Regulatory Review

REGULATORY REVIEW

Keep Your Patient Data Secure

The Information Age has revolutionized the health care industry, giving patients and providers greater, more specific access to personal health data. Care coordination operates with greater efficiency through the electronic transfer of personal health information (PHI), and providers and facilities can be reviewed on an expanded range of quality metrics.


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ASCs Gain Significant Ground under Proposed Rule

The 2019 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center Payment System Payment Rule that the Centers for Medicare & Medicaid Services (CMS) released at the end of July is the most positive for ASCs since 2009, when the ASC payment system was aligned with the hospital outpatient department (HOPD) payment system.


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CMMI: Pursuing Innovation in Medicare and Medicaid

In March 2010, after more than a year of development, President Obama signed into law the Patient Protection and Affordable Care Act (PPACA). Of particular note was Part III, Sec. 3021, which created a new Center for Medicare & Medicaid Innovation (referred to as CMI in the bill, now commonly known as CMMI) within the larger Centers for Medicare & Medicaid Services (CMS).


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Citation Trends in Emergency Preparedness

Medicare-certified ASCs have been required to have a disaster preparedness plan since 2009. As noted in State Operations Manual Appendix L—Guidance for Surveyors: Ambulatory Surgical Centers, the intent was for an ASC to “have in place a disaster preparedness plan to care for patients, staff and other individuals who are on the ASC’s premises when a major disruptive event occurs.”


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ASC Quality Reporting Program Requirements for 2019

With the ASC Quality Reporting (ASCQR) Program web-based measure deadline of May 15, 2018, in the rearview mirror, it is time to look ahead to the data that will be reported for the Centers for Medicare & Medicaid Services (CMS) ASCQR Program in 2019 for 2020 payment determinations. It also is a good time to review some of the publicly available data on current measures to determine where ASCs can improve.


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The History and Regulation of EHRs

In recent years, health information technology (HIT) has been the talk of the health care industry. Central to this discussion are products known as electronic health records (EHR), systems that electronically capture patient-provider encounter information, securely store the digital information and make it available for future reference. The potential benefits of such a system are boundless: streamlined provider workflows, increased information sharing across sites of service, reduction in medical errors, increased patient access to their health record, better medication tracking and more. Developing and implementing tailored, functional EHRs, however, has been a rocky road even for those with time and resources.


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ASCA Takes Aim at Medicare Payment Policy

From survey and certification issues to quality reporting and physician payment issues, there is always something happening on the federal regulatory front. One of the primary areas of focus for ASCA regulatory staff is on Medicare payment policy issues, and advocacy efforts related to Medicare’s 2019 ASC payment rule are already underway.


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Be Ahead of the Construction Curve

Constructing or renovating a medical facility is expensive and complicated. Do not make the mistake of believing moving a wall is “no big deal,” and that a regular home builder is up to the task. When it comes to medical construction, consult an expert and get a copy of the 2018 Guidelines for Design and Construction of Outpatient Facilities by the Facility Guidelines Institute.


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TKA Comes Off the Inpatient-Only List

One of the most heavily discussed policy changes in the calendar year (CY) 2018 Hospital Outpatient Prospective Payment System (OPPS) was the removal of total knee arthroplasty (TKA), CPT 27447, from Medicare’s inpatient-only (IPO) list as of January 1, 2018. While TKA is not on the ASC-payable list, its removal from the inpatient-only list is a positive step toward reimbursement in the ASC setting for fee-for-service Medicare patients.


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CMS’ New Emergency Preparedness Requirements

During the fall of 2016, the Centers for Medicare & Medicaid Services (CMS) released a final rule titled Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers. The regulation became effective on November 16, 2016, and as of November 15, 2017, the 17 health care provider and supplier types that must comply with the rule, including ASCs, began being held to these revised standards during their Medicare surveys.


