In just four months from now, starting in January 2021, CMS will require electronically prescribing controlled substances (EPCS) for Medicare Part D prescribers.

The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, HR6 - Public Law 115-271, was signed into law on October 24th, 2018. The Act’s primary purpose is to combat the growing opioid epidemic by:

• Teaching addiction medicine by increasing and strengthening the workforce
• Standardizing the delivery of addiction medicine and care
• Covering addiction medicine in a way that facilities the delivery of treatment

One of the more than 60 policies included is the Every Prescription Conveyed Securely Act. This Act will require prescribers to electronically prescribe controlled substances for Schedule II-V drugs covered under a Medicare Part D or Medicare Advantage prescription drug plan. While many states have enacted their own laws requiring e-Prescribing, this is the first federal mandate for EPCS.

According to Surescripts, 55.2% of prescribers in the US are currently enabled for EPCS.  This number is up drastically from only 32% in 2018 when the SUPPORT Act was signed.  The increase is likely due to state-level mandates, as well as the rise of telemedicine usage during the Covid-19 pandemic.

Additional relevant requirements set in place by the SUPPORT Act and CMS rulings that begin in 2021 include:

• Electronic prior authorizations will be required for all Medicare Part D covered drugs requiring a prior authorization. Electronic prescription programs will be required to securely transmit the requests and Part D sponsors and processors must respond electronically using a defined standard. A facsimile, proprietary payer portal, or an electronic form that does not meet the standards will not be counted as an electronic submission.
• Provisions to enhance states’ Prescription Drug Monitoring Programs (PDMPs). The goal is to ensure each state has a PDMP, improve their functionality, make sure all prescribers are utilizing the systems, and foster data sharing between states. Beginning October 1, 2021 states must require health care providers to check their PDMP for a Medicaid enrollee's prescription drug history before prescribing controlled substances to the enrollee.
• On May 23, 2019, CMS published a final rule (CMS-4180-F) requiring that Part D plans adopt one or more real time benefit tools (RTBTs) capable of giving prescribers clinically appropriate patient-specific real-time formulary and benefit information. This mandate is also effective January 1, 2021.

CMS is currently seeking public comments regarding the EPCS requirement. CMS is requesting input as to whether there should be exceptions provided and if so, what circumstances would qualify prescribers for an EPCS exception. CMS also wants feedback on whether penalties should be imposed for noncompliance with the EPCS mandate and if so, what the penalties should be. Comments can be made until October 5^th, 2020.  These rules and exceptions are expected to be provided before the 2021 deadline.

MDToolbox applauds this bipartisan legislation. We are continually encouraging providers to take advantage of the technologies we provide including Electronic Prescribing of Controlled Substances (EPCS), Electronic Prior Authorization (e-PA) and Real-time Price Transparency as they are important tools to use in fighting the devastating opioid epidemic and making electronic prescribing as convenient as possible for prescribers. Putting these federal mandates in place is an important step towards fully utilizing the available technology to save lives. 

The world has seen remarkable changes this year, the methods we receive healthcare being a significant part of that change. COVID-19 has hurried the adoption of telemedicine into mainstream usage during the declared public health emergency (PHE). Legislation has now been presented to keep telemedicine as part of standard healthcare and make its usage more convenient for both providers and their patients.

President Trump’s Executive Order on Improving Rural Health and Telehealth Access

President Trump signed executive orders on August 3^rd to promote the expansion of telehealth services. The Center for Medicare & Medicaid Services (CMS) outlined 135 services that are allowable via telehealth during the PHE, Trump’s executive order outlines that the services become permanently available via telehealth. The executive order also offers financial incentives for rural hospitals to continue seeing patients with a high-quality of care and directs the federal government to improve the healthcare communication infrastructure in rural areas.

