Issue 9, Fall 2020
General OrthoForum Policy Issues
OrthoForum Advocacy Committee Strategic Planning Meeting
On June 5, 2020, the Brownstein Hyatt Farber Schreck (BHFS) team hosted a virtual strategic planning meeting of the OrthoForum Advocacy Committee, which was led by the Chair of the Committee, Dr. Richard Bruch. The strategy meeting focused on identifying policy priorities for the OrthoForum, including ways to leverage opportunities for the organization.
The OrthoForum Advocacy Committee and the BHFS team have been engaged in advocacy with Capitol Hill on these priority policy issues. Due to the COVID-19 pandemic, however, House and Senate offices are reluctant to have in-person meetings. Several Capitol Hill advocacy days have been cancelled. The Advocacy Committee and BHFS have, therefore, had to adapt our congressional outreach strategies. In the current virtual environment, we now focus on conference calls and emails with key staff on Capitol Hill. We are still able to pursue strategies to further the OrthoForum’s policy priorities. For example, we’ve recently had conference calls with key House and Senate staff on both BPCI-A issues and telehealth issues, and we’ve also had numerous email exchanges on these issues with Hill staff. In addition, we’ve been in touch with the Hill on the Medicare payment cuts recently proposed by the Department of Health and Human Services. The OrthoForum Advocacy Committee has mapped out essential next steps on our priority issues and will continue our work with Capitol Hill.
OrthoForum Webinars: Building and Strengthening Legislative Relationships
The OrthoForum Advocacy Committee, in conjunction with the BHFS team, hosted two webinars in July, titled, ”Building and Strengthening Legislative Relationships in Support of Vibrant Independent Medical Practices”. One was held on July 13 and the other on July 23. The webinars, designed for OrthoForum practice CEOs, provided an overview of how to engage in advocacy efforts with House and Senate offices, as well as an overview of five of the OrthoForum’s priority issues. These include: 1) ASC Cost and Quality; 2) Real Time Prior Authorization; 3) Telehealth; 4) Population Health/Condition Based Models; and 5) Physical Therapy Cuts.
As a follow-up to the webinars, the BHFS team had discussions with Dr. Bruch and then developed an advocacy primer document to assist OrthoForum members in developing relationships with their representatives and senators in Congress. The primer serves as a procedural step-by-step guide to assist in learning about these representatives and senators, including the locations of their State offices, their positions on various issues, the legislation they have sponsored or cosponsored, and the current procedural status of that legislation. The primer also includes important OrthoForum economic impact information (e.g., contributing $1.7 billion to the national economy each year), as well as talking points and a request (the “ask”) on each of those five priority issues to be used in calls or emails with Hill offices. The document was recently made available to all OrthoForum members. To view the OrthoForum congressional advocacy primer, please click HERE.
Focus on Prior Authorization Issue
Prior Authorization COVID-19 Process Reforms
The COVID-19 pandemic continues to impact the health care system and disrupt the provision of patient care in unprecedented ways. On July 23, Department of Health and Human Services (HHS) Secretary Alex Azar signed a 90-day extension of the federal declaration of a COVID-19 public health emergency (effective July 25), which in turn extends the various HHS authorities that apply only during the emergency. This includes authorities under the Families First Coronavirus Response Act (enacted on March 18), which prohibits Medicare and Medicaid, as well as group and individual health plans, from imposing prior authorization or cost sharing for Covid-related testing and diagnosis-related visits.
While the COVID-19 pandemic has reportedly led to additional and widespread prior authorization delays, additional temporary process reforms have been developed to help reduce the overall volume of prior authorization requests during the course of the pandemic. In recent months, a number of States have responded to the pandemic by making changes to the prior authorization process, including removal of prior authorization for COVID-19 testing and treatment. Over 30 States have required that prior authorizations granted before the public health emergency declaration remain valid until the end of the public health emergency, now extended to late October 2020. In addition, over 40 States have temporarily suspended prior authorization requirements for fee-for-service Medicaid and some States have also suspended prior authorization requirements for Medicaid managed care plans.
The prior authorization issue, however, far pre-dates the COVID-19 pandemic, which has only highlighted the problem, and the recent flexibilities and process reforms are temporary. While extensive data on these recent developments is not yet available, several professional and stakeholder organizations are compiling and releasing data on the impact of prior authorizations on physicians and patients. On June 23rd, the American Medical Association (AMA) released its findings from a December 2019 survey of 1,000 physicians. The survey found that, on average, prior authorizations took two business days per week per physician to complete and delayed a patient’s access to necessary care roughly 90 percent of the time. The OrthoForum joins other national and State physician, patient, health care professional and stakeholder organizations in seeking permanent reforms.
Improving Seniors’ Timely Access to Care Act of 2019
As reported in the previous newsletter, the OrthoForum supports the bipartisan Improving Seniors’ Timely Access to Care Act of 2019 (H.R.3107). This House bill, introduced by Reps. Susan DelBene (D-WA), Mike Kelly (R-PA), Roger Marshall (RKS), and Ami Bera (D-CA), continues to gain traction and currently has 234 cosponsors (113 Republicans and 124 Democrats). The bill aims to reduce unnecessary administrative burdens and expedite access to provider care by requesting online prior authorizations for Medicare Advantage (MA) plans. Specifically, the bill would establish an electronic prior authorization process that would help ensure timely processing for items and services that require such authorization. The bill would also require HHS to establish a process for “real-time decisions” for items and services that are routinely approved. In addition, the bill would prevent plans from requiring prior authorization on any additional surgical or other invasive procedure if it is furnished during the perioperative period of an already-approved procedure. H.R. 3107 would also ensure accountability and transparency by requiring MA plans to report to CMS on their extent and use of prior authorizations and the rate of approvals and denials.
