Top 10 FAQs on Medicare’s Virtual Check-In Codes: The New Brief Communication Technology-Based Service



Telemedicine providers rejoice: Medicare will cover new virtual care services starting January 1, 2019.  The Centers for Medicare and Medicaid Services (CMS) just published the final rule for the 2019 Physician Fee Schedule, introducing a new code: Virtual Check-Ins, officially titled “Brief Communication Technology-Based Service” (HCPCS code G2012).  This article discusses the new code and explains how it will work.

Medicare Virtual Check-Ins Frequently Asked Questions (FAQs)

  1. What are Virtual Check-Ins? , Officially titled “Brief Communication Technology-Based Service, e.g. Virtual Check-In.”  Virtual Check-In  is defined as “Brief communication technology-based service, e.g. virtual check-in, by a physician or other qualified health care professional who can report evaluation and management (E/M) services, provided to an established patient, not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment; 5-10 minutes of medical discussion).”
  2. What Modality is Allowed? CMS stated the code allows “audio-only real-time telephone interactions in addition to synchronous, two-way audio interactions that are enhanced with video or other kinds of data transmission.”  (Note: telephone calls that involve only clinical staff cannot be billed using HCPCS code G2012 since the code explicitly describes (and requires) direct interaction between the patient and the billing practitioner.)  Unfortunately, CMS did not state that pure asynchronous modalities would qualify for this code.
  3. Is There a Patient Co-Payment for Virtual Check-Ins? Yes, as a Medicare Part B service, the patient is responsible for a co-payment for the service.  While several groups asked CMS to eliminate any beneficiary co-payment for the service, CMS explained that it does not have the authority to change the applicable beneficiary cost sharing for most physician services.  Providers are cautioned to bill the patient (or the patient’s secondary insurer) for the co-payment, as routine waivers of patient co-payments can present a fraud & abuse risk under the federal Civil Monetary Penalties Law and the Anti-Kickback Statute.
  4. Is Patient Consent Required? Patient consent is required for this service, due in part to the fact that there is a patient co-pay. CMS stated that written consent is not required; a practitioner can obtain the patient’s verbal consent and note that in the medical record for each billed service (i.e. every time the patient wants to obtain a virtual check-in).  This is a disappointing requirement for the patient’s user experience, particularly as CMS could have allowed a process where the patient gave consent once, and the practitioner kept a copy on file.
  5. Are There Any Patient Restrictions? CMS limits this code to established patients only. With regard to what constitutes an “established patient”, CMS defers to CPT’s definition of this term. CPT defines an established patient as one who has received professional services from the physician or qualified health care professional or another physician or qualified health care professional of the exact same specialty and subspecialty who belongs to the same group practice, within the past 3 years.
  6. Who Can Deliver Virtual Check-Ins? Virtual Check-Ins can be delivered only by those practitioners authorized to furnish E/M services.  This service is meant to describe, and account for the resources involved, when the billing practitioner directly furnishes the virtual check-in.  Accordingly, only physicians and qualified health care professionals are allowed to bill for this service.
  7. Are There Any Frequency Limits? There is no frequency limitation on this code.  Indeed, the service might potentially be an excellent fit in behavioral health treatment for specific patients (e.g., assessing suicidal risk), in which case the frequency should not be limited since routine virtual check-ins would be clinically warranted in some cases. CMS will monitor utilization of the code to determine whether or not it will impose a frequency limitation in the future.  Even without an express frequency limitation, Virtual Check-Ins, like all other physicians’ services billed under Medicare, must be medically reasonable and necessary to be reimbursed.
  8. Are There Any Timeframe Limitations? CMS considered and appreciated the comments to remove the timeframe limitations, but ultimately decided to retain them in the code.  Of particular disappointment is that CMS retained the “or soonest available appointment” language. CMS agreed that in each individual case, it might be challenging to prove whether or not other appointments were available prior to the visit, especially since beneficiary convenience is also presumably a factor for when appointments are scheduled.  However, CMS concluded that as a whole, retaining the language in the code description could help to guard against the potential for abuse that would be present if CMS instead adopted a purely time-based window for bundling of this service.
    1. If the Virtual Check-In originates from a related E/M service provided within the previous 7 days by the same physician or other qualified health care professional, then the service is considered bundled into that previous E/M service and G2012 would not be separately billable (provider liable). In that event, do not bill either the patient or the Medicare program for that code.
    2. If the Virtual Check-In leads to an E/M service with the same physician or other qualified health care professional within the next 24 hours or soonest available appointment, then this service is considered bundled into the pre- or post-visit time of the associated E/M service, and therefore, would not be separately billable (provider liable). In that event, do not bill either the patient or the Medicare program for that code.
  9. What are the Documentation Requirements? There are no service-specific documentation requirements for Virtual Check-Ins (other than documenting the patient’s consent, of course). Documentation for Virtual Check-Ins is consistent with the requirements for other Medicare covered physician services.
  10. Are There Any Patient Location Requirements? The patient need not be located in a rural area or any specific originating site.  The patient can be at home.  Providers frustrated with the labyrinthine and narrow Medicare coverage of telehealth services can take comfort in the fact that Virtual Check-Ins are not considered a Medicare telehealth service.


The new code represents a sizeable change to allow providers to efficiently use new technologies to deliver medical care. By reimbursing for virtual check-ins, the new code exemplifies CMS’ renewed vision and desire to bring the Medicare program into the future of clinically-valid virtual care services.

For more information on telemedicine, telehealth, virtual care, and other health innovations, including the team, publications, and other materials, visit Foley’s Telemedicine and Digital Health Industry Team and read our 2017 Telemedicine and Digital Health Executive Survey.

Source link

read more

Medicare Remote Patient Monitoring Reimbursement FAQs:   Everything You Need to Know About Chronic Care Remote Physiologic Monitoring Codes 



Remote Patient Monitoring (RPM) is the next big thing in medical care; patients just don’t know it yet.  And, it seems, neither do many physicians.  On Thursday, CMS published the final rule on its new RPM codes, officially titled “Chronic Care Remote Physiologic Monitoring.”  There are three new RPM codes, all of which will go live starting January 1, 2019.  These codes incentivize providers to effectively and efficiently use RPM technology to monitor and manage patient care needs.  

Medicare Remote Patient Monitoring Frequently Asked Questions (FAQs)

1. Does Medicare Already Cover Remote Patient Monitoring? 

Yes.  Even before the new codes, Medicare already offered separate reimbursement for RPM services billed under CPT code 99091.  That service is defined as the “collection and interpretation of physiologic data (e.g., ECG, blood pressure, glucose monitoring) digitally stored and/or transmitted by the patient and/or caregiver to the physician or other qualified health care professional, qualified by education, training, licensure/regulation (when applicable) requiring a minimum of 30 minutes of time.”  It went live for the first time on January 1, 2018.   

