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May 11 and PHE: Provider Alert

On May 11, the COVID Public Health Emergency (PHE) is set to end and along with it, a whole slew of requirements end or change, and regulatory waivers applicable to the Public Health Emergency, the same (ending). The end of the PHE will have positive and negative impacts on providers of all types though some things that were applicable during the PHE will continue via CMS rulemaking (tele-health provisions for example). One of the most negative impacts of regulatory waivers ending is the return of the three-overnight rule (3 day stay) for patients entering an SNF and potentially, receiving Medicare coverage for their qualifying stay. I wrote a post on this waiver change here: https://wp.me/ptUlY-w5

Among the most notable changes that will occur for providers with the end of the PHE are the requirements around masking, testing, and vaccination mandates for staff.  Each of these conditions are effectively, eliminated with the expiration of the PHE.  While other countries across the world have eliminated all or most of their pandemic restrictions/requirements over the past year, the U.S. and its health system have been slow to relax requirements with the Biden Administration extending the emergency up until May 11.  Similarly, the emergency patchwork has followed through to states, some long ago abandoning masking requirements, vaccination mandates, testing, etc.  What has been confounding is the myriad of rule interpretations and requirements that varied from municipalities to counties, to states, and ultimately, to the Federal government.  For Medicare/Medicaid providers, Federal requirements superseded all other provisions in any other jurisdiction.

Within the Public Health Emergency period, even providers not participating in Medicare or Medicaid were impacted by the Federal policies.  Many states chose to follow the Federal PHE provisions, layering the same over providers within the senior housing industry (aka Assisted Living and some CCRC/Independent Living under state law).  Illinois is an example.  In contrast, other states chose to ignore the Federal PHE provisions when not applicable to providers such as hospitals, nursing homes, home health, etc.  Iowa, Florida, Texas are examples of states that early-on in the pandemic created rules or as in the case of Iowa, passed legislation prohibiting vaccine or mask mandates within state control.

Come May 11, confusion will no doubt remain prominent on COVID infection control/public health requirements.  For example, the only updated CDC guidance on masking requirements dates back to September of 2022.  In this guidance, the recommendation for masking requirements for visitors, patients, and staff is conditioned on a CDC tracking mechanism for the level of community concentration of COVID infection.  Reporting from health departments, hospitals, SNFs, etc., fed this mechanism.  Masking recommendations were tied to this level (high recommending masking vs. low, recommending optional masking).  COVID testing requirements were also tied to this measure.

Effective with the end of the PHE, CDC has indicated that it would no longer report on the level of community infection/transmission.  The PHE has deferred consistently to various agency recommendations for requirements and then subsequently, enforcement as needed.  Clearly, we will see extensive confusion unless the CDC issues new guidance clearing up, the masking requirements tied to community COVID prevalence. I’ve watched many providers already move to a “no mask required” status, regardless of updated guidance.  I’ve also watched many providers stuck and confused by virtue of state requirements vs. CDC requirements vs. where the community COVID prevalence really was in their area. The CDC guidance for long-term care (fundamentally the same for hospitals) is here: https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fhcp%2Fnursing-home-long-term-care.html

I’ve seen some news coverage/reporting on the end of the Public Health Emergency, but it is very spotty.  I also know by virtue of travel, etc., the awareness of COVID among providers and the community is varied.  As I routinely traverse Illinois, Wisconsin, and Iowa, I see wide differences in COVID precautions, alerts, monitoring, requirements being applied, etc. Some of this due to region and state policy and some of it is due to provider behavior.  Iowa as I mentioned, long ago took a stance against most PHE COVID related mandates and recommendations whereas Illinois, has followed the PHE Federal recommendations consistently. Iowa hospitals required to follow CMS COVID regulations, maintained vaccination and masking conditions though recently, I have seen most hospitals end masking requirements.

For providers, May 11 is very near.  I suggest providers adopt the following strategies realizing, come May 11, regulatory confusion will likely remain.

  • Update internal infection control policies regarding vaccination, testing, masking to conform to the changes that will occur with the end of the PHE.
  • Communicate these changes to staff ASAP.
  • Communicate these changes to patients and families, ASAP.  Remember, the end of a mandate does not mean a change in behavior.  It may be that staff will want to maintain their masks in some cases and patients/families the same.  Allow for flexibility.
  • State agencies that are required to survey and enforce compliance may also be slow to adopt.  Trade associations are your best bet to help with regulatory transition.  Recognize, state agency behavior will not adjust in some cases, as quickly as provider behavior.
  • Conduct ongoing public communication via your website, via newsletters, etc.  One and done won’t work.
  • Definitely, DON’T, follow a path of resisting the end of the PHE and its requirements.  I’ve watched provider sometimes, fail to adjust and in this failure, more problems occurred.  I know the old “an ounce of prevention” thinking may still apply when it comes to vaccines or masking but be careful.  If the regulation is not there, a forced or strongly urged condition, can lead to regulatory problems, labor law problems, community relations problems, and potentially, litigation.

