Summit on Controlled Substances

I am excited to announce that I will be serving as the co-chair of the American Conference Institute’s Summit on Controlled Substances – Regulation, Litigation, and EnforcementThis is a one-of-a-kind event, bringing together subject matter experts from the pharmaceutical industry and government.  The Summit will address the most pressing topics in controlled substance regulation, litigation and enforcement, including

  • Suspicious Order Monitoring;
  • Abuse-deterrent opioid products;
  • State Prescription Drug Monitoring Programs;
  • State and Federal Enforcement actions against the supply chain; and
  • Policies and Politics of Controlled Substances.

Pre and post-conference workshops will also be available providing a primer on the fundamentals of the laws governing controlled substances and a simulated exercise on responding to a DEA inspection.

The Summit will be held in Washington, D.C. from January 29-31, 2018. Register today and use this code P10-999-DEA18 to receive a discount on registration fees.

An “Open Letter” to President Trump Regarding the Prescription Drug Abuse Epidemic

Dear President Trump,

For several years the prescription drug epidemic has ravaged communities across the United States.  During that time, the Drug Enforcement Administration (“DEA”) has aggressively pursued enforcement actions against the regulated industry.  Despite admirable efforts to curtail the epidemic through enforcement actions, prescription drug abuse continues to be a public health crisis.  There have been many solutions put forth in the past several months.  These solutions, while well-intended, failed to address the root causes of the epidemic – overprescribing of controlled substances.  Mr. President, this is a unique opportunity for you to reset our approach to this crisis.  As a first step, we need to reassess the enforcement-first approach of the past several years.

Before I go further, I would like to make a few things very clear.

  • I have a tremendous amount of respect for law enforcement. My father was a police officer for more than 24 years and I greatly admire the law enforcement personnel I had the pleasure of working with in my 12 + years at the Department of Justice.
  • While many of the recent past administrators of DEA came from DEA and law enforcement backgrounds, this is not a criticism of the work they did. This is also not a criticism of DEA’s and state and local law enforcement’s approach to addressing the issue.  Rather, this is about taking a different approach to combating the prescription drug abuse epidemic.

Now that I have gotten that out of the way, let me explain myself.  The prescription drug abuse epidemic has continued in this country for more than a decade.  The Office of National Drug Control Policy, DEA, and others have repeatedly stated that enforcement alone will not solve the problem.  Refreshing in this day and age, I think that is something that we can now all agree on.  What we can’t seem to agree on is how to make real measurable progress in addressing the root causes of prescription drug abuse and to stop prescription drug abuse from turning into addiction.

Reassessing the enforcement first approach and perhaps appointing someone from outside of the law enforcement community as the next Administrator would be a good first step in making measurable progress.  Enforcement has been DEA’s and state and local law enforcement’s default response to prescription drug abuse.  Let’s be fair.  Reporting arrest and seizure statistics are an easy way to show progress, right?  Unfortunately, that is not the case with the prescription drug abuse epidemic.  DEA has long discussed the balloon effect of its enforcement efforts.  That is to say, you squeeze the balloon in one area and another area grows.  Despite the realization that addressing controlled substance diversion operates in nearly the same manner, enforcement first seems to be the agency’s go-to response.  Again, an observation and not a criticism.

DEA is first and foremost a law enforcement agency.  DEA personnel say as much at conferences – “enforcement is our middle name.”  It has shown to be uncomfortable in its own skin when operating as a regulator.  Instead of looking at everyone as a potential “bad guy,” a regulator must collaborate, educate, and work with the regulated industry, using enforcement as a last option and for the most egregious misconduct.  Moreover, a regulator must understand how its regulated industry operates and should stay on top of technological and process advancements in the regulated industry.

Perhaps it is time for a change in addressing prescription drug abuse.  An approach that is in line with how the Food and Drug Administration (“FDA”) operates would be a good starting point.  Publishing guidance on its website that it provides to registrants should be a no-brainer.  Currently, DEA will meet with industry groups and respond to individual letters from registrants seeking guidance.  On a daily basis DEA is providing guidance to registrants, but does not share such guidance on its website.  Same for when DEA speaks to industry groups.   A more educated registrant population will lead to a more compliant registrant population, which will ideally lead to less diversion of controlled substances.

