CMS recently issued an Advisory Opinion suggesting that physicians who refer diagnostic tests reimbursable under Medicare to a laboratory may, under certain circumstances, receive electronic pop-up notifications in the laboratory’s web-based portal alerting the physicians to various potential issues related to the test results.  In the Advisory Opinion, CMS considered certain alerts which a laboratory proposed to provide to its referring physicians without charge via the laboratory’s web-based portal.  The entire Advisory Opinion can be read here.

In short, CMS concluded that the alerts proposed by the laboratory, which would be limited to issues relating to the test results, would not constitute illegal remuneration under the federal Stark law, as long as (1) the alerts are provided solely in connection with the ordering or communication of diagnostic test results from the laboratory, and (2) appropriate safeguards are in place to avoid overutilization or medically unnecessary testing.

Some of the key safeguards that CMS found persuasive included the following:

  • Alerts recommending additional testing would be based on industry-standard, peer-reviewed guidelines;
  • The alerts would not be “overly intrusive” and would not override the physician’s independent medical judgment;
  • Where multiple additional tests would be recommended in an alert, there would be no “select all” button for the physician to click to order all of the tests together;
  • The physician could turn off the alerts for a particular disease condition; and
  • The physician could obtain the information provided in the alerts free of charge from other sources.

An advisory opinion from CMS is a rare occurrence, in comparison to advisory opinions issued by the Office of Inspector General regarding the federal Anti-Kickback Statute, which occur a number of times each year.  This is the first and only advisory opinion issued by CMS in 2017.  To that end, CMS likely considers this Opinion to be useful guidance to physicians and providers regarding their use of online web portals to order diagnostic tests.

If you or your practice has any questions regarding alerts or other benefits you may receive via a laboratory’s online web portal, please consult experienced legal counsel.

[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.

Gov. Christie’s Administration recently proposed a regulation to curtail the prescription of unnecessary opioid painkillers.  Christie, who serves as the Chairman of President Trump’s Commission on Combating Drug Addiction and the Opioid Crisis, expressed concern that treatment decisions of all prescribers (including physicians, dentists and advanced practice nurses) are being improperly influenced by pharmaceutical companies.  According to Christie’s press release, four out of every five new heroin users began by misusing prescription painkillers, and, in 2016, $69 million was paid to physicians in New Jersey by drug companies and device manufacturers, two-thirds of which went to just 300 physicians.

The New Jersey regulation would take big steps toward restricting what prescribers may receive from pharmaceutical companies, including limiting the value and frequency of meals that may be provided in educational settings, and prohibiting the giving of a variety of items to prescribers, except in limited circumstances (such as for educational materials, for presenting at continuing education events and for bona fide consulting arrangements).  Annual payments for bona fide services would be limited to $10,000.

The proposed regulation will be published for comment in the New Jersey Register on October 2, 2017.  Stay tuned to Fox Rothschild’s Physician Law Blog for updates.

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.

Under CMS’s new Quality Payment Program, which will adjust Medicare Part B payments starting in 2019 based on data from this year, physicians and other eligible clinicians must qualify for one of two payment “tracks”, either the Merit-Based Incentive System (MIPS) or the Advanced Alternative Payment Model (Advanced APM) track.   A physician who qualifies under the MIPS in 2017 can earn up to a 4% payment adjustment to Medicare Part B payments in 2019.  Physicians who qualify under the Advanced APM track can earn up to a 5% payment adjustment in 2019.  For more information on the Quality Payment Program and the MIPS, please see our prior blog post on the topic here.

Since the Quality Payment Program went into effect on January 1, 2017, it has been unclear whether physicians participating in an Advanced APM in 2017 would be able to meet CMS’ quality and reporting requirements and earn a 5% payment adjustment to their Medicare Part B claims in 2019.

CMS recently provided clarity on this issue by predicting that almost 100% of physicians and other eligible clinicians participating in Advanced APMs in 2017 will qualify for a 5% payment adjustment to their Medicare Part B claims in 2019.  CMS based this prediction on an analysis of Advanced APM claims data submitted from January through August 2016 (before the Quality Payment Program went into effect).

CMS also stated that physicians who participate in an Advanced APM need to meet only one of two criteria to earn the 5% payment adjustment in 2019:  (1) receive 25% of the physician’s Medicare Part B payments through the Advanced APM; or (2) see 20% of the physician’s Medicare patients through the Advanced APM.  [A list of Advanced APMs in which a physician may participate in 2017 can be found at the following link: CMS List of Advanced APMs]

Participating in an Advanced APM can have several benefits (including being exempt from reporting quality data under the MIPS payment track), but also involves taking on some risk.  If you are considering participation in an Advanced APM, please contact an experienced attorney to discuss.

CMS is expected to issue formal determinations regarding the qualification of particular physicians for the Advanced APM track later this year.  Stay tuned to Fox Rothschild’s Physician Law Blog for updates.

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.

The Medicare Access and CHIP Reauthorization Act of 2015 requires Centers for Medicare and Medicaid Services (“CMS”) to remove Social Security Numbers (“SSNs”) from all Medicare cards. Physicians currently use a SSN-based Health Insurance Claim Number (“HICN”) for Medicare transactions like billing, eligibility status, and claim status. Starting April 1, 2018, CMS will begin mailing new cards with a randomly assigned Medicare Beneficiary Identifier (“MBI”) to replace the existing HICN. All Medicare cards will be replaced by April 1, 2019, affecting approximately 57.7 million beneficiaries.

The initiative is intended to better protect private health care and financial information; however, many physicians are unclear as to their responsibilities to ensure that billing privileges aren’t affected.  Although CMS has designated the time period running from April 1, 2018 through December 31, 2019 as a transition period, during which physicians may use either the HICN or MBI in Medicare transactions, physician systems must be able to accept the new MBI format by April 1, 2018, which is the beginning of the transition period.

Earlier this month, CMS released a five-point bulletin on steps physicians can take to prepare for the change. CMS advises physicians to do the following:

  • Go to CMS’ provider website and sign up for the weekly MLN Connects newsletter;
  • Attend CMS’ quarterly calls to get more information;
  • Verify all Medicare patients’ addresses. If the addresses on file are different than the Medicare addresses on electronic eligibility transactions, ask patients to contact Social Security and update their Medicare records;
  • Work with CMS to help patients adjust to their new Medicare cards. When available later this fall, display helpful information about the new Medicare cards; and
  • Test system changes and work with billing office staff to be sure the office is ready to use the new MBI format.

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.