. RPM is defined differently from telehealth by Medicare. Medicare pays for RPM services with no additional requirements regarding originating sites or use of the telehealth place of service codes. This allows for patients to receive RPM services in their home.

4. Because of the complications is using CPT code 99091, the Centers for Medicare & Medicaid Services (CMS) introduced three new codes for RPM services in 2019 – codes 99453, 99454, and 99457.

5. For telehealth (not RPM), the American Medical Association, released six new CPT codes to support virtual visits. Watch for additional CPT codes coming in 2020 for telehealth and RPM.

Successful reimbursement-based revenue depends on complex billing mechanisms beyond the CPT codes. State-based laws can also affect telehealth and RPM billing. Know how federal and state entities define, fund, and regulate healthcare delivery options when it comes to remote care. Work with RCM experts to determine if your RPM-based care delivery model can generate adequate revenue using these codes.

2020 looks to be a landmark year for finalized regulations dictating how health data can be exchanged.  Health technology entrepreneurs must understand the regulatory landscape of how care can profitably be delivered.  Your clients – hospitals, provider groups, payers and patients – will be affected by these finalized regulations.  Gone are the days where hospitals and providers were simply concerned with mandatory collection of certain data points to recoup investments in electronic health record systems through government incentives.

Health providers in the post-Meaningful Use era are focused on how to efficiently leverage health data for improved health outcomes and maximizing value-based reimbursement payments.  Time is money, and providers need health data technology that provides actionable data, strengthens the provider-patient relationship, and personalizes the ever-shortening clinical visit window.

Moving forward, health data applications will thrive or die based on their ability to access, exchange and analyze health data from multiple sources providing comprehensive and relevant views of an individual’s health story.  In a highly regulated market such as health care, it would be remiss to not fully understand how this year’s finalized health regulations will affect you or your clients.  Some important regulations to follow:

• The Information Blocking Rule from the Office of the National Coordinator for Health Information Technology (ONC).

• The Health Data Interoperability Rule from the Centers of Medicare and Medicaid Services (CMS).

• Trusted Exchanged Guidance from ONC.

• The Stark and Anti-kickback Updates from the Office of the Inspector General (OIG) and CMS.

In the New Year, Elevation will be blogging on regulatory provisions, governmental resources, related business opportunities, red flags, stakeholder sentiments and implementation best practices. Stay tuned.

Almost a third of the US population will travel during the holidays. With flu season already in full swing, tracking flu outbreaks is vital to caregivers of small children and the elderly, in addition to those with compromised immunity. Those building health and wellness apps to support caregivers tracking medical information for their loved ones have access to multiple surveillance databases from the Center of Disease Control (CDC) that may be of interest.

CDC’s National Syndromic Surveillance Program (NSSP) BioSense 2.0 Platform: Originally developed to support counter-terrorism efforts post 9/11, BioSense now collects a vast amount of information from health outbreaks to injury prevalence to drug-related overdoses.

CDC’s WONDER Program: WONDER manages almost 20 different collections of health information including data on births, deaths, cancer diagnoses, tuberculosis cases, vaccinations, environmental exposures, and population estimates.

CDC’s Prevention X Program: Prevention X is a new program in development that aims to collect information of chronic disease prevention.

In this season’s motto of giving and not just receiving, it’s important to highlight the CDC’s history of public and private partnerships build the rich data within their programs and databases. The CDC works to establish partnerships with hospitals, state entities, and private industries to gather valuable information that provides the most wholistic view of public health. CDC’s historic and ongoing partnership with Google to enhance flu outbreak data has proven successful for years. The CDC continues to seek collaboration with industry to obtain data, test the robustness of their data platforms, and develop better data standards to more efficiently “give and receive” syndromic surveillance information.

Happy Holidays and keep on sharing…data.

Are you building an application that allows an individual or a provider a comprehensive view of a person’s health care journey? Have you run into data access barriers when trying to link into a person’s health data from a hospital system’s electronic health record (EHR) system?  The federal government will soon release new rules that may open access to this coveted data – helping you provide a fuller value to your company’s digital health solution.

The Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule is expected in early 2020, defining scenarios in which data sharing can be refused.  Outside of these scenarios, holders of health data will be considered “information blockers.”  All certified digital health technologies, as defined by the Department of Health and Human Services (HHS), must comply with this Rule – most likely – within months of the Rule being released. The scenarios for refusing data sharing will be limited, thus opening the opportunities for developers to request data access for their applications.

Here are some important takeaways from HHS’ Information Blocking Rule:

• The Good: HHS wants more choices for patients and healthcare providers. This opens opportunities for health IT developers to create easy-to-use interfaces for patients to access their health information on smartphone apps –while still ensuring security and privacy.

• The Bad: Health IT developers must display tact in preparing for the potential ‘disruption’ regarding how electronic health information will need to be shared by healthcare facilities.  Most likely, these providers and hospital systems will be scrambling to understand what they can and can’t share.  Since they may be your potential clients or partners, establish your knowledge – while avoiding an adversarial posture – of the Information Blocking Rule.

• The Ugly: Fines imposed for information-blocking may reach $1 million per infraction for vendors. In September, a Florida hospital was fined $85,000 for delaying a patient’s timely access to records.  After the passage of the HHS Information Blocking Rule, you can anticipate more enforcement actions similar to the Florida case throughout the industry.

This new world of mandatory data sharing is sure to present additional hurdles to understand and navigate – stay tuned for updates from us once the Final Rule is released.

With almost 20% of our nation’s GDP tied to health care, an often complex and convoluted sector, it is an exciting time, ripe with opportunities to disrupt the status quo and create tech-enabled efficiencies for large scale profit.  However, it is crucial to understand that positive disruption in the health sector must combine the realization of improved patient outcomes and cost savings.  This cannot happen without data interoperability…and data interoperability is impossible without standardization.

It seems like an oxymoron for standardization to be essential for disruption, but the drive to standardize health tech data to achieve interoperability is steadily gaining momentum. CMS has put their shoulders behind FHIR® based application programming interfaces, a data standard developed and maintained by the standards development organization HL7.

Why FHIR? Because adoption determines the success of any standard.  Multiple health stakeholders have committed to adopt FHIR, such as major EHR vendors, tech developers, and hospital systems. To use or be compatible with FHIR, this standard will likely become the health sector’s default.  Building your tech using FHIR profiles is now a no-brainer.

Already,  87% of hospitals and 57%  of Merit-based Incentive Payment System-eligible clinicians are served by tech products certified to FHIR Release 2. Incorporating the requirements from the Office of the National Coordinator for Health Information Technology (ONC) for FHIR interoperability standards into tech platforms is a must for developers looking to effectively and profitably disrupt health delivery.

Digital health tech entrepreneurs find themselves grappling with the following question as the buzz around social determinants of health (SDoH) data gets louder:

What’s the return on investment (ROI) for incorporating SDoH data capabilities into our platform, product or service? 

Most of our personal health story happens outside of the walls of clinical care delivery organizations. With the Centers for Medicare & Medicaid Services (CMS) and other payers moving to a value based care (VBC) reimbursement system, it seems common sense to understand the factors, such as SDoH, affecting an individual’s health outcomes beyond their clinical encounters. Though the current percentage of VBC payments hovers around 35 percent, most sub-sectors across the health deliver ecosystem agree that this percentage will rise over the next 5 years.

The value of SDoH lies in the opportunity to enhance predictive analyses for VBC-based business models. The ROI in these analyses depends on the accessibility and usability of SDoH data. However, the practicalities of exchanging and using non-standardized SDoH data has been a major limiting factor in its use. Multiple private payers agree and have now joined forces with other key health delivery stakeholders to create much needed data standardization for SDoH.

The rise of VBC payments coupled with the enforcement of new health data interoperability requirements by 2020 opens the door for both the ability and appetite to integrate SDoH into downstream health care innovations.  Unless you are planning for acquisition in the next year or so, ignoring SDoH data in your product design may cost you revenue potential.

Want to understand more about how regulatory forces will affect your health tech innovations? Meet with us at HLTH 2019 this Oct 27-30th.

Health tech disruptors creating in-home monitoring and wearable technologies that collect health data may be interested to know that the FDA is getting into the business of what they call “Real World Data (RWD).” RWD is data, often collected directly from the user or patient and provides information on  their health beyond a clinical encounter, like a visit to the doctor. This month the FDA awarded over $200 million to fund the next five years of their drug surveillance data program, The Sentinel Initiative.

