Category: Providers

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20 FAQs for Telemedicine Providers in Ohio

The Ohio Medical Board just published new FAQs and guidance on practicing via telemedicine, addressed to Ohio physicians and physician assistants.  The FAQs follow the Ohio rules for telemedicine prescribing of drugs and controlled substances adopted by the Board in March 2017.  The guidance should be welcome news to providers who deliver healthcare services via telemedicine.  Although frequently referred to as the “telemedicine prescribing” rule, the regulation applies in all situations where the physician or physician assistant is in one location and the patient is in another and the physician or physician assistant has never personally examined the patient.

Ohio Telemedicine FAQs

The guidance also includes the following FAQs:

  1. Why does this FAQ include physician assistants in the questions and answers when the language of the rule only states “physician?”

The rule is applicable to physician assistants because Rule 4730-1-06, Ohio Administrative Code, states that all rules in Chapter 4731-11 of the Ohio Administrative Code are applicable to physician assistants. In addition, Section 4730.42, Ohio Revised Code, provides that a supervising physician shall not grant physician-delegated prescriptive authority to a physician assistant in a manner that exceeds the supervising physician’s prescriptive authority.

  1. What is meant by the term “healthcare provider?”

A “healthcare provider” is a licensed individual acting within the scope of their professional license. The term includes advanced practice nurses and physician assistants who hold prescriptive authority.

  1. When the patient is remote from the physician or physician assistant, does an “evaluation” require the use of devices that allow there to be a visual connection with the patient?

No.

  1. Is there a difference between prescribing controlled medications versus non-controlled medications to a patient under Rule 4731-11-09?

Yes, controlled substance (or Drug Enforcement Administration [DEA] scheduled) medications can only be prescribed via the procedures outlined in Rule 4731-11-09(D). Non-controlled medications can only be prescribed by following the procedures in Rule 4731-11-09(C).

  1. Are there any situations in which the physician or physician assistant can prescribe a controlled substance medication to a patient who is not in the same location as the physician or physician assistant, even though the physician or physician assistant has never conducted a physical examination of the patient?

Yes, paragraph (D) of the rule lists the situations in federal law that authorize an Ohio prescriber to prescribe a controlled substance to a patient whom they have not personally examined and who is at a different location than the prescriber, as follows:

  • When providing on-call or cross coverage for a physician or other appropriately licensed healthcare practitioner who has the patient as an active patient and all of the requirements of 4731-11-09(C) for non-controlled medication prescriptions are met. The on-call or cross coverage must be per an agreement between the on-call/cross covering physician and the healthcare provider.
  • The patient is in a hospital or clinic that is registered with the DEA and the patient is being treated by a healthcare provider who has a DEA certificate of registration.
  • The patient is in the physical presence of a health care provider who has a DEA certificate of registration and the patient is being treated by that healthcare provider.
  • The physician or physician assistant has obtained from the DEA administrator a special DEA certificate of registration. (NOTE: At this time the special DEA certificate of registration is not available although it may be in the future.)
  1. Does Rule 4731-11-09 recognize the unique prescribing needs presented by patients enrolled in state licensed hospice programs?

Yes, Rule 4731-11-09(D)(5) authorizes the medical director, hospice physician, or attending physician for a licensed hospice program to prescribe a controlled substance to a remote patient whom they have not personally examined, when all of the following are met:

  • The controlled substance medication is being provided to a patient enrolled in the hospice program and
  • The prescription is transmitted to the pharmacy by a means that is compliant with Ohio board of pharmacy rules.
  1. Does Rule 4731-11-09 recognize the unique prescribing needs of patients in institutional settings?

Yes, Rule 4731-11-09 authorizes a medical director or attending physician at an institutional facility as defined by Pharmacy Board Rule 4729-17-01 to prescribe a controlled substance to a patient who is remote from the physician and whom the physician has never conducted a physical examination when the following conditions are met:

  • The controlled substance medication is being provided to a person who has been admitted as an inpatient or is a resident of that institutional facility and
  • The prescription is transmitted to the pharmacy by a means that is compliant with Ohio board of pharmacy rules.
  1. What types of facilities are included in the definition of “institutional facility?”

