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Regulatory Update: 2014 A Journey Together HFAM and Lifespan Howard L. Sollins Ober|Kaler 4/27/2015.

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Presentation on theme: "Regulatory Update: 2014 A Journey Together HFAM and Lifespan Howard L. Sollins Ober|Kaler 4/27/2015."— Presentation transcript:

1 Regulatory Update: 2014 A Journey Together HFAM and Lifespan Howard L. Sollins Ober|Kaler 4/27/2015

2 S&C 14-43-NH Completion of Minimum Data Set (MDS) 3.0 Discharge Assessments for Transfer from Medicare- and/or Medicaid-Certified Beds to Non-Certified Beds: CMS is reinforcing the requirement for MDS 3.0 Discharge assessments to be completed when a resident transfers from a Medicare- and/or Medicaid-certified bed to a non-certified bed. Discharge assessments are required assessments and are critical to ensuring the accuracy of Quality Measures (QMs) and in aiding in resident care planning for discharge from the certified facility. 4/27/2015

3 S&C 14-42-NH Release of Training Materials: CMS announce the release of a free learning tool on Building Respect for LGBT Older Adults. Program Content and Design: The learning tool addresses the needs and rights of older LGBT adults in long term care (LTC) and is presented in six online training modules. Target Audience: The learning tool is intended for LTC providers. 4/27/2015

4 S&C 14-37-NH Revisions to Appendix PP of the SOM: Revisions to the Interpretive Guidelines and Investigative Protocols for the following F Tags to incorporate Survey & Certification (S&C) policy memos issued from October 2003 through May 2014. 4/27/2015

5 Specifically, the guidelines have been updated for the following F Tags: F161 - Assurance of Financial Security F202 - Documentation for Transfer and Discharge F208 - Admission Policy F221 - Physical Restraints F278 - Accuracy of Assessment/Coordination/Certification/Penalt y for Falsification 4/27/2015

6 F281 - Services Provided Meet Professional Standards of Quality F286 - Maintaining 15 Months of Resident Assessments (Use) F332 - Medication Errors/Free of Medication Errors of 5% or Greater F333 - Medication Errors/Residents are Free of Significant Medication Errors 4/27/2015

7 F371 – Sanitary Conditions F387 - Frequency of Physician Visits/Timeliness of Visits F388 - Personal Visits by the Physician F390 - Physician Delegation of Tasks in SNFs/Performance of Physician Tasks in NFs F425 - Pharmacy Services F428 - Drug Regimen Review 4/27/2015

8 F431 - Service Consultation/Labeling of Drugs and Biologicals/Storage of Drugs and Biologicals F441 - Infection Control F492 - Compliance with Federal, State and local laws and Professional Standards F514 - Clinical Records F516 - Resident Identifiable Information/Safeguard against loss, destruction, or unauthorized use 4/27/2015

9 Revisions to SOM Chapter 4: Section 4132.1E Waiver of Program Prohibition has been revised to incorporate information consistent with CFR 483.151(c)(1). Section 4542.2 State Agency (SA) Expenses for Training of SA Personnel has been revised to include Association of Health Facility Survey Agencies (AHFSA) to the list of annual meetings. 4/27/2015

10 S&C 14-34-NH Skilled nursing and nursing facilities should use pasteurized shell eggs or liquid pasteurized eggs to eliminate the risk of residents contracting Salmonella Enteritidis (SE). The use of pasteurized eggs allows for resident preference for soft-cooked, undercooked or sunny-side up eggs while maintaining food safety. In accordance with the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) standards, skilled nursing and nursing facilities should not prepare nor serve soft- cooked, undercooked or sunny-side up eggs from unpasteurized eggs. 4/27/2015

11 Guidance for Surveyors: Signed health release agreements between the resident (or the resident’s representative) and the facility that acknowledges the resident’s acceptance of the risk of eating undercooked unpasteurized eggs are not permitted. Pasteurized eggs are commercially available and allow the safe consumption of eggs. If the facility prepares or serves unpasteurized or undercooked eggs which are not cooked until both the yolk and white are completely firm, surveyors should consider citing deficiencies at F371. Determination of the appropriate scope and severity shall be based upon the actual or potential negative resident outcomes in accordance with guidance given at F371. 4/27/2015