 

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May 2, 2023 Posted by | Health Policy and Economics, Home Health, Hospice, Policy and Politics - Federal, Skilled Nursing | , , , , , , , , , , , , , , , , , , , | Leave a comment

New SNF Conditions of Participation: Implementation Timeframes

About ten days ago, I published a post regarding the new Federal Conditions of Participation for SNFs.  This long awaited regulatory update includes new, revised, and existing regulations published in final rule form last week (October 4).  The post is here for reference http://wp.me/ptUlY-kL

The questions frequently asked regarding the new CoPs (since release) are around implementation dates.  As readers will note, whether in my post or in the actual Final Rule, enforcement is in phases spanning a three year time frame – November 2016 through 2018. Recall that the CoPs in the Final Rule are the broad law changes.  Implementation requires specificity found (typically) in the Interpretive Guidelines – the actual “regs”.  We aren’t there yet and given the breadth of change in certain instances, time is necessary for regulations to be written and providers to comply.  Hence, the phasing.

I have posted below, the implementation timeframe for reference.  This guide is available via this post and is hosted on the Reports and Other Documents page on this site. I have articles forthcoming (soon) here and on other sites regarding implementation strategies and tips.  In the meantime, readers can always forward a question via comment to this post or to my e-mail address noted on the Author page.  Remember: If you want an answer direct, please provide a current, working e-mail address.  I do respond to all questions and comments as efficiently as I can.

The timeframe document is here:

implementation-timeframes

 

October 11, 2016 Posted by | Policy and Politics - Federal, Skilled Nursing | , , , , , , , , | Comments Off on New SNF Conditions of Participation: Implementation Timeframes

CMS Releases Proposed New SNF Rule

Concurrent with the White House Conference on Aging, CMS released its “proposed” rules of reform for the SNF Conditions of Participation.  The proposed rule is set for publication tomorrow in the Federal Register but readers with interest can access the document/PDF on this site on the “Reports and Other Documents” page.  The Federal Conditions of Participation for SNFs have not undergone substantial revision or update since 1991 (OBRA implementation and PPS).  A portion of the impetus for the update is the continued roll-out of the various pieces of the ACA (Obamacare).  Within the ACA are several directions to the Secretary of Health and Human Services to make modernization recommendations and regulatory updates for all provider segments within the Medicare/Medicaid domain.

In researching the content for this post and reviewing the released document (402 pages), it seemed the best use of space and the most expeditious for readers/followers that I summarize the “impactful” elements rather than regurgitate the content of the document.  In so doing, I need to preference my summary with a bit of a preamble.

The document is a release of “proposed” rules not concretized rules.  There is a lengthy comment period and the final rule will morph from this release.  While I won’t profess to have a crystal ball, I have certain insight and 30 plus years of experience so I think my summary will provide a solid look into what the salient changes are and what is likely to happen.  The latter is for another post and a planned webinar (watch for details).  The key to remember for anyone reading this post and any other information that is current and forthcoming regarding the proposed rule is that this is the “macro” level; the finite level is the implementation and the survey and enforcement data otherwise known as Interpretive Guidelines.  What you see now, read now, etc. is and will be a far cry from how the same (when final) is interpreted at the facility level and enforced.  I can’t emphasize this point enough as anyone who has a similar history to me knows, the stuff in the Federal Register as the actual law can be widely and sometimes, astoundingly interpreted and enforced at the ground level (again, fodder for another post).

To begin: What is proposed to change is an actual bifurcation of clarifications and new elements.  Oddly enough, there isn’t a tremendous amount of overhaul moreover, language changes and “modernizations”. In certain instances, the words are just references to current industry vernacular such as “care transitions” rather than transfer and discharge.  Resident Rights are also a section where nothing substantive changes other than references and language.  Ironically (and I could run a fun contest here), a number of proposed changes are nothing more than an incorporation of what I have seen evolve as survey tasks and enforcement tasks (current) that aren’t really tied (bright line) to current law.  (Feel free to comment to this post if you see some of these ironic elements in the proposed rule).  So, without further dribble, here is what my summary of the key proposed changes.

