Regulatory Review

REGULATORY REVIEW

Updated Nondiscrimination Requirements Take Effect

The US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a Section 1557 final rule (FR) recently that provides revised civil rights regulations ASCs must adhere to beginning July 5, 2024 (the rule’s effective date). Section 1557 is part of the Affordable Care Act of 2010 (ACA) and prohibits “discrimination on the basis of race, color, national origin, sex, age, or disability in certain health programs and activities.”


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ASCA Advocates for Changes to CMS 2025 Proposed Medicare Payment Rule

ASCA submitted comments on the Centers for Medicare & Medicaid Services’ (CMS) 2025 proposed payment rule for ASCs and hospital outpatient departments (HOPD).


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Overview of CMS’ Quality Reporting Programs

The Centers for Medicare & Medicaid Services’ (CMS) now manages dozens of quality reporting and value-based programs and initiatives that “encourage improvement of quality through payment incentives, payment reductions, and reporting information on health care quality on government websites,” according to the CMS website.


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Site-Neutral Payment Policies Continue to Gain Traction

Site-neutral payments have taken center stage in national health policy conversations, thanks in part to analyses from the Medicare Payment Advisory Commission and the Blue Cross Blue Shield Association that showed significant savings potential from the adoption of these policies.


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Six Months Left to Implement Patient Experience Survey

The Outpatient and Ambulatory Surgery Consumer Assessment of Healthcare Providers and Systems (OAS CAHPS) Survey, a patient experience survey, will become a mandatory component of the Centers for Medicare & Medicaid Services’ (CMS) ASC Quality Reporting (ASCQR) Program on January 1, 2025.


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HIPAA Biannual Update

During the last half of 2023, healthcare organizations across the country posted 336 breaches of protected health information (PHI) affecting 500 or more individuals.


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Update on No Surprises Act

In December 2020, then President Donald J. Trump signed the Consolidated Appropriations Act, 2021 (CAA) into law. Included in the 1,067-page bill was Section BB, Title I, the No Surprises Act (NSA), which established new protections for patients against surprise bills in certain emergency and nonemergency situations.


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Medicare Advantage in the Spotlight

In the January 2023 issue of ASC Focus magazine, ASCA highlighted the growing proportion of Medicare beneficiaries enrolled in Medicare Advantage (MA) plans. MA plans, which covered less than 15 percent of Medicare beneficiaries in 2005 according to an issue brief from the Commonwealth Fund, now cover a majority of Medicare beneficiaries according to the Kaiser Family Foundation.


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A Look at the Biden Administration’s First Term from a Healthcare Perspective

During the Biden administration’s first year, the primary health policy priority was the COVID-19 pandemic. Now, three years into Biden’s presidency, ASCA takes stock of the administration’s health-related actions and other current issues that will shape health policy conversations in future years.


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Analyzing CMS’ 2024 Final Medicare Payment Rule

In its 2024 final payment rule for ASCs and hospital outpatient departments (HOPD), the Centers for Medicare & Medicaid Services (CMS) added multiple procedures to the ASC Covered Procedures List (ASC-CPL) that were not included in the proposed rule, including total shoulder arthroplasty (TSA).


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Patient Experience Survey to Become Mandatory Soon

The Outpatient and Ambulatory Surgery Consumer Assessment of Healthcare Providers and Systems (OAS CAHPS) Survey will become a mandatory component of the ASC Quality Reporting (ASCQR) Program in 2025. Facilities should start the process of selecting a vendor now to ensure they are able to meet this deadline.


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ASCA Advocacy Moves Medicare Total Joints to ASCs

Orthopedic surgeries, in particular total joint replacements, represent a major driver of growth in the surgery center industry over the coming years. According to research presented at the 2023 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS), annual volume of total joint replacements will grow 70 percent to more than 2.25 million procedures per year in 2050.


