Life Science Compliance Update

May 09, 2018

CMS Announces Medicare Data Roll-Out

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On Thursday, April 26, 2018, Centers for Medicare and Medicaid Services Administrator Seema Verma announced the Agency’s new Data Driven Patient Care Strategy, as part of the MyHealthEData initiative. CMS is hoping to make its data more accessible and usable in a secure manner that honors the privacy of patients and ensures that CMS will support industry innovation in unleashing the power of data to drive system transformation – enhancing efficiency, improving quality, and reducing costs.

Included in this new Strategy are three pillars: putting patients first, increasing the amount of available data, and taking an application programming interface (API) approach to exchanging data in a secure and digital manner.

Essentially these changes will allow CMS to demonstrate whether providing patients and researchers with claims and encounter data will enhance efficiency, improve quality, and reduce costs across healthcare systems.

Putting Patients First

Verma noted that CMS is committed to putting the patients at the center of the healthcare system and plans to do so by “empowering them with the data they need as consumers of healthcare to make informed decisions.”

CMS is also putting patients first by ensuring that across all its efforts, strict privacy and security requirements to protect patient data are put in place from the beginning and play a prominent role in all decisions. CMS already has strong controls in place to protect the privacy and security of all data the agency collects and recognizes that this issue is a critical part of unlocking the power of data and will be continuing efforts to protect patient data across all our programs.

Increasing the Amount of Data Available

CMS is expanding the data made available to researchers starting with the 2015 Medicare Advantage Encounter Data. This data provides detailed information about services provided to beneficiaries enrolled in a managed care plan under the Medicare Advantage program in calendar year 2015. Roughly one-third of Medicare beneficiaries (19 million) are enrolled in these privately managed care plans, but to date none of their utilization or diagnosis information has been widely available for research. Since researchers already have access to detailed data for beneficiaries enrolled in the fee-for-service program, this release will provide researchers with data to understand a fuller picture of care provided to Medicare beneficiaries. CMS hopes that this information will be used to conduct research that helps to drive innovation and competition throughout the healthcare system.

CMS also announced the availability of a preliminary version of the 2015 Medicare Advantage (MA) encounter data. A final version of that 2015 data will be released later this year. CMS plans to release encounter records for subsequent service years on an annual basis.

API Approach for Exchanging Data

CMS is taking an API approach to modernize how the Administration exchanges data with its partners and ensuring the data is available in a timely, secure, and private fashion. According to CMS, the API approach allows CMS to focus on putting patients first and increasing the amount of data available while at the same time allowing the market to surface that data in new ways to clinicians and patients.

Conclusion

During her remarks on the subject, Administrator Verma tried to differentiate this new path in relation to previous efforts CMS has taken to move towards a value-based system. She noted, “…what is different now is that we know we can’t achieve value-based care until we put the patient at the center of our healthcare system. And that requires that we empower patients with the data they need to become a consumer of healthcare and make informed decisions. Ultimately, the cornerstone of a patient centered system is data, quality data, cost data, a patient’s own data.”

May 08, 2018

Oklahoma Requires CME for Prescribers

H-OKLAHOMA

Many states have taken the cue from the federal government and started their own investigation and research into opioids and the way opioids affect their particular state. Recently, Oklahoma joined the ranks of the states who have not just looked into the situation, but also went so far as to pass legislation to stymy the state’s opioid epidemic.

One of the pieces of legislation passed was Senate Bill 1446, which asks the Oklahoma Board of Medical Licensure and Supervision to require continuing medical education (CME) for prescribers on opioid abuse and misuse, and also restricts initial prescriptions for opioids to a seven day supply. With respect to the CME requirement, the legislation requires that “The Board shall require that the licensee receive not less than one hour of education in pain management or one hour of education in opioid use or addiction each year preceding an application for renewal of a license, unless the licensee has demonstrated to the satisfaction of the Board that the licensee does not currently hold a valid federal Drug Enforcement Administration registration number.”

Oklahoma Attorney General Mike Hunter commended the Oklahoma House of Representatives and Senate for working in a bipartisan fashion to pass all the legislation requested by the state’s Commission on Opioid Abuse.