12 S&C 14-25-NH Tag F441, Infection Control, Preventing Spread of Infection/Indirect Transmission has been revised. Single-Use Device Guidance: Nursing homes may purchase reprocessed single-use devices when these devices are reprocessed by an entity or a third party reprocessor that is registered with the Food and Drug Administration. Single-Use Device (SUD): A SUD is a device that is intended for one use on a single patient during a single procedure. Reprocessed SUD: A reprocessed SUD is an original device that has previously been used on a patient and has been subjected to additional processing and manufacturing for the purpose of an additional single use on a patient. 4/27/2015

13 S&C 14-29-LSC On August 13, 2008, the Centers for Medicare and Medicaid Services (CMS) published a final rule entitled “Medicare and Medicaid Programs: Fire Safety Requirements for Long Term Care Facilities, Automatic Sprinkler Systems.” This regulation required all long term care facilities to be equipped with a supervised automatic sprinkler system by August 13, 2013. Limited Extensions: On May 12, 2014, CMS also published a final rule (CMS-3267-F) to permit a very limited extension of the automatic sprinkler due date for a facility that is building a replacement facility or undergoing major modifications to unsprinklered living areas. 4/27/2015

14 S&C 14-28-NH A notice of proposed rule-making (NPRM) regarding Nursing Home Civil Monetary Penalties was published Tuesday, May 6, 2014. The proposed rule provides clarification of statutory requirements under Section 6111 of the Affordable Care Act regarding the approval and use of Civil Money Penalties (CMPs) imposed by The Centers for Medicare & Medicaid Services (CMS) against nursing facilities. 4/27/2015

15 S&C 14-20-NH Revised total SFF Slots: Effective April 2014, we have adjusted the number of designated slots and candidates so States can resume selecting and replacing nursing homes for SFF designation. Adjustment to Number of Slots: Pursuant to the FY2013 budget sequestration, we reduced the number of SFF slots. We are now re-building the program by a gradual increase in the number of SFF slots from its reduced base. Later, we will also introduce additional methods to address persistently poor quality in nursing homes. 4/27/2015

16 Phase in period: States may have the option to start selecting SFFs immediately or phase in the total to meet the required number by July 2014. Continuation of Program Changes: As outlined previously the Centers for Medicare & Medicaid Services (CMS) Regions and States will continue with the Programmatic and Operational Adjustment by conducting the 18 month “last chance” onsite survey and reviewing the progress of all facilities that have been on the SFF list for more than 12 months. 4/27/2015

17 S&C 14-22-NH Focused Nursing Home Surveys Under Development: The Centers for Medicare & Medicaid Services (CMS) is currently developing two distinct focused survey processes to assess dementia care and Minimum Data Set, Version 3.0 (MDS 3.0) coding practices in nursing homes. CMS is planning to pilot these survey types beginning in 2014. The intent of the dementia care focused survey is to document dementia care practices in nursing homes. The intent of the MDS focused survey is to document MDS 3.0 coding practices and associated care planning in facilities. 4/27/2015

18 Training: CMS will provide training for those States participating in the focused reviews via webinar. This training will be mandatory for those State Survey Agency (SA) staff conducting reviews as well as one manager or trainer within the SA. Enforcement Implications: Deficient practices noted during the survey will result in relevant citations. 4/27/2015

19 S&C 14-18-NH Document updated and posted on 4/2/14 and contains updates made to the SOM effective 12-13- 13 and corrects formatting issues in the previous version. Advance Copy of Chapter 7: Chapter 7 of the State Operations Manual (SOM) has been revised to incorporate the following provisions of Section 6111 of the Patient Protection and Affordable Care Act (the Affordable Care Act): Independent IDR: An independent informal dispute resolution process (independent IDR) will be available when a civil money penalty (CMP) is imposed. 4/27/2015

20 Escrow: After an independent IDR, CMP funds will be collected and placed in escrow pending completion of any formal appeal. 50 Percent Reduction: A CMP may be reduced by 50 percent in certain cases of prompt correction for self-reported non- compliance. Use of CMP Funds: A portion of the CMP attributable to Medicare may be used for programs for the protection or benefit of nursing home residents. Reminder of Survey Process Timeframes: We are also highlighting specific timeframes associated with the survey process and emphasizing the importance of meeting these timeframes. 4/27/2015