  • Transitions of Care: There are two elements of change – one in 483.15 (Transfer, Discharge) and the other in 483.30 (Physician Services). First, any transition from the SNF to any provider will require additional documentation to accompany the resident such as present illness, reason for transfer, medical history, etc. This isn’t major.  The major element is for any non-scheduled hospital transfer, the rule would require an in-person evaluation of the resident prior to the transfer by a physician, physician assistant, or advance practice nurse (qualified nurse specialist or NP).  This means the 2:00 AM transfer to the hospital for an urgent/emergent condition could not occur without one of the aforementioned individuals being “on-site” and certifying the need for the discharge.  I believe this element will either evaporate from the final rule or be substantially changed and better defined.  It is not only impractical but frankly, in rural areas, etc., completely improbable and virtually impossible (heavy emphasis on “virtual’ as that is the only way it could occur, via tele-medicine).
  • Care Planning: A new section is added titled “Comprehensive Person-Centered Care Planning” that will require an initial care plan in 48 hours, an expanded definition of Interdisciplinary Team to include a CNA, a food service/nutrition staff member and a social worker. The rule also proposes to implement the requirements of the IMPACT Act (Improving Medicare Post-Acute Care Transformation Act) as pertaining to discharge planning (med reconciliation to include pre-admission meds and current meds plus OTCs, discharge summary recommendations for follow-up care, resources and information for the resident regarding his/her discharge plan, etc.  I believe this element will remain in the final rule, substantially unchanged.
  • Nursing Services: The proposed rule would incorporate a competency requirement for determining sufficient number of staff based on a facility assessment which incorporates number of residents, acuity, diagnoses and careplans.  This one I see changing quite a bit as it is so vague and potentially fraught with huge implementation and oversight problems.  It also as written, is a bit confusing and disconcerting in terms of a survey element.
  • Behavioral Health: This is proposed as a new section.  It, similar to Nursing Services prior, would require a facility assessment to determine direct care staff needs regarding staff competency and skill sets to meet resident psychological and mental health needs.  Again, I see this changing dramatically as it is horribly vague and fraught with implementation challenges.
  • Pharmacy Services: The proposed rule includes a required 6 month pharmacist review of resident medication regimes and upon admission when the resident is new and post-hospitalization (return). and monthly when the resident is on an antibiotic, psychotropic drug or any other drug that a QAA (Quality Assurance) committee requests the pharmacist review.  Irregularities are to be noted and reported to the attending physician, the medical director and the director of nursing.  Attending physicians are then to document that the irregularity was reviewed and any action taken/not taken plus the reasoning for the action.  I see this fundamentally staying with some clarifications.
  • Dental Services: The “big” shift is the proposed requirement that facilities are prohibited from charging a Medicare resident for loss or damage of dentures, if the facility is responsible for the dentures.  I’m not sure where this will fall out but if it remains fundamentally intact, facilities will be paying for lots of dentures, regardless of how the loss or damage occurred.
  • Food Service: Following thematically with other elements in the proposal, the requirement is for a facility to assess the resident population by care needs, diagnoses, acuity and census and employ sufficient staff with sufficient competency to provide food and nutritional services.  A Director of Food Service in the proposal must meet certain education and training requirements such as Certified Dietary Manager, Certified Food Service Manager, have at least an Associate’s degree in food service management or similar from an accredited institution.  The proposal also requires facility menus to be reflect the cultural, religious and ethnic needs and preferences of residents, be periodically updated and not limit the resident’s right to make food choices.  In addition, facilities will have to allow residents to consume and store foods brought by visitors and families.  I see major changes forthcoming in this requirement, especially around the staff adequacy determination, menus and food brought into the facility by visitors and families.  The latter is a huge infection control risk.
  • QAPI: This requirement is added anew – not surprising.
  • Facility Assessment: This also is a new element requiring the facility to conduct and document a facility-wide assessment to insure the resources necessary to care for residents are available daily and in emergencies.  This assessment must be updated regularly.  The assessment must address the resident population by number, overall care delivered and the staff competency to provide the care and meet resident preferences plus incorporate a facility-based and community-based risk assessment.  I see this element changing dramatically as it is vague and potentially problematic to enforce and implement.
  • Binding Arbitration Agreements: The rule will require facilities that use such agreements to meet certain requirements. Chief among the provisions is that a resident and/or his/her legal representative cannot be required to sign the agreement upon admission.  Additionally, the agreement must indicate the resident’s right to communicate with federal, state and local officials (regulatory) including Ombudsmen. I do not see much change in this element.
  • Infection Control: In addition to having an Infection Control Program the facility would be required to have an Infection Control Officer and this individual’s primary responsibility must be infection control. I see the Infection Control Officer element subject to change.
  • Compliance and Ethics Program: This is a new element requiring the operating organization (not just the facility if part of a larger organization) to have at each facility a compliance and ethics program with written standards, policies and procedures such that the same are capable of reducing criminal, civil ad administrative violations.  I see this element staying but changing to be a bit more definitive and relevant.
  • Staff Training Requirements: This is also a new element requiring facilities to develop, implement and maintain for all staff, a training program that encompasses (minimally) the following (I don’t see much change in this requirement);
    • Communication
    • Resident Rights and Facility Responsibilities
    • Abuse, Neglect and Exploitation
    • QAPI
    • Compliance and Ethics
    • Ongoing education for CNAs in dementia education and abuse prevention (12 annual hours minimum)
    • Behavior Health Training

