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Department of Health and Human Services Extends Deadline to Apply for Provider Relief Funds

The Department of Health and Human Services (HHS) recently announced that it would be extending the deadline for health care providers to apply to receive general distribution funding from the HHS Provider Relief Fund.  The deadline to apply for these funds was previously June 3, 2020.

Relevant Background

On March 27, 2020, President Trump signed into law the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).  As part of that Act, Congress allocated $100 billion to the creation of a “CARES Act Provider Relief Fund,” which will be used to support hospitals and other healthcare providers on the front lines of the nation’s coronavirus response.  An additional $75 billion was allocated as part of the Paycheck Protection Program and Health Care Enhancement Act, bringing the total “Provider Relief Fund” up to $175 billion.  This $175 billion will be distributed to health care providers and suppliers to fund healthcare-related expenses or to offset lost revenue attributable to COVID-10.

HHS ultimately elected to allocate these funds through a $50 billion “general allocation,” and multiple smaller “targeted allocations.”

Under its general allocation program, HHS intended to provide health care providers with funds roughly equal to 2% of the provider’s 2018 “net patient revenue,” i.e., the provider’s total revenues from patient care minus provisions for bad debt, contractual write-offs, and certain other adjustments.   This general allocation was made in two tranches, with the first tranche being distributed to all providers in mid-April.  This first tranche was made based on provider’s 2019 Medicare revenues.  As a result, any provider that received payments from the Medicare Fee-for-Service Program in 2019 automatically received an initial relief payment.  However, HHS required providers to submit an application to receive relief funding as part of the second tranche.  The deadline for applying for the second tranche of relief funding was June 3, 2020.

Scope of New Extension

 HHS indicated that the new extension is limited to health care providers that missed the June 3, 2020 deadline to apply for the second tranche of relief funding.  The extension also applies to providers that were ineligible for the first tranche of relief funding due to a recent change of ownership.  The specific situations that HHS indicated would meet the requirements for the extension include:

  • Health care providers who were ineligible for the first tranche of relief funding because: (1) they underwent a change in ownership in calendar year 2019 or 2020 under Medicare Part A and (2) did not have Medicare Fee-for-Service revenues in calendar year 2019;
  • Health care providers who received a payment in the first tranche of funding but: (1) missed the June 3, 2020 deadline to submit revenue information or (2) did not receive funds in the first tranche that total approximately 2% of their net patient revenue; or
  • Health care providers who received a payment in the first tranche of funding, but who ultimately elected to refund that payment (e.g., because they did not believe they met the eligibility requirements), and who are now interested in reapplying.

Health care providers that meet one of the requirements listed above will have until August 28, 2020 to submit an application for additional relief funds.  This deadline aligns with the extended deadline for other eligible Phase 2 providers, such as Medicaid, Medicaid Managed Care, CHIP, and dental providers.

Applications should be submitted through the CARES Provider Relief Fund webpage, which can be found at: https://cares.linkhealth.com/#/.

California’s 50 years of prehospital medicine

From EMS1 on July 14 by AAA Communications Chair Rob Lawrence

The history of our history: 50 years of prehospital medicine: A transatlantic tale of former army doctors, paramedic development, cardiac arrest survival, and Johnny and Roy

Fifty years ago, on July 15, 1970, then California Governor Ronald Reagan signed into law the Wedworth-Townsend Paramedic Act. The law created the conditions for the establishment of the first accredited paramedic training program in the United States.

The story of American paramedicine did not begin in California or even in the U.S., but in Belfast, Northern Ireland. The inspiration for this program came from World War II era British Royal Army Medical Corps (RAMC) Medical Officer, Professor Frank Pantridge, MD.

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CMS Announces Resumption of Program Integrity Functions

On July 7, 2020, CMS updated its Coronavirus Disease 2019 (COVID-19) Provider Burden Relief Frequently Asked Questions (FAQs).  As part of this update, CMS indicated that it would resume several program integrity functions, starting on August 3, 2020.  This includes pre-payment and post-payment medical reviews by its Medicare Administrative Contractors (MACs), the Supplemental Medical Review Contractor (SMRC), and the Recovery Audit Contractors (RACs).  This also includes the resumption of the Prior Authorization Model for scheduled, repetitive non-emergency ambulance transports.  These programs had been suspended by CMS in March in response to the COVID-19 pandemic.

