The following topics will be covered in this alert:
- Blanket waivers issued by CMS under section 1135
- Seeking case-by-case section 1135 waivers
- HIPAA waivers issued by HHS
- Relaxation of reimbursement requirements for telehealth services
On March 13, 2020, the Centers for Medicare & Medicaid Services (CMS) took quick action to issue blanket waivers under section 1135 of the Social Security Act (SSA) following President Trump’s declaration of a national emergency related to COVID-19, the disease caused by novel coronavirus (2019-nCoV). As CMS Administrator Seema Verma recognized, “[i]t is vital that federal requirements designed for periods of relative calm do not hinder measures needed in an emergency.”1
As discussed in our previous client alert, when the secretary of Health and Human Services (HHS) declares a public health emergency (PHE), the secretary is authorized to waive or modify certain Medicare, Medicaid, Children’s Health Insurance Program (CHIP), and Health Insurance Portability and Accountability Act (HIPAA) requirements to ensure that sufficient health care items and services are available to meet the needs of individuals enrolled in federal health care programs and to provide flexibility to and reduce administrative burdens for providers of such items and services (1135 Waivers). CMS did just that, announcing 11 categories of blanket waivers covering a variety of providers, including skilled nursing facilities; excluded and distinct part acute care hospital units; suppliers of durable medical equipment prosthetics, orthotics, and supplies (DMEPOS); long-term acute care hospitals; home health agencies; and administrative burdens, such as provider enrollment and Medicare appeals. These waivers are similar to other waivers HHS has issued for other PHEs, such as hurricanes and other natural disasters.
We discuss below each of these blanket waivers, as well as the process for 1135 Waivers on a case-by-case basis for modifications requested outside the announced blanket waivers; HHS’s related waiver of certain sanctions and penalties against a covered hospital under HIPAA; and CMS’s waiver of certain telehealth reimbursement requirements. We note that these waivers do not apply to conditions of payment, which cannot be waived.
A. Waivers applicable to skilled nursing facilities
CMS issued 1135 Waivers and waivers under section 1812(f) of the SSA to alleviate certain administrative reimbursement rules otherwise applicable to skilled nursing facilities (SNFs) in an effort to ensure access to care for those beneficiaries affected or dislocated by the COVID-19 PHE. These include waivers of the “3-Day Rule,” removing requirements that affect a beneficiary’s “benefit period” for Medicare Part A benefits, and alleviating certain timing requirements for completing functional assessments, as discussed below.
Generally, Medicare beneficiaries must meet the so-called “3-Day Rule” to qualify for SNF services. The 3-Day Rule requires the beneficiary to have a medically necessary, 3-day consecutive inpatient hospital stay prior to admission to an SNF, with that three-day period not including the date of discharge or any preadmission time spent in the emergency room or any outpatient observation status.2 Such services are considered an “extension of care” needed after hospital discharge or within 30 days of their hospital stay.3
Additionally, there are certain limitations on Medicare beneficiaries’ Part A benefits that can impact coverage of an extended SNF stay. Most notably, for each “benefit period,” Medicare Part A covers up to 20 days of care in full.4 After the 20 days are exhausted, Part A will cover part of the costs of services up to an additional 80 days; however, the beneficiary is responsible for paying coinsurance for each additional day.5 After the additional 80 partially covered days, or a total of 100 days, a beneficiary is said to have “exhausted” his or her Part A benefits for that benefit period, and the beneficiary is responsible for all costs of care, except for certain Part B services, thereafter.6 A “benefit period,” also termed a “spell of illness,” begins the day the beneficiary is admitted to a hospital or an SNF as an inpatient and ends after they have not been an inpatient of a hospital or SNF for 60 consecutive days.7
Section 1812(f) of the SSA provides Medicare payment for SNF care that does not follow an inpatient hospital stay if the secretary of HHS determines that the inclusion of such services will not result in any increase in total payments made or alter the acute care nature of Medicare Part A benefits.8 In connection with the COVID-19 outbreak, CMS issued a blanket national waiver under section 1812(f) (1812(f) Waiver) that waives the 3-Day Rule for people who: (1) are evacuated from a nursing home in the emergency area; (2) are discharged from a hospital (in the emergency or receiving locations) in order to provide care to more seriously ill patients; or (3) need SNF care as a result of the emergency, regardless of whether the individual was in a hospital or nursing home prior to the emergency.9 Importantly, this waiver read broadly may allow for the admission to an SNF of a qualifying individual directly from the community (for example, their homes), and may apply to all SNF patients in all regions of the United States. Based on informal guidance from CMS, we understand that CMS intends to take a broad interpretation of the applicability of its 3-Day Rule waiver. However, in the absence of written clarification from CMS on the extent to which this waiver applies to SNFs not impacted directly by COVID-19, certain admissions to those SNFs may be at risk for purposes of reimbursement. We therefore suggest that SNFs contact their Medicare Administrative Contractor (MAC) or CMS regional office for further guidance regarding the application of this waiver to their patients.
