Coronavirus Update: March 31, 2020

Coronavirus Update: March 31, 2020.

Yesterday the federal Centers for Medicare & Medicaid Services (CMS) published a major update of Medicare and Medicaid regulations that included blanket waivers of a large number of Medicare and Medicaid regulations and requirements.  The following is a summary of the major aspects of this new regulation.

New Policies and Waivers From Medicare and Medicaid Regulations and Requirements

CMS has introduced dozens of changes that involve waivers from current regulations and requirements.  A comprehensive, 26-page CMS document describing these changes can be found here and below are the highlights organized into four broad categories:

  • increasing hospital capacity (what CMS calls “hospitals without walls”)
  • expanding the health care workforce
  • increasing the use of telehealth in Medicare
  • reducing paperwork

Increasing Hospital Capacity

  • CMS is waiving the enforcement of section 1867(a) of EMTALA to permit hospitals to screen patients at off-site locations to help prevent the spread of COVID-19.
  • CMS is waiving certain requirements under the Medicare conditions of participation allow for flexibilities during hospital and psychiatric hospital surges, permitting non-hospital buildings/space to be used for patient care and quarantine sites.
  • For the duration of the public health emergency, CMS is waiving certain requirements under the Medicare conditions of participation and the provider-based department requirements to permit hospitals to establish and operate as part of the hospital any location meeting those conditions of participation for hospitals that continue to apply during the public health emergency. This waiver also permits hospitals to change the status of their current provider-based department locations to the extent necessary to address the needs of hospital patients.
  • CMS is waiving requirements to permit acute-care hospitals to house acute-care inpatients in excluded distinct part units, such as excluded distinct part unit inpatient rehabilitation facilities or inpatient psychiatric facilities, where the distinct part unit’s beds are appropriate for acute-care inpatients.
  • CMS is permitting acute-care hospitals with excluded distinct part inpatient psychiatric units to relocate inpatients from the excluded distinct part psychiatric unit to acute-care beds and units as a result of a disaster or emergency.
  • CMS is permitting acute-care hospitals with excluded distinct part inpatient rehabilitation units that, as a result of a disaster or emergency, need to relocate inpatients from the excluded distinct part rehabilitation unit to an acute-care bed and unit.
  • CMS is waiving certain physical environment requirements. Provided that the state has approved the location as one that sufficiently addresses safety and comfort for patients and staff, CMS is waiving requirements to allow for a non-skilled nursing facility building to be temporarily certified and available for use by a skilled nursing facility in the event there are needs for isolation processes for COVID-19-positive residents, which may not be feasible in the existing skilled nursing facility structure to ensure care and services during treatment for COVID-19 are available while protecting other vulnerable adults.
  • CMS is waiving certain conditions of participation and certification requirements for opening a nursing facility if the state determines there is a need to quickly stand up a temporary COVID-19 isolation and treatment location.
  • CMS is waiving requirements to temporarily allow for rooms in a long-term care facility not normally used as a resident’s room to be used to accommodate beds and residents for resident care in emergencies and situations needed to help with surge capacity.

Expanding the Health Care Workforce

  • CMS is waiving current requirements to permit physicians whose privileges will expire to continue practicing at the hospital and for new physicians to be able to practice before full medical staff/governing body review and approval to address workforce concerns related to COVID-19.  CMS also is waiving requirements about details of the credentialing and privileging process.
  • CMS is waiving the requirement that Medicare patients be under the care of a physician.
  • CMS is waiving requirements that a certified registered nurse anesthetist (CRNA) work under the supervision of a physician. CRNA supervision will be at the discretion of the hospital and state law.
  • CMS is waiving the requirement that a skilled nursing facility and nursing facility may not employ anyone for longer than four months unless they meet current training and certification requirements. CMS is not waiving the requirement that such facilities ensure that nurse aides are able to demonstrate competency in skills and techniques necessary to care for residents’ needs.
  • CMS is waiving the requirement that physicians and non-physician practitioners must perform in-person visits for nursing home residents and will permit visits to be conducted, as appropriate, via telehealth options.
  • CMS is temporarily waiving requirements that out-of-state practitioners be licensed in the state where they are providing services when they are licensed in another state. CMS will waive the physician or non-physician practitioner licensing requirements when the following four conditions are met:
    • must be enrolled as such in the Medicare program;
    • must possess a valid license to practice in the state which relates to his or her Medicare enrollment;
    • is furnishing services – whether in person or via telehealth – in a state in which the emergency is occurring to contribute to relief efforts in his or her professional capacity; and,
    • is not affirmatively excluded from practice in the state or any other state that is part of the 1135 emergency area.
    • This does not have the effect of waiving state or local licensure requirements or any requirement specified by the state or a local government as a condition for waiving its licensure requirements.
  • CMS has a toll-free hotline for physicians and non-physician practitioners and Part A-certified providers and suppliers establishing isolation facilities to enroll and receive temporary Medicare billing privileges. CMS is waiving the following screening requirements:
    • application fee,
    • criminal background checks associated with fingerprint-based criminal background checks,
    • site visits,
    • postpone all revalidation actions,
    • allow licensed providers to render services outside of their state of enrollment,
    • expedite any pending or new applications from providers,
    • allow physicians and other practitioners to render telehealth services from their home without reporting their home address on their Medicare enrollment while continuing to bill from their currently enrolled location, and
    • allow opted-out physicians and non-physician practitioners to terminate their opt-out status early and enroll in Medicare to provide care to more patients.
  • CMS has issued blanket waivers of sanctions under the Stark Act.  The blanket waivers may be used now without notifying CMS.  Individual waivers of sanctions under section 1877(g) of the Act may be granted upon request.  For more information, go here and here.

