CMS Finalizes New Regulations for Facilities: Part 3

Review of Changes to Sections on Laboratory, Radiology and Other Diagnostic Services; Dental Services; Food and Nutrition Services; Specialized Rehabilitative Services; Administration; and Quality Assurance and Performance Improvement

This is the third article in a series discussing the complete overhaul of Part 483 to Title 42 of the Code of Federal Regulations, the Requirements for States and Long-Term Care Facilities by the Centers for Medicare & Medicaid Services (“CMS”).

Because CMS’s Final Regulations (“Final Regulations”) impose numerous requirements on long-term care facilities, we will be issuing a series of articles on various components of the Final Regulations. This article focuses on provisions regarding Laboratory, Radiology and Other Diagnostic Services; Dental Services; Food and Nutrition Services; Specialized Rehabilitative Services; Administration; and Quality Assurance and Performance Improvement.

Recently, Hall Render published an overview of Final Regulations components as well as Parts 1 and 2 in the series, which are located here and here.

Background

On September 28, 2016, CMS released a complete overhaul of Part 483 to Title 42 of the Code of Federal Regulations, the Requirements for States and Long-Term Care Facilities. CMS’s Final Regulations cover many regulatory requirements for long-term care facilities and create new compliance obligations for providers. The Final Regulations seek to target rehospitalizations, facility-acquired infections, overall quality and resident safety.

Laboratory, Radiology and Other Diagnostic Services – Sec. 483.50

The Final Regulations create a new Section 483.50 addressing Laboratory, Radiology and Other Diagnostic Services. Laboratory Services were previously found in Section 483.75(j) while Radiology and Other Diagnostic Services were found in Section 483.75(k). This new regulation provides flexibility for facilities with regard to ordering and notification of laboratory, radiology and other diagnostic tests. Under the previous regulations, facilities could obtain laboratory, radiology or other diagnostic services “only when ordered by a physician.” The Final Regulations now allow “a physician, a physician assistant, nurse practitioner, or clinical nurse specialist” to order laboratory, radiology or other diagnostic services in accordance with state law, including scope of practice laws. With regard to notification of results, under previous regulations, facilities were required to “promptly notify the attending physician.” The Final Regulations now allow the ordering physician, physician assistant, nurse practitioner or clinical nurse specialist be notified and have the ability to receive laboratory, radiology or other diagnostic services results. The ordering physician or practitioner must still be notified “promptly” if the results fall outside of “normal” ranges, unless orders for the test or facility policies or procedures dictate otherwise.

Implementation Timeframe. Section 483.50 will be implemented in Phase 1, upon the effective date of the Final Regulations, November 28, 2016.

Detailed Summary. In addition to providing flexibility with regard to the ordering and notification of laboratory, radiology and other diagnostic services, this new regulation sets forth other requirements. These requirements include:

• The facility is responsible for the quality and the timeliness of laboratory, radiology and other diagnostic services.
• If the facility provides its own laboratory, blood bank or transfusion services, it must meet the applicable CLIA requirements found at 42 CFR Part 493. If the facility laboratory refers specimens to another laboratory for testing, the referral laboratory must also meet the applicable specialty and subspecialty CLIA requirements found at 42 CFR Part 493.
• The facility must assist the resident in making transportation arrangements to and from the source of service if the resident needs assistance.
• All laboratory reports must be dated, included in the resident’s clinical record and contain the name and address of the testing laboratory.
• If the facility provides its own diagnostic services, they must meet the conditions of participation for hospitals found at 42 CFR Section 482.26.

Dental Services – Sec. 483.55

The Final Regulations make changes to Section 483.55, Dental Services. Under the Final Regulations, facilities are prohibited from charging a Medicare resident for the loss or damage of dentures and must assist eligible Medicaid residents with the application for reimbursement of dental services under the Medicaid state plan when applicable.

Implementation Timeframe. As noted below, the new requirements under Section 483.55 will be implemented in Phase 2, November 28, 2017. The existing requirements of Section 483.55 will remain in effect at Phase 1, November 28, 2016.

Detailed Summary. The revisions to Section 483.55 maintain the existing requirements and add new facility obligations related to resident dentures.

• Facilities must develop a policy to identify when the loss or damage of dentures is the facility’s responsibility. (Phase 2, November 28, 2017)
• Facilities may not charge a resident for the loss or damage of dentures when determined to be the facility’s responsibility in accordance with the facility’s policy.  (Phase 2, November 28, 2017)
• If the facility does not refer a resident with lost or damaged dentures to a dentist within three days, the facility must provide documentation of what they did to ensure the resident could still eat and drink adequately while awaiting dental services and the extenuating circumstances that led to the delay. (Phase 2, November 28, 2017)
• Facilities must assist residents who are eligible and wish to participate to apply for reimbursement of dental services as an incurred medical expense under the Medicaid state plan. (Phase 2, November 28, 2017)

Food and Nutrition Services – Sec. 483.60

The Final Regulations move Section 483.35 “Dietary services” to Section 483.60 and retitle it “Food and nutrition services.” The “qualified dietitian” at a facility must be either registered by the Commission on Dietetic Registration of the Academy of Nutrition and Dietetics or meet state licensure or certification requirements. A facility’s menus must reflect the religious, cultural and ethnic needs and preferences of the residents. Facilities may obtain food from local producers and may use food grown in facility gardens, subject to compliance with applicable safe growing and food-handling practices.