The 1812(f) Waiver also waives the Medicare Part A “benefit period” restrictions described above, which HHS views as potentially impacting beneficiaries who are dislocated as a result of the emergency (whether by delayed discharges, transition to other care settings, or otherwise). For the duration of the waiver, additional SNF care for qualifying beneficiaries will be covered by Medicare Part A without requiring a break in the spell of illness. Notably, this waiver only applies to those beneficiaries who have been delayed or prevented from commencing or completing the process of ending their current benefit period and renewing their SNF benefits due to the COVID-19 outbreak.10
CMS additionally issued a 1135 Waiver for the completion of functional assessments. Generally, SNFs are required to conduct initial and periodic comprehensive, accurate, and standardized assessments of residents’ functional capacities.11 These assessments are required to consider specific elements and must be completed at specific timeframes (for example, 14 calendar days after admission) and transmitted by way of the Minimum Data Set.12 The blanket 1135 Waivers remove these requirements with respect to the time frames.13 Thus, while SNFs must continue to complete and transmit these assessments to CMS, they do not have to do so within the time frames set forth in 42 C.F.R. section 483.20.
B. Waivers applicable to long-term care hospitals
Long-Term Care Hospitals (LTCHs) are hospitals that are primarily engaged in providing inpatient services to beneficiaries with medically complex conditions that require a long hospital stay and specialized programs of care.14 LTCHs are paid under the LTCH Prospective Payment System (LTCH PPS), which uses the same Medicare Severity Diagnosis-Related Groups (MS-DRGs) as the Inpatient Prospective Payment System (IPPS), under which short-term acute care hospitals are paid; however, such MS-DRGs are weighted to reflect the different resources used and required by LTCHs.15
Generally, in order for a hospital to be classified as an LTCH and to receive payment as an LTCH, it must maintain an average length of stay (ALOS) of greater than 25 days.16 The ALOS for an LTCH is calculated by “dividing the total number of covered and noncovered days of stay of Medicare inpatients (less leave or pass days) by the number of total Medicare discharges for the hospital’s most recent complete cost reporting period.”17
The blanket 1135 Waivers issued by CMS provide for a relaxation of the ALOS requirement and allow an LTCH to exclude patient stays from the ALOS calculation where the LTCH admits or discharges patients in order to meet the demands of the COVID-19 outbreak.18 Practically speaking, this waiver will protect an LTCH’s reimbursement status to the extent that, in order to meet community demand for treatment related to COVID-19, the LTCH has to make the difficult decision of discharging or admitting patients who will not meet the expectation of 25 days of treatment by the LTCH.