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Evolution of Emergency Preparedness Requirements

The Centers for Medicare & Medicaid Services (CMS) expects healthcare facilities to be prepared for emergency situations. With the expiration of the COVID-19 public health emergency (PHE) last May, now is a good time for facilities to take stock of CMS’ emergency preparedness requirements, analyze how their emergency plans were executed during the PHE and identify opportunities for improvement.


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Site-Neutral Payment Policies Gain Traction

Medicare pays clinicians the same rate whether they deliver service in an ASC or hospital but pays them a different rate when they provide care in the physician office. Also, Medicare’s facility payments differ significantly depending on site of service.


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Medicare Reimbursement Policy Impedes Migration to ASC Setting

ASCs saved the Medicare program more than $5 billion in 2021, and according to a 2020 study by ASCA and KNG Health Consulting LLC, absent any major policy changes, ASCs are already expected to provide more than $10 billion in annual savings to Medicare by 2027. Researchers assert that “policymakers can further offset the expected growth in Part B payments to hospitals by prioritizing payment policies that encourage the migration of procedures to the lower-cost ASC setting.”


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ASCs Should Prepare for Patient Experience Survey Rollout

After a multiyear delay, measures in the ASC Quality Reporting (ASCQR) Program that are based on responses to the Outpatient and Ambulatory Surgery Consumer Assessment of Healthcare Providers and Systems (OAS CAHPS) Survey will become mandatory in 2025.


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Analyzing Changes in ASC Quality Reporting Requirements

The Centers for Medicare & Medicaid Services (CMS) did not make significant changes to its ASC Quality Reporting (ASCQR) Program for 2023, but over the past two years of rulemaking the agency did make changes that are relevant to ASCs.


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Top CMS Citations in 2022

Historically, ASCs have performed well on their Medicare surveys, and last year was no exception. Between 2021 and 2022, although the number of ASCs that underwent surveys increased significantly, the total number of citations issued to ASCs declined, and the percent of ASCs surveyed in 2022 that received citations in any area remained low.


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Analyzing CMS’ 2023 Final Medicare Payment Rule; Looking Ahead to 2024

In its 2023 final payment rule for ASCs and hospital outpatient departments (HOPD), the Centers for Medicare & Medicaid Services (CMS) showed a willingness to advance policies that will drive volume to the ASC setting and save Medicare and its beneficiaries money.


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CBO Report Shows the Rise of Medicare Advantage

The Congressional Budget Office (CBO), the nonpartisan agency that provides economic estimates and analysis to Congress, recently released The Budget and Economic Outlook: 2022 to 2032. The report projects budget and economic effects across the entire federal government assuming taxes and spending remain unchanged.


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Explaining HIPAA

Health institutions have existed in the US for hundreds of years—Benjamin Franklin founded the first hospital in Pennsylvania in 1751—but national policies offering protections for confidential patient health information are more recent. The Health Insurance Portability and Accountability Act, commonly known as HIPAA, was signed into law on August 21, 1996.


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Analyzing CMS’ 2023 Proposed Medicare Payment Rule

The Centers for Medicare & Medicaid Services (CMS) will release the 2023 hospital outpatient prospective payment system (OPPS)/ASC final rule in early November. Upon its release, we will know if CMS took into consideration any of ASCA’s concerns raised in its comment letter in response to July’s proposed rule analyzed here.


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CMS Updates ASC Guidance for Surveyors

The Centers for Medicare & Medicaid Services (CMS) recently updated the State Operations Manual (SOM) Appendix L—Guidance for Surveyors: Ambulatory Surgical Centers. CMS released the updated Appendix L in June, just two weeks after it announced an advance copy of the changes in a surveyor memo.


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What to Know about the No Surprises Act in Year One

The No Surprises Act (NSA) has new requirements for ASCs that fall under two major categories: disclosure of patient protections and good faith estimates. With regard to disclosures, all health providers and facilities are required to make publicly available a one-page notice that gives patients information on restrictions against balance billing, applicable state-level protections, and appropriate contact information for reporting violations.