As defined in Pharmacy Board rule, an “institutional facility” means a hospital as defined in Section 3727.01 of the Ohio Revised Code, or a facility licensed by the Ohio State Board of Pharmacy and the Ohio Department of Health, Ohio Department of Rehabilitation and Correction, Ohio Department of Development Disabilities, or the Ohio Department of Mental Health and Addiction Services at which medical care is provided on site and a medical record documenting episodes of care, including medications ordered and administered, is maintained. The following facilities are examples of institutional facilities:

  • Hospitals registered with the Ohio Department of Health
  • Convalescent homes
  • Developmental facilities
  • Long term care facilities
  • Nursing homes
  • Psychiatric facilities
  • Rehabilitation facilities
  • Developmental disability facilities
  • Level III sub-acute detoxification facilities
  1. I am a gastroenterologist and routinely prescribe non-controlled laxatives to patients prior to providing screening colonoscopies. Am I required to interact with the patient prior to prescribing these non-controlled substances?

If the patient has been referred for a screening colonoscopy by a healthcare provider who has prescriptive authority, the information contained in the referral, including patient history and physical examination notes, are sufficient for the gastroenterologist to rely upon in prescribing the non-controlled substances for preparation for the colonoscopy. The evaluation by the referring healthcare provider with prescriptive authority would meet the requirements of 4731-11-09(C)(4).

  1. I am a psychiatrist. Am I able to prescribe Schedule II controlled substance stimulants such as Vyvance or Adderall to a patient who is remote when I have never conducted an in-person examination of the patient?

In general, no. However, if the prescribing situation meets one of the exceptions listed in Paragraph (D) of the rule then the answer is yes.

  1. I am a psychiatrist. Am I able to prescribe Schedule II controlled substance stimulants such as Vyvance or Adderall to a patient in a cross-coverage arrangement with an advanced practice nurse who can only prescribe Schedule II medications for a seventy-two hour period?

It depends. “Cross-coverage” under Rule 4731-11-09 and federal law is defined as a practitioner who conducts a medical evaluation at the request of another practitioner who conducted a medical evaluation of the patient within the previous twenty-four months and is temporarily unavailable to conduct a current evaluation. Therefore, the advanced practice registered nurse would not be considered “unavailable” for cross-coverage purposes if the reason the physician is being asked to prescribe is because the advanced practice registered nurse does not have authority to prescribe Schedule II controlled substances to the particular patient. The advanced practice nurse would have to be truly unavailable.

  1. I am a physician who has a collaboration agreement with an advanced practice registered nurse or a supervision agreement with a physician assistant. Can I rely solely on the assessment conducted by the advanced practice registered nurse or physician assistant for the evaluation aspect before prescribing a controlled substance to the patient?

No, not solely on the assessment of the advanced practice registered nurse or physician assistant. Federal law recognizes that some of the evaluation may be conducted by the advanced practice registered nurse or physician assistant, however, federal law still requires that the collaborating or supervising physician must have conducted at least one in-person or telemedicine evaluation of the patient within the previous twenty-four months, unless one of the situations in Paragraph (D) of Rule 4731-11-09 applies.

  1. In a cross-coverage or on-call situation, I am considering prescribing a non-controlled substance to a patient who I have never physically examined. Can I rely on a nurse’s assessment of the patient to comply with 4731-11-09(C)(4)?

Yes, in a cross-coverage situation the interaction with the patient required by Paragraph (C)(4) of the rule may be coordinated through another licensed health care provider acting within the scope of their professional license. Examples of licensed healthcare providers include a nurse, pharmacist, or physician assistant. “Cross-coverage” is defined in Rule 4731-11-01 to include “on call coverage.”

  1. Before prescribing a non-controlled substance to a new patient via a telemedicine encounter, am I required to personally perform all of the steps in 4731-11-09 (C)(1) through (C)(9)?

The physician or physician assistant must interact with the patient to complete a medical evaluation, as required by 4731-11-09(C)(4), and to establish or confirm a diagnosis and treatment plan, to include the utilization of any prescription drug, as required by 4731-11­09(C)(5). However, all documentation and other requirements may be delegated to appropriate personnel.

  1. I am in a cross-coverage arrangement with another health care provider and I am covering for that healthcare provider who is on vacation. What do I need to do if I am considering prescribing a controlled substance medication to a patient of the vacationing healthcare provider?

The prescribing of controlled substances must comply with 4731-11-09(D):

  • Under (D)(1), you must comply with the requirements of paragraph (C) of the rule. See Questions 15 and 16 for information concerning compliance with paragraph (C) requirements.
  • Under (D)(2) – (6), you must have sufficient information to prescribe within the minimal standards of care.
  1. I am in a cross-coverage arrangement as described above. What do I need to do if I am considering prescribing a non-controlled substance medication to the same patient?