For situations in which prior authorizations are required, the OrthoForum supports an electronic prior authorization process to be used in all CMS health programs and commercial insurance plans. Although H.R. 3107 concerns only MA plans, it is a good first step toward this broader goal.
Physical Therapists Update
CMS 2021 Medicare Physician Fee Schedule (MPFS) Proposed Rule
On August 3, 2020, the Centers for Medicare and Medicaid Services (CMS) released the 2021 Medicare Physician Fee Schedule (MPFS) proposed rule, which if adopted as is would result in an estimated 9% payment cut for codes commonly used in physical therapy and occupational therapy. Cuts would also be made for a variety of other health disciplines, including an estimated 5% cut for orthopaedic surgery. In contrast, some specialties would see payment increases of up to 17% under the proposed MPFS. Many of the payment increases are for evaluation and management (E/M) codes for primary care. Under the statutory requirement for budget neutrality, the increases must be offset by cuts for other codes, which CMS refers to as “redistributive effects”. Further, due to the COVID-19 pandemic, CMS plans to implement the rule 30 days after it is finalized instead of the typical 60-day implementation period. The deadline for submitting comment letters on the proposed rule to CMS is October 5, 2020, and the OrthoForum intends to submit a letter opposing the cuts for physical therapy, occupational therapy, and orthopaedic surgery. The OF is also engaged in advocacy efforts with Congress to seek legislation to waive Medicare’s budget neutrality requirement and thereby prevent the payment cuts.
Anticipating that CMS would consider a reduction for 2021 in payment rates for hip and knee joint replacement surgery, the American Academy of Orthopaedic Surgeons (AAOS) and the OrthoForum recently helped coordinate a letter from the House of Representatives to CMS Administrator Seema Verma arguing that the agency should maintain the current rates. The letter was sent on June 22, 2020, and was signed by 37 members of the House. To view the letter, please click HERE.
The OrthoForum Advocacy Committee urges physical therapists and occupational therapist to write or call the State offices of their representatives and senators in Congress to express opposition to the 9% payment cut for their services proposed by CMS. For more information, please contact Physical Therapy Subcommittee Chair Renee Duncan (see below for contact information).
Immediate and Permanent Changes for Telehealth
As reported in the previous newsletter, CMS issued a second round of temporary “blanket” regulatory waivers and rule changes in late April, which waived the limitations on the types of clinical practitioners who can furnish Medicare telehealth services and expanded it to include physical therapists, occupational therapists, and speech pathologists. Currently, providers and States may use the blanket waivers for the duration of the COVID-19 public health emergency declaration, which on July 23 was extended for an additional 90 days by Department of Health and Human Services (HHS) Secretary Alex Azar. These waivers, however, are only temporary and do not address the full scope of issues faced by physical therapists and occupational therapists, including the proposed Medicare payment cuts discussed above. The OrthoForum is supporting legislation to amend the Medicare statute to permanently allow physical therapists and occupational therapists to provide telehealth services, without geographic limitations. In addition, their assistants should be allowed to provide telehealth services in appropriate circumstances.
Since its formation, the OrthoForum Physical Therapy (PT) Subcommittee has been extremely active in advocating for permanent changes regarding telehealth services. The PT Subcommittee continues to foster new and existing relationships with partners on a variety of shared interests, including those discussed above. The OrthoForum is supporting several bills in Congress that would help achieve our policy goals (see below).
OrthoForum Letter and Outreach to Top Senate Sponsors of the CONNECT Act
As previously reported, the OrthoForum supports the bipartisan, bicameral Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act (S.2741/H.R.4932). The bill would expand the use of telehealth services and ease restriction on telehealth coverage under the Medicare program. It would allow CMS to grant waivers to allow additional types of providers to provide telehealth services, which could include physical therapists and occupational therapists. For more information about the bill, please click HERE and HERE.
On July 7, 2020, the OrthoForum sent a letter to the top Senate sponsors and original cosponsors of the legislation requesting that the CONNECT Act be modified to expressly include physical therapists and occupational therapists, emphasizing their central role in value-based care. In addition, during the month of July 2020, the Chair of the OrthoForum Advocacy Committee, Dr. Richard Bruch, along with PT Subcommittee Chair, Renee Duncan and PT Subcommittee member, Eric Chapman, joined the Brownstein team in having telephone discussions with staff from the CONNECT Act’s Senate sponsor and original cosponsors—Sens. Brian Schatz (D-HI), Roger Wicker (R-MS), Ben Cardin (D-MD), John Thune (R-SD), Mark Warner (R-MS) and Cindy Hyde-Smith (R-MS). (The Brownstein team sent follow-up messages to these offices once all the calls were completed.) To view the letter, please click HERE.