Resumption of Medicare Fee-For-Service Medical Reviews

 CMS suspended most Medicare FFS medical reviews on March 30, 2020.  This included pre-payment medical reviews conducted by its MACs under the Targeted Probe and Educate program, as well as post-payment reviews by its MACs, the SMRC, and the RACs.  CMS indicated that, given the importance of medical review activities to CMS’ program integrity efforts, it expects to discontinue its “enforcement discretion” beginning on August 3, 2020.

CMS indicated that providers selected for review should discuss any COVID-related hardships that might affect the provider’s ability to respond to the audit in a timely fashion with their contractor.

CMS further indicated that its contractors will be required to consider any waivers and flexibilities in place at the time of the dates of service of claims selected for future review.

Resumption of Prior Authorization Model

 Under the Repetitive, Scheduled, Non-Emergent Ambulance Transport Prior Authorization Model, ground ambulance providers in affected states are required to seek and obtain prior authorization for the transportation of repetitive patients beyond the third round-trip in a 30-day period.  The Prior Authorization Model is currently in place in Delaware, Maryland, New Jersey, North Carolina, Pennsylvania, South Carolina, Virginia, West Virginia, and the District of Columbia.

On March 29, 2020, CMS suspended certain claims processing requirements under the Prior Authorization Model.  During this “pause,” claims for repetitive, scheduled, non-emergency transports were not be stopped for pre-payment review to the extent prior authorization had not been requested prior to the fourth round trip in a 30-day period.  However, CMS continued to permit ambulance providers to submit prior authorization requests to their MACs.

CMS indicated that full model operations and pre-payment review would resume for repetitive, scheduled non-emergent ambulance transportation submitted in the model states on or after August 3, 2020.  CMS stated that the MACs will be required to conduct postpayment review on claims that were subject to the model, and which were submitted and paid during the pause.  CMS further indicated that it would work with the affected providers to develop a schedule for postpayment reviews that does not significantly increase the burden on providers.

CMS stated that claims that received a provision affirmation prior authorization review decision, and which were submitted with an affirmed Unique Tracking Number (UTN) will continue to be excluded from most future medical review.

IRS Guidance on Taxation of HHS Provider Relief Funds

On July 7, 2020, the Internal Revenue Service published a series of Frequently Asked Questions that address the taxation of payments to health care providers under the HHS Provider Relief Fund.

As part of the Coronavirus Aid, Relief and Economic Security Act (CARES Act), Congress appropriated $100 billion to reimburse eligible health care providers for health care-related expenses and/or lost revenue attributable to the COVID-19 pandemic.  The Paycheck Protection Program and Health Care Enhancement Act appropriated an additional $75 billion to the Provider Relief Fund.

The first FAQ addressed the issue of taxation for for-profit health care providers.  Specifically, the IRS was asked whether a for-profit health care provider is required to include HHS Provider Relief Fund payments in its calculation of “gross income” under Section 61 of the Internal Revenue Code (Code), or whether such payments were excluded from gross income as “qualified disaster relief payments” under Section 139 of the Code.

The IRS indicated that payment from the Provider Relief Fund do not qualify as qualified disaster relief payments under Section 139 of the Code.  As a result, these payments are includible in the gross income of the entity.  The IRS further indicated that this holds true even for businesses organized as sole proprietorships.

The second FAQ addressed the issue of taxation for tax-exempt organizations.  The IRS indicated that health care providers that are exempt from federal income taxation under Section 501(a) would normally not be subject to tax on payments from the Provider Relief Fund.  Notwithstanding this general rule, the IRS indicated that the payment may be subject to tax under Section 511 of the Code to the extent the payment is used to reimburse the provider for expenses or lost revenue attributable to an unrelated trade or business as defined in Section 513 of the Code.

The IRS FAQ can be viewed in its entirety by clicking here.  Members are advised to discuss the issue of potential taxation of any relief funding they received with their tax professionals.

