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<img class="alignright size-medium wp-image-4657" src="https://healthlawupdate.bakerhostetlerblogs.com/wp-content/uploads/sites/19/2016/12/Lab-Petri-Science-iStock-543823562-300x204.jpg" alt="Antimicrobial susceptibility testing" width="300" height="204" />Antibiotics and similar drugs, known more broadly as antimicrobial agents, are an instrumental weapon in the healthcare armory, rendering once-lethal infections treatable, and dramatically reducing instances of sepsis and secondary infections associated with cancer chemotherapy and organ transplants. However, sub-therapeutic use of antimicrobial agents in livestock, over-prescription, bacterial evolution and myriad other factors have contributed to the emergence of resistance in the infections that these agents are intended to combat. Antibiotic-resistant bacteria pose a critical threat to the global healthcare system. According to the <a href="https://www.cdc.gov/drugresistance/">Centers for Disease Control and Prevention</a>, at least 2 million people become infected with bacteria that are resistant to antibiotics each year in the United States, and at least 23,000 people die annually as a result of these infections. As part of a government-wide response, CMS has proposed a series of measures to combat antibiotic resistance in healthcare facilities.

Long-Term Care Facilities

On October 4, 2016, CMS published a <a href="https://www.cdc.gov/drugresistance/">Final Rule</a> to revise Medicare and Medicaid participation requirements for skilled nursing facilities and nursing homes (collectively, long-term care facilities). The Final Rule requires that long-term care facilities establish and maintain an Infection Prevention and Control Program (IPCP) by November 28, 2016 that includes “[a] system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents, staff, volunteers, visitors, and other individuals providing services under a contractual arrangement based upon the facility assessment . . . and following accepted national standards.”

By November 28, 2017, facilities must establish an “antibiotic stewardship program” as part of the IPCP, and the program must include antibiotic use protocols and a system for monitoring their use. These requirements are significant, with CMS estimating that implementing such a program and ensuring proper oversight would cost long-term care facilities $19,000 per year, which CMS hopes will be greatly offset by the savings achieved through lowered rates of infection, a cost estimated to range between $4,000 and $11,000 per patient.

To help achieve compliance by the deadline, the Agency for Healthcare Research and Quality (AHRQ) has created a <a href="http://www.ahrq.gov/nhguide/index.html">Nursing Home Antimicrobial Stewardship Guide</a> to help long-term care facilities improve antibiotic use and decrease harms caused by inappropriate prescribing.

The guide’s four toolkits are designed to help facilities:
<ul>
 	<li>Implement, monitor and sustain an antimicrobial stewardship program.</li>
 	<li>Determine whether it is necessary to treat a potential infection with antibiotics.</li>
 	<li>Create antibiograms (a table of antibiotics to which a bacterial strain is resistant or susceptible) to help prescribing clinicians choose the right antibiotic to treat a particular infection.</li>
 	<li>Educate and engage residents and family members on proper use and risks associated with antibiotics.</li>
</ul>
Long-term care facilities are not alone. Starting next year, CMS plans to include hospitals as another front in the government-wide attempt to rein in the problem of antibiotic-resistant bacterial infection.

Hospital and Critical Access Hospitals

Beginning in FY 2017, as part of the Hospital Acquired Conditions Reduction Program, hospitals and critical access hospitals (CAH) will be required to report MRSA bacteremia and Clostridium difficile infections in addition to central line-associated blood stream infections, catheter-associated urinary tract infections and surgical site infections. These data, along with a hospital or CAH’s Patient Safety Indicator-90 composite measure, will be used to rank facilities on <a href="https://www.medicare.gov/hospitalcompare/search.html">Hospital Compare</a>. Low-ranking facilities will have their Medicare payments reduced.

Additionally, on June 16, 2016, CMS released a <a class="js-autopdflink" href="https://www.gpo.gov/fdsys/pkg/FR-2016-06-16/pdf/2016-13925.pdf" target="_blank" rel="noopener">proposed rule</a> to improve antibiotic-prescribing practices and mitigate patient risk for infections, which would require hospitals and CAHs to:
<ul>
 	<li>Have hospital-wide infection prevention and control, and antibiotic stewardship programs for the surveillance, prevention and control of healthcare-associated infections and other infectious diseases, and for the appropriate use of antibiotics.</li>
 	<li>Designate leaders of the IPCP and the antibiotic stewardship program who are qualified through education, training, experience, or certification. This requirement allows for flexibility in staffing in order to suit the needs of each hospital or CAH.</li>
</ul>
CMS estimates that these revisions, which would apply to approximately 6,200 hospitals and CAHs, would produce savings of up to $284 million. These proposed regulations are very similar to provisions recently finalized for long-term care facilities. We would not be surprised if these conditions of participation were finalized and implemented in largely the same form as their proposed version.

Physicians (MACRA)

Beginning in 2017, physicians will have a part to play as well. As part of the <a href="https://www.healthlawupdate.com/2016/11/making-sense-of-macra/">switch to the Medicare Access and Chip Reauthorization Act of 2015 (MACRA)</a>, data regarding the treatment of infections will be incorporated into the MACRA <a href="https://qpp.cms.gov/measures/quality">quality measures</a>, potentially having a major impact on how physicians will be paid. Under MACRA, physicians may earn a payment adjustment based on evidence-based and practice-specific quality data. The program includes measures aimed at combating the spread of infection generally (e.g., surgical site infections) as well as measures specifically tied to combating overuse of antibiotics, such as:
<ul>
 	<li>Adult Sinusitis: Antibiotic Prescribed for Acute Sinusitis (Overuse).</li>
 	<li>Adult Sinusitis: Appropriate Choice of Antibiotic: Amoxicillin With or Without Clavulanate Prescribed for Patients With Acute Bacterial Sinusitis (Appropriate Use).</li>
 	<li>Appropriate Treatment of Methicillin-Sensitive Staphylococcus Aureus Bacteremia.</li>
 	<li>Tuberculosis Prevention for Psoriasis, Psoriatic Arthritis and Rheumatoid Arthritis Patients on a Biological Immune Response.</li>
</ul>
In addition to Quality Measures, development of an antibiotic stewardship program is included as one of the potential MACRA Improvement Activities, where clinicians are rewarded for <a href="https://qpp.cms.gov/measures/ia">care focused on care coordination, beneficiary engagement, and patient safety</a>.

While many of the required elements of the IPCP policies and procedures are likely reflected in facilities’ existing infection control plans, some requirements will almost certainly be new for many facilities. It may be difficult to determine whether existing practices will meet CMS’s requirements and Medicare’s Conditions of Participation, given that much of the guidance and training has yet to be developed. However, one thing is certain: Going forward, CMS expects providers to get serious about antibiotic resistance.

Resistance Is Futile: CMS Gets Serious About Antibiotic-Resistant Bacteria