Issue 16, Spring 2022
General OrthoForum Policy Issues
Duration of Public Health Emergency; Effects From Its End
On January 14, 2022, the Secretary of Health and Human Services, Xavier Becerra, extended the Covid-19 public health emergency (PHE) for an additional 90-day period, using authority under section 319 of the Public Health Service Act. That period would have expired in mid-April, but on April 12 Secretary Becerra extended the PHE for another 90-day period, to mid-July. The Biden Administration has stated that it will provide a 60-day notice that the PHE will end, which means that such a notice will be issued in mid-May if the intent is to end it in mid-July. The end of the PHE will terminate the emergency flexibilities created by the Centers for Medicare & Medicaid Services (CMS) regarding the Medicare, Medicaid, and CHIP programs (but see the telehealth section elsewhere in this newsletter). Millions of people may lose access to emergency health insurance coverage when the PHE ends. Note also that the authority for emergency use authorizations (EUAs) for drugs and devices issued by the Food and Drug Administration is not provided under section 319 of the Public Health Service Act, but rather under section 564 of the Federal Food, Drug, and Cosmetic Act. Separate action by Secretary Becerra under section 564 will be necessary to terminate EUAs. In December 2021, FDA released draft guidance on the process it will use to terminate EUAs.
Enactment of Telehealth Legislation
The Consolidated Appropriations Act, 2022, which was enacted on March 15, 2022 (Public Law 117-103), includes provisions to extend the Medicare telehealth flexibilities for 151 days beyond the end of the Covid-19 public health emergency (PHE). Although Congress could have accomplished this extension in a single sentence without amending the telehealth provisions of the Medicare statute, Congress chose instead to make a number of detailed amendments to those Medicare provisions. This may indicate that Congress is considering making these provisions permanent at some point, which could be done simply by striking the references to 151 days. Another possibility is that, in order to reduce the extent to which continuing the telehealth flexibilities increases the federal budget deficit, Congress will periodically extend the 151-day period for relatively short periods.
No Surprises Act; First Court Decision on Arbitration Process
The second interim final rule to implement the No Surprises Act, which was issued on October 7, 2021, gave priority to the “qualifying payment amount” (QPA) in the independent dispute resolution (IDR) process under the Act to resolve payment disputes between physicians and health plans (i.e., the arbitration process). The QPA is the median in-network contracted rate in the geographic area involved for the applicable insurance market (large group market, small group market, or individual market) as adjusted for inflation occurring after January 31, 2019.
Several lawsuits have been filed against the Biden Administration on the basis that the statutory text of the No Surprises Act specifies that the QPA is only one of six factors to be considered in the IDR process and, therefore, the QPA should not be given more weight than the other factors. On February 23, 2022, a federal district court in Texas issued a ruling on this arbitration issue. The court agreed that the QPA should not be given more weight than the other factors, finding that the interim final rule conflicts with the text of the No Surprises Act and that the Administration violated the Administrative Procedure Act by issuing the final rule without first having issued a proposed rule with a comment period. Accordingly, the Biden Administration has withdrawn guidance documents that are based on, or that refer to, giving priority to the QPA in the IDR process.
Medicare Sequester Cuts Begin Taking Effect
As noted in the previous newsletter, legislation was enacted in December 2021 to mitigation Medicare payment cuts to physicians. Although the 2% Medicare sequester cut under the Budget Control Act of 2011 (BCA) that would have taken effect on January 1 was waived for the first quarter of 2022, a 1% BCA sequester cut took effect on April 1 for the second quarter. Beginning with July, the BCA cut will be 2% for the third and fourth quarters. Importantly, however, the 4% Medicare sequester cut under the Statutory Pay-As-You Go Act of 2010 that would have taken effect on January 1 will not take effect at all.
Reminder on Other Medicare Changes
The 2022 final rule for the Physician Fee Schedule included the following changes:
- Appropriate use criteria (AUC) for determining when the use of advanced diagnostic imaging is appropriate: The effective date for AUC program claims processing edits and for the payment penalty phase is the later of January 1, 2023, or the January 1 that follows a government declaration ending the PHE.
