Do you remember
When reconciliation
Was the biggest news?
The Rundown
- House rushes to finalize reconciliation, infrastructure plans
- Administration releases vaccine mandates
- CMS issues final OPPS and PFS rules
- The latest from our desks
Federal Updates
Reconciliation on final approach?
Reconciliation week has nearly been supplanted by rules week (as you’ll read below), but Democratic leaders have spent this week clearing the runway as much as possible for an attempted landing of the months-long, circling reconciliation and infrastructure debate – at least in the House.
Some potential provisions of an emerging Build Back Better Act (BBBA) compromise package have been released, including recently re-added language to allow Medicare to negotiate prices of the costliest prescription drugs, but final details and account lines are still uncertain. What is clear? House Speaker Nancy Pelosi (D-CA) is tired of the back and forth and the House Rules Committee is preparing a floor rule to allow the House to vote before the end of the weekend on both the $1.75 trillion BBBA (“human” infrastructure plan) and $1.2 trillion bipartisan “traditional” infrastructure bill passed by the Senate in August.
As we have seen throughout this process, there are a number of outstanding factors that could impact this timeline, including a segment of lawmakers awaiting the Congressional Budget Office score of the BBBA and ongoing conversations about the plan’s treatment of immigration and paid leave provisions.
Even assuming the Democrats can muster the votes to pass both bills in the House, the BBBA still has to face the Senate, where additional changes are expected that may involve weeks of negotiations.
Will Democratic leaders simply “buzz the tower” and come back for another approach – or are they ready to “call the ball,” line up the runway, and put this thing down?
We continue to monitor the situation closely and advocate for priorities important to Duke Health and the communities served by our institution.
Administration releases major vaccine mandates
On Thursday, the Biden administration officially announced two new sweeping vaccine mandates that will impact tens of millions of American workers, including those in health care.
First, the Department of Labor’s Occupational Safety and Health Administration (OSHA) released details of an emergency temporary standard requirement for employers with 100 or more employees to ensure each of their workers is fully vaccinated or tests for COVID-19 on at least a weekly basis. The OSHA rule also require that these employers provide paid-time for employees to get vaccinated, and ensure all unvaccinated workers wear masks in the workplace. Covered employers must comply by January 4, 2022.
Second, and more relevant to Duke Health, is an emergency interim final rule released by the Centers for Medicare and Medicaid Services (CMS) that mandates COVID-19 vaccine compliance for workers at health care facilities participating in Medicare and Medicaid. The rule applies to health care employees regardless of whether their positions are clinical or non-clinical and includes employees, students, trainees, and volunteers who work at a covered facility that receives federal funding from Medicare or Medicaid. It also includes individuals who provide treatment or other services for the facility under contract or other arrangements. Among the facility types covered by the rule are hospitals, ambulatory surgery centers, dialysis facilities, home health agencies, and long-term care facilities. There is no testing exception under the current CMS rule. The rule covers approximately 76,000 health care facilities and more than 17 million health care workers. Employees and individuals covered under the new requirements must also be fully vaccinated, which means either two doses of Pfizer or Moderna, or one dose of Johnson & Johnson, by January 4, 2022.
The OSHA rule will not apply to workplaces covered by either the CMS rule or the federal contractor vaccination requirements, which were also modified on Thursday to extend the compliance deadline to January 4th.
What Now?
The publication of the rules has been anticipated over the past few months following an executive order by the Biden administration. While the President is hailing the new directives as the most effective path out of the pandemic, backlash from some in the business community and congressional Republicans has been immediate.
Shortly after the rules were announced, Republican leadership from at least two congressional committees, including the House Energy and Commerce Committee, announced plans to draft Congressional Review Act (CRA) disapproval resolutions to push back against the administration. The CRA, passed by Congress in 1996, allows for review of agency issued rules within a 60-day window of their initial release. Since its inception, the CRA is more commonly used to review rules issued by outgoing administrations following presidential elections (and was the case during the Trump-Biden transition) but may be invoked at any time. The process requires a joint resolution passed by the House and Senate under simple majorities “disapproving” of a specified rule or rules. The president must also sign the resolution for it to take effect and officially remove the rule – otherwise Congress is subject to the two-thirds majority veto-override requirements to have the resolution enacted. The CRA can also be used to delay the implementation of a new rule, but a majority in both chambers is still needed to move forward.
The problem with this strategy for Republicans is that they don’t hold true majorities in either chamber and can’t necessarily count on enough Democrats to cross the aisle – especially to override what would be an automatic veto by President Biden.
Outside litigation with respect to the new rules is anticipated in the coming days, which has the potential for various court challenges to put temporary holds on enforcement.
Our office will continue to monitor this issue in conjunction with health system leadership.
CMS issues final CY 2022 OPPS and PFS rules
This week, CMS also released final rules for the Calendar Year (CY) 2022 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgery Centers and the CY 2022 Physician Fee Schedule (PFS).