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Make Compliance Easier

With Medicare’s 2018 payment rule in final form and the calendar refreshing toward a new year, now is a good time for ASCA members to consider how to make the most of all the regulatory resources ASCA makes available for their use each year. Navigating the assortment of rules and regulations tied to ASC oversight, payment and accreditation can be a complex proposition, even for those with experience.


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Joint Replacement Front and Center in OPPS/ASC Proposed Rule

Advances in medical technology have expanded the types of patients who can be treated outside the hospital. Despite these advances, the Centers for Medicare & Medicaid Services’ (CMS) payment policies have traditionally lagged innovation, and many procedures, such as total joints, are currently on the inpatient-only (IPO) list.


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MACRA Is Here

In last year’s November- December Focus magazine we outlined the Medicare Access and CHIP Reauthorization Act, commonly known as MACRA. This act, passed in 2015, instituted new mechanisms for Medicare physician payment, replacing the old Sustainable Growth Rate (SGR) formula. With the arrival of a new administration, as well as the June release of proposed updates, it seems worthwhile to reiterate MACRA’s overarching structure, highlight some new developments and give an indication of how it might affect clinicians operating in ASCs in the coming years.


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Got OAS CAHPS Questions?

In July, the Centers for Medicare & Medicaid Services (CMS) proposed to delay the mandatory implementation of the Consumer Assessment of Healthcare Providers and Systems Outpatient and Ambulatory Surgery Survey (OAS CAHPS) under the ASCQR Program for CY 2018 data collection in the 2018 Proposed Medicare Payment Rule. A lot of questions remain about the survey.


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CPI-U and Secondary Rescaling

Beginning January 1, 2008, the Centers for Medicare & Medicaid Services (CMS) began paying ASCs for the facility services they provide to Medicare beneficiaries using a system that is linked primarily to the Hospital Outpatient Department (HOPD) payment system, also known as the Hospital Outpatient Prospective Payment System (OPPS).


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Safeguarding PHI

In 2016 alone, there were 329 Health Insurance Portability and Accountability Act of 1996 (HIPAA) breaches of protected health information (PHI) that affected 500 or more individuals. Two hundred and fifty-four of those breaches involved electronic protected health information (ePHI).


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Patient Experience Survey Coming to ASCs

While many ASCs conduct their own patient satisfaction surveys, there is currently no single instrument that assesses patient experiences in outpatient surgical settings. This will change beginning next year when facilities will need to start using the Consumer Assessment of Healthcare Providers and Systems Outpatient and Ambulatory Surgery Survey (OAS CAHPS) survey to meet ASC Quality Reporting (ASCQR) Program requirements.


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Analyzing CMS’ Final Emergency Preparedness Rule

The Centers for Medicare & Medicaid Services (CMS) accommodated ASCA’s comments in several ways in its final rule on Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers. The rule establishes national emergency preparedness requirements for Medicare and Medicaid participating providers and suppliers.


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Medicare’s 2017 Final Payment Rule

The Centers for Medicare & Medicaid Services (CMS) issued its final payment rule regulating 2017 ASC Medicare payments on November 1, 2016. Provisions in that rule went into effect January 1, 2017.


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Massachusetts Proposes DoN

Massachusetts has proposed a Determination of Need (DoN) regulation that would prohibit freestanding ASCs from applying for a DoN for any proposed project unless they are affiliated with or in a joint venture with an acute care hospital. The affiliation described in the proposed regulation broadly includes: capital expenditures, substantial change in service, original license, DoN-required service or DoN-required equipment. Massachusetts enacted a moratorium on DoNs for ASCs in 1994. Since then, the number of Medicare-certified ASCs in the state has decreased from 63 to 56. The proposed regulations would lift this moratorium, which prevented ASCs from applying for DoNs. This type of “controlled expansion” has been proposed only in Massachusetts. Moreover, ASCs in the state are the only stakeholders subject to such a restriction.