2. Why Did CMS Create the New RPM Codes? 

While industry advocates generally applauded CMS for activating CPT 99091, they recognized how that code fails to optimally describe how RPM services are furnished using current technology and staffing models.  This failure may be due to the fact that CPT 99091 is 16 years old and had never before been a separately payable service.  (It is an older code CMS “unbundled” and designated as a separately-payable service.)  Indeed, the AMA’s CPT Editorial Panel developed and finalized the three new RPM codes in late 2017.  These are the codes CMS finalized effective in 2019.  The new codes do a far better job in accurately reflecting contemporary RPM services. 

3. What Are the New RPM Codes? 

The new Chronic Care Remote Physiologic Monitoring codes are: 

  • CPT code 99453: “Remote monitoring of physiologic parameter(s) (eg, weight, blood pressure, pulse oximetry, respiratory flow rate), initial; set-up and patient education on use of equipment.” 
  • CPT code 99454: “Remote monitoring of physiologic parameter(s) (eg, weight, blood pressure, pulse oximetry, respiratory flow rate), initial; device(s) supply with daily recording(s) or programmed alert(s) transmission, each 30 days.” 
  • CPT code 99457: “Remote physiologic monitoring treatment management services, 20 minutes or more of clinical staff/physician/other qualified healthcare professional time in a calendar month requiring interactive communication with the patient/caregiver during the month.” 

4. How Much Time is Required to Bill CPT 99457? 

At least 20 minutes per calendar month.  This differs from CPT 99091, which requires at least 30 minutes per 30-day period.  CPT 99457 is much easier to track because it is based on a calendar month, not 30-day periods.  This will more easily align with recordkeeping and claims submission, as CPT 99457is reimbursed on a monthly basis.   

5. What Type of Technology Qualifies Under the New RPM Codes? 

Many advocates asked CMS to clarify the kinds of technology covered under CPT codes 99453, 99454, and 99457.  Some groups gave examples of the kinds of technology they believe these codes should cover, such as software applications that could be integrated into a beneficiary’s smartphone, Holter-Monitors, Fitbits, or artificial intelligence messaging.  Other examples included behavioral health data and data from wellness applications, or results of patients’ self-care tasks.  Unfortunately, CMS did not offer any specifics in the final rule on what technology qualifies, but CMS does plan to issue forthcoming guidance to help inform practitioners and stakeholders on these issues.  This may likely be in the form of a CMS MLN article or Q&A. 

6. Who Can Deliver RPM Services? 

CPT 99457 allows RPM services to be performed by the physician, qualified healthcare professional, or clinical staff.  Clinical staff includes, for example, RNs and medical assistants (subject to state law scope of practice and state law supervision requirements).  The inclusion of “clinical staff” is the most significant differentiator from CPT 99091, as that code is limited only to “physicians and qualified health care professionals.”  All practitioners must practice in accordance with applicable state law and scope of practice laws.  The term “other qualified healthcare professionals” used in CPT 99457 is a defined term, and that definition can be found in the CPT Codebook. 

7. Can RPM (CPT 99459) Be Billed “Incident To?  What Supervision Level is Required? 

CMS stated that CPT code 99457 describes professional time and “therefore cannot be furnished by auxiliary personnel incident to a practitioner’s professional services.” 

This position is notably different from how CMS chose to deal with Chronic Care Management (CCM) services (CPT 99487, 99489, and 99490).  For those CCM Services, CMS made an exception allowing incident to billing under general supervision.  (“CCM services that are not provided personally by the billing practitioner are provided by clinical staff under the direction of the billing practitioner on an “incident to” basis (as an integral part of services provided by the billing practitioner), subject to applicable State law, licensure, and scope of practice. The clinical staff are either employees or working under contract to the billing practitioner whom Medicare directly pays for CCM.”) 

In light of how CMS treated CCM services, it is difficult to understand CMS’ dissimilar treatment of CPT 99457.  Like CCM, most RPM services are most efficiently delivered under general supervision, which does not require the physician and auxiliary personnel to be in the same building at the same time, and the physician could instead exert general supervision via telemedicine.  This makes a huge difference in operations and business models.  We believe CMS should revisit its decision and, instead, allow incident to billing of CPT 99457 under general supervision. 

8. Will Medicare Pay for Setting Up the RPM Device and Patient Education? 

Yes.  CPT 99453 offers separate reimbursement for the initial work associated with onboarding a new patient, setting up the equipment, and patient education on use of the equipment. 

9. Must the Patient be in a Rural Area for RPM Reimbursement? 

No, the patient need not be located in a rural area or any specific originating site.  Providers frustrated with the labyrinthine and narrow Medicare coverage of telehealth services can take comfort in the fact that RPM is not considered a Medicare telehealth service.  Instead, like a physician interpretation of an electrocardiogram or radiological image that has been transmitted electronically, RPM services involve the interpretation of medical information without a direct interaction between the practitioner and beneficiary.  Medicare pays for RPM services under the same conditions as in-person physicians’ services with no additional requirements regarding permissible originating sites or rural geographies.   

10. Can the Patient be at Home for RPM Reimbursement?  

Yes, patients can receive RPM services in their homes. 

11. Does RPM Require a Face to Face Exam or Interactive Audio-Video? 

RPM services to not require the use of interactive audio-video, as these codes are inherently non face-to-face.  A few groups urged CMS not to be prescriptive regarding the technology that could be used to perform consultations, including real-time video, a store-and-forward visit, or simply a patient-provider message via a patient portal.  CMS expressed sympathy with the desire not to be overly prescriptive about the technology used to furnish RPM services, and stated it CMS defers to the CPT code descriptors and guidance to ascertain the technological modalities used to furnish RPM services. 

However, for new patients or patients not seen by the practitioner within one year prior to billing RPM, the practitioner must first conduct a face-to-face visit with the patient (e.g., an annual wellness visit or physical). E/M services levels 2 through 5 (CPT codes 99212 through 99215) should qualify for this face-to-face visit. Transitional care management (TCM) services should also qualify. However, services that do not involve a face-to-face visit by the billing practitioner or which are not separately payable under Medicare (e.g., online services, telephone and other E/M services) would not qualify as an initiating visit. 

12. Must the Patient Give Consent to RPM Services? 

Yes, the practitioner must get the patient’s consent for RPM services and document it in the patient’s medical record.  Although CMS did not directly address this in the final rule for the new codes, it is a requirement for CPT 99091 and can likely be expected as a requirement for CPT codes 99453, 99454, and 99457.  