Legislative hurdles check hazard pay, PSOB benefits

Frustration mounts as small print delays the HEROES Act, and presents a dual standard for provider benefits for the fallen

May 22 at 2:20 PM | EMS1 | By AAA Communications Chair Rob Lawrence

In  my last EMS One-stop column, I commented on the legislative to-do list to ensure that EMS receives the federal support it deserves right now as we staff the front lines and perhaps brace ourselves for COVID-19 round two as the nation craves a return to the normality and liberty enjoyed before the lockdown.

On May 15, 2020, the much talked about HEROES Act narrowly passed from the U.S. House of Representatives by a 208 to 199 vote to the Republican-controlled Senate.  The HEROES Act proposed $3 trillion in tax cuts and spending to address the negative health and financial impacts of the COVID-19 pandemic. This included benefits for the public safety community, extensions to enhanced unemployment benefits, debt collection relief, direct cash payments to households and possibly even hazard pay.

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Massachusetts | Convoy of Champions

A parade of more than 50 ambulances, representing more than 20,000 paramedics, EMTs, and 911 dispatchers, traveled from UMass Medical Center in Worcester, Massachusetts to the warning track inside Fenway Park on Wednesday, May 20. The Boston Red Sox, Mayor Marty Walsh, state officials, and healthcare professionals joined the Massachusetts Ambulance Association, the Professional Fire Fighters of Massachusetts, and municipal ambulance providers in celebrating these front line heroes during National EMS Week.

Once inside the park, the EMS professionals were greeted by video tributes from dignitaries and celebrities and a select number of live speakers following safe social distancing guidelines.

The event takes on even greater significance this year because of the unprecedented response to the COVID-19 crisis from EMS professionals and their colleagues across the state’s medical community.

The Commonwealth’s EMS professionals have been crucial in responding to the current COVID-19 pandemic. Massachusetts has been among the nation’s hardest-hit states, experiencing the third most deaths and fourth-most cases of the novel coronavirus.

During the current public health crisis, EMS professionals have helped manage testing and treatment for homebound patients and provided supplemental support for hospitals and neighborhood health centers, in addition to its duties in responding to daily emergencies.

Watch the Facebook Live Video

Thank you to everyone who participated in yesterday’s #ConvoyofChampions parade in celebration of #EMS! The event was a…

Posted by Massachusetts Ambulance Association on Thursday, May 21, 2020

CMS Modifies the Cost Data Collection System Year 1 Data Collection

CMS has issued a blanket waiver modifying the data collection period for the ground ambulance services that were selected to report in Year 1.  Under the current law, these organizations would have been required to collect data beginning January 1, 2020, and through December 31, 2020.  The waiver allows these organizations to select a new continuous 12-month data collection period that begins between January 1, 2021 and ends December 31, 2021.  This modification means that such organizations will collect and report data during the same time period as the ground organizations that CMS will select for Year 2 of the cost collection program.

From the summary of the waiver, it appears that organizations will have the choice of submitting data in Year 1 or Year 2.  CMS has not moved the timeline for any other data collection year, so there is the potential for a substantial number of organizations to report in Year 2, which would increase the amount of data available.

The AAA has supported the data collection system to make sure that CMS and the Congress have valid and reliable data to support maintaining the geographic add-ons to the Medicare Ambulance Fee Schedule and to support efforts to address the chronic underfunding of the Medicare Ambulance Fee Schedule.

The complete FAQ is below and also available at: https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdf (on page 29).

“CMS is modifying the data collection period and data reporting period, as defined at 42 CFR § 414.626(a), for ground ambulance organizations (as defined at 42 CFR § 414.605) that were selected by CMS under 42 CFR § 414.626(c) to collect data beginning between January 1, 2020 and December 31, 2020 (year 1) for purposes of complying with the data reporting requirements described at 42 CFR § 414.626. Under this modification, these ground ambulance organizations can select a new continuous 12-month data collection period that begins between January 1, 2021 and December 31, 2021, collect data necessary to complete the Medicare Ground Ambulance Data Collection Instrument during their selected data collection period, and submit a completed Medicare Ground Ambulance Data Collection Instrument during the data reporting period that corresponds to their selected data collection period. CMS is modifying this data collection and reporting period to increase flexibilities for ground ambulance organizations that would otherwise be required to collect data in 2020- 2021 so that they can focus on their operations and patient care.”