The estimate provided by CMS for implementation cost at the facility level is $46,491 in the first year, $40,685 in the following year totaling $729 million industry-wide in the first year.  I guarantee that these numbers are light by 50% or more and in stable to declining reimbursement periods (now and going forward), this will be the driving point the industry will use in lobbying Congress, among the other points noted herein.

 

July 15, 2015 Posted by | Policy and Politics - Federal, Skilled Nursing | , , , , , , , , , | Comments Off on CMS Releases Proposed New SNF Rule

New HIPAA Provision Now in Effect

In August of 2009, the Department of Health and Human Services issued an interim final rule requiring that all HIPAA covered entities and their business associates develop notification requirements for a breach of unsecured protected health information (PHI).  These new requirements are part of the Health Information Technology for Economic and Clinical Health Act (HITECH).  In order to comply with the provisions, covered entities need to develop revised policies, assessment tools and notification processes specific to a breach of unsecured PHI.

The new regulations are designed to expand the coverage scope of HIPAA to the increased use of electronic communication. Under the new provisions, a breach that occurs requires the covered entity to notify the individuals affected by the breach, the Secretary of HHS and in certain circumstances, the media.

The fundamental issue in the new provisions centers on the difference between unsecured and secured PHI.  PHI that is secured by encryption or has otherwise been rendered unreadable or unusable and is ultimately disclosed, does not require notification.  PHI that is unsecured and may be readable or useable and is subsequently disclosed, requires notification as specified in the Act. A breach is defined as the acquisition, use or disclosure of PHI which compromises the security and/or privacy of the information.

 According to the rules, if a breach of unsecured PHI occurs, the covered entity must notify the individuals affected no later than 60 days from when the breach was discovered. The notification must include a description of what occurred, a description of what information was disclosed (social security numbers, addresses, etc.), steps the affected individuals should take to protect themselves, a description of what the covered entity is doing to reduce harm to the individuals and to prevent further disclosures and finally, relevant contact information for the covered entity (including toll-free telephone numbers) so that individuals may ask questions.  The notification is required to be written.

In addition to notifying the affected individuals, covered entities are required to notify the Secretary of HHS.  If the breach affected less than 500 individuals, the covered entity is required to maintain a log of the breach and any prior or subsequent breaches (for the prior year) and submit the information to the Secretary within 60 days of the end of the calendar year.  If the breach affected more than 500 individuals, the covered entity must notify the Secretary within 60 days of discovery of the breach.  HHS will post the names of covered entities involved in breaches affecting more than 500 individuals on its website.

If the breach involves more than 500 individuals, the covered entity is also required to notify the media outlets within the region or area where the breach occurred.  The notice must contain the same information as provided in the notice to individuals.  The notification also must occur within 60 days of discovery of the breach.

For Business Associates, the discovery of a breach on their part must be disclosed to the covered entity within 60 days after discovery. If the breach involves multiple covered entities, the business associate is required to notify each covered entity.  Notification requirements on the part of the covered entity to affected individuals still apply however, the time frames for providing such notice depend on whether the business associate was an agent or an independent contractor of the covered entity.  For example, if the business associate is an agent of the covered entity, the discovery of the breach on its part is viewed in the rules as discovery on the part of the covered entity.  In summary, in this case, the rules for notification apply as if the covered entity discovered the breach (60 days from the date of discovery), even if the business associate/agent did not immediately communicate the discovery to the covered entity.

For health care providers who haven’t yet sought to comply with the new regulations, there is a bit of a breather.  HHS will not enforce the sanctions provisions for any breaches that occurred prior to February 22, 2010.  Complying with the “intent” of the new provisions will require health care providers to obtain new or updated Business Associate agreements with all related parties.  The new agreements need to spell out the new notification requirements and the roles and responsibilities of the entities.  In addition, providers should review and update their policies to conform with the notification requirements and the time frames as specified for notification.  Annual HIPAA training should reflect the new requirements and it is advisable that some form of interim training should occur to alert key staff to the new requirements.

February 17, 2010 Posted by | Policy and Politics - Federal | , , , , , , , , | Comments Off on New HIPAA Provision Now in Effect