13. Is there a Patient Co-Payment for RPM Services? 

Yes, as a Medicare Part B service, the patient is responsible for a 20% co-payment for RPM services.  While several groups asked CMS to eliminate any beneficiary co-payment for RPM services, CMS explained that it does not have the authority to change the applicable beneficiary cost sharing for most physician services, including RPM.  Providers are cautioned to bill the patient (or the patient’s secondary insurer) for the co-payment, as routine waivers of patient co-payments can present a fraud & abuse risk under the federal Civil Monetary Penalties Law and the Anti-Kickback Statute.   

14. Can RPM Also Be Billed with Chronic Care Management (CCM)? 

Yes, a provider can bill both CPT 99457 and CPT 99490 in the same month.  This is allowed because CMS recognizes the kind of analysis involved in furnishing RPM services is complementary to CCM and other care management services. However, time spent furnishing these services cannot be counted towards the required time for both RPM and CCM codes for a single month (i.e., no double counting).  Accordingly, billing both requires at least 40 minutes total (20 minutes of CCM and 20 minutes of RPM). 

What to Do Next? 

Providers, technology companies, and virtual care entrepreneurs interested in RPM should consider the following steps now to prepare for this new opportunity: 

  • Take the time to truly understand, with precision, the billing and supervision rules fundamental to a compliant RPM service model.  While a proof of concept is wise, providers should not overly focus on the technology and business development issues until they are confident the model they are “selling” or delivering does, in fact, comply with Medicare billing requirements.  Otherwise, they (or their customers) could face significant overpayment liability if a Medicare administrative contractor conducts a post-payment audit and finds the claims deficient.   
  • Develop a model business-to-business RPM contract, whether this contract is technology-only, support services-only, or a combination of both.   
  • Companies currently offering CCM services should be particularly focused on expanding their business lines into RPM.  Not only do CCM companies have current customers who can benefit from RPM services, the non-face-to-face technology and clinical integration requirements are fairly similar.  Moreover, CCM and RPM can both be separately billed for the same patient in the same month, allowing additional revenue.  Pro tip: you cannot double count the minutes for CCM and RPM, so billing both would require at least 40 minutes per month (20 minutes of CCM and 20 minutes of RPM). 


Entrepreneurs and start-ups offering RPM technologies and services should take steps now to understand these new billing opportunities under Medicare.  With the new CPT codes for Chronic Care Remote Physiologic Monitoring, RPM will become an area of significant upside potential over the coming years.  Hospitals and providers using RPM and non-face-to-face technologies to develop patient population health and care coordination services should take a serious look at these new codes, and keep abreast of developments that can drive recurring revenue and improve the patient care experience. 

For more information on telemedicine, telehealth, virtual care, and other health innovations, including the team, publications, and other materials, visit Foley’sTelemedicine and Digital Health Industry Team and read our 2017 Telemedicine and Digital Health Executive Survey. 

Source link

read more

Investigating Research Misconduct: The Legal Process



The alarming news about potential research misconduct can come in a variety of ways: a negative report in Retraction Watch, an anonymous “Clare Francis” letter, or a tip on the employee hotline. Regardless of the source, every institution must take each allegation seriously, especially if it involves research funded with federal dollars. Not only can a single allegation grow into a full-blown investigation regulated by the Health and Human Services Department’s Office of Research Integrity (ORI), but the Department of Justice (DOJ) might pursue its own probe seeking treble damages and penalties under the federal False Claims Act.

The important thing to remember is that once an allegation has been raised, the subsequent inquiry is a legal process—not just a scientific one. Institutions may have scientists who are qualified to evaluate the research, but they also must follow legally prescribed steps that will be crucial as the inquiry advances. Records must be sequestered, confidentiality must be respected, and everybody must act in good faith and document their actions. Although the underlying motivation of a misconduct investigation may be to identify bad research and correct the scientific record, the financial and reputational stakes
are too high—for the institution and accused researcher alike—to neglect the legal rules and requirements that proceed alongside.

So how does a properly conducted research misconduct investigation unfold? It starts with an allegation, however it arrives. The next step, according to ORI regulations, is to determine if the allegation is “sufficiently credible and specific so that potential evidence of research misconduct may be identified.”

For Compliance Today: “Copyright [2018] Compliance Today, a publication of the Health Care Compliance Association (HCCA).”

The full article is available here.

Source link

read more

President Signs New Law Allowing Telemedicine Prescribing of Controlled Substances: DEA Special Registration to Go Live


Public Affairs

President Trump just signed into law the “Special Registration for Telemedicine Act of 2018” (the Act), requiring the Drug Enforcement Administration (DEA) to activate a special registration allowing physicians and nurse practitioners to prescribe controlled substances via telemedicine without an in-person exam. The DEA has no more than one year to complete the task.

Until now, the federal Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Ryan Haight Act) did not allow practitioners to prescribe controlled substances unless the practitioner either: (1) conducted a prior in-person exam; or (2) met one of seven “practice of telemedicine” exceptions.  However, the “practice of telemedicine” exceptions are very narrow. They created an unintended barrier for legitimate practitioners seeking to use telemedicine to address practitioner shortages and deliver clinically-appropriate medical care to patients located in settings such as homes, schools, and rural areas (all common “originating sites” in contemporary direct-to-patient telemedicine service models). One of the exceptions – the special registration exception – was designed to allow telemedicine prescribing in these other settings without an in-person exam. However, for nearly ten years, the DEA never activated that special registration.  The President’s new law changes that.

What Does the Law Actually State?

The law, which was added to Title III, Subtitle B, Chapter 4 of a larger legislation titled the “SUPPORT for Patients and Communities Act,” reads as follows:

Section 311(h)(2) of the Controlled Substances Act (21 U.S.C. 831(h)(2)) is amended to read as follows:

“(2) REGULATIONS.—Not later than 1 year after the date of enactment of the SUPPORT for Patients and Communities Act, in consultation with the Secretary, the Attorney General shall promulgate final regulations specifying—

“(A) the limited circumstances in which a special registration under this subsection may be issued; and

“(B) the procedure for obtaining a special registration under this subsection.”