“Telemedicine can never fully replace in-person care, but it can complement and enhance in-person care by furnishing one more powerful clinical tool to increase access and choices for America’s seniors,” said CMS Administrator Seema Verma. “The Trump Administration’s unprecedented expansion of telemedicine during the pandemic represents a revolution in healthcare delivery, one to which the healthcare system has adapted quickly and effectively. [1]

CMS Proposes Permanent Expansion of Telehealth

Consistent with Trump’s executive order, CMS proposed that many telehealth service payments should be expanded to be permanently covered past the PHE. A major hurdle hindering providers from adopting telemedicine as part of their practice is the disparity in the CMS reimbursement payment structure for in-person versus telehealth visits. During the PHE, CMS allowed parity in the payment structure for in-person and telehealth visits, making telehealth even more attractive for providers to participate. According to CMS, before the PHE, only 14,000 beneficiaries received a Medicare telehealth service in a week while in the last week of April, nearly 1.7 million beneficiaries received telehealth services.

Source: CMS Health Affairs Blog. Internal CMS analysis of Medicare FFS claims data, March 17, 2020 through June 13, 2020(using data processed through June, 19, 2020) Notes: Telemedicine is defined to include services on the Medicare telehealth list including audio-only visits, as well as virtual check-ins and e-visits. https://www.healthaffairs.org/do/10.1377/hblog20200715.454789/full/

Many medical providers and associations have requested that the parity remain to allow telehealth to continue growing due to the better hold on financial security. CMS is asking for input from stakeholders regarding what services should bee added to the Medicare telehealth list and the public comment period for the proposed rule is open until October 5, 2020.

Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act

Another barrier that providers are facing is the lack of inter-state licensing ability to be able to practice telemedicine for patients residing in other states. Senators Chris Murphy and Roy Blunt have presented the Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act which would grant providers the ability to treat patients in any state during and immediately following the PHE. The Act also establishes that the reciprocity can be reactivated should another PHE happen in the future, again reducing inter-state complications. Some states have reduced the requirements for providers to get a license, and some states have granted temporary licenses. Mandating nation-wide reciprocity could be invaluable to patient health during a worsening or future PHE.

DEA Telehealth Policies

EPCS

The Ryan Haight Act of 2008 established regulations and prohibited healthcare providers from prescribing controlled substances to patients that they haven’t first examined in-person. Section 802(54)(D) of the Controlled Substances Act allows for the Ryan Haight Act to be circumvented during a public health emergency which the DEA invoked on March 16, 2020. This currently allows MDToolbox users to electronically prescribe controlled substances (EPCS) for patients via telemedicine. Patients must be evaluated using a real-time, two-way, audio-visual communications device.

The DEA has missed several deadlines to establish rules and a waiver system to allow electronic prescribing of controlled substances via telemedicine when there is not a PHE. Reducing these road-blocks, as we are seeing with the emergency measures in place due to COVID-19 can help bring healthcare into the 21^st century and help reduce stress on our medical system and patients.

DEA State Registration

The DEA has also waived the requirement for state-specific registrations during the PHE. The exception to separate registration requirements across state lines was issued March 25, 2020 and allows prescribers who are registered in at least one state to prescribe controlled substances to patients in other states via telemedicine.

Opioid Use Disorders

The DEA, in partnership with the Substance Abuse and Mental Health Services Administration (SAMHSA), also stated that it is allowing authorized providers to prescribe buprenorphine to new and existing patients with Opioid Use Disorder (OUD) via only telephone voice calls without first requiring an examination of the patient in person or via telemedicine. This exception is only during the PHE and prescribing practitioners must be DATA-waived.

Telehealth Response for E-prescribing Addiction Therapy Services (TREATS) Act

Not to be confused with the earlier mentioned TREAT act, the Telehealth Response for E-prescribing Addiction Therapy Services (TREATS) Act was introduced by Senators Rob Portman (R-OH) and Sheldon Whitehouse (D-RI) and looks to make some of the telehealth substance use disorder (SUD) treatment changes permanent.

The bill adds to and replaces language in the current Telehealth for Substance Use Disorder Treatment codes. The changes would allow a Schedule III or IV medication to be prescribed for the purpose of treatment for an Opioid Use Disorder via “1 in-person medical evaluation or 1 telehealth evaluation”.  The bill then clarifies that the “1 telehealth evaluation” shall not be construed to imply that a single telehealth evaluation demonstrates the usual course of professional practice. The medical provider will need to continue follow-up and management of the patient and medication after the initial in-person or telehealth visit per current guidelines.