Outpatient Therapy Modernization and Stabilization Act
The OrthoForum supports the Outpatient Therapy Modernization and Stabilization Act (H.R. 7154). This bipartisan House bill, introduced on June 11, 2020, by Reps. Brendan Boyle (D-PA) and Vern Buchanan (R-FL), currently has 13 cosponsors (12 Democrats and 1 Republican). The bill would amend the Medicare statute to prevent the proposed 2021 Medicare payment cuts for physical therapists (PTs) and occupational therapists (OTs) by providing a budget-neutrality exemption so that the payment increases for certain types of physicians and other health professionals do not force payment cuts for other types. (This would also prevent the payment cuts for orthopaedic surgery.) In addition, the bill includes an amendment to the telehealth provisions of the Medicare statute to establish permanent authority for PTs and OTs to provide telehealth services without geographic limitations, independent of a national emergency declaration or a CMS-granted waiver. The bill also would make small increases in Medicare payments for 2021 through 2023 and amend the CARES Act to clarify that PTs, OTs, and other types of health professionals are eligible for grants under the HHS Provider Relief Fund. Finally, the bill would streamline the administrative process by clarifying that either a physician’s signed order for services, or obtaining a certification of a patient’s plan of care, is required for Medicare-covered outpatient therapy services, but not both (as is currently the case). For more information about the bill, please click HERE.
On July 23, 2020, the OrthoForum sent a letter of support for H.R. 7154 to Reps. Boyle and Buchanan and the other original cosponsors of the bill—Reps. Michael Doyle (D-PA), Bill Pascrell (D-NJ); Darren Soto (D-FL); Joyce Beatty (D-OH), Mikie Sherrill (D-NJ); Lisa Blunt-Rochester (D-DE), and Bobby Rush (D-IL). The OrthoForum supports H.R. 7154, which provides important solutions to critical Medicare issues faced by PTs and OTs and the patients they serve. (The Brownstein team sent follow-up messages to these offices after the 2021 MPFS proposed rule was released by CMS on August 3.) To view the letter, please click HERE.
Knowing the Efficiency and Efficacy of Permanent (KEEP) Telehealth Options Act of 2020
The OrthoForum endorsed the Knowing the Efficiency and Efficacy of Permanent (KEEP) Telehealth Options Act of 2020 (H.R. 7233). The bipartisan legislation, introduced on June 18, 2020 by Reps. Troy Balderson (R-OH-12), Cindy Axne (D-IA03), Roger Williams (R-TX-25) and Bob Gibbs (R-OH-07), currently has 24 cosponsors (11 Democrats and 13 Republican). The bill calls for a federal study on improving the permanent nationwide offering of telehealth services. Specifically, the bill would require HHS to conduct a comprehensive study and report to Congress including information on available expanded telehealth services; new provider reimbursement options; a review of the public health impacts of this expansion, in addition to other information that would assist Congress in legislating a permanent expansion of telehealth services. H.R. 7233 would also require the Government Accountability Office (GAO) to conduct a study and report to Congress on the efficiency, management, and successes of expanded telehealth programs during the COVID-19 public health emergency and include recommendations for improving these programs. The Senate companion bill was introduced on July 20, 2020, by Sens. Deb Fischer (R-NE) and Jacky Rosen (D-NV). The legislation has been endorsed by over 20 organizations to date. For more information about the bill, please click HERE and HERE.
Trump Executive Order to Expand Telehealth
On August 3, 2020, President Trump signed an executive order (EO) to expand access to telehealth services during the COVID-19 pandemic and beyond. Under the order, HHS is directed within 30 days to create a model to test innovative payment mechanisms to help rural providers deliver high-quality care. HHS will also propose a regulation extending telehealth flexibilities beyond the duration of the COVID-19 public health emergency. (Note that it is unclear whether, without the enactment of new authorities, HHS has the legal authority to expand the availability of telehealth services beyond the end of the emergency.) Additionally, the department is directed to submit a report on policies to improve health outcomes in rural communities, reduce maternal mortality, and eliminate regulations that limit the availability of healthcare professionals. To view the EO, please click HERE.
Physical Therapy Subcommittee
For more information on PT issues, or to join the OrthoForum Advocacy Committee Physical Therapy Subcommittee, please contact Renee Duncan at: renee.duncan@orthotennessee.com.
CMS, CMMI and BPCI-A Updates
COVID-19 Amendments for BPCI-A and CJR Participants
On June 3, 2020, the Centers for Medicare and Medicaid Services (CMS) and the Center for Medicare and Medicaid Innovation (CMMI) announced a series of flexibilities and optional adjustments the agency is offering to current and future CMMI alternative payment model (APM) participants in response to the COVID-19 public health emergency. The adjustments are related to the models’ financial methodologies, quality reporting requirements, and timelines. For the BPCI-A and CJR programs, these optional adjustments technically are amendments to the existing agreements. An overview is below:
- Bundled Payments for Care Improvement Advanced (BPCI-A): CMS and CMMI announced three options regarding model flexibilities for BPCI-A Model Year (MY) 3 participants as it relates to financial risk for Performance Periods 3 and 4. Two of these options would allow participants to sign amendments to the current BPCI-A contracts.
- Option 1- Removing all upside and downside risk: BPCI-A participants may now opt to eliminate both upside (Net payment reconciliation amount or NPRA) and downside risk for the full 2020 calendar year by excluding all clinical episodes from reconciliation for Model Year (MY) 3.
- Option 2- Removing only COVID-19 patients from calculations: If BPCI-A participants choose to remain in two-sided risk, participants would have the ability to exclude certain clinical episodes with a COVID-19 diagnosis from reconciliation during the episode.
- Option 3- Continued participation: BPCI-A participants may remain under the current CMS MY3 participation agreement, which includes remaining in the two-sided risk with all clinical episodes triggered by the organization.
- Comprehensive Care for Joint Replacement (CJR): CMMI is removing the downside risk from by capping actual episode payments at the target price for episodes with a date of admission to the anchor hospitalization between January 31, 2020 through the length of the public health emergency. In addition, CMMI is also extending performance year (PY) 5 of the model through March 2021 and has extended the appeals timeline for PY 3 and PY 4 from 45 days to 120 days.