“As a result of this modification, ground ambulance organizations selected for year 1 data collection and reporting will collect and report data during the same period of time that will apply to ground ambulance organizations selected by CMS under 42 CFR § 414.626(c) to collect data beginning between January 1, 2021 and December 31, 2021 (year 2) for purposes of complying with the data reporting requirements described at 42 CFR § 414.626.”

Send AAA Your COVID-19 Photos!

We are living through challenging and historic times. Please help the American Ambulance Association share YOUR story, the true impact of EMS on the front lines of the global COVID-19 pandemic.

We need your service’s photos and videos! Please send us pictures and videos of your medics in action. (Of course no HIPAA violations, please.) Pictures in the field, in PPE, caring for patients, interacting with the community, taking off a mask after a long shift, etc are all essential for communicating visually with the legislators and regulators who impact our ability to operate effectively. A mix of closeups and broader shots would be great, and candid is typically (although not always) better than posed—use your best judgment!

There are a few ways to share:

  • Tag the American Ambulance Association on Facebook (@americanambulanceassoc) or Twitter ( @amerambassoc)  when you post your own photos that you don’t mind us borrowing for media, PR, etc.
  • Text or email photos to Amanda Riordan at ariordan@ambulance.org or 703-615-4492
  • Share your photos with your local news media!

Need a photo or video release waiver for patients and medics? Borrow ours!

Thank you for taking time away to help with this project when your services are so very busy. We are here to support you as you care for your communities! #SupportEMS

AAA Sends Letter to CMS on COVID-19 Response

The AAA has sent a letter to CMS on how the agency can most help ground ambulance service providers and suppliers be better prepared to respond to potential cases of COVID-19. The AAA has requested priority access to personal protection equipment for EMS personnel and COVID-19 test kits and results, as well as easing Medicare and Medicaid policies on alternative destinations and treatment in place. The letter was also sent to the National Highway Traffic Safety Administration (NHTSA) and the Assistant Secretary for Preparedness and Response (ASPR). Read the letter HERE.

Read the Letter

President signs law providing funds to combat Corona Virus

President Donald Trump today signed H.R. H.R. 6074 into law, approving $8.3 billion in supplemental appropriations to fund programs in response to the COVID-19 illness. The bill would bolster vaccine development, research, equipment stockpiles, and state and local health budgets as government officials and health workers fight to contain the outbreak, which has claimed 11 lives in the U.S. and sickened more than 160 people across more than a dozen states.

The AAA advocated to negotiators of the bill that first responders needed to be included in the funding package and that all communities be eligible for the funding. Due in part to our outreach, the emergency funding provides a transfer of no less than $10 million to the National Institute of Environmental Health Sciences for worker-based training aimed at preventing exposure of the virus to emergency first responders, and others at risk of exposure (i.e., hospital employees).

The supplemental also appropriates $1 billion for state and local preparedness, which will allow state and local governments to carry out preparedness and response activities, with each State receiving a minimum of $4 million. Of the $1 billion, $300 million is allocated for global disease detection and emergency response, and FY 2019 Public Health Emergency Preparedness grantees.

Member Advisory: CMMI Releases Initial List of ET3 Participants

The Centers for Medicare and Medicaid Services (CMMI) has released its initial list of applicants selected to participate in the ET3 pilot program. CMMI notes that the list is not final as it still needs to execute participation agreements with the applicants. CMMI will issue a final list once it completes the process.

Applicants from 36 states and the District of Columbia were selected to participate in the program. Approximately 200 applicants were approved with instances in which the same ambulance service organization submitted applications for multiple counties as well as more than one organization submitting an application for the same county. CMMI has sent notifications to each of the applicants letting them know to expect a follow up email with the partnership agreement, program guidance and additional details.