“I appreciate the members of the legislature for their decisive action this session on the recommendations by the Oklahoma Commission on Opioid Abuse,” Hunter said. “The bipartisan support from both chambers shows the commitment of members to saving lives and putting a stop to the opioid crisis that continues to claim an average of 1,000 Oklahomans every year.

“Since last April when my colleagues on the commission and I began meeting, we knew we had to act without delay to stem the daily loss of life attributed to this epidemic. After hours of meetings that brought all stakeholders together, we put forth the very best policy recommendations that would serve as a framework for ending the death and despair this plague has placed on our friends, family members and loved ones,” said Hunter.

Oklahoma State Senator AJ Griffin said she was honored to work with the commission to achieve the successful outcome. “The commission’s work will be a turning point that we can point to in the future and say this is where Oklahoma drew the line to curb its opioid epidemic,” Senator Griffin said. “I believe our work will also serve as a blueprint on a national level that states struggling in a similar way can use to save lives. I appreciate the leadership and passion from Attorney General Hunter, who championed the commission and initiated action to combat the growing problem.”


Among other legislation passed were: House Bill 2931, which creates electronic prescribing for all schedules of drugs; Senate Bill 1367, which creates the Good Samaritan Law and provides immunity from prosecution under certain circumstances; House Bill 2795, which requires medical facility owners to register with the Oklahoma Bureau of Narcotics and Dangerous Drugs; House Bill 2796, which requires manufacturers and distributors of opioids to make data available for review by the Oklahoma State Bureau of Narcotics and Dangerous Drugs; and House Bill 2798, which creates the Opioid Overdose Fatality Review Board.

May 07, 2018

House Introduces Bill to Require CME for Controlled Substance Prescribing

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House of Representatives member Representative Susan W. Brooks recently introduced the ADAPT Act of 2018. The ADAPT Act (Abuse Deterrent and Prescriber Training Act of 2018) is an attempt to require training for prescribers of controlled substances.

The bill would amend the Controlled Substances Act to include a requirement for all practitioners who are licensed under State law to prescribe controlled substances in Schedule II, III, IV, or V, a written certification that the practitioner has completed 3 hours of training under a specific training program, in all registration or renewal requests.

The training program will meet the requirements only if it includes information on the following:

  • safe opioid prescribing guidelines, including the Guideline for Prescribing Opioids for Chronic Pain issued by the Centers for Disease Control and Prevention;
  • the risks of opioid medications and other prescription drugs that are controlled substances;
  • pain management, including the need to provide individualized care particularly for active cancer treatment, palliative care, and end-of-life care;
  • early detection of opioid and other substance use disorders;
  • the risks of prescribing opioids to any individual in recovery from a substance use disorder;
  • a basic understanding of addiction;
  • the treatment of opioid-dependent patients and their treatment options;
  • the risks of misuse of all prescription drugs that are controlled substances; and
  • alternative non-opioid pain management medications and other effective treatments; 

The legislation also assigns the Secretary of Health and Human Services to develop a model training program on prescribing opioids to be used for the purpose of educating prescribers on abuse deterrents with respect to opioids.

All qualifying CME programs must be approved by the State agency with the primary responsibility for licensing the practitioner to prescribe controlled substances. If states do not have in effect an approval of any training program, the program must conform to a model training program, which is to be determined.

Interestingly, the legislation currently carries the requirement of a report to Congress to be submitted two years after the date of the enactment of the Act. The report to Congress will be an overview of the effects of the Act and any amendments, including an analysis of the following: whether there has been a reduction in the volume of opioids prescribed; whether there has been an increase in the likelihood that opioid-dependent patients receive substance use disorder treatment; whether there has been a reduction in opioid-related overdoses and deaths; whether training required by this Act and the amendments made by this Act has changed prescribing practices and increased patient referrals to treatment; and the extent to which prescribers have conformed their practices to those recommended in training pursuant to this Act and the amendments made by this Act.

The legislation has been referred to the Committee on Energy and Commerce and the Committee on the Judiciary. No further actions are scheduled at this time, but we will certainly be keeping an eye on this bill as it will have ramifications for the CME community if passed.

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