Increasing the Use of Telehealth in Medicare

  • CMS is waiving the requirement that physicians and non-physician practitioners must perform in-person visits for nursing home residents and will permit visits to be conducted, as appropriate, via telehealth options.
  • Clinicians can provide virtual check-in services to new and established patients.
  • CMS will pay for telephone evaluation and management services provided by physicians and the same services provided by qualified non-physician health care providers. These services may be used for telephone-only evaluation and management services.
  • Licensed clinical social workers, clinical psychologists, physical therapists, occupational therapists, and speech language pathologists can perform e-visits via telehealth.
  • Limits have been lifted for subsequent inpatient visits, subsequent skilled nursing visits, and critical care consult codes.
  • Physicians may provide supervision virtually using real-time audio/visual technology for services that require direct supervision by a physician or other type of practitioner.
  • For additional information on new flexibilities in the use of telehealth for Medicare patients, go here.

Reducing Paperwork

  • CMS is waiving various requirements that limit and define the use and documentation of verbal orders in a hospital.
  • CMS is waiving reporting requirements when patients who have passed away required soft restraints prior to their death.  If restraints were a factor in the death, the usual reporting requirements apply.
  • CMS is waiving the current requirements for providing “detailed information” in discharge planning as long as discharging hospitals continue to provide the data patients and their families need to make decisions about appropriate post-acute care.  This does not waive the requirement that patients have all of the necessary medical information they need for their post-acute setting.
  • While maintaining the discharge planning requirements that ensure that patients are discharged to an appropriate setting with the necessary medical information, CMS is waiving some of the specific components of discharge information acute-care hospitals are ordinarily required to provide.
  • CMS is waiving requirements involving the organization and staffing of medical records departments and requirements for the form and content of medical records and is allowing for flexibility in completion of medical records within 30 days following discharge from a hospital.
  • CMS is waiving the requirements for hospitals to provide information about their advance directive policies to patients.
  • CMS is waiving the requirement that hospitals participating in Medicare and Medicaid must have a utilization review plan that meets specified requirements. CMS is waiving the entire utilization review condition of participation.
  • CMS is waiving – for “surge facilities” only – the requirement that the emergency services function operate according to written policies and procedures during surge periods.
  • CMS is waiving the requirement that hospital emergency preparedness policies and procedures include specified elements for the emergency preparedness communication plans of hospitals when a hospital is a surge site.
  • CMS is waiving requirements for hospital quality assessment and performance improvement programs that address the scope of the program, the incorporation and setting of priorities for the program’s performance improvement activities, and integrated quality assurance and performance improvement programs. The requirement that hospitals maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program remains.
  • CMS is waiving the requirement that providers must have a current therapeutic diet manual approved by the dietitian and medical staff readily available to all medical, nursing, and food service personnel. Such manuals would not need to be maintained at surge capacity sites.
  • CMS is waiving the requirement for nursing staffs to develop and keep current a nursing care plan for each patient and to have policies and procedures in place establishing which outpatient departments are not required to have a registered nurse present.
  • Completed 2019 Occupational Mix Surveys, Hospital Reporting Form CMS-10079, for the Wage Index Beginning FY 2022, are due to the Medicare Administrative Contractors (MACs). CMS is granting an extension for hospitals nationwide affected by COVID-19 until August 3, 2020.
  • CMS is waiving requirements that govern pre-admission screening and annual resident review (PASARR) to permit states and nursing homes to suspend these assessments for new residents for 30 days. After 30 days, new patients admitted to nursing homes with a mental illness or intellectual disability should receive the assessment as soon as resources become available.
  • CMS is waiving many paperwork requirements for home health agencies, skilled nursing facilities, nursing facilities, end-stage renal dialysis facilities, home health agencies, and hospices. Find those changes here (pages 9-16).
  • Medicare Administrative Contractors (MACs) and Qualified Independent Contractors (QICs) in the fee-for-service program may allow extensions to file an appeal. CMS is allowing MACs and QICs in the fee-for-service program and the MA and Part D independent review entities (IREs) to:
    • waive requests for timeliness requirements for additional information to adjudicate appeals;
    • process appeals even with incomplete appointment of representation forms;
    • process requests for appeals that do not meet the required elements using information that is available; and
    • use all flexibilities available in the appeal process if good cause requirements are satisfied.