BPCI-A participants have until September 25, 2020, to choose among the three options and, if taking Option 1 or 2, to submit their signed amendments to CMMI. For more information on these COVID-related amendment options, please click HERE.
Issues Concerning COVID-19 Options for BPCI-A Providers; Outreach to
Congress
BPCI-A providers understand that the two new COVID-related options are intended to provide relief to them as they face the uncertainty of how the pandemic will impact their care of BPCI-A patients and the uncertainty of whether it will increase their potential exposure to financial losses. These are factors over which providers have no control. Medicare claims data is critical for providers to make an informed decision as to which option would be most beneficial. Unfortunately, there are significant time lags in obtaining claims data and other important information from CMS, and it is questionable whether providers will be able to make a timely and informed decision on the two new options. Without that data, many providers may take the safest option, which is for CMS/CMMI to remove both downside risk and upside risk. Without the savings payments that result from upside risk, participants may idle essential staff and resources devoted to BPCI-A. The question is whether, for Model Year 4, these participants will be willing to shift resources back into the model. Participants may decide to exit BPCI-A altogether, which would be a significant setback for the efforts of Congress to promote value-based care.
The OrthoForum Advocacy Committee has taken this issue to Congress and asked it to tell CMS/CMMI that BPCI-A patients and providers should receive the same COVID-19 help from CMS that CJR patients and providers will receive. In other words, BPCI-A providers should also have the option to remove downside risk and keep upside risk. The CJR and BPCI-A models are fundamentally and operationally very similar for patients who need the relevant surgeries, and CMS has not provided any convincing justification for its disparate treatment of the two programs.
After consulting with several BPCI-A conveners with which a number of OrthoForum members have agreements, the Advocacy Committee drafted an issue brief for Congress on the COVID-related options and asked AAOS to join us in this effort. During July 2020, the Brownstein and AAOS teams had telephone discussions with staff for a number of senators and representatives who are physicians. These discussions were with staff for Sens. Bill Cassidy (R-LA) and John Barrasso (R-WY) and Reps. Andy Harris (R-MD), Michael Burgess (R-TX), and Raul Ruiz (D-CA). The Brownstein team sent follow-up messages to all these offices once CMS/CMMI released the text of the amendments and set September 25 as the deadline. To view the advocacy document, please click HERE.
Evaluations of BPCI-A Model
In June 2020, Acumen provided an evaluation of the drivers of the BPCI-A Performance Periods 1 & 2 Reconciliation Results in which they argue against the prospective BPCI-A pricing methodology. Also in June, CMS published the Lewin Group’s findings of an initial evaluation of the BPCI-A Model from October 1, 2018, through March 31, 2019. Among the key findings:
- Selection of Clinical Episodes Differed by Type of Episode Initiator (EI): Hospital EIs were more likely to participate in medical clinical episodes such as congestive heart failure, whereas Physician Group Practice (PGP) EIs were more likely to participate in surgical clinical episodes such as LEJRs.
- Higher Historical Payments at BPCI-A Hospitals: Hospital EIs had higher median historical payments for all 32 clinical episodes compared to eligible hospitals that did not participate in a given clinical episode. Despite this, a range of hospitals, including those with historically lower payments, participated in BPCI-A.
- General Broad Participation in BPCI-A: Approximately 22 percent of eligible hospitals participated in at least one clinical episode; 23 percent of eligible clinicians participated in the model; and up to 16 percent of BPCI-A eligible discharges and outpatient procedures were at a BPCI-A hospital or were attributed to a BPCI-A PGP.
To view the full Year 1 BPCI-A Evaluation Annual Report, please click HERE.
Population Health/Condition Based Models
The OrthoForum wants to ensure there is a pathway for independent orthopaedic practices to participate in new CMMI population-based models. Although the OrthoForum continues to make efforts to prevent harmful changes to BPCI-A, our long-term focus is ensuring that independent orthopaedic practices have a role in future APMs, which means we must have a viable population-based model. The OrthoForum continues to explore how to develop such a model.
CMMI Subcommittee
For more information on CMMI and BPCI-A issues, or to join the OrthoForum
Advocacy Committee CMMI Subcommittee, please contact Joel James at:
jjames@SignatureHealth.net.
Stark Law Update
OMB Begins Review of Stark Law and Anti-Kickback Final Rules
On July 21, 2020, the Department of Health and Human Services (HHS) submitted to the White House Office of Management and Budget (OMB) draft final rules to reform the physician self-referral exceptions under the Stark Law and the safe harbors under the Anti-Kickback Statute (AKS). The draft final rules are part of the HHS ”Regulatory Sprint to Coordinated Care” initiative, led by HHS Deputy Secretary Eric Hargan, aimed at reducing regulatory barriers and incentivizing effective coordinated care and management.
As reported in previous newsletters, HHS issued two proposed rules on October 17, 2019, one concerning the Stark Law, which was issued by HHS’s Centers for Medicare & Medicaid Services (CMS), and one concerning the AKS, which was issued by the HHS Office of Inspector General (OIG). Both rules concern exceptions for value-based arrangements (VBAs). The following notes some history on VBA-related activities over the last several years:
- In June 2018, CMS issued a request for information (RFI) concerning the possible creation of Stark exceptions for VBAs, and in August 2018 the OrthoForum submitted a comment letter to the agency in response to the RFI.