Another approach may be to appoint a DEA Administrator, from outside the ranks of law enforcement, who may bring a different perspective to the job.  I am not advocating bringing someone who will treat industry with kid gloves.  We need someone with a willingness to work with DEA registrants first, while using enforcement as a last resort.  Of course, there will always be the most egregious cases where enforcement as the primary tool must be used.  But, as DEA has acknowledged, only a very small percentage of the approximately 1.7 million DEA registrants are actively engaged or otherwise involved in the diversion of controlled substances.  DEA registrants fund the Diversion Control Division through registration fees.  Instead of using the registrant community’s money for additional enforcement mechanisms, such as tactical diversion squads or Special Assistant United States Attorneys, perhaps non-enforcement options can be funded to better educate and collaborate with the registrant community.  I understand that DEA does provide some education and training for registrants, but it can certainly do more.  Prescribers of controlled substances should be DEA’s main focus.

As a law enforcement agency, DEA is also understandably opaque when it comes to managing the regulatory aspect of its Congressional mandate.  Perhaps a leader outside of law enforcement will move the agency to be more transparent with the regulated industry.  Appointing someone without a law enforcement background is obviously not the silver bullet that will eradicate prescription drug abuse.  It is, however, time for a new perspective and a new approach to addressing prescription drug abuse.  Taking a different approach when choosing DEA leadership and regulating DEA registrants may be a good first step.

The Other Side of the Story: DEA Enforcement in the Opioid Crisis

Nobody would argue with the fact that there is an opioid crisis in our country – it is a demonstrable fact. However, there has recently been a significant focus on whether drug wholesalers and their business partners including lobbyists have caused people to die from overdoses, including a recent segment by 60 Minutes. While the segment sought to educate viewers on the causes of prescription drug abuse and the alleged slowdown in enforcement efforts by the government, it is of course journalism and takes a strong position against drug companies. Aided by reporters from the Washington Post and former employees from the Drug Enforcement Administration (“DEA”), the 60 Minutes segment, while dramatic in its presentation, only told the facts relevant to the position it was taking – which is what makes good headlines.

In the segment, a former employee of DEA provided heartfelt and explicit accusations that drug companies, through their lobbyists – especially drug wholesalers – were responsible for the drug epidemic, placing profit above public health and safety. The accusations oversimplify the problem and attribute causation unfairly rather than looking at the totality of the circumstances and the contributing factors.  Moreover, the attribution of decreased enforcement to recent legislation amending the Controlled Substances Act was incomplete and unbalanced.

Despite repeated finger pointing against certain members of the supply chain, the DEA employee made no mention of the two vitally important factors related to the surplus of controlled substances in our communities – DEA controls on manufacturing and over-prescribing by some physicians (or other prescribers). There did not seem to be a significant effort on the part of the reporters to challenge the former DEA employee’s assertions or attempt to look at the plethora of factors influencing the prescription drug abuse epidemic.

One significant factor that is often overlooked by reporters, policymakers, legislators, and the general public is that the total quantity of the most widely abused and diverted controlled substances produced and available in the United States is controlled and set by DEA. Even if the claim that Big Pharma’s lobbyists persuaded Congress to legislate in its favor is true, DEA still has the power and autonomy to limit the pharmaceutical company’s profits, by limiting the amount of drugs that can be produced.  Unless, of course, the former employee is also insinuating that DEA itself was beholden to drug lobbyists.

Instead of using its significant authority to limit the supply of these widely abused controlled substances, DEA actually became complicit in the problem by allowing significant increases in the manufacturing of these substances while the prescription drug epidemic was exploding. It is more than a bit of irony that the same former DEA employee blaming the epidemic on the regulated industry was the one whose hand was on the spigot, setting and approving the annual quota from approximately 2006 through 2016 – the heart of the prescription drug abuse epidemic. To be clear, these were not small increases over time (oxycodone quota increased by more than 300%). The graphics below show DEA-issued quota from 2004 through 2013.

You can also look at historic quota on DEA’s website.

While much attention is given to the bill passed by Congress and signed by President Obama, there was shockingly no reference to the actual content of the legislation which was only 7-pages long.  The bill did not strip DEA’s enforcement authority. It clarified an important legal term/standard that had not previously been defined. Instead of reporting both sides of the issue, 60 Minutes left its viewers thinking that one act of Congress crippled an entire agency’s enforcement operation. That is disingenuous at best. It is well known that administrative enforcement actions, including Immediate Suspension Orders, came to a screeching halt three years prior to the passage of the legislation in question. This was due to a number of factors that were not explored.

