Federal Issues

Duke Health Government Relations continues to engage lawmakers in the 116th Congress on key health care issues impacting Duke, including those listed below. Please email us if you would like to be engaged on these issues. For the most up to date information, please subscribe to our newsletter and follow us on Twitter

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FEDERAL RESPONSE TO COVID-19
IMMIGRATION
FEDERAL APPROPRIATIONS AND THE BUDGET
TELEHEALTH
MEDICARE SUPPORT FOR GRADUATE MEDICAL EDUCATION (GME)
MEDICAID AND MEDICAID DSH PAYMENTS
SURPRISE BILLING
DRUG PRICING
MEDICAID PROGRAM: MEDICAID FISCAL ACCOUNTABILITY REGULATION
WORKING IN PARTNERSHIP TO ADDRESS THE BLACK MATERNAL HEALTH CRISIS

FEDERAL RESPONSE TO COVID-19

Congress has approved four emergency spending packages to address the federal, state, and local response to the COVID-19 virus.

On March 6, 2020, Congress approved and the president signed into law a bipartisan measure that would provide $8.3 billion in emergency aid spending, including:

  • $2.2 billion, available through September 2022, for the Centers for Disease Control and Prevention (CDC), including:
  • $950 million in grants and cooperative agreements for state/local surveillance, epidemiology, laboratory capacity, infection control, mitigation, communications, and other preparedness and response (including $475 million that would be available within 30 days of enactment).
  • At least $300 million for global disease detection and emergency response.
  • $300 million for the Infectious Diseases Rapid Response Reserve Fund.
  • The ability for CDC to use such funds to support grants for construction, alteration, or renovation of non-Federally owned facilities to improve state/local preparedness and response capability.
  • $836 million, available through September 2024, for the National Institutes of Health, including:
  • $826 million for the National Institute of Allergy and Infectious Diseases (NIAID) to prevent, prepare for, and respond to coronavirus domestically or internationally.
  • $10 million transferred from NIAID to the National Institute of Environmental Health Sciences for worker-based training to prevent and reduce exposure of hospital employees and other first responders.
  • $3.1 billion, available through September 2024, for the Public Health and Social Services Emergency Fund to support, among other activities:
  • Development and purchase of necessary countermeasures and vaccines. Purchase of vaccines, therapeutics, diagnostics, and necessary medical supplies, including for potential deposit in the Strategic National Stockpile (with an additional $300 million in contingency funding to purchase additional products if needed).
  • Grants for construction, alteration, or renovation of non-Federally owned facilities to improve state/local preparedness and response capability.
  • $61 million, available until expended, for the Food and Drug Administration to support:
  • Development of medical countermeasures and vaccines. Advanced manufacturing for medical products.
  • Monitoring of medical supply chains.
  • Authority for the Secretary of Health and Human Services to waive, under the public health emergency declaration for the novel coronavirus, certain current telehealth requirements by the Centers for Medicare and Medicaid Services.

The president signed into a law a second coronavirus-related relief package ($104 billion), the Families First Coronavirus Response Act (H.R. 6201), on March 19, 2020. The legislation eliminates patient cost-sharing for COVID-19 testing and related services, establishes an emergency paid leave program, and expands unemployment and nutrition assistance. Moreover, the package provides a temporary increase in the Medicaid Federal Medical Assistance Percentage (FMAP), enabling states to apply for temporary waivers to cover COVID-19 testing for the uninsured through the Medicaid program, and provides $1 billion in testing for the uninsured. 

On March 25, the Senate approved by a vote of 96-0 a third, $2 trillion emergency relief package (CARES Act) that includes, among many other things, $100 billion for hospitals and $945 million for the National Institutes of Health to support COVID-19 research. The House approved the bill by voice vote on March 27, and the president signed it immediately.