- The October 2019 Stark proposed rule was generally consistent with some of the recommendations made by the OrthoForum in its August 2018 response to the CMS RFI.
- The October 2019 Stark proposed rule, however, was complicated and there were significant differences between it and the October 2019 AKS proposed rule.
- In December 2019, the OrthoForum submitted a comment letter to CMS on the Stark proposed rule, emphasizing the need for simplicity regarding the VBA exceptions for physician group practices (PGPs); the need for CMS to provide guidance and advisory opinions to PGPs on fair market value issues; and the need to harmonize the VBA exceptions under the Stark Law proposed rule with the VBA exceptions under the AKS proposed rule.
- In December 2019, the OrthoForum also sent an AKS-focused letter to the HHS OIG emphasizing the need to harmonize the two proposals.
- On August 7, 2020, the OrthoForum joined 18 other physician organizations in sending a letter to OMB and HHS urging them to issue Stark and AKS final rules. To view the letter, please click HERE.
- According to an agenda released by OMB on June 30, 2020, sometime during August 2020 OMB is expected to complete its review of the two draft final rules and HHS is expected to issue the final rules.
If these two final rules are issued, they will reform the Stark Law and the AKS in truly significant ways. These administratively-created reforms go far beyond anything Congress is likely to pass.
Update: On August 26, 2020, CMS announced that it is delaying publication of the Stark final rule until August 2021. The agency said it needs the additional time because it is “still working through the complexities of the issues raised by comments received on the proposed rule”. Since HHS submitted a draft of the final rule to the White House OMB on July 21 (as noted above), it is possible that HHS was actually satisfied with its draft but that OMB or other players in the White House were not. Little information is available at this point. It also is not clear at this point whether the AKS final rule submitted to OMB will also be delayed. It is under the jurisdiction of the HHS Office of Inspector General, not CMS.
Stark Law Subcommittee
For more information on Stark Law issues, or to join the OrthoForum Advocacy Committee Stark Law Subcommittee, please contact Dr. Chip Hummer at: chummer3@premierortho.com.
Ambulatory Surgery Center Update
ASC Cost and Quality Reporting
The OrthoForum believes that increased ASC utilization for LEJRs is the best path forward in demonstrating lower cost and greater quality among OrthoForum practices. However, substantive ASC cost and quality report data is essential in making a strong public policy argument, which requires the collective participation of ASCs in this process. To best advance this effort, the OrthoForum has partnered with The Leapfrog Group, a leading independent national non-profit organization and advocate in hospital transparency and patient safety. Their evidence-based national hospital data collection and public reporting initiatives have the capability to aggregate and analyze OrthoForum data at the center level, OrthoForum level, and full benchmarking level. The ASC Subcommittee is currently in the early process of reviewing collected ASC cost and quality data to obtain more complete information and maintain it in a repository that would allow for more complete outcomes reporting. The OrthoForum is urging its members and partners to work with the ASC Subcommittee on the collection of ASC utilization cost and quality data. As noted in other documents, the OrthoForum should develop a proposal to CMS for an abbreviated, streamlined version of cost reporting by ASCs in order to avoid Congress or CMS imposing the cumbersome cost-reporting approach required for hospitals. In addition, the OrthoForum should develop quality data in order to respond to any future unfavorable media articles about ASCs. For more information, please contact ASC Subcommittee Chair, Teresa Copeland (see below for contact information).
Appeal Court Ruling on HHS Site-Neutral Payments
On July 17, 2020, the U.S. D.C. Circuit Court of Appeals overturned a lower court ruling from last year, finding that the HHS site-neutral payment policy (established in the 2019 Medicare Outpatient Prospective Payment System final rule) is legal and can proceed. (The OrthoForum joined several organizations in submitting an amicus curie brief to the appellate court arguing that the decision of the lower court should be overturned.) Under this policy, CMS made payments for clinic visits site-neutral by reducing the payment rate for evaluation and management (E/M) services provided at off-campus hospital outpatient departments (HOPDs) by 60%, which made the HOPD payment levels close to those provided under the physician fee schedule (PFS) for the same services. Once the rule was finalized, the American Hospital Association, the Association of American Medical Colleges and numerous hospitals across the country sued HHS, arguing that CMS exceeded its authority when it finalized the pay cut and that the site-neutral payment policy violates the Medicare statute’s mandate of budget neutrality. In their decision, the appellate judges wrote, “Because we conclude that the regulation rests on a reasonable interpretation of HHS’s statutory authority to adopt volume-control methods, we now reverse.” To view the ruling, please click HERE.
CMS Releases CY 2021 OPPS and ASC Proposed Rule
On August 4, 2020, CMS released its proposed rule for the 2021 Hospital Outpatient Prospective System (OPPS) and Ambulatory Surgery Center (ASC) system. Overall, the rule was positive for ASCs, including that, throughout the proposal, CMS recognized that physicians are in the best position to determine the appropriate setting for the care of Medicare patients. If the proposed rule is finalized as drafted, CMS would:
- Continue to use the hospital market basket to update ASC payments for CY 2021 through CY 2023 and increase both HOPD and ASC payments by 2.6 percent in 2021.
- As to the conversion factor, set it at $48.984 for ASCs meeting quality standards and $48.029 for those that do not meet them. Both of these amounts are about 59% of the parallel amounts for HOPDs.
- Add 11 codes to the 2021 ASC payable list (covered procedures list, or ASCCPL), including total hip arthroplasty (THA).