Also absent from the reporting is any discussion or acknowledgment that over-prescribing of controlled substances is at the heart of the prescription drug abuse epidemic. We need to ask (and hopefully answer) a fundamental question – why do prescribers in the United States prescribe the overwhelming majority of opioids that are consumed in the world? DEA, state regulators, and trade associations, including the AMA, must not only hold prescribers accountable, but they must educate prescribers and significantly change prescribing practices and the medical approach to treating pain. Minimal credits in prescription drug abuse, treating pain, and prescribing opioids should be required for all attendees of medical colleges and universities.  State medical boards should require minimum CME requirements every year for these same topics. And perhaps we need to consider limiting the authority to prescribe opioids to certain types of practitioners.

Finger-pointing and Monday-morning quarterbacking only deflect our attention from addressing this serious epidemic. There is no shortage of great minds inside and outside of government, who, when working together can make measurable progress in protecting the public health and safety from prescription drug abuse. Treating pharmaceutical companies as “drug dealers in lab coats” is the failed approach of previous management at DEA. While maybe not the silver bullet, I expect that collaboration with industry will bear more positive results.

West Virginia Imposes New Suspicious Order Reporting Requirements

The West Virginia Board of Pharmacy (“Board”) rolled out a new mandatory suspicious order reporting form for wholesalers at its board meeting last month.  The one-page form is designed to be filled out for each individual suspicious order being reported. This will require wholesalers that currently create and submit automated suspicious order reports to adapt their reporting for West Virginia.

In addition to the information generally provided to regulators, the form requires the wholesaler to disclose the reason it classified the order as suspicious. If a wholesaler had no suspicious orders to report in a given month, the form also must be used to disclose that fact to the Board. The “zero reporting” requirement for suspicious orders is new. It was included in proposed changes to the Board’s suspicious order reporting rule—W. Va. Code St. R. § 15-2-4—which have not yet been formally adopted by the State.

The Board notified at least one wholesaler at the end of September that it must start using the new form. Charles “Buck” Selby, the Board’s Chief Compliance Officer, stated in the letter: “[The BOP] approved this form as a required report form to be used by every controlled drug wholesale facility shipping into our state. It is the only form to be used by a wholesale facility for issuing suspicious orders reports to the West Virginia Board of Pharmacy.” Mr. Selby stated the Board was trying to improve its review of suspicious orders after receiving “much adverse publicity and comments” in recent months about the way the Board previously handled suspicious order reports.

According to newspaper reports, only two suspicious order reports were sent to the West Virginia Board of Pharmacy between 2001 and June 2012. Then, on June 26, 2012, former Attorney General Darrell McGraw filed lawsuits against a dozen wholesalers alleging that the companies shipped an excessive number of pain pills to West Virginia and failed to report suspicious orders from pharmacies. After that, more than 7,200 suspicious order reports flooded in. The Board failed to investigate, follow-up with wholesalers or pharmacies, or inform law enforcement authorities of the reports. The new form is not posted on the Board’s website. Mr. Selby stated in the letter that wholesalers can request a copy of the form by emailing the Board.

In its rush to implement these new requirements, the Board either failed to account for or simply disregarded the fact that most wholesalers have systems in place to electronically report suspicious orders, and other required reports, to DEA and state regulators. Insisting on a paper form will significantly burden wholesalers. Perhaps more importantly, requiring a justification for why the order was flagged as suspicious is a meaningless and unhelpful burden to impose on wholesalers. As stated repeatedly by DEA and the courts, a suspicious order does not necessarily mean that diversion is occurring. The vast majority of orders reported as suspicious are suspicious only because they triggered a red flag based on volume, pattern, or frequency—the metrics listed in DEA’s regulations to define a suspicious order. Hopefully, the Board will work with wholesalers to allow the electronic filing of suspicious order reports and will reconsider its insistence on requiring a justification for categorizing an order as suspicious.

Taxing Opioids to Address Prescription Drug Abuse

Federal and state policy makers struggle to come up with solutions to the ongoing opioid crisis. As with many areas of public policy, political leaders are turning to the tax laws as a possible way to curtail opioid abuse. In the past two years, there have been many proposals to impose special or excise taxes on the sale of opioids. To date none have passed. But we believe that without the implementation of other policies to address the issue, a number of states will impose taxes in the coming year.