Some details from the final bill include: 

  • Provide $100 billion to reimburse eligible health care providers for health care-related expenses or lost revenues not otherwise reimbursed that are directly attributable to COVID-19.
    • Eligible providers are defined as public entities, Medicare- or Medicaid enrolled suppliers and providers, and other for-profit and non-profit entities as specified by the HHS Secretary.
    • Funding would be on a rolling basis through “the most efficient payment systems practicable to provide emergency payment.”
  • Provide $945 million for NIH to support research at NIH on COVID-19 for activities to expand on prior research plans.
  • Eliminate the Medicare sequester from May 1 through Dec. 31, 2020.
  • Provide a 20% add-on to the DRG rate for patients with COVID-19 during the emergency period.
  • Expand the existing option for hospitals to request and receive "accelerated" Medicare payments.
  • Eliminate the FY 2020 DSH cuts and reduce in half (to $4 billion) the scheduled FY 2021 DSH cuts to begin December 1, 2020.
  • Provide zero liability for volunteer health care professionals during the COVID-19 response as long as no act or omission potentially causing harm was done willfully, recklessly, or under the influence.
  • Reauthorize Health Professions Workforce Programs and Nursing Workforce Development Programs
  • Provide $150 billion for state and local governments, with $8 billion set aside for local governments, in a coronavirus relief fund (we will watch for guidance when this begins to be drawn down).

On March 23, 2020, House Democrats introduced their version of a third package, and some of these provisions made it into the final third emergency funding bill. Specifically, that proposal would have:

  • Provide $100 billion for hospitals to reimburse health care related expenses or lost revenue directly attributable to the public health emergency resulting from coronavirus
  • Establish a loan program to help eligible health care organizations with anticipated revenue loss or higher operating costs as a result of COVID-19.
  • Eligible health care organizations include hospitals, critical access hospitals, skilled nursing facilities, physician practices, home health providers, community health centers, ambulatory surgical care center, or hospices that participate in Medicare or Medicaid.
  • Provide $800 million to expand COVID-19-related research on the NIH campus and at academic institutions, including on vaccines, treatments, diagnostics, and complications of the virus.
  • Require states and local governments, labs, and health systems to report real-time data coronavirus testing results, including both positive and negative results.
  • Provide that hospitals can qualify for tax credits for charity care they provide and for creating or expanding facilities to handle the COVID-19 patient load.
  • Prevent the HHS Secretary from finalizing the Medicaid Fiscal Accountability Rule (MFAR).
  • Eliminate Medicaid DSH cuts in FY 2020 and reduce cuts in half in FY 2021.
  • Temporarily increase Medicaid DSH allotment to 2.5 percent during emergency period.
  • Require OSHA to issue “an emergency temporary standard to protect from occupational exposure” to the coronavirus. The rule would apply to workers in the health care sector, first responders; and anyone the CDC identifies as having an elevated risk of infection. All covered employers would have to develop “a comprehensive infectious disease exposure control plan,” and within two years, the Department of Labor would have to issue a permanent rule protecting these workers from other “occupational exposure to infectious pathogens.”
  • Create a mechanism automatically increasing a state’s FMAP if a state experiences an increase in the state unemployment rate.
  • Provide a one percent increase to FMAP for telehealth services for state Medicaid programs that cover telehealth services.
  • Renew the Medicare payment rate floor for primary care services furnished under Medicaid for the duration of the public health emergency.   

On April 24, Congress enacted a $484 billion interim relief and stimulus package to boost support for hospitals and providers, as well as the small business assistance fund that ran out of its initial allotment of CARES Act funding. As part of the new package, $75 billion is being made available to hospitals and medical providers, $25 billion to aid in testing, and $1 billion to cover costs for the uninsured. Duke Health worked closely with the NC congressional delegation and association partners in support for the additional funding for health care systems and providers.

What’s happening now?

The government is implementing the CARES Act, which infused almost 10% of the nation’s GDP into the economy in less than a month. As Congress heads into summer, Congressional attention is turning to a fourth COVID-19 relief package. Speaker Pelosi and House Democrats released a $3 trillion “Phase IV” COVID-19 stimulus and recovery package entitled “The HEROES Act (H.R. 6800)” on May 12, 2020.  This bill that passed along party lines and among other provisions would provide: 

      •    $4.7 billion for NIH (including $3 billion to offset costs related to reductions in lab productivity)
      •    $100 billion for hospitals and providers
      •    FMAP increase through June 2021 by a total of 14% points
      •    DSH payment increase of 2.5%
      •    Lowered interest rates for the Medicare Accelerated and Advance Payment Program
      •    $75 billion for testing and contact tracing
      •    $7 billion for the public health infrastructure
      •    Nearly $1 trillion for state and local government relief.