Next Steps: Look for Proposed Regulations from the DEA

To Congress’ credit, the final version of the law addressed a key problem with one of the initial drafts, which originally required the DEA to issue “interim final regulations.” Had that version been signed into law, the DEA would have been directed to simply publish the rule and effective date, without considering public comment. Fortunately, the final version signed into law sets a one-year deadline for the DEA to issue a “final regulation.” The law affords DEA ample time to issue proposed regulations, allow a 60 or 90-day period for the public to submit comments, consider and respond to those comments, and then publish the final regulations. Interested providers and telemedicine advocates should watch for the proposed regulations, submit comments, and make their voices heard on this important issue. Indeed, many states expressly allow telemedicine prescribing of controlled substances, and telemedicine advocates should celebrate how federal law will now serve to encourage, rather than inhibit, clinically appropriate telemedicine prescribing practices for controlled substances.

We will continue to monitor progress of the DEA special registration and other developments on the Ryan Haight Act, so please check back for updates.

For more information on telemedicine, telehealth, virtual care, and other health innovations, including the team, publications, and other materials, visit Foley’s Telemedicine and Digital Health Industry Team and read our 2017 Telemedicine and Digital Health Executive Survey.

Source link

read more

Nurse Staffing Ratios May Be Coming to a Hospital Near You


nurse station

On November 6, 2018, when Massachusetts voters go to the polls to select a new Governor and other key elected officers, they will also consider Ballot Question 1, which will mandate rigid registered nurse staffing ratios for hospitals across the Commonwealth effective as of January 1, 2019. This proposal would make Massachusetts the second state in the United States to have specific staffing ratios mandated in all units. This initiative follows only California, which passed a less comprehensive law through the legislative process in 1999 and provided over five (5) years for hospitals to implement by 2004.[1] The Massachusetts ballot initiative process, like that of some other states, allows the voters to write entirely new law into books. Question 1 appears to be the most heavily-fought ballot initiative in Massachusetts in recent memory. While Massachusetts seems to be the only state this year with a nurse staffing ratio as a referendum ballot initiative,[2] unions nationally will focus on the results of this year’s effort.

What is Question 1?

Question 1, if passed, would mandate highly-prescriptive and specific nurse-to-patient ratios based on the type of patients/units in hospitals, regardless of market, acuity of the patient, physician orders, or nursing judgement. Hospitals are required to implement a written plan detailing the maximum number of patients to be assigned to a registered nurse by unit at all times, while also “concurrently detailing the facility’s plans to ensure that it will implement such limits without diminishing the staffing levels of its health care workforce.”

Hospitals would also be required to develop a “patient acuity tool” for each unit to be used to determine whether the maximum number of patients that may be assigned should be lower than the assignment limits in the law. Notices regarding the patient assignment limits must be posted in conspicuous places, including each unit, patient room, and waiting area.

What are the Ratios?

The specific ratios mandated are summarized as follows (nurse:patient):

  • Step-down/intermediate care 1:3
  • Post anesthesia care (PACU) 1:1; PACU post-anesthesia 1:2
  • All units with operating room (OR) patients 1:1; OR patients post-anesthesia 1:2
  • Emergency Services Department: 1:1, 1:2,1:3, or 1:5 depending on the emergent or urgent nature of a patient which often changes by the minute
  • Maternal child care patients:
    • Active labor, intermittent auscultation for fetal assessment, and patients with medical or obstetrical complications 1:1
    • During birth and for up to two hours immediately postpartum 1:1 for mother and baby; when the condition of the mother and baby are determined to be stable and the critical elements are met, 1 nurse may care for both the mother and the baby(ies)
    • During postpartum for uncomplicated mothers or babies 1:6 (either 6 mothers or babies, 3 couplets of mothers and babies, or, in the case of multiple babies, not more than a total of 6 patients
    • Intermediate care or continuing care babies is 1:2 for babies
    • Well-babies 1:6
  • Pediatric 1:4
  • Psychiatric 1:5
  • Medical, surgical and telemetry patients 1:4
  • Observation/outpatient treatment 1:4
  • Rehabilitation units 1:5
  • All others 1:4

How Would the New Law be Enforced?

Question 1 also requires the state’s Health Policy Commission (HPC) (as opposed to the Department of Public Health, which is the state authority to license and regulate hospitals and other health care providers) to promulgate regulations and conduct inspections governing the implementation of the initiative.  The HPC is a six year old independent state agency charged with monitoring health care spending growth, it does not have the staff or infrastructure to conduct routine hospital surveys to monitor internal facility management and operations. It is also important to note that the proposed ballot would restrict the HPC by preventing it from issuing any delays, temporary or permanent waivers, or modifications of the ratios. Thus, even if the HPC believed that the January 1st  implementation date was unfeasible, it may be prohibited from offering waivers.

The HPC may report violations to the State Attorney General, who could file suit to obtain injunctions as well as civil penalties of up to $25,000 per violation and up to $25,000/day for continued violations.

The Impact if Question 1 Passes

Coalitions have lined up on both sides of Question 1.  Each side has painted dramatically-different pictures of a future for the industry with mandated nurse staffing ratios. The supportive nursing union has cast the initiative as being relatively small dollars for the industry, costing only $47 Million for all hospitals in the state in total according to their study.[3],[4]  The Massachusetts Health and Hospital Association and a broad-based coalition of health care providers and other nursing organizations opposed to the initiative point to studies estimating that the cost will be in excess of $1 Billion to the industry.[5]  Increased costs are based on the need to recruit new nurses, as well as the across-the-board increases in pay. There will be a need to hire 5,911 registered nurses within 37 business days to comply with January 1st  deadline and this is in a state that already has a shortage of approximately 1,200 registered nurses.[6]  Individual community hospitals are reporting projected additional expenditures that amount to more than the $30 Million per year, with teaching hospitals anticipating increased expenditures higher than that.[7]

On October 4, 2018, the HPC issued its independent report on the estimated costs of Question 1, essentially validating the opposition’s concerns, and projecting annual increased costs of $676 Million to $949 Million, and noted that the projections were “conservative.” The HPC study undercounted costs as it only looked at increased costs in certain units, and excluded costs associated with increased staffing in emergency departments, observation units, outpatient departments, or any costs for implementation or to non-acute hospitals.[8]  Wage increases of 4 – 6% are predicted in the HPC study, based on the California experience with across-the-board staffing requirements in place, and estimated increases of total health expenditures in Massachusetts of 1.1 – 1.6%, with increases of 2.4 – 3.5% for hospital spending alone, again, based on a conservative and partial analysis. Thus, it appears that the industry fears of greater than $1Billion in annual increased expenses are valid.

Ancillary adverse impacts anticipated by the HPC included reduced access to emergency care, increased wait times, decreased patient flow, increased “boarding,” and more ambulance diversions.

The HPC also compared Massachusetts to California hospitals and concluded that there was “no systematic improvement in patient outcomes post-implementation of ratios.”