In March, West Virginia Senator Joe Manchin introduced a bill (S 523) that would impose a federal excise on opioid sales. The law would impose a one cent per milligram tax on the sale of active opioids by a manufacturer, producer, or importer. Prescription drugs used exclusively for the treatment of opioid addiction as part of a medically assisted treatment effort would be exempt.  The revenue would be earmarked for state run addiction treatment programs. A similar bill was introduced in the House (HR 2038).

More recently, lawmakers in Delaware were the latest to propose the tax. On June 22, the House Majority leader co-sponsored a bill (HB 250) that would impose a ten percent tax on the sellers of opioids. It would apply to manufacturers, producers, importers, and distributors of opioids in the state. It would exempt opioids used to treat opioid addiction. Opioids sold outside of Delaware would also be exempt from tax.  The tax would be imposed at the wholesale level on the first sale into the state.

There have been proposals to tax opioids in seven other states in the past year. The Delaware proposal is a gross receipts tax.  An almost identical tax was proposed in Pennsylvania (SB 1213) and Connecticut (SB 5) although the rate in Connecticut was lower (6.35 percent). Some states have proposed a unit tax or fee on prescription opioids. For example, Washington state lawmakers proposed a .05 cents per dose (HB 1505) while proposals in California (AB 1512), Kentucky (HB 467), Massachusetts (HB 2633), and Minnesota (HF 1440) would set the rate at one cent per one milligram dose. In every state, the revenue would be earmarked for opioid addiction treatment or law enforcement.

There are a myriad of policy and legal issues surrounding the taxation of opioids. The taxes will likely make health care more expensive. And there are Federal laws prohibiting taxation of Medicare Part D prescriptions. There are also many variations of the state tax proposals. From a policy perspective, will the taxing of opioids really impact prescription drug abuse or are lawmakers missing the mark on how to make significant gains in eradicating drug abuse?

Contact David Brunori for additional issues regarding this or other matters involving federal, state or local taxes.

 

DEA Prevails Over Masters Pharmaceutical, Inc.

On June 30, 2017, the Court of Appeals for the D.C. Circuit issued an order in Masters Pharmaceutical, Inc. v. Drug Enforcement Administration (No. 15-1335). In sum, the Court denied Masters Pharmaceutical, Inc.’s (“Masters”) Petition for Review seeking to overturn the Drug Enforcement Administration’s (“DEA”) revocation of Masters’ DEA registration. This decision has wide-ranging implications for DEA-registered wholesalers, who are required to detect and report suspicious orders of controlled substances.

Here are a few takeaways from the Court’s decision:

  • The facts here were not on Masters’ side, making them less than a sympathetic petitioner. In a time where the opioid crisis is now considered an “epidemic” and garnering attention at the highest levels, it was likely difficult for the Court to justify overturning the DEA’s Final Order in a case where the petitioner: distributed large quantities of controlled substances to pharmacies that it knew or should have known were dispensing controlled substances for other than legitimate medical purposes; failed to follow its own policies and procedures; ignored/overlooked questions from its own employees regarding the distributions and allowed the drugs to be shipped anyway; and has been in trouble with the Agency before for similar misconduct.
  • These “bad facts” led to a decision that will have a significant impact on suspicious order detection and reporting across the industry. In affirming the DEA’s decision, the Court interpreted the suspicious order reporting requirement much more broadly than DEA. 21 C.F.R. § 1301.74(b) provides that non-practitioner registrants must design and implement a system to disclose suspicious orders of controlled substances. This regulation defines suspicious orders as “orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.” Consistent with DEA’s past guidance, the Court agreed that the criteria listed in DEA’s regulations for determining whether an order is suspicious is not an exhaustive list. The Court, however, then went on to take a less nuanced view on what must be reported to DEA under this regulation. DEA field division offices across the country have historically differed on how they interpret their own regulations. Some offices demand that registrants provide notice of all orders that are flagged by the registrant’s suspicious order monitoring program, while others only want orders reported that are deemed to be suspicious after the registrant has conducted an investigation of the order. The Court’s decision clearly supports the former reporting system. Arguably, the Court left open the possibility that flagging an order and investigating the order before reporting to DEA could satisfy a registrant’s reporting obligations. The Court cautioned registrants that if they “choose to shoulder the burden of dispelling suspicion in hopes of shipping…” then the distributor must conduct a detailed investigation each and every time in attempting to resolve the suspicion. On the contrary, the Court clearly states that “it is not necessary for a distributor of controlled substances to investigate suspicious orders if it reports them to DEA and declines to fill them.” With that said, it is difficult to envision a scenario where the flag and investigate approach would not violate the reporting requirement, especially where the Court’s unanimous view is that all orders that are flagged based on objective mathematical criteria designed to identify unusual volume, pattern, or frequency fall within the “suspicious order” definition of the regulations.
  • While the Masters case was obviously an important win for DEA, there are significant collateral consequences for the Agency. Whether a company utilizes an off-the-shelf product or has developed its own methodology for detecting and reporting suspicious orders, all suspicious order monitoring programs rely on objective mathematical criteria based on historic ordering patterns. As DEA has ramped up enforcement action against distributors the past ten or so years, many registrants have become more conservative in their monitoring of orders and reporting as suspicious orders flagged by their monitoring systems. The Masters decision may result in more registrants simply reporting every order flagged by their monitoring systems instead of conducting an investigation to determine whether the order should really be reported as suspicious. In turn, this could lead to DEA receiving voluminous amounts of suspicious order reports, making it more difficult for the Agency to use the data as a means of investigating potential bad actors within the system.
  • Perhaps the Masters decision will prompt DEA to take meaningful action, by working with the industry it regulates to figure out a better way to monitor for and report suspicious orders. Reporting orders that are truly suspicious provides useful investigative tools for DEA, whereas reporting all orders that are flagged by a mathematical algorithm is a frankly less than helpful exercise. If DEA really wants to make meaningful progress in combating the opioid epidemic, then it should create a working group with subject matter experts and representatives from industry to develop new suspicious order regulations. If DEA continues to be unwilling to do so, then it is going to need a lot more storage space to accommodate the influx of data coming its way.

 

Disclosure:  The author submitted an amicus brief in this matter on behalf of a client. 

Oregon Adds Suspicious Order Reporting to Wholesale Distributor Requirements

Recently, the Oregon Board of Pharmacy adopted a new rule for wholesale distributors, requiring that they report suspicious orders to the Board for review. The rule goes into effect on July 1, 2017.

The adoption of the new rule followed several recent settlements by wholesale distributors around the country, who are facing severe penalties for failing to report suspicious orders of controlled substances to the Drug Enforcement Administration (DEA). Continue Reading

Pharmacy Law Trends Q&A: Opioids, Specialty Drugs Among Top Issues for Retail Pharmacies

2017 Pharmacy Law Symposium-Art-vAThe opioid crisis in the United States continues to worsen, with the Centers for Disease Control reporting more than 33,000 human deaths by overdose in 2015 – up from about 29,000 in 2014 and quadruple the number in 1999. As in-house counsel from some of the nation’s 65,000 retail pharmacies prepare to meet in Chicago for Quarles & Brady’s 2017 Pharmacy Law Symposium this July, partners Amy Cotton Peterson and Roger Morris discussed the opioid epidemic. The partners also discussed specialty pharmacies, another important and evolving topic for those involved in the sector in 2017.

Q:  Given the severity of the opioid crisis, what are some of the challenges pharmacies are facing?

RM: Pharmacies – an important link in the chain that gets products from the manufacturer to the consumer – are continuing to be criminalized for the dispensing of opioids. This generates significant concerns for the pharmacies and their legal counsel, and some might wonder whether it’s worth it to continue selling opioids at all.

While deciding to discontinue carrying opioids would be a drastic step to take, it’s understandable that some pharmacies might at least entertain the notion, given the overall thorny nature of the issue. It’s worth noting that opioids make up only about 10 percent of all prescriptions.

Going deeper, pharmacies are faced with a lot of difficulties – how do they verify the validity of prescriptions? How do they determine if doctors are overprescribing, and what’s the pharmacist’s responsibility when it looks like they are? How do you work across state lines, given the different rules and regulations in each state? How do you work with different sets of records that might be maintained in a myriad of different ways?

We’ll address these questions, and more, at the Symposium in July.