The Senate is pausing to consider policy proposals for what will likely become their version of recovery and stimulus legislation, including additional tax cuts and liability protections for employers during the national health emergency. 

As Congress considers a future recovery and stimulus package, Duke Health Government Relations, in addition to continued assistance for hospitals, is prioritizing emergency federal funding of at least $26 billion to support the research infrastructure impacted by COVID-19. The Association of American Medical Colleges, Association of American Universities, American Council on Education, and the Association of Public and Land-grant Universities joined in a coordinated effort to request supplemental appropriations of $26 billion for major research agencies. North Carolina Senator Thom Tillis (R) co-led a letter in the Senate supporting this effort and requesting $26 billion in the next COVID-19 relief package. A similar letter was sent in the House and was supported by Reps. G.K. Butterfield (D-NC-01), George Holding (R-NC-02), David Price (D-NC-04), David Rouzer (R-NC-07), and Alma Adams (D-NC-12). 

IMMIGRATION

During the COVID-19 national health emergency, Duke Health Government Relations is monitoring closely immigration and visa-related issues impacting our health system's ability to maintain a strong and well-trained medical workforce. The NC Congressional delegation is aware of the challenges presented by current J-1 and H1-B visa regulations with respect to bolstering our frontline response to COVID-19, and efforts are underway to urge the United States Citizenship and Immigration Services (USCIS) Office to provide additional flexibilities.

Congress
On April 14, Rep. David Price (D-NC-04) joined with a bipartisan group of colleagues in the House and Senate to send a letter to Acting USCIS Director Ken Cuccinelli asking for waiver flexibility to allow for holders of J-1 and H1-B visas - including physicians in the Conrad-30 State program, which helps retain U.S.-trained doctors who work in underserved areas - to practice in locations and in specialities outside of those specified on their visas. The letter argues the waiver of such restrictions allow for more of our medical professionals to readily step in to support areas of need in health systems across the country.

On April 6, a bipartisan group of Congressional leaders also sent a letter to USCIS requesting the agency to resume premium processing of employment for international physicians seeking employment-based visas in the United States.

Rep. Price has also joined his House colleagues in several other letters to the Trump Administration in response to immigration policies that could negatively impact students and trainees at academic medical institutions.

The Administration
Orders and Proclamation
On April 22, President Trump signed an Executive Order initially suspending for 60 days, immigration procedures for those outside of the United States seeking lawful permanent residence. Notably, health care professionals and medical researchers are exempt from the order. The order has since been extended through December 31, 2020.

On May 29, President Trump issued a proclamation that would suspend visa processing for certain individuals from China who are seeking to enter the United States to pursue graduate studies or conduct research. The proclamation, limited in scope and justified through national security concerns, would suspend F and J visa processing from "any national of the People’s Republic of China who receives funding from or who is currently employed by, studies at, or conducts research at or on behalf of, an entity in China that implements or supports China’s military-civil fusion (MCF) strategy.” How these “entities” are defined must still be determined by State and Homeland Security and that process will likely take some time. The proclamation describes the MCF strategy efforts by China to "acquire and divert foreign technologies, specifically critical and emerging technologies, to incorporate into and advance [its] military capabilities." A follow up briefing by State Department officials did not provide much clarification or additional details, only that the order is only "intended" to apply to a small percentage of Chinese students. Specific fields of study were not identified, but officials described artificial intelligence, quantum tech, 5G, nuclear, and advanced manufacturing as technologies of interest that may have military applications. The proclamation does include a number of exemptions, including for areas of study and research determined to not be connected to MCF and those considered to be in the "national interest."

Duke Health Government relations is seeking additional guidance on how the exemptions may be applied and advocating strongly that they should include individuals engaged in the practice of medicine and medical research.