The FDA’s vision, based on their Initiative, is to expand upon use of real-world data sources in order to enhance evaluation of medical product/drug performance. To achieve this aim, the new Sentinel award will include funds for an innovation center that focuses on developing and syncing with new technologies that funnel RWD to the FDA’s Sentinel Initiative.

The FDA is exploring new avenues of user-derived information beyond intended investments in accessing and use of EHR data. Currently, the agency has little to no access to data regarding the real-world experiences of patients that focus on their personal perspective, such as:

• improvement or decline in ability to perform Activities of Daily Living (ADLs)

• whether the medical device or drug helps or hinders

• if a medication causes depression or boosts mental outlook

New projects must explore the effectiveness of information received from patient-derived data. That implies direct engagement with users inside and outside the scientific community. The FDA stated in its Sentinel Five Year Strategy, that wearables, mobile health technologies, and other wireless technologies will be data sources important to their surveillance efforts.

To keep up health technology activities at the Sentinel’s new Innovation Center, tune in here.

This February, draft federal rules on health data interoperability, information blocking, health IT certification, and health data exchange related to Medicare/Medicaid conditions of participation were proposed by the Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health IT (ONC). After releasing these proposed new rules CMS and ONC opened the field to comments and questions from interested and invested parties such as health care companies, providers, and current and future patients. In part 1 of this series, ONC Rules On APIs, Information Blocking, and Data Exchange, we dove into the implications that stakeholder sentiments on the ONC rule may have on digital health or health IT-enabled companies. Here we’ll focus on how the top issues raised by stakeholders on the CMS Interoperability and Patient Access Proposed Rule may impact your current business model and product designs. While the CMS rule targets providers and health plans, the changes this rule will demand, in it’s  final form, will have impacts on digital health companies or technology vendors. Companies building health technologies or offering health IT enabled services must design solutions that address provider burdens and patients’ desired outcomes in order to be successful in today’s CMS-influenced health care markets. Understanding public input on the draft versions of these federal rules and preparing for the final versions should not be overlooked—this can improve your company’s sustainability trajectory. Our experts at Elevation Health Consulting have poured over the array of submitted public comments and distilled the following top five takeaways:

1. API-based access for patients and caregivers to their health information: CMS’ rule requires Medicare Advantage organizations, state Medicaid Fee For Service (FFS) programs, Medicaid managed care plans, Children’s Health Insurance Program (CHIP) FFS programs, CHIP managed care entities, and Qualified Health Plans (QHPs) issuers in Federally Facilitated Exchanges (FFEs) (excluding issuers of Stand Alone Dental Plans (SADPs)) to implement, test, and monitor an openly-published API that is accessible to third-party applications and developers. This is designed to help give patients access to their longitudinal health information via the Application Programming Interface (API). CMS’s intent here is to provide patients and caregivers with the full breadth of the patient’s electronic health information so that the patient can fully control their information and actively engage in their own health care. Commenters were largely in favor of this change. However, there were concerns that the information provided to the patient might be of minimal value or difficult to interpret (such as a document with a billing code, or an imaging test that does not include the image itself). They were also concerned that individuals may not understand the HIPAA implications of downloading or sharing their health information through an API.

What this may mean for your company – This issue raises an opportunity for health IT developers to create user-centered health IT interfaces that allow patients to better access their health data, interpret their health conditions in actionable layman’s terms, and transmit their health data to their care team . Patients require more information in order to more easily and effectively engage in their care and make decisions that truly represent the outcomes they desire for themselves. The market is ripe for middleware products that provide “data access with guidance” to provide patients and caregivers maximum utility of the health data CMS is enabling them to now access and control.

2. APIs between providers and payers: The CMS proposed rule included a request for information (RFI) regarding the sharing of information across APIs between providers and payers. The data to be shared falls into two categories: payer/claims data (e.g., billing codes that indicate what services were provided) and encounter data (e.g., physician notes, clinical encounter details not added to billing data). The RFI signals CMS’s interest in exchanging both types of data but falls short on clarifying the implementation approach. As a result, many commenters requested that CMS also include requirements for dates-of-service data. Commenters noted the lag time between the dates services are delivered to a patient and when claims are processed. Without the availability of dates-of-service information, commenters were worried that large scale data analyses will result in faulty conclusions and therefore should only be for educational purposes.