You must comply with the requirements of 4731-11-09(C) regardless of whether or not the patient is in an in-patient setting. However, the interaction with the patient required by Paragraph (C)(4) may be coordinated through another licensed healthcare professional working within the scope of their professional license.

  1. I am a hospice medical director. May I prescribe a controlled substance medication to a hospice patient I have never personally examined?

Yes, 4731-11-09(D)(5) permits you to do so when you comply with the requirements of that paragraph.

  1. I am the medical director of a hospice. May I prescribe a non-controlled substance medication to a hospice patient I have never personally examined?

Yes, but you must follow all of the requirements in 4731-11-09(C). However, the interaction with the patient required by Paragraph (C)(4) of the rule may be coordinated through another licensed health care provider acting within the scope of their professional license.

  1. I am an attending physician of a hospice program. I am considering prescribing a non-controlled substance to a hospice patient whom I have never examined. Do I need to follow all of the requirements in 4731-11-09(C) if the patient is in a home care setting?

Yes. However, the interaction with the patient required by Paragraph (C)(4) of the rule may be coordinated through another licensed health care provider acting within the scope of their professional license.

  1. What if the patient is in an in-patient setting? Do I still have to follow all of the requirements in 4731-11-09(C) in a cross-coverage situation?

Yes. However, the interaction with the patient required by Paragraph (C)(4) of the rule may be coordinated through another licensed health care provider acting within the scope of their professional license.

  1. I am the physician for a home health program. I am the collaborating physician for advanced practice registered nurses and supervising physician for physician assistants who make the home visits. Many of the patients require Schedule II controlled substances, however, the situation is not one in which the advanced practice registered nurse or physician assistant is authorized by the Ohio Revised Code to prescribe a Schedule II drug. Even though I have never personally examined the patient, may I prescribe a Schedule II medication to the patient based upon the physical examinations and assessments performed by the advanced practice registered nurse or physician assistant?

No. While federal law recognizes that a part of the physical examination may have been conducted by another licensed healthcare provider acting within the scope of their professional license, the home health situation is not one for which the federal law provides an exception to the requirement that the prescriber have personally examined the patient prior to prescribing a controlled substance.

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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DOJ and OIG Focus on Opioid Abuse: Medical Professionals Who Overprescribe May Be Targets

Two recent announcements reflect that the U.S. Government is taking aggressive steps to address opioid abuse by identifying and targeting the involvement of medical professionals in facilitating opioid abuse involving Federal health care program beneficiaries.  The U.S. Department of Justice announced on July 13, 2017 fraud charges involving 412 defendants in 41 federal districts across the country, including 115 doctors, nurses, and licensed professionals.  In what the DOJ asserted was the “largest ever health care fraud enforcement action by the Medicare Fraud Strike Force,” DOJ alleged $1.3 billion in false billings were involved, and the enforcement action had a particular focus on medical professionals involved in the unlawful prescription and distribution of opioids. On a related matter, the Department of Health and Human Services (HHS) initiated payment suspension actions against 295 providers.

Attorney General Sessions attributed the action to tips from people in the affected communities and sophisticated computer programs utilized to identify outliers (i.e., datamining).

Data Brief Issued on Questionable Opioid Prescribing

Nearly simultaneously, the HHS Office of the Inspector General (OIG) issued a data brief entitled Opioids in Medicare Part D: Concerns About Extreme Use and Questionable Prescribing.  The data brief, likely reflecting the computer programs that identify outliers referred to by Attorney General Sessions, recited data on opioid use and overuse in the Medicare Part D population.

The data brief noted that one in three Medicare Part D enrollees, or approximately 14.4 million beneficiaries, received at least one prescription opioid in 2016,* and one-tenth of the Part D beneficiaries received opioids on a regular basis.  The data also showed that over 500,000 beneficiaries, excluding those in hospice care, received high doses of opioids, consisting of more than 120 mg/day over three months, which is in excess of the maximum daily level recommended by the Centers for Disease Control.

The OIG identified nearly 90,000 Medicare beneficiaries who are at serious risk of opioid abuse, because they either received extreme dosages of an opioid (more than 240 mg daily for 12 months, which is more than two and a half times the dose the CDC recommends) or appeared to be doctor shopping (received high amounts and had four or more prescribers and four or more pharmacies).  The OIG also reported data showed beneficiaries receiving opioids from as many as 46 different prescribers from 20 different pharmacies in multiple states.