What Should Hospitals be Doing Now?

Question 1, if passed, would only apply to Massachusetts licensed hospitals.  But hospitals and health systems in other jurisdictions should be prepared for similar efforts in their states. The following are some initial steps hospitals should be considering

Access Management.  Access problems will be common starting in January if Question 1 passes. Elective procedures, non-emergent appointments and other services may need to be curtailed effective January 1, 2019.  Hospitals will need to meet staffing levels on that day with respect to then-current inpatients and outpatients.  Avoiding new admissions in December may be necessary to assure the hospital is not in instant violation on New Year’s Day. Early patient contact to warn about the possibility of rescheduling procedures will prudent.

Payer Contract “Reopeners.”  Payer contracting “reopeners” should be added to managed care contracts now. The hospital community has been watching the interest of the unions in pushing nurse staffing ratios in Massachusetts and other states for a number of years. Health systems and hospitals negotiating long-term contracts with payers have often included “reopeners” to permit the hospital to revisit contract rates even during the term of an agreement if certain extreme events come to pass.  Hospitals in all jurisdictions are encouraged to consider adding such reopeners to their agreements today.

Massachusetts hospitals should review their payer contracts now to confirm if they have the right to a mid-term reopening and, if so, provide notice immediately upon passage to their payers that the hospital will need to renegotiate rates to address the increased costs. Charge masters will also need to be reviewed immediately.

Union status? Based on their efforts to rally public support around Question 1, the Massachusetts Nurses Association is trying to do an end-run around the collective bargaining table where their past efforts on the issue of staffing ratios have failed.  Health systems and hospitals should review their collective bargaining agreements to determine whether they are in a position to trigger a reopener during the term of the contract to address the numerous monetary and non-monetary consequences of rigid staffing ratios contemplated by Question 1.

Unit Closure Plans.  If passed, hospitals in Massachusetts will likely need to immediately assess whether and how they could comply with these new ratios. Units that already operate at a loss, or for which meeting the staffing requirements is impossible, should be closed or reduced to the smallest possible patient compliment.  Closure plans and negotiations will need to commence immediately.

Massive Recruitment Efforts.  While there are believed to be a few hospitals that may already meet these staffing levels (at some times), most hospitals will need to recruit many more registered nurses, as well as have additional nurses standing by for fluctuations in patient loads on various units on a daily basis.  As noted above, the law will require hiring nearly 6,000 RNs in the fourth quarter of this year.[9]


If Question 1 passes, conservative projections estimate extreme new costs will be incurred by Massachusetts hospitals, which will result in both reductions in levels of service, and increased costs to payers and patients.  It is important to note that the dire circumstances of the ballot has led to an increasing large number of nursing organizations and physician groups in Massachusetts to all oppose Question 1. While Massachusetts hospitals are making plans akin to natural disaster preparedness, hospitals in other states should watch carefully these events to be ready should similar initiatives arise locally.


[1] A few other states have limited ratios in certain special types units (like intensive care units), but Question 1 applies to all hospital units.

[2] See (June 6, 2018); downloaded on October 8, 2018.

[3] See

[4] See

[5] See

[6]  See Mass Insight Global Partnership, Protecting the Best Patient Care in the Country, Local Choices v Statewide Mandates in Massachusetts (April, 2018) (“Mass Insight Study”)

[7] See Financial impact of nurses ballot question? Depends who’s counting, Priyanka Dayal McCluskey, Boston Globe (Sept. 17, 2018).

[8] See Analysis of Potential Cost Impact of Mandated Nurse-to-Patient Staffing Ratios, October 3, 2018,

[9] Mass Insight Study.

Source link

read more

Health Care Policy Happenings – October 1 – 5, 2018


Public Affairs

In case you missed it, here are some key health care policy headlines from the past week.


Legislation and Committee Activity

Alexander: Senate Sends Opioids Legislation Called “Landmark” by Leader McConnell  to President – On Wednesday, the U.S.  Senate passed by a vote of 98-1, the SUPPORT for Patients and Communities Act, sponsored by Senator Lamar Alexander (R-TN). Majority Leader Mitch McConnell (R-Ky.) has called the bill, which is now heading to the President’s desk for his signature to become law, “landmark” opioids legislation. Read More

Becks Hospital Review: Hospital CEOs Petition Congress Over Prescription Drug-Pricing Program – The CEOs of more than 700 hospitals and health systems penned a letter to U.S. lawmakers, urging them to protect the 340B drug pricing program amid efforts to reduce prescription drug costs.  The letter, dated Oct. 2, came from CEOs representing hospitals and health systems from all 50 states and Washington, D.C., that participate in 340B. Read More

The Hill: Drug Companies Fear Democratic Congress – Drug companies are gearing up for a fight if Democrats take over the House. Democratic lawmakers say Republicans have gone too easy on the industry and are vowing that will change if they take power in November’s midterm elections. They are promising investigations into rising drug prices and say they will push to allow importation of cheaper medicines from other countries and to allow Medicare to negotiate prices with pharmaceutical companies. Read More



Politico: Trump’s Short-Term Health Plans Have Arrived – Health insurers and brokers are gearing up for the first open enrollment period under the Trump administration’s revamp of the individual market, creating new plans and expanding marketing efforts to take advantage of laxer restrictions on skinny short-term coverage. Read More


Proposed Rule: Medicare Program: Changes to the Medicare Claims and Medicare Prescription Drug Coverage Determination Appeals Procedures – On Tuesday, the Centers for Medicare & Medicaid Services (CMS) published a new proposed rule on the Medicare Program. Read More

Final Rule: Medicare Program – On Wednesday, CMS corrected a published final rule on Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2019 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (Promoting Interoperability Programs) Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Medicare Cost Reporting Requirements; and Physician Certification and Recertification of Claims”. Read More

CMS Accelerates Innovation and Promotes Patient Access to Medical Technology – On Wednesday, as part of broader efforts to modernize the Medicare program and bring the latest technologies and innovations to Medicare beneficiaries, CMS announced changes to the way contractors decide which technologies are covered by publishing a revision to Medicare’s Program Integrity Manual. Read More

WSJ: Trump Administration to Step Up Oversight of Hospital Watchdogs – On Thursday, the Trump administration announced “increased oversight of organizations that accredit and inspect most U.S. hospitals,” according to a report in The Wall Street Journal. “The Centers for Medicare and Medicaid Services, which grants accrediting authority, said it will change the way it measures the performance of accrediting organizations in a pilot project and will provide the public with new information about accreditors’ and hospitals’ performance.” Read More