What this may mean for your company – If your company is in the business of collecting, storing, or exchanging health data via APIs, it will be critical to ensure date-of-service metadata as part of your platform’s design. Even if CMS does not require date-of-service information this time around, it will most probably be included in a future version of the rule. Most importantly dates-of-service metadata that travels with exchanged health data will allow your data platform to immediately be more valuable to your “provider” and “payer” clients who will be using this data to improve their revenue models.

3. Patient Event Notification Requirements in Conditions of Participation (CoPs): CMS has proposed new Conditions of Participation (CoPs) that require Medicare and Medicaid participants to meet certain data interoperability capabilities or lose the ability to participate in Medicaid and Medicare programs – even if they never received health IT incentives (a.k.a Promoting Interoperability Incentives) from CMS. One such CoP requirement involves notifying the patient’s primary care physician (PCP) of a new patient event outside of the PCP’s office. Commenters on this requirement fell into two groups: those who do not receive health IT incentives felt that these rules were punitive and costly. However, data interoperability and continuity of care advocates were very much in favor of this CoP requirement and felt that requiring everyone to participate would result in significantly improved patient outcomes.

What this may mean for your company – If your company supports health professionals and their practices in serving Medicaid and Medicare beneficiaries, they’re going to need your application or service to support patient event notification to the patient’s primary care physician. Building on the previous section, dates of services will be important for creating a comprehensive medical record. Clients who have not been previously incentivized to adopt health IT may be more reluctant to adopt digital platforms and services that do not directly correlate to CMS requirements. Your company must design relevant revenue models that recognize which stakeholders are in a position to support any products to meet CMS’s interoperability CoP requirements, including patient event notification capabilities. Our experts at Elevation are familiar with numerous areas of additional HIT funding and novel approaches to revenue models that support various health care providers, whether they do or do not fall within federal definitions for Meaningful Use Health IT Incentive dollars.

4. CMS is doubling down on National Plan and Provider Enumeration System (NPPES). In July 2018 CMS updated the National Plan and Provider Enumeration System (NPPES) to include digital contact information for providers. However, many providers have not added their information to the system. CMS is now requiring that providers add their practice information and proposes public reporting of providers who do not add their contact information within a specified timeframe. While many commenters supported this update, some worried about its practicality in modern distributed health care practices, such as telehealth. While it may have been true that a typical doctor’s office used to have one address and phone number, it may not be practical or realistic to assume that all healthcare providers do. Those who work in multiple locations (such as a multi-office private practice or a hospital system) or health care professionals who do not have a traditional office probably don’t have one single address. Other considerations include telehealth professionals who worry about their own safety if they are required to add their home address and phone number.

What this may mean for your company – While CMS is getting pushback on this requirement from some stakeholders, you and your company will have to provide a product or services that can incorporate different care delivery modalities for the practicing providers – whether it be institution-based, community-based, telehealth/virtual, mobile – but takes physician safety seriously. This suggestion is particularly important for Health IT companies employing telehealth models where they have providers deliver care exclusively through their remote platforms.

5. Timing of the Trusted Exchange Networks requirements. One new provision would require MA plans, Medicaid managed care plans, CHIP managed care entities, and QHPs in the FFEs to participate in trusted exchange networks. Many commenters were very supportive of this provision, but they want CMS to ensure that requirements to participate in trusted exchange networks are aligned with ONC’s final Trusted Exchange Framework and Common Agreement (TEFCA) guidelines and do not go into effect until they have reasonable time to comply with TEFCA. The final TEFCA rule is expected at the end of 2019.

What this may mean for your company – ONC’s TEFCA rule may be released as early as this year. Enactment dates can differ from the date a rule is released, so paying close attention to them could save you and your company time, money, and headaches. Building in a buffer within your business strategies and product release timeline lines that allow you to incorporate the TEFCA rule and enable your clients to become TEFCA complaint could result in significant cost and time savings. For example, it will be crucial to determine if and how your product will interface with or serve as a health information service provider (HISP) and what local or regional data exchange partnerships will make sense for your company. Our experts here at Elevation Health Consulting have spent the better part of their careers working with ONC and CMS on all the rules and guidelines mentioned in this blog. We can help you work through the business implications of these new regulations.