- Split/shared E/M services: When both a physician and a non-physician practitioner (NPP) provide services to a patient for an E/M visit in the office setting, the physician can bill for the visit rather than the NPP as long as the visit meets the conditions of payment for services furnished ‘‘incident to’’ a physician’s professional services. In contrast, when both a physician and an NPP provide services to a patient for an E/M visit in the facility setting, the person who provides the “substantive portion” of the services will bill for the visit and reimbursement will be based on the rate applicable to that person (physician or NPP, as the case may be). The rule is that time, and not medical decision making (MDM), is the determinative factor; therefore, whoever provides more than 50 percent of the total time for the visit is providing the “substantive portion”. For 2022 only, however, there is a special rule (except that it is not applicable to critical care visits). For that one year, there are options—the substantive portion can be determined (1) by time (more than 50 percent), or (2) by performing the history, or (3) by performing the exam, or (4) by performing the MDM.
Medicare Prior Authorization Requirements; House Bill on Electronic Process
The Advocacy Committee supports a bipartisan bill that was introduced in the House of Representatives on May 13, 2021, to require Medicare Advantage plans to electronically issue real-time prior-authorization decisions. This requirement would take effect with the second plan year beginning after the bill’s enactment. The bill is H.R. 3173, the Improving Seniors’ Timely Access to Care Act of 2021, which was introduced by Representatives Suzan DelBene (D-WA) and Mike Kelly (R-PA). As of mid-April, the bill had 278 cosponsors, of which 160 were Democrats and 118 were Republicans. The bill clearly has momentum and now has more than the number of supporters necessary to pass the bill in the House (218). The bill’s cosponsors include senior Democrats and Republicans on the two committees of jurisdiction, House Energy & Commerce and House Ways & Means. The OrthoForum Advocacy Committee’s contacts on Capitol Hill have said there is a possibility that the Ways & Means may consider H.R. 3173 sometime within the next few months.
Additional Information
For more information on any of the topics discussed in this section, please contact the chair of the OrthoForum Advocacy Committee, Dr. Richard Bruch, at rich.bruch@gmail.com.
Therapy Services Update
New law extends telehealth flexibilities:
As noted elsewhere in this newsletter, on April 12, 2022, the Secretary of Health and Human Services extended the Covid-19 public health emergency (PHE) for an additional 90-day period, to mid-July. It is unclear at this point whether the PHE will be extended again when the July termination date is reached. The end of the PHE would have resulted in the removal of physical therapists and occupational therapists from the list of health professionals who are considered telehealth providers under the Medicare statute. Recently enacted legislation has, however, temporarily changed that.
The Consolidated Appropriations Act, 2022, which was enacted on March 15, 2022, includes provisions to extend the Medicare telehealth flexibilities for 151 days beyond the end of the PHE. That Act amended the Medicare statute to expressly provide that, for this 151-day period, PTs and OTs are considered telehealth providers. The question is whether Congress will at some point make this change permanent, which could be done simply by striking the references to 151 days. As an alternative, Congress could periodically extend the 151-day period for relatively short periods in order to minimize increases in federal spending.
Current bills:
The telehealth provisions of the Consolidated Appropriations Act, 2022, are a step in the right direction. It may be that other legislation supported by the Advocacy Committee is a good indication of whether Congress will permanently make PTs and OTs Medicare telehealth providers. The relevant bills are H.R. 1332 and S. 368. As of mid-April, the House bill has 122 cosponsors (62 Democrats and 60 Republicans), and the Senate bill has 18 (six Democrats, one Independent, and 11 Republicans). These bills would give CMS the authority to designate PTs and OTs as telehealth providers (but would not require the agency to do so).
The Advocacy Committee will continue to work toward the goal that physical therapists and occupational therapists are considered Medicare telehealth providers on a permanent basis.
Reimbursement Cuts Regarding Therapy Assistants
As noted in the prior edition of the newsletter, a law took effect on January 1, 2022, that requires a 15% reduction in Medicare reimbursement when therapy services are “furnished in whole or in part” by a therapy assistant. The law therefore applies to physical therapy assistants (PTAs) and occupational therapy assistants (OTAs). A bipartisan bill was introduced in the House in October 2021 that would delay this 15% reduction until January 1, 2023, and would permanently exempt from the reduction PTA and OTA services provided in rural areas or medically underserved areas. The bill is H.R. 5536, introduced by Representatives Bobby Rush (D-IL) and Jason Smith (R-MO).