Implementation Timeframe. Except as noted below, Section 483.60 will be implemented in Phase 1, upon the effective date of the Final Regulations, November 28, 2016.

Detailed Summary. Current regulations at Sec. 483.35 address dietary services. The Final Regulations move Section 483.35 to 483.60 and retitle it “Food and nutrition services.” The new Section 483.60 revises some sections from the old Section 483.35 and adds others.

• Staffing. The Final Regulations require facilities to employ sufficient staff with the competencies and skill sets to carry out the dietary services while considering resident assessments and individual plans of care (including diagnoses and acuity), as well as the facility’s resident census.
• Dietitian Qualification. The Final Regulations clarify that a “qualified dietitian” must: (1) hold a bachelor’s degree (or higher) in nutrition or dietetics; (2) have completed 900 hours of supervised dietetics practice; and (3) be either registered by the Commission on Dietetic Registration of the Academy of Nutrition and Dietetics or meet state licensure or certification requirements. If a facility hired or contracted a dietitian prior to November 28, 2016, CMS gives them five years to meet the new requirements.
• Menus and Nutritional Adequacy. Menus must: (1) reflect the religious, cultural and ethnic needs and preferences of the residents; (2) be updated periodically; and (3) be reviewed by the facility’s qualified dietitian or other clinically qualified nutrition professional for nutritional adequacy.  Menus cannot limit a resident’s right to make personal dietary choices.
• Providing Food and Drink. The Final Regulations require that a facility take into consideration resident allergies, intolerances and preferences and ensure adequate hydration when providing food and drink that is palatable, attractive and at a safe and appetizing temperature.
• Ordering Therapeutic Diets. The Final Regulations allow the attending physician to delegate to a registered or licensed dietitian the task of prescribing a resident’s diet, including a therapeutic diet, to the extent allowed by state law.
• Frequency of Meals. The Final Regulations require facilities to have available suitable and nourishing alternative meals and snacks for residents who want to eat at non-traditional times or outside of scheduled meal times in accordance with the resident’s plan of care.
• Food Safety. Facilities may obtain food from local producers and may use food grown in facility gardens, subject to compliance with applicable safe growing and food-handling practices. Other changes include allowing residents to consume foods that are not procured by the facility and require facilities to have a policy on the use and storage of foods brought to residents by family and other visitors.

Specialized Rehabilitative Services – Sec. 483.65

The Final Regulations relocated the existing Section 483.45 to Section 483.65 and added respiratory services to those identified as specialized rehabilitative services.

Implementation Timeframe. This change will become effective in Phase 1, upon the effective date of the Final Regulations, November 28, 2016.

Detailed Summary. The current Section 483.45 is relocated to Section 483.65 under the Final Regulations.

• Respiratory therapy is added as a specialized rehabilitative service provider.

Administration – Sec. 483.70

The Final Regulations move Section 483.75 “Administration” to Section 483.70 and retain the title. Facilities are required to conduct and document an annual facility-wide assessment to determine what resources are necessary to care for its residents competently during day-to-day operations and emergencies. The Final Regulations provide new requirements for facilities that use binding arbitration agreements. A facility must not enter into a pre-dispute agreement for binding arbitration with any resident or resident’s representative nor require that a resident sign an arbitration agreement as a condition of admission to the facility.  Admission to a facility cannot be contingent upon the resident or the resident representative signing a binding arbitration agreement.

Implementation Timeframe. Except as noted below, Section 483.70 will be implemented in Phase 1, upon the effective date of the Final Regulations, November 28, 2016.

Detailed Summary. The Final Regulations move Section 483.75 “Administration” to Section 483.70, retain the title, retain existing obligations in Sec. 483.70, revise some provisions and add others.

