PA Electronic Prescription Requirement for Controlled Substances Takes Effect

Beginning October 24, 2019, pursuant to Act 96 of 2018 (“Act”), every licensed health care practitioner in Pennsylvania will be required to electronically prescribe controlled substances by sending the prescription directly to a pharmacy via the Internet. The Act replaces the traditional method of prescribing controlled substances to a patient, i.e. paper prescription pads.

The primary goal of the Act is to combat the opioid epidemic by using electronic prescriptions to reduce medication errors and minimize the chances of prescription forgery, diversion, and theft. To comply with the Act, a practitioner must use an electric health record (“EHR”) system or similar software that:

  1. Provides the capability to create an electronic prescription and send it to a pharmacy; and
  2. Is DEA federal security-certified for electronic prescribing of controlled substances.

There are a number of exceptions to the Act, including, but not limited to:

  • Controlled substance prescriptions for drugs dispensed by a physician in their office;
  • Practitioners or health care facilities that do not have either Internet access or an EHR; and
  • Practitioners treating patients in the emergency room or a health care facility when the practitioner reasonably determines that electronically prescribing a controlled substance would be impractical or cause an untimely delay resulting in an adverse impact on the patient’s medical condition.

A practitioner or health care facility that does not meet an exception to the Act can apply for a temporary exemption from the law’s requirements based on economic hardship, technical limitations or exceptional circumstances. The exemption expires one year after it is issued or the date on which final electronic prescription regulations are issued by the Pennsylvania Department of Health (“Department”) (whichever is earlier)[1]. The Department estimates it will take a minimum of ten business days to render a decision on an exemption application, though the time period could be longer depending on the number of requests.

Practitioners must document in the patient’s medical record when they are unable to electronically prescribe a controlled substance for the patient in any of the following scenarios:

  1. Technological or electrical failure;
  2. Circumstances where an electronic prescription would result in an untimely delay causing an adverse impact on the patient’s medical condition;
  3. Pharmacy is not set up to process electronic prescriptions; and
  4. Transmission of electronic prescription failed (in which case another can be submitted).

Penalties for violating the law are $100 per violation for the first 10 violations and $250 per violation thereafter, with a $5,000 per year cap. [2]

The Act’s obligations should not be viewed as cumbersome in this day and age of widespread Internet access. The Act will better protect practitioners from unscrupulous patients and employees attempting to divert controlled substances through fraudulent prescriptions. It also will help practitioners keep better records of their controlled substance prescriptions. 

Practitioners should ensure their timely compliance with the Act. Law enforcement continues to aggressively enforce controlled substance prescription laws and is less inclined in the current opioid epidemic climate to allow any flexibility for violators of this type of law. Those not yet in or near compliance with the Act should expedite measures to do so, or promptly contact the Department about obtaining an exemption.

The Grail Law Firm has extensive experience representing medical professionals and health care facilities in federal and state criminal and regulatory actions involving controlled substance prescription issues.  Feel free to contact us to discuss how the Act will affect your practice and related compliance issues.

[1] The Department is required to issue regulations by April 22, 2020.

[2] The Department has provided a quick reference document for more information on the Act – See Electronic Prescribing of Controlled Substances FAQs – https://www.health.pa.gov/topics/Documents/Programs/FINAL_EPCS_Public%20FAQ_9-5-2019.pdf.

Victims of Business Crimes Aren’t Always Better Off Seeking Prosecution

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A week hasn’t gone by since I left my job as a prosecutor in 1995 (yes, 1995:  Bill Clinton was president, the Dow topped 5,000 for the first time ever, O.J. Simpson was acquitted of murder that year and the iPod wouldn’t come out for another six years) when a client hasn’t called asking how to have someone prosecuted and sent to jail. Businesses find local, state and especially federal law enforcement almost uniformly unresponsive to their victimization at the hands of employees and competitors. Companies often feel victimized a second time by “the system,” when all they really want is what almost no victim ever gets in the way of justice: vindication, to make up for the betrayal of trust.

