Kenneth Maxik

Kenneth Maxik – director of patient safety and compliance for CompleteRx – has worked with hospitals for more than 20 years on a range of pharmacy operations and management issues.

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	With the first couple of months of 2017 behind them, many in the healthcare industry remain uncertain as to what regulatory challenges they may face as the year unfolds. The debut of the American Health Care Act, proposed by House Republicans on March 6 to replace the Affordable Care Act (ACA), has some optimistic about new reimbursement rates, others bracing for potential regulatory whiplash, and many more just waiting to see what might be passed into law, and when.

	Regardless of what lies ahead, it’s imperative for healthcare professionals at all levels, and particularly those in strategic positions, to keep a close eye on regulatory updates as they occur and to think critically about their potential impact on their businesses and patients. These savvy leaders needn’t wait for an update from Washington to start, however; there are several critical regulations, which have, at least somewhat, more certain futures, that they can begin to prepare for today.

	In the pharmacy department alone, the most significant of these include:

Pharmaceutical Compounding-Sterile Preparations

. On January 1, 2004, USP chapter 797, Pharmaceutical Compounding-Sterile Preparations, was approved, replacing USP chapter 1206. Hospitals and health systems continue to struggle with the implementation and implications of USP’s chapter <797>. According to a 2015 self-assessment study conducted by Clinical IQ, overall compliance was reported at just 80% (

). The last published document for revision was available for public comment until January 2016, and among other things, included more environmental control requirements and increased accountability for staff competency. These changes are significant, and almost every state board of pharmacy in the country except for Pennsylvania has some verbiage related to sterile compounding or a direct reference to USP chapter <797>. CMS surveyors have also been trained on sterile compounding to enhance surveyor knowledge on the subject. Anecdotally, these regulators are already taking the new requirements very seriously-observing staff for compliance, and posing in-depth questions regarding storage, documentation, disposition, and more. Facilities that do not meet USP <797> standards risk, at best, a citation or a fine, and at worst, the revocation of their license. Now, in 2017, we await the next draft of this chapter to be released for public comment. Health systems of all sizes would benefit from a thorough review of the chapter to ensure comprehensive compliance 

 a CMS or state board of pharmacy survey.  

USP <800> Hazardous Drugs-Handling in Healthcare. 

USP <800>-which defines hazardous drug containment processes to promote patient safety, worker safety, and environmental protection-was approved and passed in February 2016. Health systems have now had a year to implement the sweeping changes-which, in some cases, require complete redesign of clean rooms and HVAC systems to maintain appropriate environmental controls (a project that may cost $500,000 or more to implement), but the clock is ticking. By July 1, 2018, the new rules will be enforceable by multiple regulatory agencies, and many hospitals aren’t ready. Recently, at the 51st Midyear Clinical Meeting and Exhibition of the American Society of Health-System Pharmacists in Las Vegas, an audience poll found that while 12% of attendees were already in full compliance with USP <800> standards, 20% reported their organizations were “in trouble.” Healthcare systems still have time to adapt their budgets and operational plans to accommodate these changes, but only if they act now, the closer they get to the deadline, the higher the chance that they’ll not only have to complete these activities anyway, but that in the meantime, they’ll also jeopardize patient safety and face regulatory action.

MM.09.01.01-Antimicrobial Stewardship Standard.

 As of January 1, 2017, the Joint Commission requires all accredited hospitals, critical access hospitals, and nursing care centers to have an antimicrobial stewardship program. The new standard follows growing concerns over antibiotic resistance, as evidenced by former President Obama’s action plan to combat the rise of antibiotic resistant bacteria in 2015, and many experts’ assertions that the existence of such “superbugs” has reached epidemic levels. Health systems have flexibility in terms of what these programs look like-depending on their size and scope -but all organizations are likely to face challenges related to identifying the appropriate leaders to establish the program, pulling together an interdisciplinary team to ensure its adherence, and allocating appropriate staff to the initiative while providing adequate coverage for other essential duties. Some hospitals have even identified a need to hire additional staff for the program, particularly those with expertise in infection prevention. While the Joint Commission had provided health systems a “grace period” of six months to ramp up and demonstrate results, there will continue to be more and more oversight in this space, and CMS recently suggested it will soon use antimicrobial stewardship as a criterion for Medicare participation. Fortunately, there are many great resources for health systems committed to implementing a successful program: as one example, the 

 has published their recommendations for antimicrobial stewardship programs, widely considered the industry standard.   

Three years after the enactment of the Drug Quality and Security Act, regulatory experts may have noticed the FDA was relatively busy in 2016, publishing guidances on a variety of subjects, including for 503A (most health system pharmacies) and 503B (registered outsourcing) facilities. While this is a broad topic, and health systems are encouraged to take a close look at the multiple guidances to determine what changes may affect them, there are a couple with widespread impact. For example, with the updated guidance, h

, facilities that are not compounding sterile product for specific patient use 

 ship that product more than a mile away from their facility. This will have the largest impact on health systems that have already or intend to implement a centralized IV model under 503A, as they will no longer be permitted to ship compounded drug product to their sister facilities. Secondly, larger facilities that have housed 503A and 503B facilities under the same roof will now have to consider both as 503B facilities, subjecting them to more stringent guidelines (503B facilities must comply with current good manufacturing practices, where hospital pharmacies that are predominately mixing for specific patient use, do not).

On Jan. 31, 2017, the Department of Health and Human Services, in response, many believe, to President Trump’s “two-for-one” plan to eliminate two old regulations for every new one that’s added, announced it had withdrawn the final 340B mega-guidance from White House review. The 340B Drug Pricing Program is a U.S. federal government program which requires drug manufactures to provide outpatient drugs to certain health care organizations and covered entities at reduced prices. In August 2015, The Health Resources and Services Administration (HRSA) proposed 

, which would narrow the definition of which hospitals and health systems were eligible for the program. For many health systems and hospitals, the withdrawal of this guidance is good news, as they will continue to be able to serve vulnerable populations through the program. While many experts believe it’s unlikely the guidance will now move forward, healthcare executives should watch HRSA closely for any other proposed changes to the program which may affect their businesses. The d

raft legislation released on March 6 did not mention the ACA provision of eligibility for covered entities such as rural and freestanding children’s and cancer hospitals’ that are currently eligible for 340B drug discounts. 

Kenneth Maxik is director of patient safety and compliance for 

. He has more than 20 years of pharmacy operations and management experience and works closely with hospitals and health systems across the country to help their organizations stay ahead of current and imminent regulatory standards.     

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Here are five critical regulations that executives can begin to prepare for today.

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