Overall, commenters were supportive of improving API capabilities to exchange data, both between providers and payers, and payers and patients. Stakeholders seemed to be unified in seeking increased utility of health data for improved patient outcomes as well as streamlined and optimized payments. However, there are several pitfalls an unsuspecting health tech company could find themselves when providing digitally-enabled services to health providers, payers and patients if certain aspects of this draft rule survive in the final version. Paying close attention to the CoPs and enactment dates are key. Our experts are available to aid you in navigating these changing rules and regulations to help you and your company optimize compliance, maximize revenue, maximize relevance in today’s health care delivery market.

Since this past February, many health IT companies have been reviewing, commenting on, and trying to understand the business model and production implications of the newly proposed Federal rules on health data interoperability, information blocking, health IT certification, and health data exchange related to Medicare/Medicaid conditions of participation. If your business touches the health IT sector and you haven’t been following these rules, you should be—the final versions of these rules will be game changers for the health IT sector. Now that the comment periods for these rules have closed, Elevation Health Consulting is working to support savvy health IT business leaders in trying to understand public sentiments and anticipate regulatory language for the upcoming final versions of these rules to accurately steer their companies.

We have poured over the public comments submitted on these draft rules and want to provide you with important common themes that have risen from health IT stakeholders across the health sector. Here, we’ll focus on the draft rule released by the Office of the National Coordinator for Health IT (ONC) that focuses on ensuring that health information technology (HIT) systems send and receive electronic health information (EHI) in a way that would make the information more readily available to users across platforms while ensuring patient privacy and security. Notably, the rule includes information blocking exceptions, which specify what is and is not information blocking. Information blocking is defined as: a health care provider, health IT company, or health information exchange or network attempting to block the sharing of EHI. The goal of these updated rules is to encourage competition in the Health IT field while simultaneously helping patients access their information in a helpful, secure way.

Here are the top 5 issues raised in public comments on the February 2019 ONC draft rule:

1. Movement towards FHIR APIs for certification: While most commenters supported the ONC’s decision to update the certification program to Fast Healthcare Interoperability Resources (FHIR®) standards, there were a mix of commenters who want the ONC to drop the certification requirement for application programming interfaces (APIs) or felt that compliance would be too expensive, both for the Health IT company as well as patients. In order to assuage these cost worries, both monetary and level of effort, most commenters believed that FHIR Release 4 would be the best option, as it is the most standardized and forward-looking. Additionally, developers not currently using Release 4 will have time to adopt and implement these standards. Commenters also noted that Release 4 is the only version that has backwards compatibility with prior versions of FHIR and can manage population level-data.

What this may mean for your company – Your company should be thinking about adopting FHIR Release 4 for data exchange. Consider the fact that you may need to invest additional business resources to update your product design and become ONC certified. That said, if ONC finalizes a requirement for certified health IT developers to adopt FHIR Release 4 there will be plenty of time for vendors to adopt the standard.

2. The definitions of HIN, EHI, and Providers: Many of the commenters felt that the way the ONC rule applied these terms to companies and providers was much too broad. They felt that this could lead to misunderstandings about who the information blocking rules are applicable to and what information could, or should, be disclosed. For example:

a. On the HIN (Health Information Network) definition, the feedback noted that basically every vendor who provides even a tiny slice of interoperable capabilities is a HIN, and could include organizations such as banks who provide electronic payment for claims. This would encompass a number of companies that have not considered themselves part of the industry, and require them to follow ONC’s rules.

b. Many commenters worried that the definition of EHI was too broad and could cause companies to release more information than necessary in order to avoid an information blocking penalty. The expansive definition also makes data not normally thought of as health data (such as risk scores, clinical decision support rules, etc.) freely available to everyone, including those who did not pay for the development of such data .

c. In the current version, commenters felt that ONC’s definition of “provider” is too broad and includes many sectors of stakeholders who never received Health IT incentive dollars for the government’s Meaningful Use (of Health IT) program to improve their health information interoperability capabilities. Commenters from these sectors felt that it would not be fair to be held under the same umbrella as those groups who received government assistance over the last decade.