According to the OIG, such high use shows not only that the beneficiary may be addicted to opioids, but also there is a risk of diversion for resale.

Prescription patterns of various prescribers to the Medicare D population were also reported.  OIG identified over 400 prescribers with “questionable prescribing patterns”; that is where they ordered opioids for those at high risk for abuse because of their extreme use or because of their apparent doctor shopping. OIG also identified that it has information on a smaller subset of prescribers with a high number of beneficiaries who received extreme amounts of opioids or who appeared to be doctor shopping.

OIG Continues  to Focus on Opioid Abuse

OIG is focused on the issue of opioid abuse, and that, through information available as reflected in the data brief, it can readily identify Part D beneficiaries and their prescribers who have high or extreme usage of opioids or appear to be prescriber shopping. OIG indicates that, armed with this data, it will work with its law enforcement partners and CMS to follow up with identified prescribers.  The DOJ enforcement action may well reflect this cooperation.  In the report OIG specifically calls on “Part D sponsors to work with OIG and CMS to better combat opioid abuse in Medicare.”

A clear warning has been given to those prescribing or involved with heavy use of opioids through this data brief. Improved datamining makes prescribing patterns of individual practitioners relatively transparent, at least with respect to Federal healthcare beneficiaries. Combined with the DOJ reported enforcement action, it likely shows that medical professionals who are significant outliers in prescribing opioids to the Medicare population are likely to be viewed as potential targets for enforcement and that the Federal government is serious about pursuing whatever leads it has.

* The most commonly prescribed opioids were tramadol, hydrocodone and oxycodone.

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Proving Utility, Demonstrating Value: How to Align the Moving Parts in Personalized Medicine Reimbursement

HC-Reiumbursement

Of the many business, operational, legal, regulatory and clinical obstacles standing in the way of widespread delivery of personalized medicine, the single greatest challenge may lie in solving the reimbursement puzzle. Advocates of personalized medicine contend that it results in better care for the patient, as therapy is targeted specific to an individual, and that it should result in cost savings as treatment that is unlikely to work for that patient is avoided.

The lack of standardized reimbursement codes and definitions covering precision medicine treatments and services, particularly molecular genetic laboratory tests — when the industry hasn’t even settled on a standard definition of “personalized medicine” — make it difficult for providers to get reimbursed, especially for new or innovative offerings. In order to secure payment from insurers, personalized medicine providers must prove not only the clinical efficacy of their treatments or genetic testing, but also the value they offer to payers. Doing so requires a deep understanding of health care economics.

That formidable landscape provided the backdrop for panel discussion at the Business of Personalized Medicine Summit on March 28 in San Francisco. Moderated by Foley partner Judith Waltz, the discussion carried the title “Moving Targets,” an apt description of a market in the midst of dramatic structural and philosophical change. Even in light of the recent failure of a sweeping health care bill in Congress, the market remains mired in uncertainty. The Affordable Care Act, and other government and payer initiatives, pushed the industry toward value-based reimbursement, and the Obama administration provided vocal support for personalized medicine. Thus far the Trump administration has yet to signal whether it will support continued movement in those directions.

In that environment, Waltz said, the imperative for personalized medicine providers is to recognize and fully understand, at the earliest possible stage, how they’ll make money. “Every personalized medicine business strategy has to identify who the payer will be, and how pricing and reimbursement will work,” she said. “And it has to articulate the product differentiation – because payers often won’t cover it unless it’s better or cheaper than what they’re already doing.”

They’ll also need to have a plan for demonstrating clinical utility in order to meet payers’ evidentiary requirements for coverage, said Mark McCoy, Senior Director, Reimbursement at Guardant Health. In most cases that means building a body of clinical literature, since most payers want to see published data proving either cost savings or cost effectiveness of outcomes.

That has ramifications for sales and marketing, McCoy said. It’s vital to work with providers to set up clinical tests with appropriate utilization and other elements that payers will expect to see – and to keep in mind that providers [physicians who order and rely upon the test that is reimbursed by payers] have little if any financial incentive to use your test. That means, as the business and product evolve, changes must be carefully communicated to providers – who can’t be expected to take pains. “We’ve found you can get good early adoption, but if you change your ordering process a year or two in providers will get frustrated and just drop you,” he said.

Providers also require a lot of education on not only personalized medicine treatments or tests, but on how to apply new evidence to specific patients and how to articulate the results. Amber Trivedi, Senior Vice President, Market Development and Innovation at InformedDNA, said payers want to see that providers are involved, and that puts the impetus on companies to ensure that providers understand how payers define clinical utility and that they document that utility in encounter notes.