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MACRA Is Just Around the Corner

The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) was hailed at the time of its enactment for repealing the Sustainable Growth Rate (SGR), the much maligned annual payment adjustment factor that perennially forced Congress to approve legislation to avoid steep, often double-digit cuts to Medicare physician payments. This new law profoundly alters how and how much physicians will be paid for services furnished to Medicare beneficiaries and how physicians will interact with the program. These changes are expected to alter payment and impose substantial new administrative obligations on physician groups and, potentially, realign the market for physician services. For ASCs, these changes present some new and unique challenges and opportunities.


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Patient Experience Survey Coming to ASCs

ASCs pride themselves on the high-quality care they provide and the high level of satisfaction that their patients report. Patients appreciate the convenience of ASCs and the fact that performing only outpatient elective procedures better controls the environment and limits patient exposure to potential health care acquired infections.


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Medicare Proposes Quality Reporting Changes

ASCs began reporting quality data to Medicare in 2012. There were five quality measures, all of which could be submitted on the claim forms that ASCs already submit to Medicare. Four years later, the number of measures in the ASC Quality Reporting (ASCQR) Program has more than doubled, and if the seven new measures referenced in the 2017 ASC proposed payment rule that are intended for inclusion starting in 2018 are finalized, the number will have almost quadrupled.


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CMS Adopts 2012 Life Safety Code

The Centers for Medicare & Medicaid Services (CMS) recently adopted. provisions of the 2012 editions of the Life Safety Code (LSC) (NFPA 101) and the Health Care Facilities Code (NFPA 99) in order to “simplify and modernize the construction and renovation process for affected health care providers and suppliers, reduce compliance-related burdens, and allow for more resources to be used for patient care.”


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Serious Reportable Events

Today, “never events” are referred to by a variety of terms, including “adverse patient events,” “patient safety events,” “sentinel events” and “serious reportable events” (SRE). While there are minute differences in the definitions of these terms, they aim to capture injuries that are caused by avoidable errors while providing medical care. ASC clinicians and administrators are familiar and experienced with documenting and reporting these events, but state and federal legislation and regulations requiring they do so are relatively modern developments.


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HIPAA Enforcement

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) and its Breach Notification, Privacy, and Security Rules are well-known to health care providers and facility administrators. The lesser known Enforcement Rule contains provisions relating to investigations, hearings and penalties and takes effect when, despite a facility’s comprehensive and well-documented HIPAA compliance program, something goes wrong. Observing the Enforcement Rule process can provide valuable lessons as your ASC evaluates its HIPAA compliance program.


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ASC Payment Rates

Chances are you already know that the Centers for Medicare and Medicaid Services (CMS) ties ASC reimbursement rates to its hospital outpatient department (HOPD) rates. Do you also know what goes into setting the HOPD rates, how ASC rates differ from HOPD rates and who advises CMS on how this payment system should look?


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Data, Changes to Regulations Needed to Expand ASC-Payable List

Advances in medical technology have expanded the types of patients who can be treated outside the hospital. Despite these advances, the Centers for Medicare & Medicaid Services’ (CMS) payment policies often lag behind innovation, with many procedures—such as total joints—still on the inpatient-only list.


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Medicare’s 2016 Final Payment Rule

The Centers for Medicare & Medicaid Services (CMS) issued its final payment rule regulating 2016 ASC Medicare payments in late October last year. Provisions in that rule went into effect January 1, 2016.


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On the Regulatory Side

Trying to predict all of the regulatory requirements that may change for ASCs in 2016 would require clairvoyant abilities that most do not possess. It is possible, however, to look to proposed rules and language in the past to determine what might be coming our way in 2016.


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Track the Latest Regulatory and Legislative News for ASCs

Visit ASCA's web site every week to stay up to date on the latest government affairs news affecting the ASC industry. Every week, ASCA's Government Affairs Update newsletter is posted online for ASCA members to read. The weekly newsletter tracks and analyzes the latest legislative and regulatory developments concerning ASCs.

www.ascassociation.org/GovtAffairsUpdate.