What this may mean for your company – If your business products and data platforms hold data, you will want tighter definitions of these terms that provide clarity on which rules will apply more specifically to you. Broader definitions will require more effort and resources to avoid government penalties for non-compliance. However, if your company’s products rely on increased data access to information from other health data stakeholders, you will want ONC to stick to broader definitions so that information blocking rules will apply more widely to entities from which you want data access. Note that most products that rely on access to information from other stakeholders would also be regulated themselves should the broader definitions remain.

3. Clarification on EHI privacy and security updates: Many commenters were concerned about the stated exceptions to information blocking regulations and how they would interact in real life situations. They are worried about having to choose which rule to break, HIPAA or information blocking. Additionally, commenters are concerned about entities that take overly broad interpretations of HIPAA, as they worry these organizations will use it as a justification for avoiding information blocking requirements. Stakeholders have asked for clearer rules that lay out specifically how to release/hide information to protect patient confidentiality without violating information blocking rules or running into an issue of other companies not acting in good faith and trying to hide information blocking tactics behind adhering to HIPAA regulations.

What this may mean for your company – Clearer rules will help your company avoid accusations of information blocking (and the possible legal and monetary consequences) or prevent other companies from using these overlaps to gain an unfair advantage. Wherever the ONC rule remains ambiguous, you will have to create a business model that incorporates time and resources to learn from real-world evidence regarding what penalties the federal government will enforce around information blocking practices.

4. Definition of “costs reasonably incurred”: Commenters were noticeably worried about what “reasonable costs” meant in relation to companies using information blocking (particularly blocking access to, exchange of, or use of EHI) to recoup costs (or make a profit). Some commenters were concerned that this was open to a large array of interpretations and that companies could choose to understand it as they wanted. Others were concerned that companies would not be able to remain sustainable and may be beholden to product design decisions made before this rule was proposed. Commenters seem to be looking for a more defined explanation of what “reasonable” might mean in regards to company size or age, and want the ONC to lay out how companies can generate appropriate profit for valuable tools and services without federal overstepping.

What this may mean for your company – If your company’s revenue model relies on fees for data access, data processing data exchange, or even services such as risk score or clinical decision support generate, this portion of the ONC rule can have major consequences to your bottomline. You will want ONC to lay out an even playing field that ensures your cutting edge technology can be a profitable business without withholding access to patient, customer, and client information arbitrarily.

5. Timeframe of rule enforcement: As we noted in a prior blog, just because a law is signed does not mean it immediately goes into effect. Many commenters interpreted the information blocking provisions as going into effect the day the rule is finalized, and worried about the new business and accounting practices that entities would need to adopt to comply with the regulations. This will be a reality for some of the information blocking rule exceptions. However, the certification requirements in the rule would not go into effect until years after the final ONC rule is published. This would give invested parties plenty of time to make their companies compliant in a reasonable and responsible way.

What this may mean for your company – Your company must consider scenarios where information blocking may be enforced immediately. That said, ONC’s intent seems to be for case precedent to define information blocking outside of what they have specifically defined as “not information blocking.” This means that in some cases, it may take some time to identify some of the nuances around the definition of information blocking against which your company can design evolved business strategies and product designs. It will be important to seek counsel from experts on the breath of the “information blocking” definition throughout the next few years.

Overall, commenters appreciated ONC’s aim to improve the flow of information, but advised that the final outcome of ONC’s rule would not produce the intended results and would in fact lead to multiple unintended consequences. Stakeholders are looking to ONC to release a final Rule with less confusion and potential pitfalls, that incorporates better business sustainability. Whatever direction ONC takes, it will be important for you to work with regulatory experts, like Elevation Health Consulting, to stay ahead of the competition and to navigate this changing environment seamlessly.

Stay tuned for our next blog where we will cover the business implications of the top issues stakeholders addressed in the 2019 CMS Interoperability and Patient Access Proposed Rule.

It’s probably been a long time since you were knowledgeable about civic processes, but as a business owner the knowledge of how a bill becomes law can be foundational to your business’s strategic trajectory — knowing when and how to influence policy and regulation can have significant impacts on your bottom line. Say you want to propose a law that could clear a path for tremendous growth for an industry in general, and your company in particular. Many current laws on the books are outdated for the rapid advances in health information technology, outpacing the ability of our legislative processes to keep up. If you’re not paying attention and getting solid guidance about the regulations impacting your business, a law might be proposed that could put a chokehold on the future growth of your company and you would miss your chance to fight it. By knowing the steps of legislative changes and proposals you can ensure that you act with the appropriate timing and speed to ensure your business continues to thrive within the bounds of the law.