Continue to follow our blog and social media for information related to telehealth and electronic prescribing. MDToolbox looks forward to providing tools and resources to assist telemedicine providers throughout the United States to ease the transition, helping our customers increase the efficiency of their office and combat the opioid epidemic. With MDToolbox, prescribers have access to tools such as Electronic Prescribing of Controlled Substances (EPCS), the ability to check most State’s PMPs without having to separately login to their State portal, and convenient on the go e-prescribing with our mobile app! We offer a free 30 day free trial, so Contact us for more information!

[1]https://www.cms.gov/newsroom/press-releases/trump-administration-proposes-expand-telehealth-benefits-permanently-medicare-beneficiaries-beyond

Earlier this week, the United States Senate passed The Opioid Crisis Response Act of 2018. The bill is focused on battling the opioid epidemic and was almost unanimously passed with a 99-1 vote. According to the Centers for Disease Control and Prevention, overdose deaths killed an estimated 72,000 Americans in 2017 and the total estimated "economic burden" of prescription opioid misuse alone in the United States is $78.5 billion a year, including the costs of healthcare, lost productivity, addiction treatment, and criminal justice involvement. The bill provides $3.8 billion in funding.

The bill contains a large number of different proposals from five Senate committees. One of those proposals requires prescribers to electronically prescribe controlled substance prescriptions for Medicare Part-D covered medications. The Centers for Medicare and Medicaid Services (CMS) would be responsible for specifying a list of exceptions and outlining the penalties for failing to comply with the e-prescribing requirement. 

Other provisions in the Opioid Crisis Response Act of 2018 include:

1.       The STOP ACT—to stop illegal drugs, including fentanyl, at the border
2.       New non-addictive painkillers, research and fast-track
3.       Blister packs for opioids, such as a 3 or 7-day supply
4.       More medication–assisted treatment
5.       Prevent “doctor-shopping” by improving state prescription drug monitoring programs
6.       More behavioral and mental health providers
7.       Support for comprehensive opioid recovery centers
8.       Help for babies born in opioid withdrawal
9.       Help for mothers with opioid use disorders
10.     More early intervention with vulnerable children who have experienced trauma

This bill comes after similar legislation passed through the House in June. Senate Health, Education, Labor and Pensions Committee Chairman, Lamar Alexander, R-Tennessee, said he is working to combine the bills "into an even stronger law to fight the nation’s worst public health crisis, and there is a bipartisan sense of urgency to send the bill to the President quickly." A combined version is expected to reach President Donald Trump’s desk for signing by early October.

Earlier this week, a bipartisan group of U.S. Senators introduced the Every Prescription Conveyed Securely (EPCS) Act. Under the act, all controlled substance prescriptions under Medicare would have to be sent electronically. The aim of the bill is to combat the opioid epidemic by preventing fraudulent prescriptions and doctor shopping.

The legislation was introduced by four senators: Elizabeth Warren, D-Massachusetts; Michael Bennet, D-Colorado; Dean Heller, R-Nevada, and Pat Toomey, R-Pennsylvania.

As we wrote about previously, companion legislation was introduced in the House of Representatives in July by Congressman Markwayne Mullin (R-OK) and Congresswoman Katherine Clark (D-MA). House bill 3528¹ has a lot of bipartisan support with 21 cosponsoring representatives including 11 Republicans and 10 Democrats.

“We need to be using every tool at our disposal to fight the opioid epidemic,” Warren said in a statement². “I’m glad to partner with Senator Bennet on a bipartisan bill that will help gather better data on the opioid epidemic while also helping health care providers make the best decisions for their patients.”

A Department of Justice report recently released found that misused prescription opioids are often obtained illegally using forged or altered prescriptions and by consulting multiple doctors. It was also found that most prescription fraud remains undetected.