Before calling 911, though, business crime victims should consider the risks and drawbacks of involving themselves in the criminal justice system.  Investigations and court cases are rarely short or cut-and-dried, especially when the target has significant knowledge of your business and its employees or operations. Meeting with police and prosecutors, going to court and even testifying there can be a major distraction to key personnel. It can risk the confidentiality of company processes or trade secrets, and can even provoke investigation of the business victimized in the first place. The decision to “blow the whistle,” then, even when justified, should be made for good business reasons, and not for emotional ones, and be thought through thoroughly at a high level of policy/decision making.

The exception to the “think before you fink” rule is for highly-regulated business, which are likely required to report thefts or other misconduct by employees, directors and competitors: chiefly banks and financial institutions, health care providers which seek reimbursement of federal or insurance funds, environmental permit holders (mandated to regularly report discharges), and industries which handle classified national security data (e.g., defense contractors, advanced software and computing research, etc.).

Simple embezzlements by employees, additionally, should always be reported when the identity of the culprit is certain.  Reporting to the police is almost always a prerequisite to recovering on a dishonest employee provision to the business’s insurance coverage or employee fidelity bond.  (Note: let this be a reminder to check with your company’s broker or risk managers to ensure that there is dishonest employee coverage, in sufficiently high enough dollars to adequately protect the entity against loss.)

But affirmatively pressing for criminal charges (beyond simple reporting) can be counter-productive. Often a company’s best chance of recovering any restitution informally is before a prosecution, through negotiation. This should be done by experienced counsel consistent with lawyers’ professional conduct rules, to prevent accusations against company personnel of committing extortion and themselves becoming a target of an investigation, and also to ensure the company’s duty under a policy of insurance to cooperate with law enforcement is fulfilled, thereby preserving coverage.

Prosecutors and investigators often see businesses’ reports of crime as pressing them into service for a private entity, and not the public safety.  Trade secret theft allegations are most often ignored by law enforcement.  Federal prosecutors are reluctant to become involved in lengthy disputes between private parties, for which there are civil remedies available, such as the private right of action recently provided by the recent enactment of the Defense of Trade Secrets Act.    The exception, again, is for employees and competitors of banks, government contractors (primarily including health care providers,) and businesses in which there is a national security interest.  And state and local police and prosecutors aren’t set up to bring “white collar” cases that exceed simple fraud/theft matters (even those can tax a district attorney’s office, more comfortable with ‘guns and drugs’ case).

Sophisticated theft prosecutions can harm the victim as well.  Prosecutors may not be sufficiently attuned to protecting confidential security or manufacturing/development processes, and courts may not adequately protect against their disclosure to the defense.   While the Justice Department is getting better at handling trade secret misappropriation cases, early prosecution efforts under the Economic Espionage Act of 1996 risked disclosure of the very trade secrets alleged to have been stolen.

And the unfortunate truth is that former employees and competitors  facing criminal prosecution often retaliate by alleging criminal wrongdoing by the complaining business, rightly or not. This is especially true in small businesses, or small units of larger ones. It does no good to accuse an employee whose wages are not being completely reported of theft, when that employee can in turn complain to the IRS about the employer’s tax fraud.  (That case led to convictions of both the business owner and the former controller). Employers need to understand what they risk in publicizing an internal matter, including in the way of adverse publicity, when it is them who have been ripped off.

Seeking redress as the victim of a theft or other crime shouldn’t be difficult, and it shouldn’t require a business seconding-guessing itself.  But the realities of the justice system, the economics and the politics of what drives it, and especially the fact that desperate persons facing the possibility of criminal conviction and jail will often lead desperate people to desperate acts, to your detriment. Economic crime victims shouldn’t shy away from seeking justice and restitution, if for no other reason than to highlight to others that crimes against them will not be tolerated. But how best to be made whole after being victimized requires a well-thought out decision with the help of counsel experienced in the justice system, and not an emotional response to make senior executives feel better. In the long run, it may only make things much worse.

Grail Law Firm Helps Lead Coalition Of Pennsylvania Lawyers To Protect Individuals’ Due Process Rights Before The Commonwealth’s Supreme Court

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In a pair of decisions on December 3 and July 27 of, the Pennsylvania Supreme Court backed significant restraints on state prosecutors and their power over secret grand jury proceedings.  The Opinions in the In Re: Fortieth Statewide Investigating Grand Jury case held that principles of fundamental fairness demanded enhanced procedural protections be afforded to persons named in state Grand Jury “Reports,” who are not prosecuted and thus do not have sufficient procedural rights to safeguard their right to reputation.  The opinions reaffirmed that “…the judicial branch serves a critical role in guarding against unjustified diminution of due process protections for individuals whose right of reputation might be impugned,” which the Court recognized “has been accorded the same exalted status as other basic individual human rights, such as freedom of speech, freedom of assembly, and freedom of the press.”