Others

  • CMS offers stakeholders examples of section 1135 waivers available to individual providers.  Find those examples here beginning on page 23.
  • CMS is waiving certain patient rights involving copies of medical records, patient visitation limits, and quarantine processes in states that have had more than 50 confirmed COVID-19 cases.

For further information:

To learn more about these changes, you may wish to consult the following resources:

The following is the latest information from the administration and federal regulators as of 4:30 today.

The White House

President Trump has issued a presidential memorandum to the Secretary of Defense and the Secretary of Homeland Security authorizing the use of the National Guard to provide COVID-19-related services to the states of Connecticut, Illinois, Massachusetts, and Michigan, with the federal government to pay 100 percent of the cost of such a deployment.  The federal assumption of 100 percent of this cost expires in 30 days.

Centers for Medicare & Medicaid Services

Department of Health and Human Services

The Department of Health and Human Services has posted a news release in which it outlines the steps it has taken and will be taking to accelerate clinical trials for possible COVID-19 vaccines and to prepare for the manufacture of approved vaccines.

U.S. Public Health Service

The U.S. Public Health Service has issued a letter on optimizing ventilator use during the COVID-19 pandemic.

Food and Drug Administration

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MedPAC Offers 2021 Medicare Rate Recommendations

MedPAC has recommended to Congress changes in Medicare payment rates in the coming year.

In its annual report to Congress, the Medicare Payment Advisory Commission recommended the following rate changes:

  • acute-care hospitals – a two percent rate increase and a suggestion that the difference between this two percent increase and the payment increase specified by law be used to increase the rewards hospitals may earn under Medicare’s hospital value incentive program.  As a result, the value incentive program would offer a possible 0.8 percent in bonus payments, and with the recommended elimination of the 0.5 percent penalty for which hospitals are at risk, hospitals could average net increases of 3.3 percent.
  • ambulatory surgical centers – no rate increase and a requirement that such facilities report cost data
  • physicians – rates updated as already provided for by law
  • long-term acute-care hospitals – a two percent increase
  • inpatient rehabilitation facilities – a five percent rate reduction
  • skilled nursing facilities – no rate increase
  • dialysis facilities – rates updated as already provided for by law
  • hospice services – no rate increase and the aggregate hospice cap should be wage-adjusted and reduced 20 percent
  • home health agencies – a seven percent rate reduction

While MedPAC’s recommendations to Congress are not binding on the administration, its work is highly respected and is considered influential in the setting of Medicare rates.

Learn more about MedPAC’s recommendations on rates and other aspects of federal Medicare reimbursement policy in the MedPAC document Report to the Congress:  Medicare Payment Policy.

MedPAC Meets

Last week the Medicare Payment Advisory Commission met in Washington, D.C. to discuss a number of Medicare payment issues.

The issues on MedPAC’s March agenda were:

  • Addressing Medicare Shared Savings Program vulnerabilities
  • The role of specialists in alternative payment models and accountable care organizations
  • Realigning incentives in Medicare Part D
  • Redesigning the Medicare Advantage quality bonus program
  • Mandated report: Impact of changes in the 21st Century Cures Act to risk adjustment for Medicare Advantage enrollees
  • Improving Medicare’s end-stage renal disease prospective payment system
  • Separately payable drugs in the hospital outpatient prospective payment system

MedPAC is an independent congressional agency that advises Congress on issues involving the Medicare program.  While its recommendations are not binding on either Congress or the administration, MedPAC is highly influential in governing circles and its recommendations often find their way into legislation, regulations, and new public policy.

Go here for links to the policy briefs and presentations that supported MedPAC’s discussion of these issues.