The ET3 program is a five-year voluntary pilot program designed to test the potential benefit to the Medicare program and patients of ambulance service providers and suppliers furnishing treatment in place as well as transport to alternative destinations. For more information about the ET3 program, please go the ET3 website.

House Committees Consider Balance Billing Proposals

This past Tuesday and Wednesday, respectively, the House Ways & Means and Education & Labor Committees marked up their proposals on balance or “surprise” billing. As we reported on Monday of this week, the Ways & Means Committee proposal, the Consumer Protections Against Surprise Medical Bills Act (H.R. 5826), did not include a provision on ground ambulance services. The House Education & Labor proposal, The Ban Surprise Billing Act (H.R. 5800), however, included a provision to create a federal advisory committee to recommend restrictions on the ability of ground ambulance service providers and suppliers to balance bill.

The Ways & Means Committee reported out H.R 5826 favorably by voice vote. While the Education & Labor Committee also reported out H.R. 5800 favorably, the vote was 30 to 13 as a block of its Committee members preferred the approach of the Ways & Means proposal on how to address balance billing for other providers. It is now up to House leadership to determine next steps on how the chamber will approach a final package on balance billing.

While H.R. 5800 as reported out by the Education & Labor Committee still includes the provision on ground ambulance services, Chairman Scott (D-VA) and Ranking Member Foxx (R-NC) prior to mark up had removed the most problematic language in the bill. As introduced, H.R. 5800 would have given the Department of Health and Human Services the authority to issue regulations to restrict balance billing based on the findings of the advisory committee. This would have eliminated federal lawmakers from being able to evaluate the recommendations prior to the changes being implemented. The language was removed in the chairman’s mark of the bill, and thus the Congress would now have an opportunity to debate and craft legislation on the recommendations.

The AAA along with the International Association of Fire Chiefs (IAFC), International Association of Firefighters (IAFF) and National Association of EMTs (NAEMT) had advocated against the ground ambulance provision. We thank Chairman Scott, Ranking Member Foxx and members of the Committee for listening to our concerns and removing the regulation authority language.

Only one of the four pieces of legislation on balance billing reported out by congressional committees includes a provision on ground ambulance services. We will continue to advocate to preserve the ability of local governments to determine the rates and standards for their EMS systems and against the inclusion of a ground ambulance provision in a final package on balance billing.

We will keep you apprised of new developments on the issue.

2018 National and State-Specific Medicare Data

The American Ambulance Association is pleased to announce the publication of its 2018 Medicare Payment Data Report. This report is based on the “Early Edition” of the 2018 Part B National Summary Data File (previously known as the Bess Report). The report consists of an overview of total Medicare spending nationwide, and then a separate breakdown of Medicare spending in each of the 50 states, the District of Columbia, and the various other U.S. Territories.

For each jurisdiction, the report contains two charts: the first reflects data for all ambulance services, with the second limited to dialysis transports. Each chart is further broken down by HCPCS code. The charts provide information on the total number of allows services and the total Medicare payments for CYs 2017 and 2018. Percentage changes will allow members to view payment trends over the past year.

2018 National & State-Specific Medicare Data

Questions? Contact Brian Werfel at bwerfel@aol.com.

 

CMS Releases List of Ambulance Organizations Selected for Data Collection

CMS Releases List of Ambulance Organizations Selected for Data Collection

The Centers for Medicare & Medicaid Services (CMS) has released the list of ambulance service providers and suppliers selected to provide data in the first year of data collection. CMS has published the data by National Provider Identifier (NPI) number and the AAA has also sorted the data by state in alphabetical order.

On Friday, CMS had made public the final rule on the Establishment of an Ambulance Data Collection System. The AAA will be issuing a Member Advisory tomorrow on the details of the final rule and changes from the proposed rule.

To access the list by NPI number click here and to access the list by state click here.

Provider List by NPI

Provider List by State

CMS Announces 2020 Ambulance Inflation Factor

On October 4, 2019, CMS issued Transmittal 4407 (Change Request 11497), which announced the Medicare Ambulance Inflation Factor (AIF) for calendar year 2020.

