As previously reported on our Physician Law Blog (see our post here), the Pennsylvania Department of Health issued draft “temporary” regulations regarding physician registration and certification of medical marijuana on April 11, 2017.   Following a brief comment period, the Department finalized its “temporary” regulations in the June 3, 2017 issue of the PA Bulletin.  A copy of the final regulations can be viewed here.

Medical marijuana in jar lying on prescription form
Copyright: megaflopp / 123RF Stock Photo

The regulations are labeled “temporary” because they were adopted to implement PA’s new Medical Marijuana Program.  As a result, they will expire in two years, unless made permanent by the Department.  However, for the first year of the Program, these regulations will govern the registration of any physician who wishes to certify the use of medical marijuana for his or her patients.  The Department has confirmed in a related press release that the Medical Marijuana Program continues to be on schedule for full implementation in early 2018.

The final physician regulations make a few notable changes to the draft regulations, but also leave physicians with some lingering questions regarding the registration process, advertising their certification services, and charging fees for re-certifying the use of medical marijuana for existing patients.

Notable Changes

1.    The publicly available Practitioner Registry maintained by the Department will include only the practitioner’s name, business address and medical credentials (as opposed to the practitioner’s phone number and/or email address).  [See 28 Pa. Code 1181.25].  As a result, a prospective patient seeking a physician on the Practitioner Registry will need to take the extra step to conduct a web search on the physician in order to locate the physician’s contact information.  While this may encourage physicians registered to certify the use of medical marijuana to ensure that their practice websites clearly advertise their services, physicians should note that the Medical Marijuana Act and these regulations prohibit a physician registered to certify the use of medical marijuana from advertising the physician’s marijuana certification services.  It is unclear to what extent this prohibition will permit practice websites to note that one or more of the practice’s physicians are registered to certify the use of medical marijuana.

2.    A physician’s certification for the patient’s use of medical marijuana will now be required to include a statement as to the length of time (which cannot exceed 1 year) for which the practitioner believes the use of medical marijuana by the patient would be therapeutic and palliative.  [See 28 Pa. Code 1181.27(a)(6)].  The certification will also be required to include the recommendations, requirements or limitations as to the form or dosage of medical marijuana appropriate for the patient or a recommendation that the patient speak only with a medical professional employed by, and working at, the dispensary regarding the appropriate form and dosage of medical marijuana.  [See 28 Pa. Code 1181.27(a)(7)].

3.    Under the final regulations, physicians may not receive or provide medical marijuana product samples, and may not serve as a designated caregiver for a patient for whom the physician has issued a certification for medical marijuana. [See 28 Pa. Code 1181.31].

4.    Under the Act, physicians will be required to complete a 4-hour training course on various aspects of the use of medical marijuana in the treatment of serious medical conditions, in order to qualify for registration.  The Department confirmed in these final regulations that it will maintain on its website a list of approved training providers offering the 4-hour course for reference by physicians seeking registration.  [See 28 Pa. Code 1181.32].

Remaining Questions

As first raised in our prior blog post on the Department’s draft temporary physician regulations, the Act and the draft regulations appeared to leave two key questions unanswered.  First, will the physician registration process be electronic or require paper application?  And second, can a physician accept payment from existing patients for re-certifying the use of medical marijuana for those patients?

The Department failed to answer those questions in the final physician regulations. Regarding the former, we will eventually find out how the Department will operate the registration process when it announces the opening of physician registration.  However, regarding the latter, which arises out of the unclear drafting of the Act and these regulations, an answer may require further inquiry with the Department.

I also note that, as raised above, it is unclear whether registered physicians will be able to list on their websites that they are registered to certify the use of medical marijuana.

Stay tuned to the Fox Rothschild Physician Law Blog for updates on physician registration for certification of the use of medical marijuana in Pennsylvania.

Should you have any questions regarding the registration process or what obligations a registered physician will have under the Act, please contact an experienced healthcare lawyer.

Earlier this month, a New York man was sentenced to 10 years in prison for allegedly operating a $26 million scheme to defraud Medicare and Medicaid. The defendant allegedly established 6 medical clinics in Brooklyn that paid elderly people to pose as patients and billed Medicare and Medicaid for unnecessary and/or non-existent medical care and equipment. The defendant, who was not a doctor, operated the six clinics between 2007 and 2013, but because New York’s corporate practice of medicine doctrine requires that such clinics be owned and operated by licensed healthcare professionals, he found three physicians to serve as nominal clinic owners. The allegations included that the physicians would periodically come to the clinic to sign medical charts for patients who they never treated, and for others, prescribe unnecessary medications, procedures and supplies. The clinics allegedly incentivized elderly patients to seek “treatment” at the clinics through cash kickbacks.