The final OPPS rule increases Medicare OPPS rates by a net 2.0 percent in 2022 and finalizes policies on price transparency, 340B drugs, and quality measures, among many other issues. The rule also includes finalized modifications related to the Radiation Oncology (RO) Model, which is set to begin on January 1, 2022 and end December 31, 2026. CMS has provided clarifications in the final rule to help address questions from stakeholders and future RO participants related to the interaction between the RO Model and the Quality Payment Program.
The final PFS rule, among other provisions, addressed several policies on expanding access to telehealth, particularly for mental health services, delays implementation of the payment penalty phase of the Appropriate Use Criteria program, and makes several changes to the Quality Payment Program. With respect to telehealth, the rule implements legislation passed in the 2020 Consolidated Appropriations Act (CAA) to allow permanent Medicare coverage for telemental health services, including for audio-only interactions beyond the public health emergency. Also included in the rule is a requirement from outdated language in the CAA that a patient and provider meet in person once at least six months before beginning covered telemental health services. There is legislation pending in Congress to remove this requirement. These changes also apply to Rural Health Clinics (RHC) and Federally Qualified Health Centers (FQHC) which can receive payment for mental health services provided by telehealth and audio-only technology under the same limitations and restrictions.
Duke Health submitted comments to CMS on both the CY 2022 OPPS and PFS proposed rules.
More information on the final CY 2022 OPPS rule is available here.
More information on the final CY 2022 PFS rule is available here.
From our desk(s): Duke Health GR this week
This week our team monitored the Senate Health, Education, Labor and Pensions Committee hearing entitled “Next Steps: The Road Ahead for the COVID-19 Response.” The hearing featured leaders from across the Department of Health and Human Services, including Dr. Rochelle Walensky, Director for the Centers for Disease Control and Prevention; Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health (NIH); Dr. Janet Woodcock, Acting Commissioner for the Food and Drug Administration (FDA); and Dawn O'Connell, Assistant Secretary for Preparedness and Response at HHS.
Among his opening remarks, Ranking Member Richard Burr (R-NC) stressed the need for the witnesses to look ahead and anticipate what we will need to be better prepared for the next public health emergency. He noted that we need to take stock of the current state of our response and identify the next critical steps that will lead us out. He described his question and headline for the hearing as simply, “What is the plan?” He also shared that a discussion draft of the pandemic preparedness bill, which he has been working on with Chairwoman Patty Murray (D-WA), is forthcoming.
We also followed a House Energy and Commerce Subcommittee on Health markup of nine public health bills, including H.R. 1667, the Dr. Lorna Breen Health Care Provider Protection Act, which would support the behavioral and mental health of health care professionals, residents, and students and passed the Senate earlier this year. Among the other bills considered, the Accelerating Access to Critical Therapies for ALS Act (H.R. 3537) would help patients take part in the Expanded Access program for experimental ALS drugs while providing a framework for the NIH and the FDA to benefit from the data of patients. Duke ALS Clinic Director Richard Bedlack, MD, PhD, previously informed the subcommittee’s examination of the bill through conversations with the staff of Rep. G.K. Butterfield (D-NC-01) in advance of a July hearing on neurodegenerative diseases.
Our office scheduled and participated in meetings with Michael Pencina, PhD, Duke University School of Medicine Vice Dean for Data Science and Information Technology and Director of Duke AI Health, with Rep. David Price (D-NC-04) and the office of Senator Burr. He gave updates on Duke AI Health and discussed the landscape of AI, offering Duke expertise in this policy area.
A member of our team joined Dr. Vincent Guilamo-Ramos, Dean of the Duke University School of Nursing, for a meeting at the Deans Nursing Policy Coalition. The DNPC is comprised of ten top research-intensive schools of nursing that generate evidence for effective health care practice and translate that knowledge to the education and policy environments.
Our team also met with the American Hospital Association to learn more about new legislation that aims to address community violence. Specifically, S. 2873, the Preventing and Addressing Trauma with Health Services (PATHS) Act, would provide grants for hospital-based violence intervention programs that work with at-risk patients to provide trauma support and link them with various community-based services.
We continue to communicate with the North Carolina congressional delegation about the health system’s concerns about the recently released surprise medical billing interim final rule part II. Reps. Richard Hudson (R-NC-08), Greg Murphy, MD (R-NC-03), and David Rouzer (R-NC-07) joined a House letter with over 124 bipartisan signatures requesting the Biden administration revisit the rule and make changes to the federal independent dispute resolution process to more closely align with legislative intent of the No Surprises Act. The House Dear Colleague letter closes today.
Finally, we facilitated the participation of Duke Health in an Ad Hoc Group for Medical Research letter to House and Senate Appropriations leadership urging robust investments in agencies and programs to improve the nation’s health and well-being, specifically requesting at least $46.4 billion for NIH’s base budget as they work toward a final FY 2022 funding agreement. |
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