- Eliminate the inpatient only (IPO) list over the next three years, beginning with the removal of 300 musculoskeletal services in 2021 and complete elimination of the list by 2024. This is an important development.
CMS also proposed two alternatives for adding codes to the ASC-CPL that are under consideration for finalization in 2021.
The proposed rule was published in the Federal Register on August 12 and the deadline to submit comments is October 5, 2020. To view the proposed rule, please click HERE.
ASC Subcommittee
For more information on ASC issues, or to join the OrthoForum Advocacy Committee ASC Subcommittee, please contact Teresa Copeland at:
teresa.copeland@orthotennessee.com
Balance Billing Update
Last-Minute Push for Balance Billing in Next COVID-19 Package
Discussions to include balance billing protections in the fourth COVID-19 stimulus package recently took place in Congress. White House and Congressional lawmakers made a last minute attempt to include a balance billing solution in this next package, which is likely the last major vehicle before the November 2020 elections (although an appropriations-focused package is expected at some point before the end of the federal fiscal year, September 30).
Specifically, House Speaker Nancy Pelosi (D-CA) had an in-person meeting in her office on July 27 with the Chairs of the three House committees with jurisdiction— Energy and Commerce (E&C), Education and Labor (Ed &Labor), and Ways and Means (W&M)—in an attempt to reach a compromise concerning the respective balance billing legislative proposals of the three committees. This meeting did not result in an agreement. W&M is the holdout, as E&C and Ed & Labor have reached an agreement with each other and with the Senate Health, Education, Labor, and Pensions (HELP) Committee. E&C, Ed & Labor, and HELP support a solution that combines a market-based benchmark payment with an arbitration backstop. The W&M approach focuses more on negotiation, but the mediator would still be required to consider the relevant median contracted rate for the health plan involved.
On July 29, HHS released a report calling on Congress to pass a legislative solution for “surprise” billing, finding that the COVID-19-related surprise billing measures advanced by the administration were insufficient. The HHS report highlighted similarities between the leading balance billing legislative proposals, noting their fit with the administration’s policies on balance billing. Although the report supported the policy of protecting patients, it did not take a position on how to determine payment amounts for physicians and hospitals. According to an HHS official, the decision to not take a position was due to the political sensitivity and the activities in Congress on the issue. To view the HHS report, please click HERE.
Following the release of that HHS report, a statement responding to it was released jointly by Senate HELP Chair Lamar Alexander (R-TN) and Ranking Member Patty Murray (D-WA); House E&C Chair Frank Pallone (D-NJ) and Ranking Member Greg Walden (R-OR); and House Ed & Labor Chair Bobby Scott (D-VA) and Ranking Member Virginia Foxx (R-NC). W&M was not involved. The joint statement supported their agreed-on legislative approach (combining a market-based benchmark payment solution with an arbitration backstop). To view the joint statement, please click HERE.
The overall House and Senate negotiations on the next COVID-19 stimulus package are not going well, with the two sides far apart on the size and scope of the package. In addition, it is unlikely Senate Majority Leader Mitch McConnell (R-KY) will include a benchmarking solution in the package, especially if doing so would complicate negotiations on the bill and further divide his caucus. It is more likely that balance billing legislation will be enacted after the November 2020 elections as part of a large funding-related package during the “lame duck” session in December.
Balance Billing Subcommittee
For more information on balance billing issues, or to join the OrthoForum Advocacy Committee Balance Billing Subcommittee, please contact Dr. Doug Lundy at: LundyDW@resurgens.com.
Physician-Owned Hospital (POH) Update
Extension of Stark POH Waivers During COVID-19 Emergency
As reported in a previous newsletter, CMS issued a number of temporary waivers in late March as part of the federal response to the COVID-19 public health emergency. The waivers included a capacity-related blanket waiver of the Stark POH restrictions for “[r]eferrals by a physician owner of a POH that temporarily expands its facility capacity above the [POH’s applicable Stark] number of operating rooms, procedure rooms, and beds without prior application and approval of the expansion of facility capacity.” Note, however, that referrals under this waiver must be solely related to one or more of six specified “COVID-19 Purposes”. The waivers only apply during the COVID-19 emergency. The HHS emergency declaration would have expired on July 25, but on July 23 HHS Secretary Alex Azar extended it for an additional 90-day period. Given the temporary nature of the waiver, caution should still be taken as to the amount of investments made toward expanding hospital capacity, particularly any structural changes.
Potential for Permanent Stark POH Changes Through CMS Rulemaking
In recent years, the OrthoForum has coordinated with AAOS on efforts to convince HHS and CMS that the Stark POH restrictions should be eliminated or modified and that they have the legal authority to do so. These efforts have included an OrthoForum-AAOS meeting with top HHS and CMS official in 2019, as well as our indirect involvement in a recent meeting with CMS Administrator Seema Verma (see below, “CMS Meeting on POH Issues”). The OrthoForum has in recent years also sent several comment letters to CMS arguing that there are no legitimate policy reasons to continue the POH restrictions given the ongoing transition to value-based care.
There is reason to believe that our efforts, together with those of a number of other organizations, are beginning to have an effect. A certain level of trust in POHs is demonstrated by the decision by HHS in March to provide the Stark POH capacity expansion waiver during the Covid-19 emergency, and then to allow the waiver to continue under the July extension of the emergency declaration. In addition, the recent OPPS/ASC proposed rule would create certain Stark POH exceptions relating to the Medicaid program (see below), which also demonstrates a level of trust. And CMS continues to consider a proposal to create a CMMI demonstration model that would allow participating POHs to expand their capacity. All of these activities by HHS and CMS are steps in the right direction. The OrthoForum Advocacy Committee will continue its efforts to foster CMS rulemaking to eliminate or modify the POH restrictions.