C. Waivers applicable to home health agencies
Home health agencies (HHAs) are public or private organizations that are primarily engaged in providing skilled nursing services and other therapeutic services.19 HHAs are required to be certified to participate in Medicare, which requires compliance with certain conditions of participation (CoPs) in order to serve Medicare beneficiaries and receive payment.20 One of these CoPs requires HHAs to collect and transmit certain performance data for all adult patients whose care is reimbursed by Medicare or Medicaid.21 The data is used to calculate quality reports and to guide quality and improvement efforts.22 The data is collected via the Outcome and Assessment Information Set (OASIS), which includes standardized terms.23 HHAs are required to electronically report all OASIS data within 30 days of completing the assessment of the beneficiary.24 The blanket 1135 Waivers issued by CMS waive the time frames related to OASIS transmission.25 Thus, while HHAs must continue to collect and report this quality data, they do not have to do so within the time frames prescribed by regulation.
Additionally, HHAs are paid under the Prospective Payment System for Home Health Agencies (HH PPS).26 Typically, there are two payments for an HH PPS unit of payment: the first is paid pursuant to a request for anticipated payment (RAP), and the second is paid upon the submission of the final claim.27 Generally, HHAs are given the greater of 120 days after the start of the episode or 60 days after the paid day of the RAP to submit the final claim.28 If the final claim is not submitted within that timeframe, the MAC auto-cancels the RAP and the full recoupment of the RAP payment is reflected on the HHA’s next remittance advice, requiring the provider to resubmit the RAP before submitting the final claim for payment.29 The blanket 1135 Waivers announced by CMS will permit MACs to extend the auto-cancellation date of RAPs.30
D. Waivers applicable to excluded distinct part units and patients of those units
Medicare statute and regulations provide for the classification of special types of Medicare-certified hospitals (or units of hospitals) that are excluded from payment under IPPS.31 Failure to meet any of the criteria specified in the Medicare regulations reverts the special classification of a hospital or unit to an acute care inpatient hospital or unit that is paid under the IPPS.
For an acute care hospital’s distinct part psychiatric unit to qualify for exemption from IPPS, a distinct part unit must be primarily engaged in providing, by or under the supervision of a psychiatrist, psychiatric services for the diagnosis and treatment of persons with mental illness as well as meet the conditions of participation for hospitals and the special conditions of participation for psychiatric hospitals.32 A distinct part psychiatric unit must meet the requirements established for distinct part units in hospitals including separately identifiable admission and discharge records and physically separate beds, and must also meet additional requirements established by regulation.33
An inpatient rehabilitation facility or unit (IRF) likewise must meet certain requirements to be excluded from IPPS and paid as an IRF. These conditions of classification require that at least 75 percent of the IRF’s inpatient population must require intensive rehabilitation services for one of 10 enumerated conditions,34 and a distinct IRF unit must have beds that are physically separate from the hospital’s other beds, separately identified admission and discharge records from those of the hospital, and policies that specify that necessary clinical information is sent to the unit upon transfer of a hospital’s patient to the unit, and it must meet additional conditions of payment.35
The blanket 1135 Waivers permit acute care hospitals to place acute care inpatients in their excluded distinct part units without causing a reversion of those units to a general acute care hospital unit for reimbursement classification purposes. Before placing patients in its excluded unit(s), the hospital must assess whether placement is appropriate for the care of acute inpatients, and the decision to place an acute care patient in such a unit must be documented in the patient’s medical record and with a note that the reason for the placement is due to capacity issues related to the COVID-19 emergency. The hospital should continue to bill for the acute inpatient’s services under the IPPS (rather than under the excluded unit’s reimbursement system).
CMS similarly will permit hospitals to relocate inpatients from an excluded distinct part psychiatric or IRF unit to an acute care unit. Before making the relocation, the hospital must assess whether relocation of the excluded unit patient to the acute care bed unit location and the staff and environment are appropriate for the patient. With respect to a psychiatric patient, this includes an assessment that the transfer will keep those around them in the acute care unit safe, and with respect to a rehabilitation patient, the assessment should include whether the patient can continue to receive the necessary intensive therapy services they require. Any relocation must be documented in the patient’s medical record and with a reference to the reason for relocation being related to the COVID-19 emergency. The hospital should continue to bill for services provided to the excluded unit patient under the applicable excluded unit payment system. Note that this waiver also applies to providers attempting to obtain IRF classification, but who have yet to be classified as such.