Guidance Notice: Adaptive Designs for Clinical Trials of Drugs and Biologics – On Monday, the Food Drug Administration (FDA) published draft guidance on an adaptive designs for clinical trials of drugs and biologics. The comment period is open for 60 days. Read More

Statement from FDA Commissioner Scott Gottlieb, M.D., on New Agency Actions to Further Deter ‘Gaming’ of the Generic Drug Approval Process by the Use of Citizen Petitions – When I announced the Drug Competition Action Plan, or DCAP, in June 2017, I committed the FDA to a number of new steps to increase competition in the market for prescription drugs and to help facilitate the entry of lower-cost alternatives to improve patient access to affordable medicines. Read More


Bloomberg: Patients May Be Losing ‘Match Game’ With Medical Records – Electronic health records that don’t match up with the correct patient may be disrupting patient care and causing unnecessary medical testing.  Patient matching rates aren’t where they should be and are hindering the national exchange of electronic patient records, according to a Pew Charitable Trusts report released Oct. 2. Matching rates may be as low as 80 percent, meaning one in five patients may not be matched with their health record when getting treated. Read More

Looking Ahead

The House is in recess and will return on Tuesday, November 13 after the elections. The Senate is in session next week.

Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team has a proven track record of helping clients achieve their policy priorities at the federal, state and local levels, with extensive experience advocating on behalf of clients involved in various aspects of government engagement. Our team employs a comprehensive approach to government relations. Our work combines high-level policy development, tactical engagement with policymakers, grassroots, business and public relations strategy and targeted lobbying, along with legal representation of an international law firm, when requested by our clients. Our team maintains strong relationships with key Members of Congress, including those in House and Senate Republican and Democratic leadership, and on key committees. The Foley team is your go-to resource in Washington, D.C., for notable Health care developments.

Source link

read more

Refusing to Hire Medical Marijuana User Puts Employer in Jeopardy


Nursing Home

The following is a wake-up call to all employers, especially those in the health care industry, that have adopted “zero tolerance policies.” These policies will increasingly butt up against the tidal wave of laws legalizing the medical and recreational use of marijuana.  In a just-decided case, a federal judge in Connecticut issued a ruling in favor of a medical marijuana user whose offer of employment at a nursing home was rescinded after she tested positive for marijuana.

In Noffsinger v. SSC Niantic Operating Co. d/b/a Bride Brook Nursing & Rehab Center the court ruled in favor of Katelyn Noffsinger, a candidate for employment as an Activities Manager at Bride Brook Health & Rehabilitation Center, a nursing home. The nursing home was held to have violated the Connecticut Palliative Use of Marijuana Act (PUMA) when it revoked Noffsinger’s employment offer based on her status as a lawful medical marijuana user. Noffsinger’s employment offer was contingent upon her passing a pre-employment drug test. She told the interviewer she was a qualified marijuana user under Connecticut’s medical marijuana law because she was receiving treatment for post-traumatic stress disorder. She explained that she used prescription marijuana only in the evenings as a “qualifying patient” under Connecticut law, and showed the interviewer her state registration certificate. Her pre-employment drug test came back positive for THC, and her employment offer was revoked.

Noffsinger sued the nursing home on a number of claims, including that the revocation of her employment offer violated the anti-discrimination provisions in PUMA, which state:

No employer may refuse to hire a person or may discharge, penalize or threaten an employee solely on the basis of such person’s or employee’s status as a qualifying patient or primary caregiver… Nothing in this subdivision shall restrict an employer’s ability to prohibit the use of intoxicating substances during work hours or restrict an employer’s ability to discipline an employee for being under the influence of intoxicating substances during work hours.

Conn. Gen. Stat. § 21a-408p(b)(3).

The nursing home argued that it was exempt from the anti-discrimination provisions in PUMA because it was subject to the federal Drug Free Workplace Act (DFWA), which is located at 41 U.S.C. § 8102. The court also rejected that argument. Instead, the court ruled that the DFWA does not prohibit federal contractors from employing someone who uses illegal drugs outside the workplace. Moreover, the court further ruled that the DFWA does not prohibit federal contracts from employing individuals who use medical marijuana outside the workplace in accordance with a program provided by state law. The court also ruled that nothing in the DFWA required pre-employment drug testing.

The nursing home also argued that that the federal False Claims Act prevented it from hiring Noffsinger because employment of someone who uses medical marijuana in violation of federal law would amount to defrauding the federal government, which could therefore violate the False Claims Act.  The court rejected this argument, too, and instead ruled that Noffsinger’s medical marijuana use outside work hours would not constitute fraud for purposes of the False Claims Act.

This decision provides some valuable lessons for employers who are confronted with the increasingly profound conflict between the way state laws and federal laws treat the use of marijuana:

  • Despite some form of legalization in over 30 states, under federal law marijuana remains a Schedule I controlled substance (along with substances like heroin). This creates a compliance paradox for employers, especially those in the health care industry who are subject to heavy federal regulation.
  • Not every state’s marijuana law has an anti-retailiation provision like Connecticut’s law. It is important for employers to know the marijuana laws in each of the states they have employees.
  • Even in states whose marijuana laws have no anti-retaliation provision, the duty to accommodate disabilities may conflict with the desire to prohibit employees from using marijuana, even when off-duty.
  • The particular job that an employee performs may give a cannabis-banning employer more leeway. For example, contrast the health, safety, and liability risks associated with the job duties of an Activities Manager in a nursing home with those of the job duties of a neurosurgeon in a hospital.
  • Employers who have a zero tolerance policy that extends to off-duty use need to rethink the defensibility of never accommodating what might otherwise be lawful marijuana use under state law.

As always, when in doubt, an employer should consult trusted legal counsel, especially in areas of compliance like medical and recreational marijuana use by employees.

Source link

read more

Health Care Policy Happenings – September 17-21, 2018


Here are some key health care policy headlines from the past week that you may have missed.