CMS Meeting on POH Issues
On June 25, 2020, Rep. Michael Burgess (R-TX), who is a physician, met with CMS Administrator Seema Verma and CMMI Director Brad Smith to discuss Stark POH issues, including the provisions CMS put in place to allow physicians to expand services during the COVID-19 emergency. Prior to the meeting, Dr. Blake Curd (chair of our POH Subcommittee) provided Rep. Burgess with an overview of the OrthoForum’s legal argument that CMS has the legal authority to eliminate or modify the Stark POH restrictions, as well as giving him the slide deck used during the OrthoForum-AAOS meeting with HHS and CMS officials in February 2019.
CMS Releases CY 2021 OPPS and ASC Proposed Rule
On August 4, 2020, CMS released its proposed rule for the 2021 Hospital Outpatient Prospective System (OPPS) and Ambulatory Surgery Center (ASC) system. With respect to the Stark POH cap on the number of additional operating rooms, procedure rooms, and beds above the baseline number, this proposal includes provisions to lift restrictions for POHs qualifying as “high Medicaid facilities”, meaning POHs that serve more Medicaid inpatients than other hospitals in the counties in which they are located. The proposal is based on a new CMS interpretation of the provisions of the Stark Law that allow exceptions to the cap on capacity. The proposed rule would also vary from current CMS policy by allowing capacity expansion at facilities of a high-Medicaid POH that are not on the main campus of the POH. In addition, such POHs could apply for an expansion more frequently than the current policy of only once every two years. Finally, for purposes of determining the baseline number of beds in a POH, a bed would be included under the proposed rule if the bed is considered licensed for purposes of State licensure, regardless of the specific number of beds identified on the physical license issued to the hospital by the State. CMS Administrator Seema Verma stated that the POH-restrictions guidance established by the Obama administration was “unnecessarily restrictive and went beyond the Congressional intent.” The proposed rule was published in the Federal Register on August 12 and the deadline to submit comments is October 5, 2020. To view the proposed rule, please click HERE.
Congress
Patient Access to Higher Quality Health Care Act of 2019
The OrthoForum continues to support and track the bicameral Patient Access to Higher Quality Health Care Act of 2019 (S. 2860/H.R. 3062), which would repeal the Stark POH restrictions. The Senate bill, introduced by Sen. James Lankford (R-OK), currently has 12 cosponsors (all Republican) and the House bill, introduced by Rep. Michael Burgess (R-TX), currently has 41 cosponsors (38 Republicans and three Democrats). For more information about the bill, please click HERE and HERE.
Creating Capacity for Communities in Need Act
On June 11, 2020, Reps. Vicente Gonzalez (D-TX) and Michael Burgess (R-TX) introduced the House companion bill to a Senate bill, the Creating Capacity for Communities in Need Act (S. 3547). This House bill is H.R. 7168. The OrthoForum supports this bicameral legislation, which would permanently allow an increase by any POH of its number of operating rooms, procedure rooms, or beds if the increase takes place during the COVID-19 emergency period or if construction of additional capacity begins in such period. The Stark baseline for the POH would be adjusted to include the new capacity. The House bill currently has 3 cosponsors (all Republican), and the Senate bill, introduced by Senator Ted Cruz (R-TX), currently has 4 cosponsors (all Republican). For more information about the bill, please click HERE and HERE.
POH Subcommittee
For more information on POH issues, or to join the OrthoForum Advocacy Committee POH Subcommittee, please contact Dr. Blake Curd at bcurd@oi.md.com
Political Update
The Democratic Convention opened with former vice president Joe Biden holding a substantial but not overwhelming lead over President Donald Trump in the 2020 presidential election.
Polling and Forecasts
As of August 18th, Biden leads by 8.4 points in FiveThirtyEight’s adjusted poll average. That same site gives Biden a 73% chance of winning the general election. The Economist’s forecast gives Biden an 87% chance of winning the Electoral College.
Two polls released on the first day of the convention show very different races. CNN has Biden’s lead at just 4 points; ABC News/Washington Post has Biden up by 10.
The CNN poll may be an outlier. CNN’s last poll, released in June, showed Biden ahead by 14 points; it’s not likely that Trump jumped 10 points in two months. Although other live-interview polls also show Biden’s lead declining, it’s just by one to three points. The latest NBC/Wall Street Journal poll had Biden leading by 9 and Fox News had Biden ahead by 7. As mentioned above, the new ABC/WaPo poll has Biden in front by 10.
Nonpartisan analyst Charlie Cook described the CNN poll as an outlier, noting that Biden has a 10-point lead in the average of the last seven live-call polls.
Biden’s lead has been remarkably stable. Much like Trump’s approval rating, the polling numbers, once averaged out, haven’t fluctuated much from week to week. However, whether Biden’s lead is 8.2 points or 10 points, it is a larger lead than Clinton had over Trump at any time in 2016.
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Battlegrounds
Trump beat Clinton in the Electoral College with 304 electoral votes to Clinton’s 227. The geographic key to Trump’s win was the Upper Midwest. Trump won very narrow victories in three historically blue states, in each of which Hillary was favored: Michigan (16 electoral votes), Pennsylvania (20) and Wisconsin (10).
One route for a Biden win in 2020 would be to restore those three states to the blue column. Added to Clinton’s 227 EVs, that would give Biden 273 EVs, a little more than the 270 needed to win.