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States Move Slowly to Align with CMS Changes

Only two states, Alaska and Delaware, have adapted their state laws to match the changes to transfer agreement and history and physical examination (H&P) requirements made by the Centers for Medicare & Medicaid Services (CMS) in 2019. Louisiana is currently considering a proposed regulation that would partly bring the state in line with CMS’ changes.


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How to Report ASC-20 Accurately

In the 2022 Outpatient Prospective Payment System (OPPS)/ASC final payment rule, regarding the ASC Quality Reporting (ASCQR) Program, the Centers for Medicare & Medicaid Services (CMS) finalized its proposal to “Adopt ASC-20: COVID-19 Vaccination Coverage Among HCP [Health Care Personnel] measure beginning with the CY 2024 payment determination.” For a new measure, this is an accelerated timeline, as CY 2024 payment determinations are impacted by data collected and reported in 2022. Now is the time to start the process to avoid future payment penalties.


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ASCs Versus Hospital Outpatient Departments

In Medicare’s 2022 proposed payment rule for hospital outpatient departments (HOPD) and ASCs, when trying to justify the removal of hundreds of codes from the ASC Covered Procedures List (ASC-CPL) that are reimbursed in the HOPD setting, the Centers for Medicare & Medicaid Services (CMS) argued that “while there are similarities between the ASC and HOPD settings, there are also significant differences between the two care settings.”


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New Surprise Medical Billing Regulations Rolling Out in 2022

On December 27, 2020, then President Donald Trump signed the Consolidated Appropriations Act, 2021 (CAA) into law. The bill allocated $1.4 trillion in federal spending for 2021 and $900 billion in COVID-19 relief measures. Tucked inside the 1,067-page bill is Section BB, Title I, the No Surprises Act, which establishes new protections for consumers against surprise bills.


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Analyzing CMS’ 2022 Final Medicare Payment Rule; Looking Ahead to 2023

In its 2022 final payment rule for ASCs and hospital outpatient departments (HOPD), the Centers for Medicare & Medicaid Services (CMS) finalized its proposal to reverse policy changes from the previous administration that added a significant number of codes to the ASC Covered Procedures List (ASC-CPL) and began the process of eliminating the inpatient-only (IPO) list, with a few modifications.


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A Look at the Biden Administration’s Health Actions in Year One

On January 20, 2021, Joseph R. Biden was sworn in as the 46th president of the United States. He assumed responsibility during a pandemic that had already killed more than 400,000 Americans.


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Understanding Site-Neutral Payments

As ASC leaders know, Medicare reimbursement rates vary significantly based on the site of service, or where the care is provided. In the case of surgical care, hospital outpatient departments (HOPD) are reimbursed, on average, twice as much as ASCs for the same services.


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Patient Experience Survey Likely Coming for ASCs

The patient experience is often cited as a primary selling point for going to an ASC for an outpatient procedure. Patients appreciate the convenience of ASCs and the fact that limiting our facilities to outpatient elective procedures better controls the environment and limits patient exposure to potential healthcare-acquired infections, which during a global pandemic is more important than ever.


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Electronic Health Records for ASCs

In February 2015, the consulting firm Accenture released market research that showed steady growth in the healthcare information technology (HIT) industry, driven largely by uptake of EHRs. EHRs are technology systems that electronically capture patient-provider encounter information, securely store the digital data and make that information available for future reference by patients, clinicians and insurers.


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Medicare Payment Policy Gains from the Past Decade

ASCA works with all federal regulators that have an impact on ASC operations, but its recent efforts have focused primarily on the Centers for Medicare & Medicaid Services (CMS). Payment policy is often at the top of the priority list.


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ASCs Severely Impacted by COVID-19 Pandemic

On January 31, 2020, then Secretary of the US Department of Health & Human Services (HHS) Alex Azar formally declared a public health emergency (PHE) in the US due to confirmed cases of the 2019 novel coronavirus (2019-n-CoV, which became known as COVID-19). At that time, we did not yet know how this new disease would impact our healthcare system or daily life.


