The New York State Department of Health recently announced two regulatory enhancements to improve patient access to medical marijuana.

On March 22, 2017, chronic pain was added as a new qualifying condition for patients seeking medical marijuana in New York. “Chronic pain” is defined as “any severe debilitating pain that the practitioner determines degrades health and functional capability; where the patient has contraindications, has experienced intolerable side effects, or has experienced failure of one or more previously tried therapeutic options.” There also must be documented medical evidence of such pain having lasted three months or more, or the practitioner must reasonably anticipate that such pain will last three months or more.

This is a significant development for New York’s medical marijuana program, which is seen as one of the most restrictive of its kind in the United States. Prior to the addition of chronic pain, only 10 conditions qualified for medical marijuana: cancer, HIV infection or AIDS, amyotrophic lateral sclerosis (ALS), Parkinson’s disease, multiple sclerosis, damage to the nervous tissue of the spinal cord with objective neurological indication of intractable spasticity, epilepsy, inflammatory bowel disease, neuropathies, and Huntington’s disease. Glaucoma and post-traumatic stress disorder are still noticeably absent from the list.

The New York State Department of Health also announced that, effective as of March 15, 2017, physician assistants may now register to certify patients for medical marijuana, as long as their supervising physician is also registered. This measure is intended to increase the number of practitioners available to certify patients (previously, only physicians and nurse practitioners had this capability).

To certify patients for medical marijuana, medical professionals in New York are required to take a four-hour online course.

As many people are discussing methods to improve healthcare, the Centers for Medicare & Medicaid Services (CMS) is giving stakeholders an opportunity to send in their thoughts on this topic.  In CMS’s April 14, 2017 proposed rule, CMS issued a “Request for Information” (“RFI”), where they described their desire to have a “national conversation” about improving the health care delivery system.

CMS would like to know, amongst other ideas: (1) How CMS can help make its healthcare delivery system (Medicare) less bureaucratic and complex; and (2) How CMS can reduce the burden on clinicians, providers and patients in a manner that increases quality of care and decreases costs.  “CMS is soliciting ideas for regulatory, sub-regulatory, policy, practice and procedural changes to better accomplish these goals.”

Per CMS, some ideas could include recommendations regarding payment system re-designs; elimination or streamlining of reporting; monitoring and documentation requirements; and operational flexibility; amongst others.  CMS is also looking for ideas on how CMS issues regulations and policies, and how these could be simplified.

In a separate RFI in the same proposed rule, CMS also seeks information on how the scope and restrictions imposed on “Physician-Owned Hospitals” affect the delivery system, particularly with regards to Medicare beneficiaries.

To the extent respondents have data and specific examples, CMS requests such information be included in the submission.  If a proposal involves novel legal questions, CMS is also welcoming analysis regarding CMS’ authority.

If you wish to submit your comments to CMS, you have until June 13, 2017 to do so.

For more information please see the CMS Fact Sheet for Fiscal Year (FY) 2018 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Acute Care Hospital (LTCH) Prospective Payment System Proposed Rule, and Request for Information CMS-1677-P.

Beginning April 1, 2017, the regulations regarding opiate prescribing will be changing.  A Delaware healthcare practitioner will only be able to prescribe initial opioid prescriptions for acute pain episodes for up to seven (7) days for adult patients, and are required to follow new rules for chronic pain patients and patients that require more opioid medications for their acute pain episode.  The new regulations do have exemptions for hospice care patients, active cancer treatment patients, and terminally ill/palliative care patients.  These requirements and more details about the Delaware regulation are provided below.

New Jersey

On February 15, 2017, New Jersey’s Governor Christie signed into law legislation that limits initial opioid medications to five (5) day supplies, which is one of the most stringent in the country.  The limit would not apply to end of life care, cancer, and chronic pain patients.  The new law also includes a requirement that prescribers take continuing education that includes issues concerning prescription opioid drugs. The law goes into effect May 16, 2017.  It is likely that new regulations are pending to address these changes and we will provide more information at that time.