That route is highly plausible. Currently, Biden leads by 7.6 points in Michigan, 6.4 in Pennsylvania, and 6.8 in Wisconsin.
Evidence of renewed Democratic strength in these three states was evident in the 2018 midterm elections. Including Minnesota, the state that Clinton won by the smallest margin, Democrats went four-for-four in governors’ races and five-for-five in Senate races.
However, Biden has an alternative path to victory, through the southeast and Sunbelt. That course includes Arizona (11 EVs), Florida (26) and North Carolina (15), with Georgia (16) and Texas (36) seen as less attainable but not completely outside the realm of possibility.
Biden leads by 3.6 points in Arizona, 5.3 in Florida, and 1.3 in North Carolina. Trump leads by 0.9 points in Georgia and 2.0 in Texas.
Harris as Vice Presidential Nominee
Biden’s selection of Senator Kamala Harris as his running mate was well-received by Democrats and by the media and the public generally. However, it is not clear that the vice-presidential nominee has any effect on the presidential campaign. Most voters in the 2020 cycle are voting for or against the president. The last election in which the vice-presidential candidate clearly affected the outcome was 1960, when John F. Kennedy won Texas with the help of running mate Lyndon B. Johnson, the Senate Majority Leader from Texas.
Per the AB/WaPo poll, 54% of Americans approve of the Harris pick, and just 29% disapprove. Independents, the critical voting bloc, approve 52% to 29%. No visible faction of the Democratic Party is complaining about the selection, a sign that the Democratic Party is more unified in 2020 than it was in 2016.
Democrats hope that the presence of Harris in the ticket will inspire increased turnout by Black voters. According to a Washington Post analysis, Black turnout “declined dramatically” from 2012 to 2016. The states that saw the largest percentage declines in Black voters were the swing states of Michigan and Wisconsin, by far. Black turnout declined by 4.7% nationally, and by more than 12% in Michigan and Wisconsin. According to the Post’s analysis, turnout of Black voters at 2012 rates would have delivered Michigan, Pennsylvania and Wisconsin to Clinton, albeit by very small margins, and Clinton would have been elected president.
From the point of view of longtime political observers, the Harris choice is likely to have a greater impact on future elections than on the present one. Former vice presidents who became Democratic nominees for president include Walter Mondale, Al Gore and Biden himself. Harris may get a head start on a future presidential campaign; in the meantime, she helps clear the path for non-white female candidates.
Social Uprisings and Black Lives Matter
The rise of the Black Lives Matter movement and related protests against police violence seem to have created an environment that is generally more favorable to Democrats and less favorable to Republicans.
According to a recent NPR/PBS/Marist survey, BLM has a net favorable rating among registered voters of +23 (+33 among independents), which is much better than either of the presidential candidates. In the same survey, 54% say the protests are mostly legitimate and 38% say they are mostly people acting unlawfully. In other words, supporters of BLM and the protests are more than a subset of Biden voters/Democrats; they’re a majority of Americans who are registered to vote.
Debate Over Mail-In Ballots
This may be the most unique macro factor in the 2020 presidential cycle, and that’s saying something. President Trump has made it clear that he wants to limit mail-in voting because he thinks that such voting favors Democrats. Last week, the US Postal Service advised 46 states that USPS might not be able to process their mail-in ballots quickly enough to be counted in the 2020 elections. These ballots would therefore be ignored even if the voters casting them abided by state laws governing voting and elections.
Thirty-four states plus DC allow no-excuse mail-in voting; this group includes 8 states that automatically mail ballots to all voters. Among the swing states in that group are Pennsylvania, Michigan, Wisconsin, Arizona, Florida and North Carolina. The remaining states allow voters who will be absent from the state on Election Day or will be unable to vote for a prescribed reason (e.g., illness, inability to change work shift) to request mail ballots and to return those ballots by mail. Research indicates that neither Democrats nor Republicans have received an advantage in states that have expanded voting by mail. Republican officials have historically supported voting by mail, as such systems would seem to accommodate older, rural voters and members of the military. The notion that voting by mail is a Democratic scam is a new one and is not widely accepted outside the president and his immediate circle.
Key Differences Between 2016 and 2020
Some of the key differences are obvious, some are a little more subtle. Trump is running for re-election in the midst of an economic crash and a pandemic that has already killed 170,000 Americans. In 2016, moderate voters could tell themselves that Trump, a former Democrat born and raised in New York City, was a moderate himself. That’s no longer tenable. The Democratic nominee won’t suffer from the animosity of a large and vocal cohort of Bernie Sanders supporters who felt that their candidate was cheated out of the nomination.
Joe Biden is generally well-liked and seems unlikely to be converted into an object of mass hatred (or fear). FBI Director James Comey is gone, and so there will not be a stunning announcement just before Election Day that an FBI investigation into the Democratic candidate is being reopened.
Finally, third-party candidates have received much less attention, and are less likely to draw votes away from Biden. In 2016, third-party presidential candidates received nearly 6% of the total vote, the largest number since Ross Perot last ran for president (Ralph Nader, seen as a spoiler in 2000, received less than 3% of the vote in that presidential election). Trump won Michigan by 0.23 points; third-party candidates got 5.5%. Trump won Pennsylvania by 0.72 points; third-party candidates got 4.4%. Trump won Wisconsin by 0.77 points; third-party candidates got 6.33%. Given the tiny margins by which Trump won those states, it’s easy to see how the reduced interest in third-party candidates could shift the election away from Trump.