In addition to his prison term, the defendant was ordered to pay $16,686,811 in forfeiture and a restitution order of $18,683,691. Although this was an extreme “billing mill” case, the severity of sentencing highlights the importance of billing compliance obligations. Also, since New York law strictly prohibits unlicensed individuals, such as the defendant, from owning medical clinics and/or influencing medical decision making, clinics should ensure that such functions are exclusively reserved to its licensed healthcare providers. The corporate practice of medicine doctrine varies from state to state, so we recommend that you contact a knowledgeable and experienced healthcare attorney in your state if you have any questions regarding these requirements.

USA Today, New York Times, BNA, and several other news outlets have been reporting over the last few weeks about non-competition agreements and non-compete laws especially related to low-wage workers.  There have been interesting changes and proposed changes to state laws that may affect several industries including healthcare.

In a recent article on Law360, titled “Noncompete Agreements Under Siege At The State Level,” the authors highlighted some developments in non-compete law.  They posit that many areas of employment and labor law have seen changes, but the law of noncompetition agreements has been relatively static.  Until recently, most changes came from case law in this area of law; however, more recently we are seeing that many state legislatures are taking up the issue.

Some states like Massachusetts, Oregon and Missouri are offering laws which include broad prohibitions on the enforcement of noncompetition agreements.  However these proposals have not made much legislative progress according to the authors.

Other states have offered legislation that has health care industry-specific prohibitions.  For example, the authors note that last year Rhode Island enacted legislation that effectively renders physician noncompetition agreements void and unenforceable, while Connecticut imposed new limits as to when noncompetition agreements can be enforced.

According to the authors, in 2017 the trend is continuing.  West Virginia enacted a statute regarding physician noncompetition agreements, which limits the ability to enforce such provisions.  The authors state:

Measures have also been introduced recently in Pennsylvania, Minnesota, Oregon (home care workers), New Mexico (certified nurse practitioners and midwives), and Connecticut (homemakers, companions and home health aides) that target noncompete enforcement against physicians and others in the health and medical profession. (emphasis added)

Low-wage employee non-compete clauses have also come under scrutiny.  The authors note that this year several states have or are currently considering income-based restrictions, including Massachusetts, Maine, Maryland (did not pass), and Washington.

With the landscape of this very important issue changing, individual healthcare providers, their employers, and anyone else who uses, or is subject to, non-compete provisions will need to keep on top of developments to their state’s specific laws.  As the laws change, it will be more important than ever to have non-compete provisions and agreements reviewed or re-reviewed to ensure you understand the effect of such changes.

We invite you to read Part 1 and Part 2 in a series of posts by Fox partner Dori K. Stibolt, regarding the new trend in ADA Title III litigation involving web access for the visually impaired.

Many of these cases have focused on travel, hospitality and financial services companies. However, there has been a micro trend of these web site accessibility cases naming dentists and physicians.

As first posted on our sister blog, “In The Weeds” (Fox Rothschild’s Cannabis Law Blog), the Pennsylvania Department of Health issued its long-awaited proposed temporary regulations regarding physicians on April 11, 2017.  A copy of the temporary regulations can be found here:  PA Temporary Physician Medical Marijuana Regulations

The temporary regulations provide additional detail on the physician registration process, including the required four-hour training session regarding the legal use of medical marijuana and research on its effects, as well as the process for patient certification for use of medical marijuana.

The temporary regulations also propose to maintain (without further modification) the following four existing statutory restrictions on physicians:

  • Physicians may not accept, solicit or offer any form of remuneration from or to any individual or medical marijuana organization (such as a grower/processor or dispensary) to certify a patient’s use of medical marijuana;
  • Physicians may not hold a direct or economic interest in a medical marijuana organization in Pennsylvania;
  • Physicians may not advertise their services as a physician who is registered to certify a patient to receive medical marijuana; and
  • A physician may not issue a certification for the physician’s own use of medical marijuana or for the use of medical marijuana by a family or household member.

[28 Pa. Code 1181.31].

Notably, the temporary regulations do not provide further clarity on certain statutory provisions, such as (i) whether the physician registration process will be electronic or require paper application, and (ii) whether a physician may accept payment from existing patients for consultation regarding certification for the use of medical marijuana after the initial certification is issued.

The Department of Health accepted comments on the proposed temporary regulations until April 20, 2017.  It is unclear when the Department plans to issue its final regulations on physicians and medical marijuana.

Stay tuned to the Fox Rothschild Physician Law Blog for updates.

 

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.