As of mid-April, the bill has 31 cosponsors, of which 21 are Democrats and 10 are Republicans. This is twice the number of cosponsors as the bill had in mid-January, so it has some momentum. Cosponsors include three high-ranking Democrats on the Energy and Commerce Committee (E&C)—G.K. Butterfield (D-NC), Jan Schakowsky (D-Ill), and Tony Cárdenas (D-CA). There are also three E&C Republican cosponsors—Debbie Lesko (R-AZ), David McKinley (R-WV), and Kelly Armstrong (R-ND). A senior member of the Ways and Means Committee, Ron Kind (D-WI), is also a cosponsor.
Therapy Services Subcommittee
For more information on therapy services issues, or to join the Therapy Services Subcommittee of the OrthoForum Advocacy Committee, please contact Renee Duncan at: renee.duncan@orthotennessee.com.
CMS/CMMI Update
MedPAC Discusses Alternative Payment Models (APMs) Portfolio
In its June 2021 report to Congress, MedPAC recommended that CMS implement a smaller number of APMs designed to work in conjunction, focusing their strategy around a single, multi-track, population-based model. In subsequent meetings this cycle, the Commissioners have discussed how to best implement this recommendation, highlighting that their June 2022 report to Congress will include a chapter with more specific suggestions for CMS to consider.
During the March meeting, the Commissioners specifically focused on methods to combine episode-based payment approaches with a population-based payment model. They discussed potential benefits of combining the models, noting that consolidating the two could help ensure incentives are in place for specialists and facilities to provide efficient care during and after an episode. They also note how this could lead to greater cost reductions compared to either model’s performance individually. Potential drawbacks included dependency on market conditions, noting the approach may not effectively incentivize episode-based providers, and potential reluctance among ACO’s that are uninterested in sharing their savings
MedPAC outlined three possibilities for combining the models: under option 1, all beneficiaries would be attributed to Medicare’s episode-based payment model; under option 2, beneficiaries in one-sided ACO’s and those not in an ACO would be attributed to Medicare’s episode model; and under option 3, only beneficiaries not in an ACO would be attributed to Medicare’s episode model. Option 1 was received the most favorably, followed by Option 3.
During the April public meeting, the Commissioners further discussed options to streamline APMs and favored reducing the amount of population-based payment model tracks to three options subjective to provider type and size. They also suggested that population-based models stop periodically “rebasing” spending benchmarks, the current practice where CMS automatically resets an ACO’s expenditures metric for calculating shared savings (and losses) every three years. The Commissioners instead suggested using historical spending data at the start of an ACO’s participation in the model to set its spending benchmark, then updating this annually to account for national Medicare expenditure trends. The Commissioners reiterated their support for a national episode-based model alongside ACOs and offered factors to consider when selecting which kinds of episodes to include in the Medicare-run model. These suggestions will be discussed in further detail in the June 2022 report.
Additional Information
For more information on CMS/CMMI issues, or to join the OrthoForum Advocacy Committee CMS/CMMI Subcommittee, please contact Dr. Wilford Gibson at: gibsonw@atlanticortho.com.
Ambulatory Surgery Center Update
ASC-HOPD Site-Neutral Payments
For procedures on the ASC covered procedures list, the Advocacy Committee has written draft legislation to provide for a single Medicare conversion factor that would apply both to ASCs and hospital outpatient departments (HOPDs). This draft would significantly increase Medicare reimbursement for ASCs. An advocacy strategy is being developed to share the draft with selected offices on Capitol Hill and to build support for it.
Nominations to Add Procedures to the ASC Covered Procedures List (CPL)
Effective for 2022, CMS reinstated the ASC CPL criteria that were in effect for 2020 (as noted in the prior newsletter). The agency also adopted a nomination process under which stakeholders may nominate procedures they believe meet the agency’s ASC CPL criteria. On or after January 1, 2023, physicians (or others) may nominate a surgical procedure by March 1 of the year involved for the ASC CPL for the following year. If CMS finds that a nominated procedure meets the agency’s criteria, it will propose to add the procedure to the CPL through the annual rulemaking process.
Upcoming ASC Conference
The ASC Subcommittee of the OrthoForum Advocacy Committee has been having discussions about the next ASC conference. The conference will be held in Chicago September 22 to 24 and will be directed toward administrators and physicians. Possible topics for the conference include presentations on cost accounting; preparing for higher acuity patients; staffing, compensation, recruitment, and technical training; working with Leapfrog; healthcare benefits; OrthoForum ASC surveys, including possible surveys on technological expertise; and building strong bridges between physician group practices and ASCs on collecting demographic and clinical information on patients.