Delaware Acute Pain Episode Opioid Treatment Requirements

If a healthcare practitioner, based on their professional medical judgment, wishes to prescribe an adult more than a seven-day supply in an initial encounter or subsequent encounter, the practitioner must: (1) document the issue requiring a greater quantity in patient’s medical record; (2) “query the Prescription Drug Monitoring Program (PMP) to obtain a prescription history”; (3) “indicate that a non-opioid alternative was not available”; (4) obtain Informed Consent consistent with the regulation; (5) “conduct a physical examination, which must include a documented discussion of elicit relevant history, explain risks and benefits of opioid analgesics and possible alternatives, other treatments tried or considered and whether opioid analgesics are contra-indicated”; (6) “schedule/undertake periodic follow-up visits and evaluations to monitor progress toward goals in a treatment plan, whether there is an available alternative to continue opioid use, and whether to refer the patient for a pain management or substance abuse consultation”; and (7) at the discretion of the practitioner, administer a fluid drug screen.

Delaware Chronic Long-Term Opioid Treatment Requirements

For chronic long-term treatment with an opioid, a healthcare practitioner must follow the guidelines listed above as well as:

(1) query the PMP at least every six months or more frequently if clinically indicated (including, when a patient is on a benzodiazepine, the patient is potentially at risk for substance abuse or misuse, or when the patient demonstrates such things as loss of prescriptions, requests for early prescriptions or similar behavior); (2) administer a fluid drug screen at least every six months; and (3) obtain a signed Treatment Agreement containing the elements in the regulation.

Delaware Opioid Treatment for Minors

For minors, healthcare practitioners cannot prescribe opioid analgesics for more than a seven-day supply at any time, and must discuss with the parent or guardian the risks associated with the use and the reason for use of the medication.

For more information on Delaware’s new changes please see the following documents on Delaware’s Controlled Substance Advisory Committee’s website Delaware Prescription Opioid Guidelines for Health Care Providers and the Uniform Controlled Substances Act Regulations.

Advancements in healthcare technology continue at an explosive pace and nowhere is this more evident than in the field of mobile healthcare applications. Technology giants such as Apple and Garmin are diving into the wearable healthcare device arena and healthcare app companies are rapidly developing technology to enable devices to transmit healthcare information directly to physicians from these devices. Not surprisingly, physicians are also being courted by technology companies to endorse, invest in, Beta test and enter into licensing agreements to utilize these technologies.

As evidenced, however, by three recent settlements between the New York State Attorney General and several healthcare app companies, the marriage between healthcare and technology is fraught with potential legal pitfalls. According to the NY Attorney General’s press release, the settlement involved the makers of Cardiio, Runtastic, My Baby’s Beat, three popular healthcare applications that, among other things, monitor user heart rates. In addition to requiring the companies to pay civil settlements, the settlement agreements require the companies to modify certain of their marketing claims which the Attorney General alleged were misleading, and to change their privacy practices regarding the use and disclosure of user information. In light of these settlements, physicians considering getting involved with app makers or other healthcare technology ventures should carefully vet those arrangements and the applications themselves for compliance with healthcare laws including, without limitation, federal and state kickback prohibitions and privacy and security considerations.

The Centers for Medicare & Medicaid Services (“CMS”) recently introduced a new education initiative for Chronic Care Management (“CCM”) patients and providers. The initiative, called Connected Care, is intended to raise awareness of the benefits of providing CCM services to Medicare beneficiaries with multiple chronic conditions and to help ensure that health care providers are receiving optimal reimbursement for providing such services.

CMS has stated that two-thirds of Medicare beneficiaries have two or more chronic conditions, and one-third have four or more chronic conditions. CMS recognizes CCM as a critical component to primary care that contributes to better quality health care at reduced cost. However, many CCM providers are not aware that the Medicare Physician Fee Schedule allows separate payments for CCM services such as telephone communication, review of medical records and test results, and coordination and exchange of health information with other providers. CCM also includes activities such as patient education or motivational counseling, which are provided either in person or by telephone. Physicians, certified nurse midwives, clinical nurse specialists, nurse practitioners and physician assistants may bill for CCM services.

Specifically, CPT Code 99490 has been available since 2015 for eligible providers to bill for at least 20 minutes of clinical staff time directed by a physician each month to coordinate care for beneficiaries who have two or more serious chronic conditions expected to last at least 12 months. Effective January 1, 2017, CMS expanded the CCM billing codes to account for more complex and time-consuming care coordination:

  • HCPCS Code G0506 is an add-on code to the CCM initiating visit for providing a comprehensive assessment and care planning to patients;
  • CPT Code 99487 is for complex CCM that requires substantial revision of a care plan, moderate or high complexity medical decision making, and 60 minutes of clinical staff time;
  • CPT Code 99489 is a complex CCM add-on code for each additional 30 minutes of clinical staff time.