Legislation and Committee Activity

Bloomberg: Opioids Compromise Already in the Works in Congress – Congress is working on a compromise package of bills to fight the opioid crisis and hopes to finish voting on it in the next two weeks. The Senate and House began working on the compromise before the Senate passed its package  on Sept. 17, Sen. Lamar Alexander (R-TN) said. They aim to have the package ready by Sept. 21, he said. Read More

Senate Passes Final Defense, Labor-HHS-Education Appropriations Minibus Conference Report – On Tuesday, Senate Appropriations Committee Chairman, Richard Shelby (R-AL),  praised the Senate’s passage of the final conference agreement reached on H.R. 6157, the second of three Fiscal Year 2019 minibus appropriations packages, which includes funding bills for the Department of Defense and Labor, Health and Human Services, Education, and Related Agencies subcommittees.  The bill also contains a continuing resolution (CR) through December 7, 2018, for any appropriations bills not enacted before October 1, 2018.  Following passage in the House, which is expected to vote on the legislation next week, the package will be sent to the President’s desk for his signature. Read More

Bipartisan Bill to Prohibit “Gag Clauses” That Can Cause Consumers to Overpay for Prescriptions Passes Senate – On Monday, by a vote of 98-2, the Senate passed legislation authored by U.S. Senators Susan Collins (R-ME) and Claire McCaskill (D-MO) to remove barriers that can prevent patients from paying the lowest possible prices for their prescription drugs. Read More

Stat: Top Trump Health Official Calls on Congress to do More on Drug Pricing – On Thursday, A top U.S. health official called on lawmakers in Congress to do more to help bring down drug prices, saying that the Trump administration had “given them a lot of opportunities to step in here.” I think Congress can do more,” said Joe Grogan, associate director for health programs at the Office of Management and Budget. Read More



Bloomberg: Health Information Blocking Proposal Under Review – On Monday, a long-awaited proposal designed to free up the electronic exchange of health-care information is under review by the government. The White House Office of Management and Budget received a proposed rule from the Health and Human Services Office for the National Coordinator for Health Information Technology that would define and prohibit information blocking by health system IT networks. Read More


Using Telemedicine to Combat the Opioid Epidemic – Combatting the opioid crisis is a top priority for the Trump Administration and HHS. We are making progress. Just last week we released the 2017 National Survey on Drug Use and Health (NSDUH) data, which showed significantly more people received treatment for substance use disorder in 2017 than in 2016; this was especially true for those with heroin-related opioid use disorders.  Read More

Politico: White House Seeks Telemedicine Expansion Advice – This week, telemedicine industry groups descended on Washington for the behind-closed doors meeting, where they complained to officials from the White House, HHS and the Federal Trade Commission about policy barriers to widespread access; many of them advocated for completely eliminating originating site restrictions for reimbursement. Read More


Medicare and Medicaid Programs; Proposed Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction – On Monday, The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to revise the applicable conditions of participation (CoPs) for providers and conditions for coverage (CfCs) as a continuation of our efforts to reduce regulatory burden in accordance with the January 30, 2017 Executive Order “Reducing Regulation and Controlling Regulatory Costs” (Executive Order 13771).  Read More

Looking Ahead

The Senate and House are in session next week. Government fiscal year ends on Sunday, September 30.

On Tuesday, the Senate Health, Education, Labor and Pensions (HELP) Subcommittee on Primary Health and Retirement Security will hold a hearing on health care in rural America.  Read More

On Thursday, the House Energy and Commerce Subcommittee on Health will hold a hearing on reducing U.S. maternal mortality. Read More

On Thursday, the Senate Health, Education, Labor and Pensions (HELP) Committee will hold a hearing on Reducing Health Care Costs: Improving Affordability Through Innovation. Read More

Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team has a proven track record of helping clients achieve their policy priorities at the federal, state and local levels, with extensive experience advocating on behalf of clients involved in various aspects of government engagement. Our team employs a comprehensive approach to government relations. Our work combines high-level policy development, tactical engagement with policymakers, grassroots, business and public relations strategy and targeted lobbying, along with legal representation of an international law firm, when requested by our clients. Our team maintains strong relationships with key Members of Congress, including those in House and Senate Republican and Democratic leadership, and on key committees. The Foley team is your go-to resource in Washington, D.C., for notable Health care developments.

Source link

read more

340B: DC Circuit Affirms Dismissal of Challenge to 2018 Reimbursement Cuts for 340B Hospitals; New Cuts Already Being Proposed by CMS for 2019


On Tuesday, July 17, 2018, the United States Court of Appeals for the District of Columbia ended a challenge brought by hospitals and hospital associations to the nearly 28 percent reimbursement cuts for 340B hospitals under the Medicare program. The payment cuts were finalized in the calendar year (CY) 2018 Medicare Outpatient Prospective Payment System (OPPS) rule and took effect on January 1, 2018. Compounding the impact of the failure of the litigation for affected 340B hospitals, CMS has now proposed to extend the 340B hospital payment cuts to new locations as part of the proposed CY 2019 Medicare OPPS rule. If finalized, the new payment cuts would take effect on January 1, 2019.

The D.C. Circuit Court’s Opinion

The appellate court affirmed the December 2017 ruling by the United States District Court dismissing the case.  The decision did not address whether HHS had authority in the OPPS to make the 340B reimbursement cuts (as plaintiffs had argued), but instead focused on whether the district court had subject matter jurisdiction to hear the plaintiffs’ challenge when the plaintiffs had not yet presented a claim for payment to the Department of Health and Human Services (HHS) for final decision.

To obtain judicial review of Medicare reimbursement disputes, section 205(g) of the Social Security Act (42 U.S.C. § 405(g)) requires that a claim be presented to the Secretary, and that a plaintiff exhaust administrative remedies, before having an opportunity to pursue a matter in federal court. At the time the action was brought, the 340B hospital rate cuts were not yet effective, and so no plaintiff had yet submitted (i.e., presented) a claim for reimbursement, and the district court dismissed the case on jurisdictional grounds. On appeal, the plaintiffs, including the American Hospital Association, America’s Essential Hospitals, and the Association of American Medical Colleges (the hospitals), argued that they had met the presentment requirement by submitting comments in notice and comment rulemaking in response to the proposed cut. Alternatively, the hospitals argued they had cured any defect in presentment because they made payment demands to HHS during the pendency of the appeal after the new payment cuts went into effect on January 1, 2018.

The court rejected the hospitals’ argument that comments made in notice-and-comment rulemaking could satisfy the presentment requirement. The court cited precedent finding that the presentment requirement generally prevents anticipatory legal challenges to Medicare rules and regulations. Although the hospitals submitted demands for payment to HHS while the case was on appeal from the district court’s dismissal, the court also found that these demands were too late to establish subject matter jurisdiction, which must be done at  the district court level.

Finally, because it concluded that it lacked subject-matter jurisdiction to hear the case, the court could not consider the merits of the case.  The court noted that it need not consider HHS’s contention that the Medicare statute forecloses judicial review even if the hospitals were able to satisfy the presentment and exhaustion requirements.

The hospitals have the option in this case of requesting review by the U.S. Supreme Court. They may also choose to pursue a new challenge by identifying a plaintiff that has presented a claim for reimbursement under the CY 2018 reduced reimbursement. Any such challenge would need to first proceed through CMS’ administrative process before review by a federal court could address the validity of CMS’ rulemaking.