Petitioners in that case, Roman Catholic priests aggrieved by state investigating Grand Jury procedures likening back to secret ‘star chamber’ proceedings marked by anonymous witnesses making inaccessible allegations in the absence of cross examination, any other evidentiary safeguards or adversary representation, and without a meaningful rebuttal or other medium of participation in the process.  The clients had all been named in the Grand Jury report written by the state Attorney General’s office about alleged historical clergy sexual misconduct with children.  They brought suit alleging they hadn’t been provided adequate opportunity to respond to the grand jury allegations, that the report stigmatized people who hadn’t been convicted of crimes, and also that the report contained inaccuracies and broad, vague generalizations not necessarily relevant to each of them, in the nature of a ‘group libel’. 

Our state Supreme Court recognized their claims, and held that Grand Jury accusations against of “heinous criminal acts” by our clients would never be tested in a criminal trial with due process safeguards, which “presents a substantial risk of impairment of those individuals’ right to their reputation … The Report will be seen as carrying the weight of governmental and judicial authority,” where the grand jury is regarded as “embodying the voice of the community.”  With respect to its specific findings, the Court determined that principles of fundamental fairness demanded enhanced procedural protections [for] Petitioners in order to safeguard their right to reputation.”

The Opinion then found that discretionary procedures available to the Grand Jury’s Supervising Judge “to allow named but nonindicted individuals to submit a written response to the report …to be inadequate.”  The Court recognized that such responses “would be hearsay, and, because of the voluminous size and scope of Report, there is a likelihood that, to a reader, the response would pale in significance to the overall report.”  In addition, because the Report contains “numerous allegations involving the reprehensible behavior of a multiplicity of individuals,” the Justices “deemed the cumulative effect of those allegations as likely to inflame a reader’s ire, and, thus, impede his or her capacity to evaluate the credibility of an individual’s response.”

The Court also found a second procedure available to the Supervising Judge under the Grand Jury Act similarly ineffective to safeguard the petitioners’ rights, that “the supervising judge examine the report and determine if the Report allegations are based on facts derived from the grand jury investigation and is supported by a preponderance of the evidence.” 

Finally, the Court “found that such a preponderance-of-the-evidence standard [which the Grand Jury applied] was ‘best suited to adversarial proceedings where competing litigants present evidence to be weighed by a factfinder[,]’”, which the grand jury proceedings wholly lacked.  Instead, in the Grand Jury, 

…evidence is not subject to meaningful testing before the grand jury, through either cross-examination or the presentation of rebuttal evidence. Inasmuch as this review process by the supervising judge does not give named individuals an opportunity to respond to the grand jury’s conclusions in “a meaningful way,” we concluded it provided inadequate due process protection for Petitioners.

The case presented a stark reminder of the importance of fighting for the presumption of innocence and the right to a fair trial for all accused.  Argued by co-counsel from Saul Ewing’s Philadelphia office, together on the briefs with dozens of top-notch lawyers from all over Pennsylvania, and supported by a laser-sharp Amicus Curie brief by Philadelphia’s Post & Schell and submitted on behalf of the Pennsylvania Association of Criminal Defense Lawyers, the case highlighted the best that committed counsel can accomplish when working together on behalf of important principles dear to our constitutional tradition.

“The effort by lawyers working for individual clients throughout the Commonwealth, many with little or no ability who were assumed to be guilty in the absence of proof or process, and in some cases, despite protestations to the contrary, was reaffirming,” Grail said after the decision.

Takeaways from the Annual Pennsylvania White Collar Criminal Defense Lawyers’ Conference

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Newsflash: the Justice Department is still an insider’s club, criminal practice is not for beginners, and courts still penalize defendants who exercise their constitutional right to have criminal charges against them tried by a jury; Western Pennsylvania is the only judicial district in the country regularly prosecuting doctors who prescribe Suboxone, and everyone’s rekindled interest in the Nixon case as a prediction of Special Counsel Robert Muller’s next move.