NASH Opposes Proposed 340B Data Collection

The federal government should not require hospitals to submit new data on their acquisition costs for prescription drugs they dispense to low-income patients through the section 340B prescription drug discount program, NASH has told the Centers for Medicare & Medicaid Services.

In a formal comment letter in response to new data collection requirements proposed by CMS last month, the National Alliance of Safety-Net Hospitals wrote on behalf of private safety-net hospitals that

The 340B program was created by Congress to enable hospitals (and other providers) that serve low-income communities to maximize their resources when working to serve those communities. The program helps improve access to high-cost prescription drugs for low-income patients and helps put additional resources into the hands of qualified providers so those providers can do more for their low-income patients: provide more care that their patients might otherwise not be able to afford, offer more services that might otherwise be unavailable to such patients, and do more outreach into communities consisting primarily of low-income residents. This was the purpose of the 340B program when Congress created it in 1992 and Congress has not modified that purpose since that time. NASH believes that through this proposed data collection CMS is seeking to exert authority it does not have to demand of providers information to which the agency is not entitled.

In the letter, NASH also objected that the proposed data collection would be costly and burdensome for hospitals and is premature because the courts are still considering challenges to CMS’s authority to reduce 340B payments to providers; the latter is why CMS seeks this data.

Go here to see NASH’s formal comment letter to CMS.

Hundreds of Hospitals Penalized for Medical Mistakes

786 hospitals will see their Medicare payments slashed one percent for a year because of their performance under Medicare’s hospital-acquired conditions reduction program.

That program penalizes the 25 percent of hospitals with the highest rate of patient safety problems, such as infections and injuries.

Among the more interesting aspects of this year’s program results:

  • Among those being penalized are seven of the 21 hospitals on the S. News “best hospitals” list.
  • Three hospitals also on that list have never been penalized.
  • 145 hospitals will be penalized for the first time.
  • 16 hospitals that have been penalized every year since the program’s launch six years ago will not be penalized for the first time.

Since the program’s launch, 1865 of the 5276 hospitals that participate in the program have been penalized.

NASH has long been concerned about the manner in which the hospital-acquired conditions reduction program works, including its failure to reflect improved performance by individual hospitals and its approach of comparing the performance of hospitals that serve very different patients under very different circumstances.

Learn more about Medicare’s hospital-acquired conditions reduction program and this year’s penalties in the Kaiser Health News article “Preeminent Hospitals Penalized Over Rates Of Patients’ Injuries.”

 

NASH Unveils 2020 Advocacy Agenda

The National Alliance of Safety-Net Hospitals has published its 2020 advocacy agenda.

To advance the interests of private safety-net hospitals, in the coming year NASH will:

  • Continue to address the major policy challenges of 2019 that had not been resolved as that year ended:  an extended delay of Medicaid disproportionate share (Medicaid DSH) cuts, surprise medical bills, and prescription drug prices.
  • Respond to administration-driven policies such as the calculation of Medicare disproportionate share (Medicare DSH) payments, reduced payments for prescription drugs under the 340B prescription drug discount program, and efforts to reduce Medicaid eligibility and benefits and to limit the means through which states may finance their share of Medicaid payments.
  • Respond to expected judicial decisions addressing the extension of site-neutral Medicare outpatient payments to additional outpatient settings and the implementation of a new public charge regulation.

For a more detailed look at NASH’s advocacy plans for the coming year, see its complete 2020 advocacy agenda.

MedPAC Meets

Last week the Medicare Payment Advisory Commission met in Washington, D.C. to discuss a number of Medicare payment issues.

The issues on MedPAC’s January agenda were:

  • The Medicare prescription drug program (Part D):  status report and options for restructuring
  • Redesigning the Medicare Advantage quality program:  initial modeling of a value incentive program
  • Hospital inpatient and outpatient payments
  • Physician payments
  • Outpatient dialysis payments
  • Skilled nursing facility, home health, inpatient rehabilitation facility, and long-term-care hospital payments
  • Hospice and ambulatory surgery center payments
  • The 340B program
  • ACO beneficiary assignment

MedPAC is an independent congressional agency that advises Congress on issues involving the Medicare program.  While its recommendations are not binding on either Congress or the administration, MedPAC is highly influential in governing circles and its recommendations often find their way into legislation, regulations, and new public policy.

Go here for links to the policy briefs and presentations that supported MedPAC’s discussion of these issues.

Good News and Bad for Hospitals on Outpatient Payments

A federal court has provided relief to hospitals that saw reduced Medicare payments for some outpatient services in 2019.

