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.

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 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.

Long gone are the days when drug reps enticed physicians with extravagant meals at five-star restaurants and box seats to the Phillies’ playoffs (and sadly, gone are the days when the Phillies actually made the playoffs).

According to a recent study published in the journal, JAMA Internal Medicine, physicians who are provided a meal for less than $20 from drug reps are more inclined to prescribe that rep’s name-brand drug, which is not always covered by insurance, over the less pricy bioequivalent generic.

Researchers from the University of California, San Francisco, the University of Hawaii, and the Pacific Health Research and Education Institute examined data from 280,000 physicians in Medicare’s prescription drug program from August through December 2013.  Four top-selling name-brand drugs were considered: Benicar and Bystolic, both of which are used to treat high blood pressure, Pristiq, used to treat depression, and Crestor, used to treat high cholesterol.

The study revealed that doctors who received a meal linked to Benicar and Bystolic promotion were 70% and 52%, respectively, more likely to choose the name-brand than those doctors who did not receive a free meal.  Those who received a meal linked to Pristiq were 118% more likely to prescribe Pristiq, and Crestor was linked to an 18% prescribing increase over the bioequivalent generic Lipitor.

Further, an alarming $73 billion per year is spent on name-brand drugs for which there is an equally effective generic, with patients themselves spending $24 billion of that amount.

Dr. Adams Dudley, the study’s lead author, remarked, “Doctors are human, and humans respond to gifts.”

Forgive me for being a skeptic, but isn’t it also quite possible that the sales pitch given during the meal was what actually influenced physicians’ prescribing habits? Call it naiveté, but let’s hope it takes more than a measly slice of pizza to buy our healthcare providers’ loyalties.

–Alexandra L. Sobol, Esq.

(Click here to view Ms. Sobol’s biography)

The deadline for providers to file a hardship exception application to the electronic health record (EHR) meaningful use requirements for the 2015 reporting period is July 1, 2016.

If you have any concern that your practice or certain eligible professionals in your practice may have been unable to meet the meaningful use requirements for the 2015 reporting period, it may be appropriate for the applicable provider to file a hardship exception application with CMS to avoid future payment adjustments.  Note also that certain provider types may automatically qualify for a hardship exception for the 2015 reporting period without the need to file an application.

For more information, please see the Health Law Practice Alert recently published by Fox Rothschild LLP on this topic, accessible at this link:  Fox Rothschild LLP Health Law Practice Alert – Hardship Exception (June 17, 2016).

Previously on the Fox Rothschild Physician Law Blog, we reported on the July 2015 amendments to the PA Child Protective Services Law.  See our August 31, 2015 post here:  What You Need to Know about PA’s Child Protective Services Law.  In particular, we noted that the PA Medical Society interpreted the amendments to the Law as requiring all health care practitioners and practice staff having direct contact with children to obtain child abuse clearances.

After further review of the Law and consultation with the PA Department of Human Services (DHS), the PA Medical Society issued a retraction of its prior statement.  On December 1, 2015, the PA Medical Society reported that it had confirmed with the DHS that physicians and other employees of a medical practice or hospital (including administrative employees) are not required to obtain child abuse clearances under the Law.  See the PA Medical Society’s Clarification here:  PA Medical Society Child Abuse Clearances Clarification.

Although the Law used to require physicians (and other health care practitioners) to obtain child abuse clearances, the July amendments to the Law limited the clearance requirement to certain programs, activities and services.  As a result, a long-standing rule that physicians must obtain child abuse clearances appears to have been eliminated.

In our post, we also reported that the PA Department of Health (DOH), which licenses hospitals and other health care facilities, had continued to require such facilities to ensure that their health care practitioners obtained child abuse clearances, even after the amendments were passed.  The DOH has not yet confirmed its position on the Law after the recent clarification by the DHS.

While the Law appears not to require health care practitioners to obtain child abuse clearances in Pennsylvania, be sure to consult your legal counsel before making an administrative decision for your practice or health care facility.

A new article in the online journal, JAMA Internal Medicine, highlights the importance for physicians of keeping valuable non-public information confidential.  Under insider trading laws, it is illegal for anyone to trade securities based on non-public information and for anyone to supply information to others who trade on such information, if the person sharing the information has an obligation to keep it confidential.  Examples of valuable confidential information to which you might be privy include data and opinions regarding unpublished or ongoing clinical trials or new medical equipment, and information regarding acquisitions involving public health care companies.

Physicians may share their opinions with investors about medical research or other valuable information that is already public knowledge, but the line quickly becomes blurry when it comes to non-public information.  If you are asked to share information with a potential investor that you think may violate insider trading laws, it would be best to consult your legal counsel before disclosing the information.  This includes instances where you are asked to disclose information to, or participate in, “expert consulting networks” and online physician forums.

The line is also blurry for physicians when disclosing non-public information to other physicians and scientists for medical research purposes.  Be careful to disclose such information only  for research purposes.  If you become aware that one of the recipients of the non-public information may be using such information to trade securities, cease disclosing the information immediately and consider seeking legal counsel.

The online JAMA article is accessible in full at this link:  http://archinte.jamanetwork.com/article.aspx?articleid=2457402

You may have heard that CMS recently expanded its authority to deny enrollment and revoke the Medicare billing privileges of providers and suppliers.  The new changes could affect any physician, group practice or other Medicare provider or supplier.  As the changes are wide reaching, all Medicare providers and suppliers, and anyone providing support services for such providers or suppliers (such as billing companies or administrative staff), should be knowledgeable about CMS’ expanded authority.

Some important changes include:

  • CMS may deny the enrollment of a new provider or supplier if one of its owners previously owned a Medicare billing entity that (1) has had its billing privileges terminated or revoked, and (2) continues to have overpayments or other Medicare debt.
  • CMS may deny the enrollment, or revoke the billing privileges, of a provider or supplier if the provider/supplier, or an owner or managing employee of the provider or supplier, has been convicted within the last 10 years of any state or federal felony which CMS determines is detrimental to the best interests of the Medicare program and its beneficiaries.
  • CMS may revoke the billing privileges of any provider or supplier which CMS determines has engaged in a “pattern or practice of billing for services that do not meet Medicare requirements”.

I co-authored two articles on the new regulations that provide providers and suppliers (as well as billing companies) with what they need to know about the important changes.  One of the articles was the Cover Article for the May/June 2015 Issue of BC Advantage Magazine (available in print and accessible online for those individuals having a login to the BC Advantage website at: http://www.billing-coding.com/detail_article.cfm?ArticleID=5310).

The other article was published in Physicians News Digest (accessible to the public online at the following link:  http://physiciansnews.com/2015/04/16/physicians-beware-cms-may-deny-or-revoke-medicare-provider-privileges/).

The new regulations took effect on February 3, 2015.