CMS’ Connected Care program provides the following educational materials for CCM services:

If you have questions regarding billing for CCM services, please contact a knowledgeable and experienced healthcare attorney.

Until March 20, 2017, the Pennsylvania Department of Health (the “DOH”) will be accepting applications from companies seeking permits as Grower/Processors and/or Dispensaries of medical marijuana in Pennsylvania.  Among other things, these applications require that the applicant raise substantial funding.  To do so, certain applicants have been seeking investment from physicians.  If you receive such a request, we encourage you to consult with a knowledgeable attorney before contributing funds to or agreeing to purchase securities in such a company.

It is important to note that the Pennsylvania Medical Marijuana Act prohibits any physician from holding a direct or economic interest in a Grower/Processor or a Dispensary, if such physician is registered with the DOH to certify the use of medical marijuana by his or her patients.  [See Section 402(a)(2) of the Pennsylvania Marijuana Act, accessible here:  Section 402].   The DOH has not yet begun accepting applications from physicians for registration to certify the use of medical marijuana, and will not do so prior to granting permits to Grower/Processors and Dispensaries.  Therefore, any physician considering ownership in a Grower/Processor or Dispensary should carefully consider whether he or she would rather be registered to certify the use of medical marijuana by patients in Pennsylvania.

It should also be noted that the DOH will be issuing regulations regarding physician registration and certification of the use of medical marijuana sometime later this year or in early 2018.  These regulations may provide further restrictions on ownership of Grower/Processors or Dispensaries by licensed physicians in Pennsylvania.

Stay tuned to the Fox Rothschild Physician Law Blog for further updates on this topic.

We recently issued a Health Law Alert on the Medicare Quality Payment Program, focusing specifically on what physicians and their medical practices need to know to be in compliance with the Program in 2017.  The Alert may be accessed at this link: Fox Rothschild Health Law Alert – Medicare Quality Payment Program

You may also view some of our recent posts on the Physician Law Blog for more information on the Medicare Quality Payment Program.  In short, compliance with the Program in 2017 can earn you and your practice anywhere from a 0%-4% increase in your reimbursements under the Medicare Physician Fee Schedule in 2019.  However, failure to meet at least the minimum level of compliance this year will result in a negative adjustment of 4% to your Medicare reimbursements in 2019.

Stay tuned to Fox Rothschild’s Physician Law Blog for updates on the Medicare Quality Payment Program in 2017 and beyond.

The Medicare incentive programs with which you and your medical practice are familiar will soon be no more.  As of January 1, 2017, these programs (including the Electronic Health Records (EHR) Meaningful Use Incentive Program, the Physician Quality Reporting System (PQRS), and the Physician Value-Based Modifier Program) will morph into the new Medicare Quality Payment Program (QPP).   The QPP will also include a fourth category of incentives entitled “Clinical Practice Improvement Activities”, which we discuss in more detail below.

The purpose of the QPP is to create one central program that will govern Medicare Part B payments to physicians, while incentivizing physicians to increase quality of care and decrease inefficiencies in the cost of care for Medicare patients.  Participation in the QPP will be mandatory beginning January 1, 2017.  The QPP will either reward or penalize physicians and their practices by adjusting their reimbursement rates under the Medicare Physician Fee Schedule two (2) years after the reporting year.  Therefore, physicians/practices will have their reimbursement rates adjusted in 2019 based on their reporting data for the year 2017.

As we noted in our first blog post in the Series, accessible here, physicians will have the option to choose between two payment tracks under the QPP:  (1) the Merit-Based Incentive Payment System (MIPS); and (2) an Advanced Alternative Payment Model (Advanced APM).  This blog post will discuss the basics of the MIPS and how to qualify for the MIPS in 2017, while our next post will touch on the basics of participation in Advanced APMs.