The AIF is calculated by measuring the increase in the consumer price index for all urban consumers (CPI-U) for the 12-month period ending with June of the previous year. Starting in calendar year 2011, the change in the CPI-U is now reduced by a so-called “productivity adjustment”, which is equal to the 10-year moving average of changes in the economy-wide private nonfarm business multi-factor productivity index (MFP). The MFP reduction may result in a negative AIF for any calendar year. The resulting AIF is then added to the conversion factor used to calculate Medicare payments under the Ambulance Fee Schedule.

For the 12-month period ending in June 2018, the federal Bureau of Labor Statistics (BLS) has calculated that the CPI-U has increased 1.6%. CMS further indicated that the CY 2020 MFP will be 0.7%. Accordingly, CMS indicated that the Ambulance Inflation Factor for calendar year 2019 will be 0.9%.

CMS Announces Comment Period for National Expansion of Prior Authorization Process

On October 29, 2019, the Centers for Medicare and Medicaid Services (CMS) posted a notice in the Federal Register announcing an opportunity for the public to provide comments on the proposed national expansion of the prior authorization process for repetitive, scheduled non-emergent ground ambulance transportation.  CMS refers to this process as its “RSNAT Prior Authorization Model.”  The CMS Notice can be viewed in its entirety at: https://www.govinfo.gov/content/pkg/FR-2019-10-29/pdf/2019-23584.pdf.

Under the Paperwork Reduction Act of 1995, federal agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, and to allow 60 days for the public to comment on the proposed action.  Interested parties are encouraged to provide comments regarding the agency’s burden estimates and other aspects of the proposed collection of information, including the necessity and utility of the proposed information for the proper performance of the agency’s functions, and ways in which the collection of such information can be enhanced.

In this instance, CMS is indicating that it is pursuing approval to potentially expand the existing RSNAT Prior Authorization Model nationwide.  Currently, the RSNAT Prior Authorization Model is in place in 8 states (DE, MD, NJ, NC, PA, SC, VA, and WV) and the District of Columbia.  National expansion is contingent upon CMS’ determination that certain expansion criteria have been met.  CMS is indicating that if the decision is made to expand the program, such expansion may occur in multiple phases.  CMS intends to use the information collected pursuant to this notice to determine the proper payment for repetitive scheduled non-emergent ambulance transportation.

In plain English, CMS is soliciting comments from stakeholders as to the efficacy of the current process, including whether the existing paperwork requirements are sufficient to ensure that approved patients meet the medical necessity requirements for an ambulance.  CMS is also seeking suggestions for how to best expand the program nationally, e.g., whether it makes sense to expand the program in phases, etc.

The AAA Medicare Regulatory Committee has been monitoring the current model for several years.  As a result, the AAA is in a good position to provide constructive feedback to CMS regarding the potential national expansion of the RSNAT Prior Authorization Model.  These suggestions will be included in the AAA’s comment letter.  The AAA also encourages members to offer their own comments.  The AAA anticipates providing members with a sample comment letter in early December that members can use to submit their own comments.

To be considered, comments must be submitted no later than 5 p.m. on December 30, 2019.  Comments may be submitted electronically by going to: http://www.regulations.gov.  Commenters would then need to click the link for “Comment or Submission,” and follow the instructions from there.  Comments may also be submitted by regular mail to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier: CMS-10708, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.

HHS OIG Issues Proposed AKS Safe Harbor Rule

On Thursday, October 17, 2019, the HHS Office of the Inspector General (OIG) issued a proposed rule titled “Medicare and State Health Care Programs: Fraud and Abuse; Revisions to Safe Harbors Under the Anti-Kickback Statute, and Civil Monetary Penalties Regarding Beneficiary Inducements.”  The proposed rule would amend the existing safe harbors to the Federal Anti-Kickback Statute (AKS) and the civil monetary penalty rules (CMPs).  These changes are part of HHS’ Regulatory Sprint to Coordinated Care.  The stated purpose of these changes is to reduce the regulatory barriers and accelerate the transformation of the healthcare system away from the traditional fee-for-service payment model, and towards a value-based system that rewards healthcare providers for better outcomes.  The proposed rule can be viewed in its entirety at: https://www.govinfo.gov/content/pkg/FR-2019-10-17/pdf/2019-22027.pdf.