The blanket 1135 Waivers further allow IRFs to exclude patients from the unit’s inpatient population for purposes of calculating the applicable thresholds associated with the requirements to receive payment as an IRF (commonly referred to as the “60 percent rule”). The IRF must document in the patient’s medical record that the patient’s admission is due solely to the COVID-19 emergency to substantiate the basis for excluding the patient from the 60 percent rule calculation. Note that this waiver does not apply to freestanding IRFs.
E. Waivers applicable to critical access hospitals
To qualify for Medicare certification and to continue participation in Medicare, a critical access hospital (CAH) must meet the requirements set forth in the CAH CoPs.36 Medicare also imposes certain conditions of payment for a CAH to receive Medicare Part A reimbursement.37 Of note, CAHs must meet two location-related requirements, cannot have more than 25 beds that are used for acute care or “swing-bed” patients, must offer 24-hour emergency services, and must achieve an annual average length of stay for patients that does not exceed 96 hours.38
The blanket 1135 Waivers are removing the 25-bed acute care/swing-bed limit for CAHs, which will allow for the admission of potentially more than 25 patients into these swing beds. CMS is also waiving the 96-hour length of stay limit for CAHs, which will allow CAHs to avoid having to transfer patients to another care setting after 96 hours.
F. Waivers available for the provision of durable medical equipment
To be eligible for payment for the purchase of covered durable medical equipment (DME) under the SSA, certain clinical conditions for coverage must be established, including, but not limited to, a face-to-face examination of the individual by a physician, a physician assistant, a nurse practitioner, or a clinical nurse specialist.39 The face-to-face encounter must be documented through a physician order confirming that it occurred during the preceding six-month period.40 Finally, certificates of medical necessity must be completed substantiating the need for the DME.41
In light of the COVID-19 pandemic, CMS has exercised its authority under section 1135 of the SSA to waive these requirements where DME is lost, destroyed, irreparably damaged, or otherwise rendered unusable. Suppliers must continue to include a narrative in their records explaining the reason DME must be replaced, and should continue to maintain documentation specifying the circumstances surrounding the loss, destruction, or irreparable damage.
G. Temporary changes to provider location and enrollment requirements
In order to receive payment for covered Medicare items or services from Medicare or a Medicare beneficiary, a provider or supplier must be enrolled in the Medicare program.42With its blanket 1135 Waivers, CMS has taken steps to alleviate the burden of the enrollment process on providers and suppliers. First, CMS has waived the application fee applicable to prospective institutional providers that are submitting an initial application or those providers that are currently enrolled but seeking to establish a new practice location.43 Second, CMS has waived its right to conduct on-site review of a provider or supplier as part of the pre-verification inspection process.44 Third, CMS has waived the screening requirements applicable to providers and suppliers for new practice locations, as well as for revalidation requests.45
In addition, CMS has postponed all revalidation actions, is allowing licensed providers to render services outside of their state of enrollment and bill for these services, and is expediting any pending or new applications from providers. Finally, in an effort to address questions related to the COVID-19 pandemic, CMS has established a toll-free hotline for noncertified Part B suppliers, physicians, and non-physician practitioners to enroll and receive temporary Medicare billing privileges.
Finally, CMS has temporarily waived requirements that out-of-state providers be licensed in the state where they are providing services if they are licensed in another state, making it easier for providers to practice across state lines without violating Medicare or Medicaid billing rules. We note, however, that state licensure requirements would continue to apply in the absence of a specific waiver or exception under state law.