“An epidemic of this magnitude requires us to address all aspects of the problem, starting with how providers prescribe opioids,” Bennet said in the statement. "This bipartisan legislation would expand a critical tool to track the use of opioids, ultimately reducing overdoses and saving lives."

Toomey added to the statement, “This commonsense measure will help improve tracking of opioid prescribing and reduce diversion due to forged prescriptions. This is a simple but important step in the direction of curbing opioid abuse.” Heller further added by stating, “This bipartisan legislation takes a critical step toward eliminating doctor shopping and duplicative or fraudulent prescriptions.”

The bill is proposed to go into effect in 2020 and does allow for some exceptions. These include prescriptions generated and dispensed by the same entity, economic hardship, technological limitations and other exceptional circumstances.

At MDToolbox, we strongly encourage all providers to not wait for legislation and to take advantage of the benefits of e-Prescribing controlled substances as soon as possible. It not only prevents fraud but makes things easier for prescribers as well. We are happy to answer any questions you may have about getting started with EPCS and offer a free 30 day trial so that you can see how quick and easy it is.

1.       H.R.3528 - Every Prescription Conveyed Securely Act https://www.congress.gov/bill/115th-congress/house-bill/3528
2.       Warren, Bennet, Heller, Toomey Introduce Bill to Combat Opioid Crisis with E-Prescriptions https://www.warren.senate.gov/newsroom/press-releases/warren-bennet-heller-toomey-introduce-bill-to-combat-opioid-crisis-with-e-prescriptions

As 2017 comes to a close, the deadline for providers to avoid a Medicare penalty in 2019 is approaching and the 2018 reporting periods are about to begin. The Centers for Medicare & Medicaid Services (CMS) has designed the Quality Payment Program (QPP) with two tracks clinicians can take under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) - Advanced Alternative Payment Models (APMs) or Merit-based Incentive Payment System (MIPS). As we mentioned at the beginning of this year, the well-known Meaningful Use program has been added as a part of MIPS. There are four components to MIPS: Quality, Improvement Activities, Advancing Care Information (ACI), and Cost. Meaningful Use is part of the ACI component. Providers have until March 31, 2018 to send in their data for 2017 which will increase, decrease, or keep their 2019 Medicare payments the same. The reporting period for 2018 starts January 1, 2018. CMS is taking a gradual approach to implementing the program so the requirements for each year differ.

2017 Requirements:

CMS offers “pick your pace” options in 2017. These include:

• Zero participation – receive a 4% penalty in 2019
• Test – submit a minimum of one quality measure, one improvement activity, or the four required ACI measures and avoid a negative payment adjustment.
• Partial participation – Submit at least 90 days of 2017 data for more than one quality measure, OR more than one improvement activity, OR more than the four required ACI measures and avoid a negative payment adjustment and possibly receive a positive payment adjustment.
• Full participation - Submit at least 90 days of data for all required quality measures, AND all required improvement activities, AND all four required ACI measures and earn a positive payment adjustment.
• Advanced Alternative Payment Model - receive 25% of Medicare payments or see 20% of Medicare patients through an Advanced APM in 2017, and earn a 5% incentive payment in 2019.

Certified Electronic Health Record Technology (CEHRT) Requirements:

• Use either 2014 or 2015 Edition CEHRT or a combination

2018 Requirements:

• Zero participation – penalty increases to 5% in 2020
• MIPS Participation Minimum Performance Periods

o   Quality – 12 months

o   Cost – 12 months

o   Improvement Activities – 90 days

o   Advancing Care Information – 90 days

• To meet the point threshold to avoid a negative payment adjustment, clinicians must:

o   Report all required Improvement Activities.

o  Meet the Advancing Care Information base score and submit 1 Quality measure that meets data completeness.

o  Meet the Advancing Care Information base score, by reporting the 5 base measures, and submit one medium-weighted Improvement Activity.

o   Submit 6 Quality measures that meet data completeness criteria.