The proposed rule makes nearly a dozen major changes to the safe harbors under the AKS and the rules related to CMPs.  Among these are revisions to the recently created safe harbor for local transportation.  The proposed change to the safe harbor for free or discounted local transportation is discussed in greater detail below.

The OIG is soliciting comments on a wide range of topics raised in the proposed rule. The AAA is not taking any formal position with respect to the proposed changes or the requests for additional information set forth in this proposed rule.  However, we encourage any member that wishes to comment to do so. 

To be considered, comments must be submitted no later than 5 p.m. on December 31, 2019.  Comments may be submitted electronically by going to: http://www.regulations.gov. Commenters would then need to click the link for “Submit a comment” and follow the instructions from there.  Comments may also be submitted by courier or by regular, express, or overnight mail to the following address: Office of Inspector General, Department of Health and Human Services, Attention: OIG-0936-AA10-P, Room 5521, Cohen Building, 330 Independence Avenue SW, Washington, DC 20201.

Revisions to Safe Harbor for Free or Local Transportation

In 2014, the OIG created a new safe harbor for free or discounted local transportation provided to Federal health care program beneficiaries. This safe harbor applied to non-ambulance transportation (e.g., wheelchair van, bus and shuttle services, taxis, etc.) provided under the following conditions:

  1. The free or discounted transportation was provided by an “Eligible Entity.” For these purposes, an “Eligible Entity” is any individual or entity, other than individuals or entities (or family members or others acting on their behalf) that primarily supply health care items;
  2. The free or discounted transportation was provided pursuant to an existing policy of the Eligible Entity, and which is applied in a uniform and consistent manner;
  3. The transportation services are not air, luxury, or ambulance transportation;
  4. The Eligible Entity does not publicly market or advertise the free or discounted local transportation services, and no cross-marketing of other health care services occurs during the course of transportation, or at any time by the drivers providing such transportation. In addition, the drivers and anyone arranging the transportation cannot be paid on a per-beneficiary-transported basis;
  5. The transportation services are limited only to “established patients” of the Eligible Entity; and
  6. The transportation is limited to 25 miles in urban areas, or 50 miles in rural areas.

 The safe harbor also permitted the use of “shuttle services” (i.e., a vehicle that runs on a set route, on a set schedule) if the following conditions are met:

  1. The shuttle service is not air, luxury, or ambulance-level transportation;
  2. The shuttle service is not marketed or advertised, and no cross-marketing occurs during the transportation, or at any time by the driver providing such transportation. In addition, the driver and anyone else arranging the transportation cannot be paid on a per-beneficiary-transported basis;
  3. The shuttle services has no stop that is more than 25 miles from any stop on the route where health care items or services are provided, except that this mileage restriction is expanded to 50 miles in rural areas.

In either situation, the safe harbor also requires the Eligible Entity to bear all costs of furnishing such transportation, i.e., they cannot shift that cost onto any Federal health care program, any other payer, or the individual.

In the current proposed rule, the OIG indicated that it received numerous comments from stakeholders that suggested that the 50-mile limit for residents of rural areas was insufficient, as many rural residents might need to routinely travel more than 50 miles to obtain certain medical services.  As a result, the OIG is proposing to expand this limit to 75 miles.

The OIG is also soliciting comments on whether the proposed 75-mile is sufficient, or whether an even larger expansion is warranted.  To the extent you intend to submit comments arguing for a greater mileage limit, the OIG is asking that you submit data or other evidence to support a more appropriate mileage limitation for the safe harbor.  The OIG is also specifically requesting information on how an Eligible Entity would provide transportation over distances in excess of 50 miles (e.g., shuttle services, bus or taxi fare, ride-sharing programs, mileage reimbursement programs, etc.).

Expansion of Safe Harbor for Transportation of Patients Being Discharged After an Inpatient Stay

The OIG is also proposing to eliminate any mileage restriction on transportation of patients back to their residence after being discharged from a facility where that patient had been admitted as an inpatient, regardless of whether the patient resides in an urban or rural area.  The OIG is also proposing to eliminate the mileage restrictions on discharges to another residence of the patient’s choice (such as a friend or relative who will care for the patient post-discharge).

