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IMPACT OF REGULATORY REFORM PROPOSALS ON HOSPICE PROVIDERS

On September 17 the Centers for Medicare & Medicaid Services (CMS) posted proposed regulations designed to reduce regulatory burdens on a number of provider types that deliver services to Medicare and Medicaid beneficiaries.  Among the changes were several that would impact hospice providers.  This short survey is designed to gauge the extent to which hospice providers believe these changes will reduce regulatory burdens on hospices.
 
Item 1:  Hospice Aide and Homemaker Services (§ 418.76)

Under existing regulations, a hospice aide must have undergone one of the following requirements to be qualified to provide services:

(i) A training program and competency evaluation as specified in paragraphs (b) and (c) of 418.76, respectively.

(ii) A competency evaluation program that meets the requirements of paragraph (c) of 418.76.

(iii) A nurse aide training and competency evaluation program approved by the State as meeting the requirements of § 483.151 through § 483.154, and is currently listed in good standing on the State nurse aide registry.

(iv) A State licensure program that meets the requirements of paragraphs (b) and (c) of 418.76.
 
CMS has proposed to revise section (iv) to delete “that meets the requirements of paragraphs (b) and (c)” of 418.76. Under this change state licensure programs would no longer be required to meet the training and competency requirements in federal regulations.
1.On a scale of 1 to 5 -- with 1 being no relief and 5 being a great deal of relief -- how much would this change provide regulatory relief for your hospice program?
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2.Which of the above four options does your hospice use to qualify hospice aides?
3.Does your State have a Certified Nurse Aide (CNA) program?
4.If CMS implements the proposed change, would you modify your hospice’s existing hospice aide training and competency requirements?
5.Do you have any specific comments or concerns about this proposal that you would like to supply to NAHC for its consideration as part of comments on this proposed change? Please provide in the box below:
Item 2:  Drugs and Biologicals, Medical Supplies, and Durable Medical Equipment (§418.106(a)(1))

CMS believes that most hospices now use pharmacy benefit management companies that directly employ pharmacy experts and that it is no longer necessary to include a regulatory requirement specifically related to the employment of or contracting with a pharmacology expert.  CMS is proposing to eliminate this requirement.
6.On a scale of 1 to 5 -- with 1 being no relief and 5 being a great deal of relief -- to what extent would this change provide regulatory relief for your hospice program?
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7.Would CMS' plans to eliminate the requirement to have a drug management expert on staff or under contract cause you to modify your hospice organization’s current arrangement with a drug management expert?
8.Do you have any specific comments or concerns about this proposal that you would like to supply to NAHC for its consideration as part of comments on this proposed change? Please provide in the box below:
Item 3: Drugs and Biologicals, Medical Supplies, and Durable Medical Equipment (§ 418.106(e)(2)(i))

The CoP require hospices, at §418.106(e)(2)), to:

(1)    Provide a copy of the hospice written policies and procedures on the management and disposal of controlled drugs to the patient or patient representative and family;

(2)    Discuss the hospice policies and procedures for managing the safe use and disposal of controlled drugs with the patient or representative and the family in a language and manner that they understand to ensure that these parties are educated regarding the safe use and disposal of controlled drugs; and

(3)    Document in the patient’s clinical record that the written policies and procedures for managing controlled drugs was provided and discussed.

 While CMS believes this requirement is still relevant for internal hospice use, the agency has concerns that patients and family members may find hospice policies and procedures difficult to understand, and also believes that a hard copy of this information may not in all cases be the best means for supplying the information.  In lieu of existing requirements CMS is proposing to replace the requirement that hospices provide a physical paper copy of policies and procedures with a requirement that hospices provide information regarding the use, storage, and disposal of controlled drugs to the patient or patient representative, and family, which can be developed in a more user-friendly form, as decided by each hospice. CMS proposes to require that, regardless of the format chosen, this information must be provided to patients and families in a manner that allows for continual access to the information on an as-needed basis in order to assure that patients and families have information available when they need it. CMS is soliciting input concerning what a standardized educational format should entail, including whether the format should be paper or electronic; in writing, pictorial, video, or audio; what general subjects should be addressed in regards to storage, disposal, use, and risks; and what specific content should be included to minimize opioid diversion and maximize safety.
9.On a scale of 1 to 5 -- with 1 being no relief and 5 being a great deal of relief -- how much would this change provide regulatory relief for your hospice program?
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10.If CMS implements the proposed change, would you modify your hospice’s existing method for supplying patient/family member with information regarding your hospice’s policies on management and disposal of controlled drugs?
11.Do you have any specific comments or concerns about this proposal that you would like to supply to NAHC for its consideration as part of comments on this proposed change? Please provide in the box below:
Item 4:  Hospices That Provide Hospice Care to Residents of a SNF/NF or ICF/IID (§ 418.112 (c)(10) and (f))

Section 418.112(f) of the hospice CoPs requires hospices to assure orientation of Skilled Nursing Facility/Nursing Facility (SNF/NF) or ICF/IID staff furnishing care to hospice patients. It is the hospice’s responsibility to coordinate the trainings with representatives of the facility. It is also the hospice’s responsibility to determine how frequently training needs to be offered in order to ensure that the staff furnishing care to hospice patients are oriented to the philosophy of hospice care.