21 S&C 14-12-ALL Revised Emergency Preparedness Checklist: The Centers for Medicare & Medicaid Services (CMS) is alerting healthcare facilities that we have revised current emergency preparedness checklist information for health care facility planning. These updates provide more detailed guidance about patient/resident tracking, supplies and collaboration. 4/27/2015

22 S&C 14-01-NH Initiation of CPR - Prior to the arrival of emergency medical services (EMS), nursing homes must provide basic life support, including initiation of CPR, to a resident who experiences cardiac arrest (cessation of respirations and/or pulse) in accordance with that resident’s advance directives or in the absence of advance directives or a Do Not Resuscitate (DNR) order. CPR-certified staff must be available at all times. Facility CPR Policy –Some nursing homes have implemented facility-wide no CPR policies. Facilities must not establish and implement facility-wide no CPR policies. 4/27/2015

23 Surveyor Implications - Surveyors should ascertain that facility policies related to emergency response require staff to initiate CPR as appropriate and that records do not reflect instances where CPR was not initiated by staff even though the resident requested CPR or had not formulated advance directives. 4/27/2015

24 S&C 13-60-ALL The Centers for Medicare & Medicare Services (CMS) Encourages New Owners of a Provider/Supplier to Accept Automatic Assignment of the Seller’s Medicare Agreement: o 42 CFR 489.18(c) provides for automatic assignment of the current Medicare agreement to a new owner. However, new owners have the option to reject automatic assignment, resulting in termination of the prior Medicare agreement in accordance with 42 CFR 489.52. If the new owner rejects assignment, the facility must be treated as an initial applicant if it seeks to participate in Medicare. Like all initial applicants the facility will experience a period (of uncertain duration) with no Medicare payments. This policy also applies in the case of hospitals that acquire another hospital, reject assignment, and make the acquired hospital a provider-based campus. 4/27/2015

25 State Survey Agency (SA) & Accreditation Organization (AO) Surveys Must Be Unannounced: o All surveys conducted for Medicare certification purposes must be unannounced in accordance with Section 2700A of the State Operations Manual (SOM). o If an initial survey of an applicant that acquired a provider/supplier but rejected assignment is conducted shortly after the acquisition date, it raises significant doubts that the survey was unannounced. At a minimum, the appearance is created that the SA or AO collaborated with the new owner on the timing of the survey. o CMS may refuse to accept a survey for certification purposes if the survey timing creates reasonable doubt that the survey was unannounced. 4/27/2015

26 SAs Must Prioritize Initial Surveys in Accordance with CMS Workload Priorities: o Unless the CMS Regional Office (RO) directs the SA to conduct an initial certification survey as soon as possible, SAs must not conduct initial surveys unless they are able to complete their higher priority workload. For initial applicants that have an accreditation option, initial certification surveys are the lowest SA priority. o When an SA conducts an initial certification survey of an applicant that acquired a provider/supplier but rejected assignment, the RO must review the facts of the case carefully to determine whether the SA deviated from CMS workload priorities as well as the SA’s typical practice for initial applicants. Such deviation may raise reasonable doubt that the survey was unannounced. 4/27/2015

27 Determination of the Medicare Agreement Effective Date: ROs determine the effective date of each Medicare provider agreement or supplier approval in accordance with 42 CFR 489.13. While the effective date can be the last day of an initial Medicare survey conducted by the SA or AO as part of the certification process, this is not always the case. SAs and AOs must not speculate to prospective providers/suppliers on what the likely effective date will be. Non-Long Term Care Survey Procedures When An Initial Survey Finds Substantial Noncompliance: We are reiterating the existing policy and process to be followed when an initial certification survey of a non-long term care applicant results in condition-level deficiency citations. 4/27/2015