On June 22, President Trump signed an Executive Order extending the prior order from April 22 through the end of the year and adding new restrictions on non-immigrant visas. In addition to extending the suspension of visa processing for permanent residency through December 31, 2020, the order also suspends through December 31 new non-immigrant visas for the following categories: H1-B, H-2B, H-4, and certain J, and L visa. 

The order only applies to individuals currently outside of the United States without a valid visa or one in process by June 24, 2020. While we are still awaiting formal guidance from the Department of State, those with currently valid visas in the listed categories seeking renewals also seem to not be affected by the order. Duke Visa Services has also advised that the order does not seem to affect J-1 Research Scholars. 

Section III(b)(iv) includes a broad exemption for any “alien whose entry would be in the national interest.” The order later offers a non-exhaustive list of what may constitute the “national interest” and includes “those involved with the medical care to individuals with COVID who are currently hospitalized and medical researchers engaged in COVID-19 related research activities.” The Departments of State, Labor, and Homeland Security will ultimately determine how the national interest is defined, but having medical workers and medical research included as examples is encouraging. 

The Federal District Court for the Northern District of California ruled October 1 that the Trump Administration exceeded its authority in issuing the June 22 order, granting a temporary injunction against its enforcement. The Administration wil likely appeal, leaving the impact of the policy unclear at this time.

Rulemaking
On July 6, Immigration and Customs Enforcement (ICE) attempted to reverse flexibilities provided in the Spring 2020 semester that allowed i
nternational students currently in the U.S. to retain their visa status while only taking online classes. The proposed guidance would have forced international students whose programs were not at least returning to some form of hybrid instruction (mix of online and in person classes) in the Fall to either leave those programs or return to their home countries. After a court challenge in which Duke University joined an amicus brief in favor of rescinding the guidance, ICE changed course and reinstated the flexibilities offered in the Spring. 

On September 25, the Department of Homeland Security (DHS) issued a notice of proposed rulemaking to change visa policies for F and J visa holders. As you know, under the current rules, F and J visa holders may remain in the United States until the completion of their degree, a policy known as “duration of status.” The proposed rule would change “duration of status” to a “fixed duration,” meaning that these visa holders would then be required to petition for extensions after certain periods of time. The proposed rule is widely opposed by universities and academic medical institutions, including Duke. Duke will submit comments to DHS formally opposing the proposed rule change.

Duke Health Government Relations is working with our Duke University government relations colleagues, professional associations, partners, and others to advocate on behalf of our international students and their contributions to the medical workforce and research enterprise. 

FEDERAL APPROPRIATIONS AND THE BUDGET

What’s at stake?
Federal funds help promote Duke Health’s multiple missions of research, education, and patient care. The National Institutes of Health (NIH) and the Department of Defense Medical Research Program are two of the primary sources of federal funding for biomedical research at Duke.

What’s happening now?
Following the enactment of two short-term continuing resolutions to fund the government since the start of the fiscal year on October 1, 2019, Congress finally approved a $1.4 trillion spending package for FY 2020. The spending bills were signed into law in two packages on December 20, 2019, funding the government through September 30, 2020, with one measure funding national security and defense and the other funding mostly domestic programs. 

The President's FY 2021 budget request was released on February 10, 2020, and as in previous years, the Trump Administration proposed slashing funding for programs of importance to academic medicine, including the National Institutes of Health (NIH), the Health Resources and Services Administration (HRSA) Titles VII and VIII health professions and nursing workforce programs, as well as proposing significant cuts to Medicare Graduate Medical Education (GME) funding and other Medicare and Medicaid funding streams.

While Congress has historically rejected the proposed budget, it provides insight into the Administration’s priorities. On behalf of Duke Health, our office submitted appropriations requests in early March to congressional offices, urging support for at least $44.7 billion in FY 2021 for the NIH (an increase of $3 billion above the FY 2020 level) and increased funding for public health agencies, Defense Health programs, health professions and nursing workforce development programs, and trauma training grants.

Congress kicked off the FY 2021 budget and appropriations process with hearings despite delays due to the ongoing COVID-19 public health emergency. While the House approved 10 of its 12 spending bills for FY 2021, the Senate did not consider any of its versions of the appropriations bills.