H. Extensions and timeline waivers for Medicare appeals in Fee-for-Service Plans (Parts A and B), Medicare Advantage Plans (Part C), and Prescription Drug Plans (Part D)
Medicare beneficiaries, providers, and suppliers have the right to appeal a Medicare coverage and payment decision once an initial determination is made under an original Medicare Plan (Part A and Part B – Fee-for-Service), a Medicare Advantage Plan (Part C), and a Medicare Prescription Drug Plan (Part D).46 Under both the standard and expedited processes, there is a five-level appeal process that proceeds as follows after an initial determination is made: (1) MAC redetermination (120 days to file); (2) Qualified Independent Contractor Reconsideration (180 days to file); (3) Office of Medicare Hearings and Appeals, ALJ hearing (60 days to file); (4) Medicare Appeals Council (60 days to file); and (5) federal district court, amount in controversy (60 days to file).47
In response to the COVID-19 pandemic, CMS has offered Medicare beneficiaries the ability to request an extension of time to file an appeal and has waived timeliness for requests for additional information to adjudicate the appeal. CMS has also made the following accommodations to those seeking to file appeals: (1) processing the appeal with incomplete appointment of representation forms while communicating only to the beneficiary; (2) processing request for appeal that do not meet the required elements using available information; and (3) utilizing all flexibilities available in the appeal process as if good cause requirements are satisfied.
I. Case-by-case 1135 Waivers available to relax Medicaid and CHIP requirements
In addition to the blanket waivers issued by CMS under section 1135, states also are eligible to apply for certain waivers of obligations under Medicaid and the Children’s Health Insurance Program (CHIP) that would be unique to the needs of the particular state. For example, states could seek the following flexibilities by requesting a waiver for:
- permission for providers located outside of the state to provide care to another state’s Medicaid enrollees impacted by the coronavirus outbreak;
- a temporary suspension of certain provider enrollment and revalidation requirements;
- a temporary suspension of certain preadmission and annual screening requirements for nursing home residents; and
- a temporary waiver of the requirement that physicians and other health care professionals be licensed in the state in which they are providing services, so long as those professionals have equivalent state licensing.
We note that these waivers pertain to billing for Medicaid and CHIP services only, and do not function as general waivers of state licensure requirements.
On March 16, 2020, Florida became the first state to receive CMS approval of its request to waive certain Medicaid requirements. Based on the requests made by Florida’s Bureau of Medicaid Policy, CMS waived multiple requirements including, for example, to allow nursing facilities, intermediate care facilities for individuals with intellectual and developmental disabilities, psychiatric residential treatment facilities, and hospital nursing facilities to be fully reimbursed for services rendered during an emergency evacuation to an unlicensed facility. CMS also waived in-state health care professional licensure requirements, approved time frame modifications associated with Medicaid fair hearings and fair hearing decisions, and approved waivers of preadmission screening and Annual Resident Review Level I and Level II assessments, among others.48 We anticipate that other states will request and receive waivers of Medicaid requirements under section 1135 in the coming days.
Interested states and territories should submit their section 1135 waiver requests directly to CMS Acting Director of the Medicaid & CHIP Operations Group Center for Medicaid & CHIP Services by email or letter.
J. Limited waivers available under HIPAA
Complementing the blanket waivers issued by CMS, HHS also announced that it would waive certain sanctions and penalties against a covered hospital under HIPAA. This waiver applies to the following provisions of the HIPAA Privacy Rule for hospitals that have instituted a disaster protocol, but only for up to 72 hours from the time that protocol is implemented:
- The requirement to obtain a patient’s agreement to speak with family members or friends involved in the patient’s care;
- The requirement to honor a request to opt out of the facility directory;
- The requirement to distribute a notice of privacy practices;
- The patient’s right to request privacy restrictions; and
- The patient’s right to request confidential communications.49
Note, too, that even without application of the narrowly tailored waiver described above, the HIPAA Privacy Rule allows covered entities to use and disclose protected health information in emergency situations to further certain public health activities and to prevent or lessen a serious and imminent risk to public health.(See: Novel coronavirus: navigating US federal and state rules and regulations during a public health emergency)
K. Telehealth requirements loosened to cope with the coronavirus emergency
HHS anticipates that the broad permissibility and availability of telehealth services will allow seniors to limit their exposure to the coronavirus by receiving care outside of densely populated health facilities. More pervasive use of telehealth services also could help control community spread generally. As a result, HHS announced its intention to relax certain requirements applicable to telehealth providers in order to assist the health care industry’s ability to respond to the coronavirus.