28 S&C 13-57-NH Applicability of CMP, Escrow, IIDR: CMPs imposed pursuant to all standard or complaint surveys that begin on or after October 1, 2013, that initiate an enforcement action in which a CMP is imposed where the highest level of deficiency is less than a “G” level, will be subject to collection and escrow in accordance with 42 C.F.R. §488.431. CMPs based on surveys in which a deficiency is cited for actual harm or immediate jeopardy (“G” or higher) are already subject to escrow. Net Effect: Previously, CMS phased in the escrow requirement by limiting it to CMPs imposed for actual harm or immediate jeopardy. Effective October 1, 2013 every CMP imposed for a deficiency in a nursing home will be subject to escrow and the nursing home may request an independent informal dispute resolution. 4/27/2015

29 S&C 13-58-LSC Several Categorical LSC Waivers Permitted: The Centers for Medicare & Medicaid Services (CMS) has identified several areas of the 2000 edition of the LSC and 1999 edition of NFPA 99 that may result in unreasonable hardship on a large number of certified providers/suppliers and for which there are alternative approaches that provide an equal level of protection. This memorandum specifies the provisions that are available for waiver, including the conditions for the alternative approaches. 4/27/2015

30 Providers and Suppliers Must Elect to Use the Waiver: Individual waiver applications are not required, but providers and suppliers are expected to have written documentation that they have elected to use a waiver and must notify the survey team at the entrance conference for any survey assessing LSC compliance that it has elected the use of a waiver permitted under this guidance and that it meets the applicable waiver requirements. The survey team will review the information and confirm they are meeting the circumstances for the waiver. 4/27/2015

31 S&C 13-56-NH MDS 3.0 Discharge Assessments: The Centers for Medicare & Medicaid Services (CMS) is clarifying steps to take to address Minimum Data Set (MDS) 3.0 discharge assessments that have not been completed and/or submitted as required under 42 CFR §483.20(g) and 42 CFR §483.20(f)(1). The memo is intended to help surveyors understand both (a) what nursing homes should do to address inactive residents remaining on their resident roster due to incomplete and/or unsubmitted discharge assessments and (b) how nursing homes can ensure compliance with discharge assessment requirements. Action by September 30, 2013: We are providing this information in order to promote nursing home completion of discharge assessments for inactive residents by September 30, 2013. 4/27/2015

32 Office of Health Care Quality Comprehensive Care Facility and Assisted Living Program Transmittal February 25, 2014 Diet Manual Revision 4/27/2015

33 Chapters 141 and 426 Maryland Medical Assistance Program - Telemedicine Requiring, to the extent authorized by federal law or regulation, specified provisions of law relating to coverage of and reimbursement for health care services delivered through telemedicine to apply to the Maryland Medical Assistance Program and managed care organizations in a specified manner; authorizing the Department of Health and Mental Hygiene to allow coverage of and reimbursement for health care services delivered in a specified manner and subject to the limitations of the State budget; etc. 4/27/2015

34 Chapter 413: Maryland Medical Assistance Program - Waivers - Consolidation and Repeal Repealing the Living at Home Waiver Program; altering the requirements for applicants, financial eligibility criteria, and services to be included in the Department of Health and Mental Hygiene's home- and community-based services waiver; repealing the requirement that the Department of Health and Mental Hygiene work with the Maryland Health Care Commission to convert a specified percentage of nursing facility beds to assisted living program waiver beds; etc. 4/27/2015

35 Chapters 92 and 657 Prescription Drug Monitoring Continuing the Prescription Drug Monitoring Program in accordance with the provisions of the Maryland Program Evaluation Act (Sunset Law) by extending to July 1, 2019, the termination provisions relating to the statutory and regulatory authority of the Program; authorizing the Program to disclose specified information to specified persons under specified circumstances; requiring the Department of Legislative Services to conduct a direct full evaluation of the Program on or before December 1, 2017; etc. Authorizing the Prescription Drug Monitoring Program to review prescription monitoring data for a specified purpose and report possible misuse or abuse of a monitored prescription drug to a prescriber or dispenser; requiring the Program, before the Program reports the possible misuse or abuse, to obtain clinical guidance and interpretation from the technical advisory committee to the Program; requiring the Secretary of Health and Mental Hygiene to adopt specified regulations; etc. 4/27/2015