On September 22, the House approved a continuing resolution to fund the government through December 11, 2020. It is expected to pass the Senate to avoid a shutdown before the start of FY 2021 on October 1, 2020.

TELEHEALTH

Both the federal and state response to the COVID-19 national health emergency has led to an unprecenteded expansion of telehealth services and access to telehealth resources. 

Executive
The federal government, through the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS), and NC Governor Roy Cooper have issued a number of temporary waivers and orders, which have relaxed requirements for the use of telehealth under Medicare and Medicaid to assist providers on the frontlines of the emergency and allow for the continuation of care for millions of patients (including more than 80 additional telehealth services for Medicare patients).  Duke Health Government Relations has been working with the NC Congressional delegation to keep them updated of the impacts of telehealth policy on Duke Health providers and through them to ensure that HHS continues to open access to the most needed telehealth services. These waivers include (but are not limited to):

  • Lifting Medicare and Medicaid licensing restrictions that require a physician to be licensed in the state where the telehealth services are being provided; however, this waivier authority does not supersede individual state requirements.
  • Establishing and allowing virtual check ins (for triage and evaluation purposes) for new patients, in addition to patients that already have an established relationship with the practice.
  • Waiving originating site requirements so patients may do these virtual check-ins from their home from any area of the United States, not just rural areas.
  • Expanding the use of telephone-only visits for certain services to patients.
  • Expanding the use of remote patient monitoring.
  • Removing Medicare limitations on the number of times certain services can be provided through telehealth.

On October 14, CMS anounced that 11 new telehealth services have been added to the list of covered Medicare telehealth services. These services include certain neurostimulator analysis and programming services and cardiac and pulmonary rehabilitation services. 

At the state level, NC Governor Roy Cooper issued an Executive Order that, among other provisions, provides for a temporary waiver of North Carolina licensure requirements for health care and behavioral health personnel licensed in another jurisdiction.

At the federal level, the current waivers and flexibilities provided by CMS remain in effect at least through the end of the public health emergency

Legislative
Congressionally activity in support of making a number of temporary telehealth policies and enhancements permanent is picking up in efforts to avoid a so-called "telehealth cliff," where the expanded policies would be allowed to lapse if the Department of Health and Human Services decided not to renew the national public health emergency. On June 29, Duke Health  joined over 340 organizations and health systems in signing on to a multi-stakeholder letter to congressional leaders outlining the actions necessary to ensure that CMS has the authority to make temporary enhanced telehealth services permanently available.

On July 16, a bipartisan group of members of the House Telehealth Caucus, including Reps. Mike Thompson (D-CA), David Schweikert (R-AZ), Bill Johnson (R-OH), Peter Welch (D-VT), and Doris Matsui (D-CA) introduced the Protecting Access to Post-COVID-19 Telehealth Act of 2020 (H.R. 7663). The legislation would remove geographic originating site restrictions on where a patient must be located in order to utilize telehealth services; make the home an eligible originating site; ensure federally qualified health centers and rural health centers can furnish telehealth services; and codify temporary waiver authority for the Secretary of Health & Human Services for future emergency periods and the 90 days after the expiration of a public health emergency period. Duke Health has publicly endorsed this legislative effort.

House Ways and Means Committee Republican leaders have released a discussion draft proposal that would, among other provisions, continue to allow Medicare beneficiaries to access telehealth services from their homes, including audio-only telehealth services, remove certain limits on the provision of telehealth services by rural health clinics, and to permanently allow physical therapists, speech pathologists, occupational therapists to deliver care via telehealth.

Senate Finance Committee ranking member Ron Wyden (D-OR) has also introduced legislation (S. 4230) that would expand access to mental health services and certain evaluation and management services furnished through telehealth under the Medicare program.

Lawmakers in the House and Senate have also introduced the Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act (S. 4421/H.R. 8283). Among other provisions, the TREAT Act would: enable providers to use telehealth to treat patients in any state for the duration of the COVID-19 public health emergency (PHE); allow for 6 month phase-out of the uniform licensing authority at the end of the PHE; and provide HHS with authority to reinstate uniform licensing for future emergencies. Duke Health has endorsed this legislation.