CEHRT Requirements:

• Use either 2014 or 2015 Edition CEHRT or a combination
• Receive a 10% bonus if only use 2015 Edition CEHRT

There are only a couple days left in 2017 to make sure you have at least met the requirements for the “Test” option to avoid the penalty in 2019. It’s also important to note that 2018 requires 12 months of reporting for Quality and Cost measures meaning that reporting period is also starting in just a couple days. It’s vital to make sure you are using a product or combination of products that are certified. MDToolbox was one of the only stand-alone e-Prescribing vendors to certify on the 2015 edition CEHRT requirements earlier this year. We are certified for e-Prescribing and Patient Education and are able to integrate with many other products to meet all of the requirements. Contact us for more info on how we can help you meet the MIPS requirements.

Congressman Markwayne Mullin (R-OK) and Congresswoman Katherine Clark (D-MA) recently introduced legislation that would mandate Electronic Prescribing of Controlled Substances (EPCS) under Medicare Part D. The “Every Prescription Conveyed Securely Act”, H.R. 3528¹, was introduced into the House of Representatives.

It states that a prescription for a covered part D drug under a prescription drug plan for schedule II – V controlled substances must be transmitted electronically. If the bill passes, it would apply to coverage of drugs prescribed on or after January 1, 2020.

The aim of the legislation is to combat the national opioid epidemic. E-Prescribing does this by providing safer and more secure prescriptions. Electronic prescriptions can’t be forged or stolen like paper prescriptions. It also allows prescribers to easily track prescriptions and prevents patients from doctor shopping.

“Opioids claim nearly a hundred lives a day, and parents across the country worry they will be next to get the call their child has overdosed,” said Clark.  “Modernizing public health practices to include electronic prescriptions will curb the over-prescribing of opioids, eliminate the costs and inefficiencies of paperwork, and strengthen communication between doctors and patients.  Congress should come together to pass this commonsense solution to prevent overdoses and save lives.”

Mullen stated, “We need to ensure that patients are receiving opioids only when absolutely necessary and take precautionary measures to prohibit them from falling into the wrong hands.  Our bill, the EPCS Act, aims to close a dangerous loophole that has been fueling the problem of excessively prescribed opioids. By requiring all doctors and pharmacists to use an online database when prescribing these highly addictive drugs, we allow e-prescriptions to control, track, and monitor these highly addictive painkillers on a new level. This bill prevents patients from doctor shopping and prevents fraudulent, handwritten paper prescriptions.”

We have seen several states including New York, Maine, Connecticut, Virginia, and North Carolina take a similar approach to combat opioid abuse by mandating e-Prescribing of controlled substances at the state level, but this would be the first bill passed at the national level. This is definitely a step in the right direction of fighting the national opioid epidemic and we are hopeful that Congress will recognize the benefits e-Prescribing can bring. We also urge prescribers and health IT vendors alike not to wait for such bills to be enacted and to start taking advantage of the benefits of EPCS now. Contact us for more information about EPCS for prescribers and integrating EPCS for vendors at info@mdtoolbox.com.

https://www.congress.gov/bill/115th-congress/house-bill/3528/text/ih?overview=closed&format=xml

As we ring in the new year, medical providers now can say goodbye to the CMS’s “Meaningful Use Incentive Program” (MU) and start preparing for the new Medicare incentive program.

Providers who used qualified systems in 2016 can still attest to Meaningful Use for the 2016 year (you must have been a “meaningful user” of certified electronic medical record system(s) for the minimum reporting period. Visit this website for more info on how the previous year’s MU programs worked and deadlines for attesting: 

https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/2016ProgramRequirements.html

Now in 2017, Meaningful Use will become one of four components of the new “Merit-Based Incentive Payment System” or MIPS. MIPS is part of the bigger Medicare Access and CHIP Reauthorization or MACRA.² 

The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) ended the Sustainable Growth Rate formula, which threatened clinicians participating in Medicare with potential payment penalties for 13 years.  

The MACRA program introduces two paths that Medicare providers can choose from for participation:

• Advanced Alternative Payment Models (APMs) (providers apply for a special payment model program) or
• The Merit-based Incentive Payment System (MIPS)  (a performance-based program)

Who Does this Affect?

