Category: Health and Human Services
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HHS to Collect Data From the EMS System: Good Time to Examine Accounting, Cost, Billing, and Collection Systems
While recent legislation impacting the Emergency Medical Services (EMS)/ambulance industry drew attention inside the industry for its reduction in Health and Human Services’ (HHS) spend on non-emergent dialysis transports and the five-year extension of the Medicare add-ons for the EMS industry, the legislation created a new forward-looking reporting obligation. Specifically, as part of the Continuing Resolution enacted into law on February 8, 2018, Congress authorized HHS to develop a “data collection system … to collect cost, revenue, utilization” and other information “determined appropriate by” HHS from EMS systems. Public Law 115-123, §50203 (b)(17)(A) (emphasis added). Congress provided HHS until December 31, 2019, to create the data collection system, the ambulance suppliers that will need to provide the data, and the type of representative samples that they will need to supply to HHS. If selected, a company will need to provide HHS with the requested data – including data about, for example, revenue, costs, vehicles, and ambulance utilization rates – once a year, with the suppliers that need to report to HHS rotating on a regular basis.
What Does this Legislation Mean to Ambulance Suppliers
This legislation means that some ambulance suppliers, including private companies, will need to provide revenue figures, ambulance utilization data, cost data, vehicle usage, and likely other data to HHS so that HHS can mine this data to see trends, spot hot spots in the country where costs are higher, and generally seek to reduce the money spent on particular segments of the EMS industry.
Preparing for the Change in Reporting Obligations – Examine Your Systems
To prepare for this coming change in the reporting obligations, EMS suppliers should consider reviewing in 2018 their accounting, transport, and billings systems (including third party vendor systems) and conducting audits of these systems, including audits of third party vendors, to square away any issues or problems ahead of the 2019 roll-out date. Some companies may want to work with counsel to do this in order to obtain legal advice for issues that arise; use of an attorney in the audit process can protect the audit from production later in an investigation or litigation because of the attorney client privilege if it is done at the request of an attorney who is providing legal advice to the company in conjunction with the audit.
HHS will be collecting data through the year 2024 pursuant to this new legislation. It will be interesting to understand what HHS observes once the agency is able to mine it for trends and perceived abuses.
For more information on legislation impacting the EMS industry, including the team, publications, and other materials, visit Foley’s Government Enforcement Defense and Investigations Group.
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Prescribing Controlled Substances Without an In-Person Exam: The Practice of Telemedicine Under the Ryan Haight Act
Editor’s Note: This article is the second in a series addressing telemedicine prescribing and controlled substances, designed to give some much needed practical guidance and orientation to established healthcare providers, hospitals, and entrepreneurs alike. The first article addressed federal rules for prescribing controlled substances under the Ryan Haight Act. Subsequent articles will discuss the prescribing controlled substances via telemedicine under state laws.
As providers are becoming more comfortable with delivering care via telemedicine technologies, many of them are looking to explore services other than low acuity triage consults. One area of patient service opportunity – and particular confusion – is prescribing controlled substances via telemedicine.
As discussed in greater detail in the first article in this series, the Ryan Haight Online Pharmacy Consumer Protection Act was designed to combat the rogue internet pharmacies that proliferated in the late 1990s, selling controlled substances online. Although the Act was intended to target “rogue” internet pharmacies, legitimate healthcare providers who prescribe controlled substances via telemedicine must carefully review the regulations to ensure compliance. Among other things, the Act requires a practitioner to have conducted at least one in-person medical evaluation of the patient prior to issuing a prescription for a controlled substance.
However, the Ryan Haight Act contains an important exception to the in-person exam requirement for practitioners engaged in the “practice of telemedicine.” Indeed, there are seven separate “practice of telemedicine” exceptions under the Act. They are technical, and providers should not assume their approach to telemedicine or telehealth does, in fact, meet an exception under the Ryan Haight Act. Providers must devote the resources to really understanding these laws and how to apply them to their business or services.