That’s our “takeaway” from the annual White Collar Criminal Defense seminar featuring top prosecutors, judges, and federal defense practitioners, hosted by the Pennsylvania Association of Criminal Defense Lawyers in Philadelphia this past month. The annual event brings key Justice Department lawyers from Washington, and practice chiefs from the local and neighboring U.S. Attorneys’ Office, together with judges and defense practitioners, to discuss the Government’s enforcement focus and the strategy and tactics to defend them. The program provides insight into current Government initiatives, and a window onto what has changed in the law; what we learned is that the more things change, the more things remain the same.

This year’s program featured the Eastern District of Pennsylvania Federal Judge Wendy Beetlestone, on sentencing practices for criminal defendants in White Collar Cases. The implicit message in her remarks, as well as in those of appellate lawyers at the program following her address, was the implicit bias of the judiciary against criminal defendants who insist on exercising their constitutional right to trial by a jury of their peers on the charges against them. Of course, this sounds counterintuitive to non-lawyers; the federal United States Sentencing Guidelines, however, place an enormous emphasis on having criminal defendants admit their guilt and show remorse, to the extent of rewarding those who plead guilty with a lesser sentence. Unlike plea bargaining in many states, however, federal criminal procedure does not provide for a plea of “no contest,” where the defendant withdraws their plea of not guilty because they believe that taking the prosecution’s offer without a trial “is in their best interest” (California law provides for this in what is known as an Alford plea; in West Virginia it’s referred to as a Kennedy plea).

Sure, the Bill of Rights to the U.S. Constitution provides that every defendant is presumed innocent until proven guilty – but defendants who put the prosecution and the courts through the exercise of a trial are routinely punished for relying on that right.  Since they have not admitted their guilt or shown remorse, this is generally true in practice even if they do not take the stand to testify in their own defense, or present evidence directly disputing that they are guilty of the charge(s), and instead exercise their constitutional right to remain silent.  Indeed, the implicit rule has not changed little: if you must go to trial, be certain that you win because the price of losing is higher than the price of admitting guilt.

And speaking of trials, the overwhelming takeaway from appeals of political trials seems to be that under no circumstances should the defense ever sit quietly while a judge sends an indictment into the jury room, as the “road map” for consideration of the charges. Indictments are in effect the government’s statement of its case, replete with excess and prejudicial allegations which in no instance reflects at all well on the defendant, and further, object strenuously to the judge holding her jury charge conference in chambers, without a court reporter present; there is too much potential to waive legal objections through lack of adequate preservation of the issues. The familiarity and closeness of the government prosecutors and defense lawyers on a personal level emphasized, once again, how many of us as defense lawyers started out as prosecutors, and oftentimes how many prosecutors start out as defense lawyers. 

We hang out together because we speak the same language, we often respect each other, and most of the time we even like each other.  Don’t underestimate the value of personal relationships and familiarity with the system in choosing your criminal defense advocate.  The “Main Justice” Department in Washington and the U.S. Attorneys Office(s), are notorious for being places where “inside baseball” is played, or as we say in Pittsburgh, where only “home cooking” is served.  If your civil lawyer who doesn’t know where the U .S. Attorney’s Office is or who sits in it, tells you they can handle the criminal matter just fine, don’t believe them; this isn’t something you want your attorney to learn at your expense.  

In health care prosecutions, as Buzzfeed recently noted online, the Western District of Pennsylvania seems to remain the only federal judicial district in the country prosecuting doctors who allegedly misprescribed buprenorphine (suboxone).  Doctors beware. 

And finally, what we learned at the White Collar Seminar was that if acting Attorney General Whitaker (or his successor) unseats special prosecutor Mueller, the Chief Judge of the judicial district in the District of Columbia may not maintain an investigation without the Justice Department leading it.  That having been said, former PA Western District U.S. Attorney Harry Littman said just several days ago on TV that, regardless of Special Counsel Mueller’s longevity in office, his plans for the further investigation and possible prosecution of Donald Trump, Jr., the President’s son, Jared Kushner, the President’s his son-in-law, and even the President himself should all be revealed in short order.  Stay tuned!