[For more information on CMS’s new Quality Payment Program and what physicians need to report in 2017, please see our prior blog posts here and here.]

CMS recently issued guidance (accessible here) on the three-part “Prevention of Information Blocking” attestation which physicians and other eligible clinicians will need to submit to CMS in order to qualify for points under the “Advancing Care Information” category of the Merit-based Incentive Payment System (MIPS).

Although making this attestation and reporting to CMS regarding use of certified EHR technology (CEHRT) is not required to avoid a penalty under the MIPS for 2017, many physicians and group practices wish to report as much as they reasonably can to seek a high score under the MIPS and a positive payment adjustment to their Medicare reimbursements in 2019.

The three-part attestation centers on the representation that the physician/group practice will not knowingly and willfully limit or restrict the compatibility or interoperability of its CEHRT.  CMS’s guidance makes clear that physicians and group practices making the attestation must use good faith and reasonable efforts to enable the exchange of electronic health records between appropriate parties.

According to CMS, examples of situations where access to CEHRT could be reasonably restricted include:

  1. System Maintenance — Disabling CEHRT for as long as reasonably necessary to complete system maintenance, provided that requests for access to EHR information during such time period are responded to when practical;
  2. Security Concerns — Blocking access to CEHRT when reasonably necessary to ensure the security of EHR information, provided that the blocking was narrowly tailored to the bona fide threat; and
  3. Patient’s Health and Well-Being — Restricting access to certain information (such as a patient’s sensitive test results), if the clinician reasonably believes that the restriction is necessary to protect the patient’s health or well-being. In the case of sensitive test results, CMS suggests that restricting access to the results could be reasonable until the physician or clinician who ordered the test has reviewed and appropriately communicated the results to the patient.

CMS expects that physicians and group practices making the attestation will ensure that their organizational policies and workflows will not restrict functionality of the CEHRT in any way, and that they will work with their CEHRT vendors to ensure that the CEHRT is fully functional.

If you or your practice will be reporting EHR data to CMS under the MIPS for 2017, a full review of CMS’s guidance on the attestation is recommended (see the five-page guidance here).  All physicians and practices reporting EHR data under the MIPS have until March 31, 2018 to report the data and make the attestation.

As first reported on our sister blog, “In the Weeds” (post accessible here), on July 26, 2017, the Pennsylvania Department of Health opened its Medical Marijuana Practitioner Registry.  Physicians licensed in the Commonwealth of Pennsylvania may now apply online to register to certify the use of medical marijuana for their patients.  The online application may be completed here.

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

The Practitioner Registry will be publicly searchable and will include each practitioner’s name, business address, and medical credentials.  As noted in one of our prior blog posts on the subject (accessible here), it is still unclear whether practitioners may represent on their own practice websites that they are registered with the Pennsylvania Department of Health to certify the use of medical marijuana.

In order to complete the registration process, physicians will be required to complete a four-hour training program on the use of medical marijuana to treat serious medical conditions.  As part of its Press Release on the opening of the Practitioner Registry, the Department of Health has announced that the following two continuing education providers have been approved to offer the training program to practitioners at this time:  Answer Page Inc. and Extra Step Assurance LLC.  Further information on the training courses can be found at the companies’ websites.

For more information on Pennsylvania’s Medical Marijuana Program and how it applies to practitioners, please see our prior blog post on the subject (link), as well as the state website for the Program (accessible at this link).  According to the Press Release, Pennsylvania’s Medical Marijuana Program is still on track to be fully implemented in 2018.

On June 20, 2017, The Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule which would exempt a greater number of small practices from complying with the  Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”).

CMS’s Administrator, Seema Verma has been quoted as saying that CMS has “heard the concerns that too many quality programs, technology requirements and measures get between the doctor and the patient. . . That’s why we’re taking a hard look at reducing burdens. ”

In order to accomplish this goal, CMS proposes to now exempt physician practices with less than $90,000 in Medicare revenue or physicians with fewer than 200 unique Medicare patients.  The current rule only exempts physician practices that have less than $30,000 in Medicare revenue or fewer than 100 unique Medicare patients.  This proposed rule could mean another 834,000 clinicians could be exempt from the quality reporting under MACRA.

While this seems like a large increase in the number of physicians that are exempt, a recent Modern Healthcare article notes that “65% of Medicare payments would still be reported under methods that adhere to MACRA even if this draft rule were finalized.”

If you are interested in commenting on the proposed rule you may do so through August 30, 2017.  The proposed rule can be found at the following website: Proposed Rule.

If you would like more information about MACRA please see the Fox Rothschild Health Law Alert – Medicare Quality Payment Program from January 2017.

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.

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.

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.