Practice of Telemedicine Under the Ryan Haight Act
The Act contains the following “practice of telemedicine” exceptions:
(1) Treatment in a hospital or clinic. The practice of telemedicine is being conducted while the patient is being treated by, and physically located in, a hospital or clinic registered under section 303(f) of the Act (21 U.S.C. 823(f)) by a practitioner acting in the usual course of professional practice, who is acting in accordance with applicable State law, and who is registered under section 303(f) of the Act (21 U.S.C. 823(f)) in the State in which the patient is located, unless the practitioner:
(i) Is exempted from such registration in all States under section 302(d) of the Act (21 U.S.C. 822(d); or
(ii) Is an employee or contractor of the Department of Veterans Affairs who is acting in the scope of such employment or contract, and registered under section 303(f) of the Act (21 U.S.C. 823(f)) in any State or is utilizing the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under section 303(f);
(2) Treatment in the physical presence of a practitioner. The practice of telemedicine is being conducted while the patient is being treated by, and in the physical presence of, a practitioner acting in the usual course of professional practice, who is acting in accordance with applicable State law, and who is registered under section 303(f) of the Act (21 U.S.C. 823(f)) in the State in which the patient is located, unless the practitioner:
(i) Is exempted from such registration in all States under section 302(d) of the Act (21 U.S.C. 822(d)); or
(ii) Is an employee or contractor of the Department of Veterans Affairs who is acting in the scope of such employment or contract, and registered under section 303(f) of the Act (21 U.S.C. 823(f)) in any State or is using the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under section 303(f);
(3) Indian Health Service or tribal organization. The practice of telemedicine is being conducted by a practitioner who is an employee or contractor of the Indian Health Service, or is working for an Indian tribe or tribal organization under its contract or compact with the Indian Health Service under the Indian Self-Determination and Education Assistance Act; who is acting within the scope of the employment, contract, or compact; and who is designated as an Internet Eligible Controlled Substances Provider by the Secretary of Health and Human Services under section 311(g)(2) of the Act (21 U.S.C. 831(g)(2));
(4) Public health emergency declared by the Secretary of Health and Human Services. The practice of telemedicine is being conducted during a public health emergency declared by the Secretary of Health and Human Services under section 319 of the Public Health Service Act (42 U.S.C. 247d), and involves patients located in such areas, and such controlled substances, as the Secretary of Health and Human Services, with the concurrence of the Administrator, designates, provided that such designation shall not be subject to the procedures prescribed by the Administrative Procedure Act (5 U.S.C. 551–559 and 701–706);
(5) Special registration. The practice of telemedicine is being conducted by a practitioner who has obtained from the Administrator a special registration under section 311(h) of the Act (21 U.S.C. 831(h));
(6) Department of Veterans Affairs medical emergency. The practice of telemedicine is being conducted:
(i) In a medical emergency situation:
(A) That prevents the patient from being in the physical presence of a practitioner registered under section 303(f) of the Act (21 U.S.C. 823(f)) who is an employee or contractor of the Veterans Health Administration acting in the usual course of business and employment and within the scope of the official duties or contract of that employee or contractor;
(B) That prevents the patient from being physically present at a hospital or clinic operated by the Department of Veterans Affairs registered under section 303(f) of the Act (21 U.S.C. 823(f));
(C) During which the primary care practitioner of the patient or a practitioner otherwise practicing telemedicine within the meaning of this paragraph is unable to provide care or consultation; and
(D) That requires immediate intervention by a health care practitioner using controlled substances to prevent what the practitioner reasonably believes in good faith will be imminent and serious clinical consequences, such as further injury or death; and
(ii) By a practitioner that:
(A) Is an employee or contractor of the Veterans Health Administration acting within the scope of that employment or contract;
(B) Is registered under section 303(f) of the Act (21 U.S.C. 823(f)) in any State or is utilizing the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under section 303(f); and
(C) Issues a controlled substance prescription in this emergency context that is limited to a maximum of a five-day supply which may not be extended or refilled; or
(7) Other circumstances specified by regulation. The practice of telemedicine is being conducted under any other circumstances that the Administrator and the Secretary of Health and Human Services have jointly, by regulation, determined to be consistent with effective controls against diversion and otherwise consistent with the public health and safety.
How Useful Are the Ryan Haight Act Exceptions for Telemedicine?
Some of the exceptions are very narrow and do not account for current clinical telemedicine practices. However, others are well-suited to institutional telemedicine arrangements. And others are of use to only a limited subset of practitioners or particular environments (e.g., public health emergency, Indian tribal organization). One exception requires a patient-site telepresenter who is also registered with the Drug Enforcement Agency (DEA) (and presumably independently able to prescribe controlled substances for the patient).
Overall, the exceptions have limited utility in contemporary telemedicine arrangements, most notably telemedicine services directly to the patient’s home. For that reason, the exceptions do not easily align with direct-to-patient service models frequently sought by patients in areas such as telepsychiatry (e.g., where the patient is at his or her home at the time of the telemedicine consult). The main exception designed to accommodate this type of telemedicine practice – the special registration – has not yet been implemented by the DEA.
The DEA seems to recognize the exceptions have not kept pace with the rapid developments in telemedicine-based practices. To be fair, Congress gave the DEA a very brief window to draft regulations in order to implement the Act within the short time period between the passage of the Act and its effective date (only six months). The DEA’s interim final rule was effective a mere nine days after it was published, leaving no time for public comment. Fortunately, DEA has announced plans to activate the special telemedicine registration provision (exception #5). This would allow practitioners to use telemedicine to prescribe controlled substances without the per se in-person exam. The new rule is anticipated to be published this year.
If I Meet an Exception, Can I Prescribe Controlled Substances Without Any In-Person Exam?
No, not necessarily. Whether the exam is conducted in-person or via the practice of telemedicine, a prescription for a controlled substance must always be issued for a legitimate medical purpose by a practitioner acting in the usual course of his or her professional practice. Moreover, practitioners must comply with both federal and state laws, as DEA considers a physician who engages in the unauthorized practice of medicine under state law to be someone who is not acting in the usual course of his or her professional practice. For example, according to DEA, a controlled substance prescription issued by a physician who lacks the license or other authority necessary to practice medicine within the state is not a valid prescription under federal law.
Some states prohibit the prescribing of controlled substances via telemedicine, but others do allow it. The remaining states are silent, or allow/disallow its use in certain specialties (e.g., cannot be used in connection with treatment of chronic nonmalignant pain). The federal and state laws must be read in harmony with each other (not unlike how HIPAA interacts with more restrictive state medical privacy laws). Understanding how these layers intersect will enable providers to see the pathways and approaches available to compliant prescribing of controlled substances via telemedicine. This is particularly useful for those telemedicine providers in specialties that involve chronic disease management with pharmacotherapy, for example, adolescent and adult psychiatry, substance abuse/recovery, endocrinology, hormone replacement therapy, and medical weight loss.
For more information on telemedicine, telehealth, virtual care, and other health innovations, including the team, publications, and other materials, visit Foley’s Telemedicine and Virtual Care practice.
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