Trivedi advised taking a very hands-on approach in dealing with physicians. “You might even have to teach them how to write letters of medical necessity to secure coverage,” she said. “There’s a lot of variation out there in understanding of even the most basic terms.”

Evidence-based review through one of the four established programs also proves extremely helpful when seeking reimbursement, said Anita Chawla, Managing Principal at Analysis Group. The MoIDX program, developed and administered by Palmetto GBA, helps determine Medicare reimbursement – making its determination of clinical utility among the most influential in the industry.

Given that influence, it makes sense for personalized medicine providers to factor in MoIDX criteria and processes when designing clinical studies. “It can save a lot of time downstream,” Chawla said. She pointed to the MoIDX hierarchy – which sets randomized, prospectively controlled trials as the gold standard – as an important road map for companies in the testing-design stage.

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Ohio Telemedicine Prescribing and Controlled Substances Laws

Ohio

The Ohio Medical Board just last week adopted new rules for telemedicine prescribing of drugs and controlled substances, allowing providers to prescribe drugs via telemedicine without conducting an in-person examination.  Effective March 23, 2017, the new rule 4731-11-09 and rule 7331-11-01 set forth the requirements a physician must follow when prescribing via telemedicine in Ohio.

Prescribing Drugs via Telemedicine

An Ohio physician may prescribe non-controlled substances via telemedicine, without an in-person exam, if the physician satisfies the following nine requirements:

  • Establishes the patient’s identity and physical location;
  • Obtains the patient’s informed consent for treatment through remote examination;
  • Requests the patient’s consent and, if granted, forwards the medical record to the patient’s primary care provider or other health care provider, if applicable, or refers the patient to an appropriate health care provider or health care facility;
  • Completes a medical evaluation through interaction with the patient that meets the minimal standards of care appropriate to the condition for which the patient presents;
  • Establishes a diagnosis and treatment plan, including documentation of necessity for the utilization of a prescription drug, including contraindications to the recommended treatment;
  • Documents in the medical record the care provided, patient’s consent, medical information, and any referrals made to other providers;
  • Provides appropriate follow-up care or recommends follow-up care;
  • Makes the medical record of the visit available to the patient; and
  • Uses appropriate technology sufficient for the physician to conduct the above as if the medical evaluation occurred during an in-person visit.

Prescribing Controlled Substances via Telemedicine

An Ohio physician may prescribe controlled substances via telemedicine, without an in-person exam, if the physician satisfies the nine steps outlined above and when one of the following six situations exists:

  • The patient is an “active patient” of a health care provider who is a colleague of the physician and the controlled substances are provided through an on call or cross coverage arrangement between the health care providers. “Active patient” is a defined term under the new rules and means that “within the previous twenty-four months the physician or other health care provider acting within the scope of their professional license conducted at least one in-person medical evaluation of the patient or an evaluation of the patient through the practice of telemedicine as that term is defined in 21 C.F.R. 1300.04, in effect as of the effective date of this rule.”
  • The patient is located in a DEA-registered hospital or clinic;
  • The patient is being treated by, and in the physical presence of, an Ohio-licensed physician or health care practitioner registered with the DEA;
  • The telemedicine consult is conducted by a practitioner who has obtained a DEA special registration for telemedicine;
  • A hospice program physician prescribes the controlled substance to a hospice program patient in accordance with the board of pharmacy rules; or
  • The physician is the medical director of, or attending physician at, an “institutional facility” (defined in rule 4729-17-01) and 1) the controlled substance is being provided to a person who has been admitted as an inpatient to or is a resident of an institutional facility, and 2) the prescription is transmitted to the pharmacy by a means that is compliant with Ohio board of pharmacy rules.

The above six situations largely mirror exceptions under the federal Ryan Haight Act.  Telemedicine advocates have noted the Ryan Haight Act’s rules on prescribing controlled substances have hindered contemporary, legitimate telemedicine practices.  Members of the American Telemedicine Association have advocated for provider-friendly changes, and the DEA is expected to issue new rules this year, opening a special telemedicine registration for prescribers.

The Buckeye State now joins others (e.g., Delaware, Florida, New Hampshire, and West Virginia) that have carved out express exceptions to allow for telemedicine prescribing of controlled substances.  This is encouraging news for providers using telemedicine in their practice, as controlled substances are an important and clinically significant component of certain specialties, including telepsychiatry and hospitalists/emergency medicine.

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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