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Medicare Payment Policy Advocacy for 2022 and Beyond

In early spring, ASCA Board President Michael Patterson and ASCA staff met virtually with the Centers for Medicare & Medicaid Services (CMS) staff responsible for payment policies in ASCs. During this meeting, ASCA representatives discussed payment policy changes needed to increase access to ASCs for Medicare beneficiaries and stop the divergence in payments between ASCs and hospital outpatient departments (HOPD).


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Federal Agency Roundup

Federal agencies, part of the executive branch of the government, issue many rules and regulations that affect ASCs. While some agencies like the Centers for Medicare & Medicaid Services (CMS) might be well known to ASCA members, others might be less familiar.


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Evolution of Cardiology Procedures in ASCs

While the addition of many cardiology codes to the ASC Covered Procedures List over the past three years may seem sudden to some, this move is more than 15 years in the making.


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Research Shows ASCs Lower Medicare Costs by Billions

ASCs perform roughly 6.8 million vital surgical, diagnostic and preventive procedures for Medicare beneficiaries each year, according to the Centers for Medicare & Medicaid Services’ (CMS) 2018 data.


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ASCA Advocacy in the Pandemic

On April 1, 2020, ASCA sent letters to the US Department of Treasury and the Small Business Administration urging ASCs to be eligible for Paycheck Protection Program (PPP) loans, as many ASCs did not meet the affiliation rules, due to relationships with corporate management companies or hospital partners.


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ASCA Advocacy in the Pandemic

On February 27, 2020, ASCA staff advocated for payment policy changes with senior level executives with the Centers for Medicare & Medicaid Services (CMS) at the US Department of Health and Human Services (HHS) offices in Washington, DC. Just two months into the new year, this ended up being our last “routine” meeting for 2020—the last one that did not center around the 2019 novel coronavirus (COVID-19).


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The Evolution of Device-Intensive Procedures

A question that ASCA staff get commonly is how does the Centers for Medicare & Medicaid Services (CMS) reimburse for devices?


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Burden Reduction Rule Update

Almost a year has passed since the Centers for Medicare & Medicaid Services (CMS) released a final rule, but the guidance for implementing the changes in the rule are still pending.


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Coronavirus Federal Legislative Roundup

Since the threat of the coronavirus came into sharper relief earlier this year, the federal government has taken many steps to support and provide regulatory flexibility to ASCs and other healthcare providers and shore up other sectors of the economy.


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ONC Releases New Electronic Health Information Regulations

On March 9, 2020, the Office of the National Coordinator (ONC), the federal agency in charge of coordinating nationwide healthcare information technology, or health IT, published a long-awaited final rule: 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program or the Information Blocking Rule. Two of eight exceptions in the rule that would absolve a party from charges of information blocking might apply to ASCs.


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Adding Procedures to the ASC-Payable List

Advances in medical technology and changes in Medicare payment policy have expanded the list of procedures that the Centers for Medicare & Medicaid Services (CMS) will reimburse ASCs for providing to the program’s beneficiaries. ASCA has advocated for its members and urged CMS to add procedures to the ASC-payable list that can be performed safely on the Medicare population in the ASC setting.


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CMS Policies that Impact ASC Payments

In the 2019 final payment rule for ASCs and hospital outpatient departments (HOPD), the Centers for Medicare & Medicaid Services (CMS) finalized its proposal to align the two entities’ update factors and moved ASCs to the hospital market basket, which has long been used to update HOPD payments. CMS plans to use the hospital market basket to update ASC payments for the five-year period of calendar year (CY) 2019 through CY 2023.


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Attend ASCA 2020 Regulatory Sessions

Year-to-year changes in Medicare policy, accreditation and quality reporting can be difficult to keep up with, but failure to stay on top of these updates can mean painful financial penalties.


