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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
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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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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