RESOURCES

  • The American Hospital Association has developed a resource document highlighting which of the telehealth flexibilities may be indefinitely extended by CMS and which will require a congressional response to be made permanent.
  • The American Telemedicine Association, which is among the professional organizations and partners the government relations team consults on telehealth issues, has outlined which of the expanded telehealth options it would like to see be made permament beyond the public health emergency.

 Duke Health Government Relations is working in partnership with Duke leadership and the Duke Telehealth Office to ensure that beneficial telehealth policies are strengthened and maintained.

MEDICARE SUPPORT FOR GRADUATE MEDICAL EDUCATION (GME)

Physician shortage continues to rise, as the population ages and grows every day. Medicare currently has a 23-year old cap on support for training new physicians, which does not reflect the needs in addressing the shortage. In addition, teaching hospitals incur additional costs in training future physicians in treating complex patients on the cutting edge of new treatments and care (indirect medical education or IME). 

Bipartisan GME legislation has been introduced in both the House of Representatives (H.R. 1763) and the Senate (S. 348) that would increase federal support for physician training by adding an additional 3,000 Medicare-supported residency positions each year for five years. Unlike the Senate bill, the House bill would distribute one third of the new positions to hospitals that already exceed their Medicare-funded residency cap by at least 10 residents. Under the bill, Duke Health would benefit from the priority order in which the Centers for Medicare and Medicaid Services (CMS) would allot new slots, including to hospitals training over their caps and hospitals affiliated with Veterans Affairs medical centers.

Duke Health Government Relations supports lifting the cap on Medicare GME to help address the shortage and continue support for GME and IME payments to teaching hospitals. 

MEDICAID AND MEDICAID DSH PAYMENTS

Medicaid is the largest health insurance program in the United States, and hospitals provide care for a large number of these patients, despite low reimbursement rates. Medicaid DSH payments help to alleviate the burden for caring for the large number of Medicaid and uninsured patients, but these payments are at risk of being cut by $4 billion in FY 2020 (increasing to $8 billion a year in FY 2021-2025).

The House Energy and Commerce Committee has recognized the importance of Medicaid DSH payments and advanced bipartisan legislation in the summer of 2019 to repeal the scheduled Medicaid DSH cuts for FYs 2020 and 2021 and reduce the burden of the cuts in FY 2022. The spending deal enacted in mid-December 2019 included delayed reductions in the Medicaid DSH program through May 22, 2020.

With passage of the third emergency relief package in March, Medicaid DSH cuts scheduled for FY 2020 were eliminated, and the $8 billion scheduled cuts in Medicaid DSH payments for FY 2021 were reduced to $4 billion in cuts to begin December 1, 2020. The current continuing resolution would delay the DSH cuts through December 11, 2020.

Duke Health Government Relations will push to protect coverage for Medicaid beneficiaries; ask that Congress maintain the commitment to spending on medically necessary care; and ask Congress not take actions that result in less care, reduced payments for safety net providers, or undermine the ability to treat Medicaid and uninsured patients. 

SURPRISE BILLING

Congress
In mid-December 2019, the House Energy and Commerce Committee and Senate Health, Education, Labor and Pensions Committee Chairman Lamar Alexander (R-TN) released the outline of compromise surprise billing deal that aims to protect patients from surprise billing and establish a federal benchmark payment with an option to go to arbitration for disputes over $750. The House Ways and Means Committee also followed up with an outline of its surprise billing proposal with plans to mark up legislative text in 2020.

In February 2020, the House Education and Labor Committee approved its version of surprise billing legislation, the Ban Surprise Billing Act (H.R. 5800). The bill draws upon the outline released by the Senate HELP and House Energy and Commerce Committees, relying on a federal benchmark payment to settle disputes between insurers and providers. For bills over $750, providers and payers could appeal to an independent arbiter. The legislation would also bar air ambulance services from sending surprise bills while allowing disputed air ambulance costs above $25,000 to be appealed to an independent arbiter. The Committee approved the bill by a vote of 32-13, with Ranking Member Virginia Foxx (R-NC-05) voting no and Rep. Greg Murphy (R-NC-03) voting yes. 