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ASCA Advocacy Bears Fruit in 2020 Payment Rules

The Centers for Medicare & Medicaid Services (CMS) released its 2020 hospital outpatient prospective payment system (OPPS)/ASC final payment rule in November 2019. The rule finalizes the addition of eight codes, including total knee arthroplasty (TKA), to the ASC-payable list.


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CMS Makes Significant Changes to ASC Conditions for Coverage

On September 25, 2019, the Centers for Medicare & Medicaid Services (CMS) announced a final rule to relieve burden on healthcare providers by “removing unnecessary, obsolete or excessively burdensome Medicare compliance requirements for healthcare providers and suppliers.”


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Trump Administration Works to Reduce Regulatory Burden

In September 2019, the Centers for Medicare & Medicaid Services (CMS) announced the finalization of burden reduction measures the ASC community has long requested: (1) removing the requirement that ASCs have a transfer agreement with a hospital or that all ASC physicians have admitting privileges with a local hospital, (2) replacing the requirement regarding history and physical assessment (H&P) with a new standard based on a clinician’s clinical judgment and (3) revisions to emergency preparedness requirements.


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ASCQC Conference Shows Industry’s Continued Commitment to Quality

On July 22, the Ambulatory Surgery Center Quality Collaboration (ASCQC) held its sixth annual conference in Washington, DC. The meeting brought together a wide-ranging group of industry stakeholders, including representatives from facilities, physician groups, management companies, health information technology (IT) vendors, regulatory agencies, specialty societies, and accreditation and quality organizations.


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Keep Your Next Building Project Compliant

The main regulatory guidance to consult when building or renovating an ASC comes from the Facility Guidelines Institute (FGI), an independent, not-for-profit organization dedicated to developing guidance for the planning, design and construction of hospitals, outpatient facilities and residential healthcare and support facilities.


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History of Prescription Drug Regulation

In an October 2018 poll conducted by the Kaiser Family Foundation (KFF), healthcare was the most important issue among registered voters, and healthcare costs, including prescription drugs, was listed as the most important issue within healthcare. A follow-up KFF poll conducted in March 2019 found that 79 percent of respondents viewed the costs of prescription drugs as unreasonable and showed broad bipartisan support for a number of drug-related reforms.


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CMS, ONC Release New Regulations on EHI

On February 11, 2019, the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) concurrently released two long-awaited federal regulations addressing health information technology (HIT). The two rules seek to ease the flow of healthcare information, both from provider to patient as well as between providers, and add to a continually expanding regulatory framework governing electronic health information (EHI).


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Growing Medicare’s ASC-Payable List

While advances in medical technology and changes in Medicare payment policy over the past four decades have expanded the list of procedures for which the Centers for Medicare & Medicaid Services (CMS) will reimburse ASCs, Medicare policies have not kept pace with innovation.


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CMS Makes Changes to its Quality Reporting Program

The Centers for Medicare & Medicaid Services (CMS) made significant changes to Medicare’s ASC Quality Reporting (ASCQR) Program for 2019 and beyond, including the suspension of four outcomes measures that have been part of the ASCQR Program since its inception in 2012. Facilities that have been collecting and reporting data on Medicare claims forms are no longer required to do so for 2019.


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Medicare’s Top Citations in 2018

The Centers for Medicare & Medicaid Services (CMS) conducted 1,185 health surveys and 819 life safety surveys at 5,772 CMS-certified facilities in 2018. A look at the top citations CMS issued during those surveys can help provide insight into what surveyors focused on and identify areas where facilities failed to comply.


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Driving Quality in ASC Total Joint Procedures

As technology and new techniques expand the possibilities for outpatient surgery, few procedures have been the focus of as much discussion as total joint replacements (TJR). The rise of these procedures—in demand, performance and overall spending— has been nothing short of meteoric.


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CMS Proposes Changes to Conditions for Coverage

In September 2018, the Centers for Medicare & Medicaid Services (CMS) announced “Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction” as part of a proposed rule that would revise the applicable Conditions of Participation (CoPs) that apply to providers and Conditions for Coverage (CfCs) that apply to ASCs.


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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