But that relief is only partial.

In response to a suit filed by several hospital groups, a federal court ruled that the Centers for Medicare & Medicaid services had illegally reduced Medicare payments for services provided in some hospital off-campus outpatient departments beginning on January 1, 2019 and ordered the federal government to repay the hospitals for the Medicare revenue they lost.  The reduced payments were part of a new Medicare site-neutral payment policy for outpatient services, and CMS has announced a plan for reimbursing affected hospitals for their losses.

At the same time, however, CMS announced that despite the court’s ruling, it will implement the same policy of reduced payments for outpatient care provided in some hospitals’ off-campus outpatient departments in 2020, and an effort by hospitals to persuade the court to ban this payment reduction was rejected by the same court that ruled against CMS on the 2019 payments.

Learn more about the ruling that CMS must reimburse  hospitals for lost payments in the Healthcare Dive article “Hospital group cheers CMS move to pay back outpatient payment cuts.”  Learn about the court decision not to impose the same decision on 2020 payments in the Fierce Healthcare article “Judge strikes down AHA’s bid to halt CMS’ site-neutral payment cuts for 2020.”

MedPAC Meets

Last week the Medicare Payment Advisory Commission met in Washington, D.C. to discuss a number of Medicare payment issues.

Among the issues on MedPAC’s December agenda that were of special interest to private safety-net hospitals were:

  • Assessing payment adequacy and updating payments: Physician and other health professional services
  • Assessing payment adequacy and updating payments: Ambulatory surgical center services
  • Assessing payment adequacy and updating payments: Hospital inpatient and outpatient services
  • Assessing payment adequacy and updating payments: Home health care services
  • Assessing payment adequacy and updating payments: Inpatient rehabilitation facility services
  • Assessing payment adequacy and updating payments: Long-term care hospital services

MedPAC is an independent congressional agency that advises Congress on issues involving the Medicare program.  While its recommendations are not binding on either Congress or the administration, MedPAC is highly influential in governing circles and its recommendations often find their way into legislation, regulations, and new public policy – policies that often have a major impact on private safety-net hospitals.

Go here for links to the policy briefs and presentations that supported MedPAC’s discussion of these issues.

Hospital Groups Critical of CMS 340B Proposal

The federal government should not survey providers to determine their costs for drugs covered by the section 340B prescription drug discount program, hospitals and hospital groups have told the Centers for Medicare & Medicaid Services.

Their comments came in response to a regulation CMS proposed in September that would require hospitals to report their acquisition costs for 340B-covered drugs.  CMS proposed such data collection after federal courts ruled against its attempt to reduce 340B reimbursement to hospitals that participate in the program.  Among the court’s objections were CMS’s lack of data about those drug acquisition costs.

Among the reasons hospitals conveyed in expressing their opposition were the cost of reporting the data in question; the design of the survey; the flawed premise underlying the survey; and the proposed rule’s requirement that all hospitals complete the survey and not just those that participate in the 340B program.

Among the groups criticizing the proposed regulation were the Association of American Medical Colleges, which wrote in its comment letter that

Congress did not design the 340B program to pay hospitals at acquisition costs…Congress designed the program so that eligible hospitals could purchase covered drugs at a discounted rate below the Medicare reimbursement rate and use the difference to reach more eligible patients and provide more comprehensive services.

The National Alliance of Safety-Net Hospitals was among the groups commenting on the proposed regulation.  Writing on behalf of private safety-net hospitals, NASH observed in its November 27, 2019 formal comment letter that

The 340B program was created by Congress to enable hospitals (and other providers) that serve low-income communities to maximize their resources when working to serve those communities.  The program helps improve access to high-cost prescription drugs for low-income patients and helps put additional resources into the hands of qualified providers so those providers can do more for their low-income patients:  provide more care that their patients might otherwise not be able to afford, offer more services that might otherwise be unavailable to such patients, and do more outreach into communities consisting primarily of low-income residents.  This was the purpose of the 340B program when Congress created it in 1992 and Congress has done nothing to modify that purpose since that time:  it has not directed that special assistance to qualified providers be reduced; it has not insisted that participating providers document the expenditure of their savings in service to their communities; and it most certainly has not dictated that 340B payments to eligible providers be reduced so that payments to non-340B providers could be increased.  NASH believes that through this proposed data collection CMS is seeking to exert authority it does not have to demand of providers information to which the agency is not entitled.

Learn more about hospital industry opposition to the proposed 340B regulation in the Fierce Healthcare article “Hospitals blast CMS’ proposed 340B survey.”