Under the authority of section 1135, during this emergency period, CMS will pay clinicians to provide telehealth services for Medicare beneficiaries across the United States. The move is a significant departure from CMS’s historical approach of paying clinicians for telehealth services in only limited circumstances, such as when a beneficiary in a rural area traveled to a local medical facility to receive telehealth from a provider in a remote location. Prior to this announcement, CMS generally prohibited reimbursement for telehealth services provided to a Medicare beneficiary at home, except for “virtual check-ins.” Now, CMS will cover telehealth services provided by doctors, nurse practitioners, clinical psychologists, and licensed social workers to Medicare beneficiaries in physician’s offices, hospitals, nursing homes, rural health clinics, and personal residences.50
CMS also has issued Medicaid-specific guidance to assist states with understanding their options for paying Medicaid providers that use telehealth. According to that guidance, states are not required to submit a state plan amendment to pay for telehealth services if payment will be made in the same manner as if the service were furnished in person. Practitioners must continue to practice within the guidelines of their scope of practice. States may pay a qualified practitioner at the distant site (the billing provider), and the state’s payment methodology may include costs associated with the time and resources spent facilitating care at the originating site. The billing provider may distribute the payment.
States are permitted to pay for appropriate ancillary costs, such as technical support, transmission charges, and necessary equipment, according to an approved state payment plan methodology. Ancillary costs associated with the originating site for telehealth may be either incorporated into the fee-for-service rates or separately reimbursed as an administrative cost.
Beyond 1135 Waivers, HHS has issued additional guidance applicable to the provision of telehealth services that will ease restrictions on providers relying on telehealth to provide patient care during the PHE. For example:
- HHS Office of Inspector General (OIG) announced in a policy statement on March 17, 2020, that physicians and other health care practitioners will not be subject to administrative sanctions for reducing or waiving cost-sharing obligations for telehealth services provided to federal health care program beneficiaries, if those services are furnished consistent with the applicable coverage and payment rules.51
- HHS Office for Civil Rights (OCR) also released guidance about its intention to relax its enforcement of HIPAA against covered entities utilizing telehealth to cope with the national emergency created by the coronavirus outbreak – particularly the use of nonpublic-facing, non-HIPAA-compliant remote communication technologies.52
Please see the forthcoming Reed Smith Telehealth Client Alert: Telehealth: COVID-19 Legal Developments, for additional information about the provision of telehealth services during this time.
The reaction of federal and state regulators to the PHE related to COVID-19 continues to evolve rapidly, with new and aggressive efforts to facilitate the provision of care to those who need it most expected to continue. The blanket 1135 Waivers and other regulatory waivers related to HIPAA and telehealth discussed in this alert are just one step in the developing response.
If you have questions with respect to the applicability of a section 1135 waiver to your business, or for additional information relating to any of the above topics or COVID-19, please contact an author of this client alert or any Reed Smith attorney with whom you work.
Our Reed Smith Coronavirus team includes multidisciplinary lawyers from Asia, EME and the United States who stand ready to advise you on the issues above or others you may face related to COVID-19.
For more information on the legal and business implications of COVID-19, visit the Coronavirus (COVID-19) Resource Center - Need-To-Know Business & Legal Issues or contact us at COVIDfirstname.lastname@example.org
- See CMS Press Release, CMS Takes Action Nationwide to Aggressively Respond to Coronavirus National Emergency (March 13, 2020), available at cms.gov.