Q. In what ways are pharmacies trying to address these problems?

ACP: Pharmacies, rightfully, have taken a lot of responsibility and initiative to address the epidemic. The steps they’ve taken include “Know Your Client” initiatives, in which pharmacists and wholesalers track suspicious ordering patterns. Some pharmacies are even using technologies like Google Maps to see if certain delivery locations have the potential to be pill mills.

Going a step further, regulatory requirements and state laws tell pharmacists what has to be on a prescription for it to be valid, but a lot falls on pharmacists’ professional judgment. Because there are gray areas – states don’t always make it easy to know what isn’t valid – pharmacies face some potential liability. To counter that, 49 states, the exception being Missouri, have Prescription Drug Monitoring Programs (PDMP), an electronic database that monitors prescriber and patient activity related to controlled substances such as opioids, for example. Some states have even gone as far as to enact regulations (some emergency) as to how PDMPs are monitored.

Arizona extended the reach of its PDMP by agreeing to share information with 22 other states, but there are major differences in how the data is kept in each state and by each pharmacy. Some states gather the data in real time, others daily and a few only weekly. Each state also identifies patients in different ways so that patient John Smith in Arizona might not be easily identified as Johnathan A. Smith Jr. in New Mexico even though they are the same person.

Big picture, the industry should step back and look at the overall processes from a public health perspective as opposed to a law enforcement perspective. Where’s the demand? Where’s the supply coming from? Where do the drugs end up?

Q: We’ve seen a growing trend with specialty pharmacies in recent years. What are the causes and challenges stemming from this growth?

ACP: Specialty pharmaceuticals, which treat complex and often rare diseases, are expensive and hard to handle, and their use is growing at a phenomenal rate. They’re expected to account for 50 percent of pharmacy revenues by 2020, and some estimates say they’ll surpass traditional brand name drug spend in the next few years. A growing number of hospitals and health systems, including the Cleveland Clinic, Rush University Medical Center and others have or are in the process of integrating specialty pharmacies.

RM: But this growth – which is spurred in part by an aging American population, but also innovation – brings with it a host of different licensure and regulatory issues. There’s also a lot of money on the line, as many of these drugs cost between $30,000 and $50,000 a month. This has generated a lot of excitement among manufacturers and developers, but when it comes to those distributing the drugs – pharmacies, among them – we’re really in a sort of “wild west” period when it comes to regulations.

Q: What are some best practices when it comes to specialty pharmacies that would be useful to pharmacies and their legal counsel?

RM: Specialty pharmacies must strictly comply with all pharmacy laws. Failure to be licensed correctly, at the facility or personnel level, can result in false or rejected claims. When prescriptions cost $30,000 each, a single misstep could eliminate any profit in this area for months. Moreover, specialty pharmacies must be vigilant in their compliance with Anti-Kickback and referral laws. Traditional gifts and benefits to prescribers from yesteryear are today’s inappropriate incentives.

To learn more about Quarles & Brady’s 2017 Pharmacy Law Symposium, or to register for the event, click here.

Alabama Battle Over Alprazolam is Done. For Now.

Prescription Medication Medicine Pill TabletsThe battle is over! For now.

Yesterday, Alabama lawmakers blocked the proposal to move Alprazolam into Schedule II, as well as blocking the other proposed changes described in this series of client updates. See here and here. The pharmacy community in Alabama took an active role in opposing these changes. According to this article from Alabama Live, members of the Alabama Pharmacy Association opposed this change and as noted in our most recent update, the Alabama Board of Pharmacy was also encouraging pharmacists to reach out to their legislators to share their concerns. It looks like all of this hard work has paid off. Will this come back? Hard to tell, but we will continue to watch how Alabama and other states try to manage and prevent the abuse of prescription medications.

Alabama Continues Efforts to Make Alprazolam a Schedule II Drug

As an update to our January 9, 2017 blog post, the Alabama Department of Public Health (ADPH) has continued with its efforts to make Alprazolam a Schedule II drug, along with rescheduling all other benzodiazepines from Schedule IV to Schedule III. The rule change would also reschedule pregabalin from Schedule V to Schedule IV and reschedule zolpidem from Schedule IV to Schedule III. The proposed rule was passed by the State Committee of Public Health and is currently scheduled to be effective on June 15, 2017.

But don’t change your systems yet. Because the rule change has not yet undergone legislative review, it is possible that the committee could vote against the rule, send it back to the state committee for reconsideration, or change the effective date.

We will provide an update when the legislative committee takes action. Read more in our alert.

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