1. The first step to creating or changing laws is recognizing that an area of law or practice has been overlooked or has come into the spotlight with technological evolutions. For example, telehealth companies have recently been working with lawmakers to advocate that telehealth services be covered at the same rate as in-person services.  Outside of working with consultants or professional advocates, these activities may be hard to track until the next step – when a bill is submitted.

2. Once the ideas and concepts for a bill are finalized, it must be drafted. While anyone can write a bill it must be sponsored and submitted to the legislature by a member of congress or the senate. If your company is actively advocating for new laws, keep in mind, that the more work you do for and with representatives, the easier it is for them to work on your behalf. Having a good working relationship with members of the house or congress who often act on health-IT bills can greatly affect the outcome of your bill proposal or amendments. When you have a proposed bill, or input on a bill, that you want considered, you (or your advocacy team) can write it up yourselves! Professional advocates routinely draft legislative language for law makers to use. Drafting your bill in the correct legislative language and presenting it to your representative or senator as a draft is the best way to get farther faster.

The Enactment Clause – This is a key part of any bill draft that you should pay close attention to – it states when the bill would go into effect if passed. This is a key detail because many people believe that once passed, a law immediately goes into effect, but this is not true. Enactment dates can vary widely and paying close attention to changing laws and regulations can give you a precious window of time to quickly alter your business model to be in compliance before you risk getting fined or worse.  If your company would be negatively affected by a new law, but the law seems likely to be passed, often a good business strategy is to advocate for an enactment date that is further in the future.

3. Once a bill has been submitted and sponsored, it is sent to the appropriate committee. Most bills die at this stage. However, it’s at this step that the public is encouraged to get involved so this is another chance to dig in! Committees often encourage members of the public to give feedback, which can have great sway in which way they vote.

During this stage there are four potential outcomes. The bill can be:

i. Tabled indefinitely.

ii. Killed.

iii. Approved in its entirety

iv. Edited by the committee, changing it a lot or not very much depending on the political landscape and make up of the committee.

4. If the bill is approved fully or with edits by the committee it then goes to the floor of whichever house it was proposed in for debate. During this stage members of the house or senate debate the bill and can propose amendments to make it more likely to gain votes and be passed. Many companies begin proposing bill language at this stage in the form of a strategic amendment that can be enveloped into a larger bill that has gained traction to be passed.  These amendments can effectively change a bill for or against your company’s goal. By working with consultants, advocates, or professional organizations, you can pay close attention to bill changes and determine whether getting more involved in legislative advocacy makes sense for your organization.

5. Once both houses have voted in favor of the bill it goes to the President or governor to become a law. If the president approves of the bill s/he will sign it into law. However if the President or governor do not approve of the bill there are a few courses of action:

a. Veto the bill, in which case it will go back to Congress with the reasons for veto – they can either redraft the bill to accommodate the  edits or override the veto with a two-thirds majority vote.

b. Do nothing. After 10 days of no action from the president the bill will automatically become a law.

c. Pocket veto, which means that if Congress ends its session before the president’s 10 days are up the bill will not become a law.

The key takeaways from this process are:

• Timing is key – A bill must be proposed at a time when its outcome is most favorable. Things like election years, presidential approval ratings, and the bipartisan climate can kill a bill that might have been enacted a year earlier or later. Following these litmus tests can help you determine whether it makes sense to spend your company’s time on legislative advocacy.

• Advocacy is a strategic investment – Advocacy involves acting passionately to advocate for legislative language that will benefit your company and your clients. If the topic is something that you feel passionately about or think will have a beneficial impact to your company’s mission or bottom line, then you should work hard to get it in front of the right people and make sure that people are paying attention to what you think are key points and takeaways. Strategically advocating on an issue or bill can give it prominence and traction in front of lawmakers and help you shape the legislative landscape to support your company’s goals.

• Don’t give up and don’t stop paying attention – Many bills go through multiple cycles of this process before becoming laws. You have multiple chances to express your support or concerns, so make sure you seek competent guidance to achieve your business’s goals.