36 Chapter 449 Community Integrated Medical Home Program Establishing the Community Integrated Medical Home Program and its mission; establishing the Community Integrated Medical Home Program advisory body; requiring the advisory body to include specified stakeholders; requiring the Department of Health and Mental Hygiene to submit a report on the recommendations of the advisory body and the development of the Community Integrated Medical Home Program to the Governor, the Senate Finance Committee, and the House Health and Government Operations Committee; etc. 4/27/2015

37 Chapter 460 Behavioral Health Administration - Establishment and Duties Merging the Alcohol and Drug Abuse Administration and the Mental Hygiene Administration in the Department of Health and Mental Hygiene to establish the Behavioral Health Administration in the Department; establishing the responsibilities, powers, and duties of the Director of the Behavioral Health Administration; requiring substance use disorder programs and mental health programs to be licensed by the Secretary of Health and Mental Hygiene, with specified exceptions; repealing a specified prohibition; etc. 4/27/2015

38 Chapters 314 and 315 Mental Health - Approval by Clinical Review Panel of Administration of Medication - Standard Altering the standard for approval by specified clinical review panels of the administration of specified medication to specified individuals with mental disorders admitted to specified facilities. 4/27/2015

39 Chapters 352 and 353 Department of Health and Mental Hygiene - Outpatient Services Programs Stakeholder Workgroup Requiring the Secretary of Health and Mental Hygiene to convene a stakeholder workgroup to examine assisted outpatient programs, assertive community treatment programs and other specified outpatient services programs, to develop a specified proposal, and to evaluate a specified standard; requiring the Secretary to submit a report of the workgroup's findings and recommendations to specified committees of the General Assembly on or before November 1, 2014; etc. 4/27/2015

40 Chapters 240 and 256 Medical Marijuana - Natalie M. LaPrade Medical Marijuana Commission Altering the purpose of the Natalie M. LaPrade Medical Marijuana Commission to include the approval of physicians, development of a Web site, establishment of an application review process, and issuance of medical marijuana grower licenses; authorizing a medical marijuana grower to distribute marijuana at specified facilities; identifying patients and caregivers; requiring the Commission to report to the General Assembly on the level of competition in the market for medical marijuana on or before December 1, 2015; etc. 4/27/2015

41 Chapter 83 Maryland Health Care Commission Authorizing the Maryland Health Care Commission to award specified funds received from any person or government agency; authorizing the Commission to make agreements with a grantee or payee of funds, property, or services; requiring the Commission, in awarding specified funds, to use a specified process and evaluate proposals for funding using a panel that consists of specified individuals; and requiring the Commission to provide specified information on its Web site and submit a specified report to the General Assembly. 4/27/2015

42 Chapter 608 Health - Statistics and Records - Electronic Filing of Death Certificates Requiring the Secretary of Health and Mental Hygiene, on or before January 1, 2015, to establish a process by which death certificates can be filed electronically and to educate physicians, physician assistants, and nurse practitioners regarding the process. 4/27/2015

43 Chapter 398 Public Health - Medical Records Charges - Medicaid Enrollees Prohibiting a health care provider from charging a person in interest except for a specified attorney who requests a copy of a medical record of an individual enrolled in the Maryland Medical Assistance Program a fee that exceeds $20 for each 100 pages or portion of 100 pages copied, adjusted annually for inflation in a specified manner. 4/27/2015

44 Chapter 650 Public Health - Drug Overdose Deaths - Local Fatality Review Teams Authorizing the establishment of a specified local drug overdose facility review team in each county; authorizing the establishment of a specified multicounty local team; providing for the composition, appointment of specified members, chair, and meetings of a local team; establishing that specified substance abuse treatment records are subject to additional limitations on disclosure or redisclosure; etc. 4/27/2015

45 Chapter 643 Health Occupations - Massage Therapy - Authority to Practice Requiring an individual to be registered by the State Board of Chiropractic and Massage Therapy Examiners before the individual may practice massage therapy in a specified setting; altering the number of hours and specified educational requirements an applicant for a specified license or registration must complete to qualify for a license or registration; etc. 4/27/2015