Providers who are in an Advanced APM or who bill Medicare for more than $30,000 a year and care for more than 100 Medicare patients a year are affected. Providers with less than that are not affected and not part of the program.³  This includes:

• Physician
• Physician assistant
• Nurse practitioner
• Clinical nurse specialist
• Certified registered nurse anesthetist

Advanced Alternative Payment Models (APMs)

The Advanced APMs program allows certain providers to apply for the APM track. This gives added incentive payments to provide high-quality and cost-efficient care. See the APM website for more information on the special programs and how providers can apply:

https://qpp.cms.gov/learn/apms

The Merit-based Incentive Payment System (MIPS)

Most Medicare Providers will be part of MIPS. They will earn a payment adjustment based on evidence-based and practice-specific quality data submitted. According to CMS, the Quality Payment Program policy will reform Medicare payments for more than 600,000 clinicians across the U.S.

Providers participating in the program in 2017 will submit their data by March 2018 and based on submission, their 2019 Medicare payments will be adjusted up, down, or not at all. 

MIPS is broken down into four categories and is setup so that the more Providers participate (and attest to), the higher score (and incentive) providers will get. A Medicare provider who does not participate at all (0%) may see up to 4% negative adjustment in 2019. A provider with a minimal amount of participation (e.g. submit one measure) may be able to avoid adjustment. For partial submission (submit the minimums for a partial year) they will see neutral or positive adjustments, and submit a full year and earn a positive payment adjustment.

If we take a quick look at how each category works:

•  Quality
•  Most Providers will report up to 6 quality measures (including an outcome type measure). Quality measures selected should be focused based on type of care and specialty as appropriate.
•  Reporting period must be a minimum of 90 days.
• There are over 250 quality measures available, be sure to check your health record software system to see which ones they support (can help gather data for you) when planning.
• Measures go across many specialties and problem sets:  For example, “Age Appropriate Screen Colonoscopy” – Report the percentage of patients greater than 85 years old seen by the Provider who received a colonoscopy screening Jan 1 to December 31.

•  Improvement Activities
• Most Providers will attest to completing a minimum of 4 improvement activities for at least 90 days.
• As of the writing of this blog, the CMS tools shows 92 activities to choose from.
• Activities range from care coordination, patient safety changes and beneficiary engagements.
• Examples: Join and participate (for a minimum of 6 months) in your States Prescription Monitoring Program (PMP). Or another example: Engage patients, family and caregivers in developing a plan of care and prioritizing their goals for action, documented in the certified EHR technology.

• Advancing Care Information
• Use a qualified (certified) product (or products) for a minimum of 90 days.
• There are two different programs to pick from depending on your Electronic Health Record Software Certification. For 2017, you will be able to use either a 2014 Certified Product (previously called Stage 2 MU Certification) or a 2015 certified product (certified for the MU Final Ruling criteria). Attest to a minimum of:

• E-Prescribing
• Provide Patient Access
• Send Summary of Care Records
• Receive Summary of Care Records
• Report up to 9 additional measures for bonus credits
• Cost
• No actions required: Cost will be computing from your claims
• The cost category will be calculated in 2017, but will not be used to determine your payment adjustment. In 2018, CMS will start using the cost category to determine your payment adjustment.

Medicare Providers will want to research the programs and decide their level of participation early in 2017. Full year participation would require making sure their Electronic Health Record system is setup for minimal data tracking and other required features like E-Prescribing and Direct Messaging.

References

1. 2017 Program requirements:

   https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/2017ProgramRequirements.html

2. MIPS and MACRA:

   http://www.impact-advisors.com/meaningful-use/mips-macra-mu-the-next-evolution-of-healthcare-payment-reform/#sthash.vMkVGSvN.dpuf

3. https://qpp.cms.gov/docs/Quality_Payment_Program_Overview_Fact_Sheet.pdf

4. MIPS Quality Payment Program Website: 

   https://qpp.cms.gov/measures/performance