- 42 U.S.C. section 1395x(i); 42 C.F.R. section 409.30(a)(1).
- 42 C.F.R. section 409.85(a)(1).
- 42 C.F.R. section 409.85(a)(2).
- 42 U.S.C. section 1395d(b)(2).
- 42 U.S.C. section 1395x(a).
- 42 U.S.C. section 1395d(f).
- See Findings Concerning Section 1812(f) of the Social Security Act in Response to the Effects of the 2019-Novel Coronavirus (COVID-19) Outbreak, Centers for Medicare & Medicaid Services (March 13, 2020), available at cms.gov.
- 42 C.F.R. section 483.20.
- 42 C.F.R. section 483.20(b)(2).
- See CMS, COVID-19 Emergency Declaration Health Care Providers Fact Sheet (March 13, 2020), available at cms.gov.
- 42 C.F.R. section 412.23(ccc)(1).
- See Long-Term Care Hospital Prospective Payment System, MLN Booklet, ICN 006956 (December 2018), available at cms.gov.
- 42 U.S.C. sections 1395ww(d)(1)(B)(iv) and 1395x(ccc); 42 C.F.R. section 412.23(e)(2).
- 42 C.F.R. section 412.23(e)(3)(1).
- See COVID-19 Fact Sheet.
- 42 U.S.C. section 1395x(o).
- See generally 42 C.F.R. part 484.
- 42 C.F.R. section 484.55; see also CMS, Home Health Quality Reporting Program, available at cms.gov.
- 42 C.F.R. section 484.45(a).
- See COVID-19 Fact Sheet.
- 42 C.F.R. section 484.200.
- 42 C.F.R. section 484.205(g).
- See Medicare Claims Processing Manual, chapter 10 – “Home Health Agency Billing,” section 40.1.
- See COVID-19 Fact Sheet.
- 42 C.F.R. part 412, subpart B.
- 42 C.F.R. section 412.23(a).
- 42 C.F.R. section 412.25(a).
- 42 C.F.R. section 412.23(b)(2).
- 42 C.F.R. sections 412.25(a) and 412.604.
- 42 C.F.R. part 485, subpart F.
- 42 C.F.R. sections 410.152(k), 412.3, 413.70, 413.114(a), 424.15.
- 42 C.F.R. sections 485.618 and 485.620.
- 42 U.S.C. section 1395m(a)(1)(E)(ii)&(iv).
- 42 U.S.C. section 1395m(11)(B)(ii).
- 42 U.S.C. section 1395(m)(2)(A).
- 42 C.F.R. section 424.505.
- 42 C.F.R. section 424.514.
- 42 C.F.R. section 424.517.
- 42 C.F.R. section 424.518.
- 42 C.F.R. section 405.906 et seq.
- Id.; see also CMS, Original Medicare (Fee-for-service) Appeals, Downloads: FFS Appeals Process Flowchart (PDF), available at cms.gov.
- Letter from Calder Lynch to Ann Dalton, Section 1135 Waiver Flexibilities – Florida Coronavirus Disease 2019 (March 16, 2020), available at medicaid.gov.
- COVID-19 & HIPAA Bulletin: Limited Waiver of HIPAA Sanctions and Penalties During a Nationwide Public Health Emergency (March 2020), available at hhs.gov.
- CMS News. President Trump Expands Telehealth Benefits for Medicare Beneficiaries During COVID-19 Outbreak (March 17, 2020), available at cms.gov.
- OIG Policy Statement Regarding Physicians and Other Practitioners That Reduce or Waive Amounts Owed by Federal Health Care Program Beneficiaries for Telehealth Services During the 2019 Novel Coronavirus (COVID-19) Outbreak (March 17, 2020), available at hhs.gov.
- HHS Office for Civil Rights Action, Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency (March 17, 2020), available at hhs.gov.
Client Alert 2020-127