46 Chapters 559 and 560 State Board of Nursing - Nurses, Nursing Assistants, Medication Technicians, and Electrologists - Licensing, Certification, Regulation, Violations, and Penalties Requiring the State Board of Nursing to establish, beginning January 1, 2015, a program through which the Criminal Justice Information System Central Repository reports to the Board specified criminal history information for specified applicants; establishing requirements for the Board to place specified licensees and certificate holders on inactive status if specified documentation of a medical condition is submitted to the Board; etc. 4/27/2015

47 Chapters 140 Health Occupations - Licensed Podiatrists - Scope of Practice and Hospital Privileges Altering the definition of "practice podiatry" to include the surgical treatment of acute ankle fracture in the scope of practice of licensed podiatrists; and requiring qualifications that a hospital or related institution sets for granting specified privileges for specified services to include consideration of specified training, education, and experience. 4/27/2015

48 Chapter 328 Maryland Behavior Analysts Act Establishing the Behavior Analyst Advisory Committee within the State Board of Professional Counselors and Therapists; requiring the Board to adopt regulations and a code of ethics; requiring the Board to set fees for services provided by the Board to behavior analysts; providing for a behavior analyst rehabilitation subcommittee to evaluate and provide assistance to any behavior analyst in need of treatment and rehabilitation for alcoholism, drug abuse, chemical dependency, or other specified conditions; etc. 4/27/2015

49 Chapters 153 and 399 State Board of Physicians - Naturopathic Doctors Establishing the Naturopathic Medicine Advisory Committee within the State Board of Pharmacy; providing for the composition of the Committee; providing for the terms of a Committee member; specifying the duties of the Committee; requiring the Board to adopt specified regulations; requiring the Board to set fees for the issuance and renewal of licenses; requiring the Board to pay the fees to the Comptroller; requiring the Comptroller to distribute the fees of the Board; etc. 4/27/2015

50 Chapter 263 Health Services Cost Review Commission - Powers and Duties, Regulation of Facilities, and Maryland All-Payer Model Contract Authorizing the Health Services Cost Review Commission, consistent with Maryland's all-payer model contract, to establish hospital rate levels and rate increases in a specified manner and promote and approve specified alternative methods of rate determination and payment; increasing the total amount of specified user fees that the Commission may assess; requiring the Commission to make a report, beginning October 1, 2014, and every 6 months thereafter, to specified individuals and the General Assembly; etc. 4/27/2015

51 Chapter 18 Maryland Health Care Commission - Requirement for Certificate of Need - Exceptions Establishing an exception to the requirement that a person have a certificate of need issued by the Maryland Health Care Commission before specified actions are taken relating to a health care facility by altering the definition of a "health care facility" to exclude a comprehensive care facility that is owned and operated by the Maryland Department of Veterans Affairs and that restricts admissions to specified individuals; and clarifying language. 4/27/2015

52 Chapter 510 Labor and Employment - Nursing Homes and Health Care Facilities - Workplace Safety Assessment and Safety Program Requiring specified nursing homes to assign to an appropriate committee the task of conducting an annual assessment of workplace safety issues and making recommendations; requiring the committee to consult specified employees of the nursing home; requiring a specified health care facility to establish a workplace safety committee; requiring a workplace safety committee to establish a workplace safety program including specified components; etc. 4/27/2015

53 Chapter 654 Secretary of State and Attorney General - Charitable Enforcement and Protection of Charitable Assets Authorizing the Attorney General to take specified actions relating to investigations of alleged violations of laws relating to charitable organizations and charitable representatives; providing that a specified enforcement action or other remedy is subject to specified immunity or limitation on liability; requiring that an action to enforce specified provisions of the Act be brought within a specified period of time; etc. 4/27/2015

54 BAA Deadline HITECH Final Rule issued in 2013 – modified the obligations of Business Associates – Covered Entities and Business Associates must both comply with the business associate agreement requirements – Liability for downstream contractors Compliant BAAs were grandfathered until 9/23/14 4/27/2015

55 OCR HIPAA Audits Round 2 of OCR audits has been announced – Will review Covered Entities and Business Associates Expectation that this round of audits will be used as an investigation and enforcement tool 4/27/2015

56 What’s Next The OCR reports that we can expect guidance on: Minimum necessary requirements Producing accountings to include information on treatment, payment, and health care operations Breach Notification safe harbors Marketing rules 4/27/2015

57 Questions? 4/27/2015

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