ASC Subcommittee
For more information on ASC issues, or to join the ASC Subcommittee of the OrthoForum Advocacy Committee, please contact Teresa Copeland at: teresa.copeland@orthotennessee.com.
OrthoForum Cybersecurity Letter to HHS
On March 1, 2022, the OrthoForum Advocacy Committee sent a cybersecurity-related letter to the Secretary of Health and Human Services and also to the Director of the HHS Office for Civil Rights (OCR), which has the day-to-day responsibility for administering the cybersecurity aspects of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the related Health Information Technology for Economic and Clinical Health Act (HITECH Act). The issue addressed by the letter was that if a breach of HIPAA protected health information by a physician group practice (PGP) affects more than 500 individuals, the HITECH Act requires the Secretary to post the name of the PGP on a public breach list on the HHS Internet site. That list, which is also known as the “Wall of Shame,” can serve as a hunting ground for litigious law firms looking to make easy money by filing frivolous class-action lawsuits, which cause PGPS to use valuable resources to defend or settle.
The OrthoForum letter requested that the HITECH public breach list indicate whether PGPs have undergone a third-party audit to confirm their compliance with the relevant HITECH cybersecurity encryption and destruction standards (which were established by HHS guidance in 2009). Noting the fact of compliance on the public breach list would help protect the reputations of the PGPs and reduce the risk of being subjected to frivolous lawsuits seeking damages.
OrthoForum Cybersecurity Draft Legislation
The OrthoForum Advocacy Committee has written a draft bill that would protect PGPs from breach-related HIPAA civil money penalties when the PGPs have undergone a third-party audit to confirm their compliance with the relevant HITECH cybersecurity encryption and destruction standards (which are the same ones identified in the OrthoForum letter to HHS of March 1, 2022).
In addition, the draft bill would require HHS to do the same thing as is requested by the OrthoForum letter to HHS, which is noting on the HITECH public breach list whether there has been compliance with those HITECH cybersecurity standards. Finally, the bill addresses a separate cybersecurity issue, which is that, under recently enacted federal legislation, PGPs could potentially become subject to multiple federal reporting requirements if they are the subject of a cyberattack, including situations in which they make ransomware payments. The draft bill would provide that the only federal cyberattack report that PGPs must submit is the breach report required by the HITECH Act.
Several Member offices on Capitol Hill are reviewing this OrthoForum draft bill.
Cybersecurity Subcommittee
For more information on any of the topics discussed in this section, please contact the chair of the Cybersecurity Subcommittee of the OrthoForum Advocacy Committee, Scott Paneitz, at spaneitz@SignatureHealth.net.
Political Update
As we write this political update, Congress is in the second week of its annual two-week April recess, which allows members to celebrate Easter and Passover with their families.
Until recently, the end of April marked the midpoint of an election-year congressional session. Congress would finish its business at least a week before Election Day; a new class would be elected, to be sworn in the following January.
In the modern era of partisan conflict and complex legislation, election year sessions have come to last beyond Election Day, creating what are universally known as lame duck sessions – lame duck in the sense that members of Congress who retired or lost their re-election races return to Washington, DC, to vote on legislation.
As the lame duck session has become the norm, Congress has increasingly deferred problematic legislation to the lame duck period. This year, that means that we are likely to see a final annual appropriations bill for fiscal year 2023 (which begins on October 1st, 2022) enacted in the lame duck. We also expect that Congress will pass legislation mitigating statutory Medicare cuts and extending various expiring tax cuts in the lame duck – possibly as two separate bills, or possibly as one.
Indeed, Congress has surprisingly little time remaining to pass legislation before the November elections. By way of illustration, consider the House’s schedule. The US House of Representatives is scheduled to meet for just eight days in May, 12 days in June, 12 days in July, and zero days in August. Members will be working on most of the weekdays that the House isn’t in session, but they won’t be together in Washington, DC, and they won’t be voting on bills.
In considering how to lobby Congress on our priorities, we have to take the schedule into account. Members of Congress will determine their positions on almost all policy matters over the next few months, but many or most key votes will happen in the lame duck, and they will happen quickly.
A related note: The House Casualty List (we didn’t come up with that name) is up to 47 members (30 Democrats and 17 Republicans). It appears that this year will not reach the record of 65 retirements set in 1992 (41 Democrats and 24 Republicans), but it’s on the high side. And of course there will be more departures – involuntary departures – in the 2022 House elections. All of which means that a lot of lame ducks will be voting on key legislation in the period between Election Day and the arrival of the 118th Congress.