• Governing Body. The nursing home administrator must report to and be accountable to the governing body. The governing body is responsible for and accountable for the QAPI program. This requirement is effective on November 28, 2019.
• Facility Assessment. A new provision requires facilities to conduct and document a facility-wide assessment to determine what resources are necessary to care for its residents competently during day-to-day operations and emergencies. A facility must review and update that assessment, as necessary, and at least annually. The facility assessment must address the facility’s resident population (number of residents, types of care and staff competencies required by the residents and cultural aspects) and resources (equipment and overall personnel) and a facility-based and community-based risk assessment. This requirement is effective on November 28, 2017.
• Binding Arbitration Agreements. The Final Regulations provide new requirements for facilities that use binding arbitration agreements. A facility must not enter into a pre-dispute agreement for binding arbitration with any resident or resident’s representative nor require that a resident sign an arbitration agreement as a condition of admission to the facility. If, after a dispute between the facility and a resident arises, the facility chooses to ask a resident or his or her representative to enter into an agreement for binding arbitration, the facility must ensure that the agreement is explained to the resident in a form and manner that he or she understands, including in a language the resident and his or her representative understands, and the resident acknowledges that he or she understands the agreement. The agreement must be entered into by the resident voluntarily and arbitration sessions be conducted by a neutral arbitrator in a location that is convenient to both parties. Admission to the facility cannot be contingent upon the resident or the resident representative signing a binding arbitration agreement. The agreement cannot prohibit or discourage the resident or anyone else from communicating with federal, state or local health care or health-related officials, including representatives of the Office of the State Long-Term Care Ombudsman.

Quality Assurance and Performance Improvement – Sec. 483.75

The Final Regulations include the implementation of QAPI, originally required in the Affordable Care Act. All facilities will be required to develop, implement and maintain an effective and comprehensive, data-driven QAPI program that focuses on systems of care, outcomes of care and quality of life.

Implementation Timeframe. The QAPI program requirements will be fully implemented during Phase 3, November 28, 2019. Some aspects will be implemented in Phase 1 and Phase 2 as noted below.

Detailed Summary. The Final Regulations add the new Section 483.75 for QAPI. Under this requirement, all facilities must develop, implement and maintain an effective, comprehensive, data-driven QAPI program that focuses on systems of care, outcomes of care and quality of life. Facilities will have to maintain documentation and demonstrate evidence of the QAPI program. As part of this requirement, facilities will have to maintain a quality assessment and assurance committee that meets at least quarterly and reports to the governing body. The Final Regulations protect the records of the committee and prevent the State or Secretary from requiring disclosure of committee records, except for any disclosure related to ensuring compliance with the meeting and recordkeeping requirements. Good faith attempts to identify and correct quality deficiencies will not be used as a basis for sanctions.

• The facility must present its QAPI plan to the survey agency beginning in Phase 2, November 28, 2017, and at every annual recertification survey and upon request thereafter.
• The program must be designed to address the full range of care and services provided by the facility. It must address all systems of care and management practices; include clinical care, quality of life and resident choice; utilize the best available evidence to define and measure quality and facility goals that have been shown to be predictive of desired resident outcomes; and reflect the complexities of care and services the facility provides.
• The program must incorporate monitoring, data collection and feedback to identify problems that are high risk, high volume or problem-prone and identify opportunities for improvements. The facility must prioritize performance improvement activities that take into account the incidence, prevalence and severity of such problems and those that affect health outcomes, resident safety, resident autonomy, resident choice and quality of care.
• The number and frequency of performance improvement projects must reflect the scope and complexity of the facility’s services and available resources.
• The facility must track the results of interventions to ensure that desired improvements are realized and sustained.
• The governing body of the facility is responsible to ensure the QAPI program is adequately implemented and resourced.
• The facility must maintain a quality assessment and assurance committee that includes the Director of Nursing; the Medical Director (or designee); at least three other members of the facility staff, one of whom must be the Administrator, owner, board member or individual in a leadership role; and, beginning in Phase 3, the infection control and prevention officer. This requirement, outside of the infection control and prevention officer, is implemented in Phase 1, November 28, 2016.
• The state or the secretary may not require disclosure of the records of the quality assessment and assurance committee, except for any disclosure related to ensuring compliance with the meeting and recordkeeping requirements. (Phase 1, November 28, 2016)
• Good faith attempts by the committee to identify and correct quality deficiencies will not be used a basis for sanctions. (Phase 1, November 28, 2016)

Practical Takeaways

• The facility must present its QAPI plan to the survey agency beginning in Phase 2, November 28, 2017, and at every annual recertification survey and upon request thereafter.
• Effective November 28, 2016, the Final Regulations will prohibit the use of pre-dispute binding arbitration agreements. This means that a facility may not utilize pre-dispute arbitration agreements at the time of admission to that facility. Facilities and residents will still be able to use arbitration on a voluntary basis at the time a dispute arises.
• Menus must: (1) reflect the religious, cultural and ethnic needs and preferences of the residents; (2) be updated periodically; and (3) be reviewed by the facility’s qualified dietitian or other clinically qualified nutrition professional for nutritional adequacy.
• While many of the Final Regulations are revisions to current regulations, facilities should keep in mind that many of the Final Regulations have changes that could impact facility operations.

If you have questions or would like additional information about this topic, please contact:

• Todd Selby at 317.977.1440 or tselby@wp.hallrender.com;
• Brian Jent at 317.977.1402 or bjent@wp.hallrender.com;
• David Bufford at 502.568.9368 or dbufford@wp.hallrender.com;
• Sean Fahey at 317.977.1472 or sfahey@wp.hallrender.com; or
• Your regular Hall Render attorney.

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