Also in February 2020, the House Ways and Means introduced and approved by voice vote its version of surprise billing legislation, which includes a mediation process to settle disputes when insurers and out-of-network providers cannot agree on a payment rate. The bill does not contain language related to air ambulances.

Despite bipartisan support, congressional leaders have yet to coalesce around a single legislative solution to address surprise billing. Duke Health has been working with Duke Life Flight to promote alternative language related to air ambulances in any final compromise bill.

The Administration
Ending surprise medical billing has been a stated priority of the Trump Administration, although it has not yet formally endorsed any of the proposals in Congress.

On September 24, President Trump issued a health care related Executive Order that includes a provision advising Congress to reach a legislative agreement on surprise billing by December 31, 2020, otherwise, Health and Human Services Secretary Alex Azar will be ordered to take measures within his authority to limit surprise billing.

It is unclear whether surprise medical billing will be among the issues taken up in an expected lame duck session of Congress at the end of the year.
 

DRUG PRICING

In 2019, the Senate stalled on how to proceed with drug legislation after the House passed a comprehensive package aimed at lowering prices. In December, the House approved H.R. 3 by a vote of 230-192 to:

  • require the HHS Secretary to negotiate the prices of at least 50 and up to 250 of the most costly drugs to Medicare and the entire U.S. health system that do not have competition from at least one generic or biosimilar on the market.
  • cap the maximum price for any negotiated drug at 120 percent of the average price charged in six industrialized countries that typically pay less than the United States.
  • create significant penalties for drug manufacturers who refuse to participate in the drug pricing negotiation process or fail to reach agreement with HHS.
  • limit price increases for Medicare Part B and Part D drugs to the rate of inflation and create a Medicare Part B and D inflation rebate.
  • mandate an annual $2,000 cap on Medicare beneficiaries’ out-of-pocket prescription drug expenses.
  • require that savings from drug price negotiations be reinvested in the NIH.

While neither drug pricing nor surprise billing were included in the end-of-year appropriations packages, it is possible that one or both issues could be attached to any must-pass health program extension in November, when funding for several health programs expires as a result of the third COVID-19 emergency relief package. The potential savings that major legislation on either issue could produce are key to funding relief from DSH cuts and other extender priorities.

MEDICAID PROGRAM: MEDICAID FISCAL ACCOUNTABILITY REGULATION

Since it was proposed, Duke Health has requested the Centers for Medicare and Medicaid Services (CMS) withdraw the proposed “Medicaid Fiscal Accountability Regulation.”  This proposed rule would restrict how states finance Medicaid programs by, among other provisions, arbitrarily capping supplemental Medicaid payments and placing limitations on intergovernmental transfers. On September 14, CMS announced it was withdrawing the proposed rule.

The regulation would jeopardize over 40 percent of Medicaid reimbursement at Duke Health and other health systems across North Carolina. On March 21, a letter was sent to CMS from 28 Senators stating this proposed rule would have disastrous consequences for the Medicaid program and the millions of individuals it serves and asking that this rule be withdrawn. 

The non-partisan Medicaid and CHIP Payment and Access Commission (MACPAC) has also urged CMS to delay implementing certain provisions, including proposed new limits for supplemental payments and financing arrangements, until CMS has fully assessed the effects of these changes. MACPAC expressed specific concerns that the proposed changes could reduce payments to providers in ways that could jeopardize access to care for Medicaid enrollees. The Association of American Medical Colleges (AAMC) had requested that Congress prevent implementation of the rule through legislative efforts.

WORKING IN PARTNERSHIP TO ADDRESS THE BLACK MATERNAL HEALTH CRISIS

The Duke Department of Obstetrics & Gynecology and the Duke Health Office of Government Relations are dedicated to providing excellent care to all of the communities we serve and committed to addressing maternal health disparities. We look forward to collaborative efforts with U.S. Reps. Alma Adams and Lauren Underwood, and the Black Maternal Health Caucus, to address one of the most urgent crises in the United States today: maternal mortality rates in America. Through actionable proposals to tackle persistent racial inequities in maternal outcomes, and through partnerships that effectively utilize Duke’s nationally recognized expertise and resources, the goal is a enabling stakeholders to address this crisis. For more information, click here.