The OIG further indicated that it is considering protecting transportation to other locations of the patient’s choice, including another health care facility.  The OIG is soliciting comments on the potential fraud and abuse risks associated with permitting free or discounted transportation to other health care facilities, and whether transportation should be protected (and, if so, under what circumstances) when the patient has not previously been admitted to an inpatient facility (e.g., where the patient had been seen as an outpatient in a hospital emergency department).  Finally, the OIG is soliciting comments on whether the transportation of patients being discharged beyond the applicable safe harbor mileage limitations should be limited to patients with demonstrated financial or transportation needs, and, if so, what standards should apply to such demonstration of need.

Possible Expansion to Include Transportation to Non-Medical Services

In the 2014 final rule creating the new safe harbor for local transportation, the OIG declined to extend the safe harbor protections to transportation for purposes other than obtaining medically necessary services or items (although they permitted a qualifying shuttle service to make stops at locations that do not relate to a particular patient’s medical needs).  The OIG has since received numerous comments suggesting that the safe harbor should protect transportation for non-medical purposes that may nevertheless improve or maintain health, e.g., transportation to food banks, social services, exercise facilities, support groups, etc.  The OIG indicated that it considering a further expansion of the safe harbor to include such non-medical needs, and is therefore seeking comments on how the safe harbor could be expanded to such needs without creating an unacceptable risk of fraud and abuse. 

 Clarification of Policy Regarding the Use of Ride-Sharing Services

 Finally, the OIG is clarifying its interpretation of the applicability of the existing safe harbor to the use of ride-sharing services.  In the preamble to the 2014 final rule, the OIG discussed the possibility that patient transportation might be provided via taxi.  In the proposed rule, the OIG indicates that, while it did not explicitly reference ride-sharing services, it views these services are being similar to taxi services for the purposes of the safe harbor.  Specifically, the OIG noted that nothing in the language of the safe harbor expressly precludes their use (or the use of self-driving cars or other similar technology that may become available at some point in the future).  The OIG is inviting anyone that disagrees with this approach to explain the possible basis for exclusion of ride-sharing services.

The OIG did reiterate that the prohibition of the marketing of such free or discounted transportation would still apply.  The OIG indicated that it would be permissible for ride-sharing services to advertise that they provide transportation to medical appointments, and to recommend that patients contact their medical providers to determine if they qualified for free or discounted transportation.  By contrast, the OIG indicated that it would not be appropriate for the ride-sharing service to advertise that it provided free or discounted transportation to particular health care providers.

Other Changes in the Proposed Rule

 In addition to the revisions to the existing safe harbor for free or discounted transportation, the OIG is proposing:

  1. The creation of three new safe harbors for participants in value-based arrangements that promote better coordinated and managed patient care. These include: (i) a safe harbor for Care Coordination Arrangements to Improve Quality, Health Outcomes, and Efficiency, (ii) Value-Based Arrangements with Substantial Downside Financial Risk, and (iii) Value-Based Arrangements with Full Financial Risk.
  2. The creation of a new safe harbor for certain tools and support furnished to patients to improve quality, health outcomes, and efficiency.
  3. The creation of a new safe harbor for remuneration provided in connection with CMS-sponsored models. The purpose of this new safe harbor is to eliminate the need for the OIG and CMS to issue model-specific waivers.
  4. The creation of a new safe harbor for donations of cybersecurity technology and services.
  5. Proposed modifications to the existing safe harbor for electronic health records items and services.
  6. Proposed modifications to the existing safe harbor for personal services and management contractors, in order to add flexibility with respect to outcomes-based payments and part-time arrangements.
  7. Proposed modifications to the existing safe harbor for warranties, to better address bundled warranties covering multiple health care items or services.
  8. The codification of the existing statutory exception for ACO Beneficiary Incentive Programs under the Medicare Shared Savings Program.
  9. A proposed amendment to the definition of “remuneration” under the CMP rules for certain telehealth technologies furnished to in-home dialysis patients.

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