While CMS believes that the intent of the requirement continues to be appropriate, the agency believes it may, as currently written, create duplication when multiple hospices provide care to residents of a single facility.  Further, CMS notes that existing language assigns sole responsibility for this effort to hospice providers, which may impede joint hospice-facility collaboration and training innovations.  In response to these concerns, CMS is proposing to remove §418.112(f) and add a new requirement at §418.112(c)(10), “Written agreement,” to address this issue.  Under the proposed change, both hospices and facilities would be expected to negotiate the mechanism and schedule for assuring orientation of facility staff.

12.On a scale of 1 to 5 -- with 1 being no relief and 5 being a great deal of relief -- how much would this change provide regulatory relief for your hospice program?
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13.Do you have any specific comments or concerns about this proposal that you would like to supply to NAHC for its consideration as part of comments on this proposed change? Please provide in the box below:
CMS has requested public comment on all of the hospice-specific changes listed above, and also is soliciting additional ideas and recommendations that would reduce burden on hospices and create cost savings while preserving the quality of care and patient health and safety.
14.In the box below, please provide any recommendations that you believe CMS should consider as part of its efforts to reduce regulatory requirements on hospice providers:

Item 5:  Emergency Preparedness Requirements for Hospice Providers

As part of the proposed regulatory changes, CMS has also suggested amendments to “Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers. ” 

Annual Preparedness Program Review:  Under 418.113, hospices are required to annually review their emergency preparedness program, which includes a review of their emergency plan, policies and procedures, communication plan, and training and testing program.  CMS is proposing that the annual review be changed to at least once every two years.  Hospices would be expected to update their emergency preparedness programs more frequently than every 2 years if needed (for example, if staff changes occur or lessons-learned are acquired from a real-life  event or exercise).

15.On a scale of 1 to 5 -- with 1 being no relief and 5 being a great deal of relief -- how much would this change provide regulatory relief for your hospice program?
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5 (a great deal)
Documentation of Cooperation Efforts:  Under 418.113(a)(4), hospices are required to develop and maintain an emergency preparedness plan that includes a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation.  As part of this requirement hospices must document their efforts to contact such officials and, when applicable, document participation in collaborative and cooperative planning efforts. CMS is proposing to eliminate the requirement that hospices document efforts to contact local, tribal, regional, State, and Federal emergency preparedness officials and facilities’ participation in collaborative and cooperative planning efforts.
16.On a scale of 1 to 5 -- with 1 being no relief and 5 being a great deal of relief -- how much would this change provide regulatory relief for your hospice program?
1 (not at all)
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5 (a great deal)
Annual Emergency Preparedness Training Program:  Under 418.113(d)(1)(ii), hospices are required to develop and maintain a training program that is based on the facility’s emergency plan. The training must be provided at least annually.  A hospice’s training program also must include initial training in emergency preparedness policies and procedures. CMS is proposing to change the annual training requirement such that hospices would be required to offer training every two years.  Hospices would still be required to offer initial training on their emergency program. In addition, CMS is proposing to require more frequent training in cases where the emergency plan is significantly updated.
17.On a scale of 1 to 5 -- with 1 being no relief and 5 being a great deal of relief -- how much would this change provide regulatory relief for your hospice program?
1 (not at all)
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5 (a great deal)
Annual Emergency Preparedness Testing:  Under 418.113(d)(2), hospices are required to conduct two emergency preparedness testing exercises every year.
 
Under existing regulations, hospices must:
  • Annually participate in a full-scale exercise that is community-based or when a community-based exercise is not accessible, an individual, hospice-based exercise. If the hospice experiences an actual natural or-man made emergency that requires activation of the emergency plan (including their communication plan) and revision of the plan as needed), the hospice is exempt from engaging in a community-based or individual, facility based full-scale exercise for one  year following the onset of the actual event;
  • Conduct an additional exercise that may include either a second full-scale exercise that is community-based or individual, hospice-based or a tabletop exercise that includes a group discussion led by a facilitator.
 CMS is proposing the following new testing requirements replace existing requirements:
  • Hospices that provide services in the home would be required to:
    • Every two years: participate in a full-scale exercise that is community-based or when a community-based exercise is not accessible, an individual functional exercise.  If the hospice experiences an actual natural or man-made emergency that requires activation of the emergency plan, the hospice would be exempt from engaging in its next required full-scale community-based or individual, hospice-based functional exercise following the onset of the actual event.
    • Conduct an additional exercise at least every two years, opposite the year the full-scale or functional exercise is conducted, that may include but is not limited to the following:
      • A second, full-scale exercise
      • A mock disaster drill
      • A tabletop exercise or workshop
  • Hospice that provide inpatient services directly would be required to:
    • Annually participate in a full-scale exercise that is community-based or when a community-based exercise is not accessible, an individual, hospice-based functional exercise.  If the hospice experiences an emergency during which the emergency plan is activated, the hospice is exempt from engaging in its next required full-scale community-based or individual hospice-based functional exercise
    • Annually conduct an additional exercise that may include, but is not limited to the following:
      • A second, full-scale exercise
      • A mock disaster drill
      • A tabletop exercise or workshop
18.On a scale of 1 to 5 -- with 1 being no relief and 5 being a great deal of relief -- how much would these changes provide regulatory relief for your hospice program?
1 (not at all)
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5 (a great deal)
19.In the box below, please provide any comments or concerns that you have about the changes to the emergency preparedness requirements that CMS is proposing:
Thank you for your willingness to participate in this survey.
Current Progress,
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