Basics of the MIPS

Each physician or group practice (you may report individually or as a group) participating in the MIPS in 2017 will earn a “composite performance score” based on the physician/group’s scores within the following four (4) categories:

  1. Quality of Care – 60%
    • Explanation: Scored based on the reporting of “quality measures”, which will be published annually by CMS.  Physicians will be able to choose which quality measures they will report each year.
    • Replaces: PQRS and quality component of the Value-Based Modifier.
  2. Advancing Care Information – 25%
    • Explanation: Scored based on the reporting of EHR use-related measures with which you are familiar from the current EHR Meaningful Use Incentive Program.  However, unlike the existing program, the QPP measures will not have “all-or-nothing” targets.
    • Replaces: EHR Meaningful Use Program.
  3. Clinical Practice Improvement Activities – 15%
    • Explanation: Scored based on attestation by the physician/group that the physician/group has performed certain care coordination, beneficiary engagement, population management and patient safety activities.
    • Replaces:   New Program.
  4. Resource Use – 0%
    • Explanation: Scored based on per capita patient costs and episode-based measures.  CMS collects and analyzes the data from your claims submissions.  No additional reporting will be required.
    • Replaces: Cost component of the Value-Based Modifier.

How to Qualify for 2017

CMS has eased the reporting requirements for the first year of the QPP.  No physician/group will be required to begin collecting data in accordance with the QPP’s requirements on January 1, 2017 (but may elect to do so).  To receive a neutral or positive payment adjustment, physicians/groups will need to report data for only a 90-day performance period during the year.  There are also minimum threshold reporting requirements to avoid a negative payment adjustment and full participation requirements which are more likely to result in a guaranteed positive adjustment.  The table below organizes the requirements in an easy-to-read format:

MIPS Measures Chart

Final Thoughts on Qualifying for the MIPS in 2017

  • Get involved sooner rather than later. CMS has kept reporting requirements minimal in 2017 in order to encourage clinicians to participate in the QPP.  Take advantage of that opportunity to ensure your practice has the right software to report the quality and EHR use-related measures.  Since adjustments will be made based on threshold scores, it may be easier in 2017 to earn a positive adjustment, and even an exceptional bonus, than in later years.
  • Ensure that your current EHR technology meets the requirements for the QPP in 2017, including reporting capabilities for quality measures and EHR use-related measures. The easiest way to do this is to contact your EHR vendor.
  • CMS has given providers plenty of time to report 2017 data. The deadline for reporting 2017 data is March 31, 2018.

As always, if you have questions specific to your practice, please contact a knowledgeable and experienced attorney.

Earlier this month, the Office of Inspector General of the Department of Health and Human Services (“OIG”), the agency charged with enforcement of key federal fraud and abuse laws, published its annual Work Plan identifying the areas of compliance concern under the Medicare program on which it will focus its review efforts in the coming year.

While the Work Plan does not provide much detail in terms of why particular areas have been identified for review, it can serve as a useful tool for physicians and other providers to identify specific areas on which they should be focusing their compliance efforts. Among other areas of potential concern for physician practices, the 2017 Work Plan identifies the following as subjects of focus by the OIG:

-Outpatient Intensity Modulated Radiation Therapy;
-Billing for prosthetics and orthotics;
-Billing for personally performed anesthesia services;
-Chiropractic billing;
-Billing for Physical Therapy by Therapists in Independent Practice.

In addition, the OIG will be studying whether there is any correlation between physicians who receive payments from drug and device manufacturers and the ordering and prescribing activities of those physicians. The basis for this review will be data reported by drug and device manufacturers under the Physician Payments Sunshine Act contained in the Affordable Care Act.

The entire FY 2017 Work Plan can be viewed on the OIG’s website.

The U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) issued an alert on November 28, 2016, regarding an email purporting to be from OCR.  This phishing email can look like an official government email which may use fake HHS letterhead and may even appear to be signed by OCR’s Director, Jocelyn Samuels.

OCR says:

The email prompts recipients to click a link regarding possible inclusion in the HIPAA Privacy, Security, and Breach Rules Audit Program.  The link directs individuals to a non-governmental website marketing a firm’s cybersecurity services. In no way is this firm associated with the U.S. Department of Health and Human Services or the Office for Civil Rights.”

If you or your organization has a question about whether you received an official communication, OCR suggests that you contact them via email at OSOCRAudit@hhs.gov.

The alert can be found at the following link: OCR Alert.