REGULATORY REVIEW
BY KARA NEWBURY | FEBRUARY 2023
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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BY ALEX TAIRA | JANUARY 2023
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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BY ALEX TAIRA | NOVEMBER-DECEMBER 2022
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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BY KARA NEWBURY | OCTOBER 2022
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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BY KARA NEWBURY | SEPTEMBER 2022
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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BY ALEX TAIRA | AUGUST 2022
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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BY STEPHEN ABRESCH | JUNE-JULY 2022
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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BY KARA NEWBURY | MAY 2022
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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BY KARA NEWBURY | APRIL 2022
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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BY ALEX TAIRA | MARCH 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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BY KARA NEWBURY | FEBRUARY 2022
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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BY ALEX TAIRA | JANUARY 2022
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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BY KARA NEWBURY | NOVEMBER-DECEMBER 2021
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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BY KARA NEWBURY | OCTOBER 2021
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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BY ALEX TAIRA | SEPTEMBER 2021
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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BY KARA NEWBURY | AUGUST 2021
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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BY ALEX TAIRA | JUNE-JULY 2021
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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BY KARA NEWBURY | MAY 2021
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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BY ALEX TAIRA | APRIL 2021
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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BY KARA NEWBURY | MARCH 2021
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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BY ALEX TAIRA | FEBRUARY 2021
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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BY KARA NEWBURY | JANUARY 2021
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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BY KARA NEWBURY | NOVEMBER-DECEMBER 2020
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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BY KARA NEWBURY | OCTOBER 2020
A question that ASCA staff get commonly is how does the Centers for Medicare & Medicaid Services (CMS) reimburse for devices?
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BY KARA NEWBURY | SEPTEMBER 2020
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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BY STEVE SELDE | AUGUST 2020
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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BY ALEX TAIRA | JUNE-JULY 2020
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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BY KARA NEWBURY | MAY 2020
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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BY KARA NEWBURY | APRIL 2020
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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BY ALEX TAIRA | MARCH 2020
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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BY KARA NEWBURY AND ALEX TAIRA | FEBRUARY 2020
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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BY KARA NEWBURY | JANUARY 2020
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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BY ALEX TAIRA | NOVEMBER-DECEMBER 2019
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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BY ALEX TAIRA | OCTOBER 2019
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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BY ALEX TAIRA | SEPTEMBER 2019
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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BY ALEX TAIRA | AUGUST 2019
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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BY ALEX TAIRA | JUNE-JULY 2019
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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BY KARA NEWBURY | MAY 2019
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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BY KARA NEWBURY | APRIL 2019
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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BY KARA NEWBURY | MARCH 2019
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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BY ALEX TAIRA | FEBRUARY 2019
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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BY KARA NEWBURY | JANUARY 2019
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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BY ALEX TAIRA | NOVEMBER-DECEMBER 2018
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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BY KARA NEWBURY | OCTOBER 2018
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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BY ALEX TAIRA | SEPTEMBER 2018
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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BY KARA NEWBURY | AUGUST 2018
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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BY KARA NEWBURY | JUNE-JULY 2018
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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BY ALEX TAIRA | MAY 2018
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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BY KARA NEWBURY | APRIL 2018
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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BY JENNIFER BUTTERFIELD, RN, CASC | MARCH 2018
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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BY KARA NEWBURY | FEBRUARY 2018
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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BY KARA NEWBURY | JANUARY 2018
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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BY ALEX TAIRA | NOVEMBER-DECEMBER 2017
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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BY KARA NEWBURY | OCTOBER 2017
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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BY ALEX TAIRA | SEPTEMBER 2017
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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BY KARA NEWBURY | AUGUST 2017
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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BY KARA NEWBURY | JUNE-JULY 2017
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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BY NAWA ARSALA | MAY 2017
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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BY KARA NEWBURY | APRIL 2017
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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BY NAWA ARSALA | MARCH 2017
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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BY KARA NEWBURY | FEBRUARY 2017
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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BY NAWA ARSALA | JANUARY 2017
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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