CMS Proposes to Extend 340B Hospital Rate Cuts to Site-Neutral Hospital Outpatient Departments for 2019

In the recently released proposed CY 2019 OPPS rule, CMS proposes to expand last year’s 340B hospital rate cuts to also apply to those off-campus, non-excepted hospital outpatient departments (HOPDs) that are subject to Medicare’s site neutrality rules (site-neutral HOPDs).  Currently, site-neutral HOPDs have their Medicare OPPS reimbursement reduced by 60%, to approximate payment rates under the Medicare physician fee schedule. However, these reductions are not applied to drugs that are separately payable under the OPPS.  In addition, while last year’s (CY 2018) OPPS reduced reimbursement to 340B hospitals for separately payable drugs purchased under the 340B program, CMS did not apply the payment reductions to site-neutral HOPDs.  Under current law, separately payable drugs dispensed at a site-neutral HOPD are reimbursed at ASP + 6%, which approximates the reimbursement available under the Medicare physician fee schedule.

The proposed CY 2019 OPPS rule would reduce reimbursement for separately payable drugs billed by site-neutral HOPDs to ASP – 22.5%. CMS defends this proposal by claiming it is necessary to prevent 340B hospitals from having a “perverse incentive” to move 340B drug-related services to site-neutral HOPDs where reimbursement for the separately payable drugs is better than at other HOPDs (reimbursement for other services is significantly lower). The result of the proposed change is to once again create equivalence between 340B hospital HOPDs that are and are not subject to the site neutrality rules. However, site-neutral HOPDs will now be reimbursed significantly less than a freestanding physician office for separately payable drugs purchased under the 340B program.

Reimbursement for 340B Hospitals of Drugs that are Separately Payable under the OPPS and Purchased under 340B

CY Site-Neutral HOPD Other HOPD
2017 ASP + 6% ASP + 6%
2018 ASP + 6% ASP – 22.5%
2019 ASP – 22.5% ASP – 22.5%

If finalized, CMS’ extension of the 340B hospital rate cuts will further depress reimbursement for 340B hospitals, and will hinder the creation of new, off-campus HOPDs.  Comments on the proposed OPPS rule may be submitted until September 24, 2018.

For more information on Foley’s Health Care Industry Team including the team, publications, and other materials, visit


Source link

read more

Medicare Proposes (and Rejects) New Telehealth Services for 2019


The telemedicine industry was pleased to learn CMS recently proposed adding new services to its list of Medicare-covered telehealth services.  But what may be more interesting are the services CMS declined to add, and why.  This article summarizes the newly-proposed additions as well as the services CMS rejected, explores some reasons for CMS’ decisions, and describes how industry advocates can submit comments to CMS and make their voice heard on these new proposals.  The public comment period is open through September 10, 2018.

Medicare Telehealth Services

Under Medicare, the term “telehealth services” refers to a specific set of services practitioners normally furnish in-person, but for which CMS will make payment “when they are instead furnished using interactive, real-time telecommunication technology.” The Social Security Act governs what telehealth services are, and are not, covered under Medicare. Generally, there are five statutory conditions required for Medicare coverage of telehealth services:

  1. The beneficiary is located in a qualifying rural area;
  2. The beneficiary is located at one of eight qualifying originating sites;
  3. The services are provided by one of ten distant site practitioners eligible to furnish and receive Medicare payment for telehealth services;
  4. The beneficiary and distant site practitioner communicate via an interactive audio and video telecommunications system that permits real-time communication between them; and
  5. The Current Procedural Terminology/Healthcare Common Procedure Coding System (CPT/HCPCs) code for the service itself is named on the list of covered Medicare telehealth services.

So long as the distant site practitioner complies with each of the above requirements, the telehealth service furnished via a telecommunication system will substitute for an in-person encounter, and it should meet the requirements for Medicare coverage assuming other standard coverage provisions are met.

How Does CMS Assess New Telehealth Services?

There is a specific process to request additions or deletions from the list of covered telehealth services. Initially, CMS assigns each proposed code to one of two buckets: Category 1 and Category 2. Category 1 includes services that are similar to professional consultations, office visits, and office psychiatry services that are currently on the list of telehealth services.  Category 2 includes services that are not similar to those on the current list of telehealth services. Proposals that fall into Category 2 undergo a more exacting review, including whether the proposed service will produce demonstrated clinical benefit for patients.  When submitting a proposal to request coverage of a new service/code, be sure to understand which category the service falls under, so you can best know the type of clinical and nonclinical support documentation CMS expects to accompany your submission.

When Does CMS Accept Requests for New Telehealth Services?

Historically, CMS has accepted requests for additions or deletions to the Medicare telehealth services list until December 31 of each calendar year. However, for 2019 and onward, CMS proposed changing the deadline to February 10 of each year. This change is designed to better align with the deadline for receipt of code value recommendations from the Relative Value Scale Update Committee.

What Telehealth Services Did CMS Add for 2019?

For 2019, CMS proposed adding two codes to the covered Medicare telehealth service list:

  1. HCPCS G0513 “Prolonged preventive service(s) (beyond the typical service time of the primary procedure), in the office or other outpatient setting requiring direct patient contact beyond the usual services; first 30 minutes;” and
  2. HCPCS G0514 “Prolonged preventive service(s) (beyond the typical service time of the primary procedure), in the office or other outpatient setting requiring direct patient contact beyond the usual service; each additional 30 minutes.”

Both of these services are sufficiently similar to services already on the list of Medicare telehealth services, so CMS classified them as Category 1.  Accordingly, they enjoyed the streamlined review process. Subject to public comment, these services are expected to be added to the list of Medicare telehealth services when the final rule is published in November.

What Telehealth Services Did CMS Reject for 2019?

Chronic Care Remote Physiologic Monitoring

Requestors proposed to add the following “Chronic Care Remote Physiologic Monitoring” codes to the list of Medicare telehealth services for 2019:

  1. CPT 990X0 (Remote monitoring of physiologic parameter(s) (eg, weight, blood pressure, pulse oximetry, respiratory flow rate), initial; set-up and patient education of use of equipment);
  2. CPT 990X1 (Remote monitoring of physiologic parameter(s) (eg, weight, blood, pulse oximetry, respiratory flow rate), initial; device(s) supply with daily recording(s) or programmed alert(s) transmission, each 30 days); and
  3. CPT 994X9 (Remote physiologic monitoring treatment management services, 20 minutes or more of clinical staff/physician/other qualified healthcare professional time in a calendar month requiring interactive communication with the patient/caregiver during the month).

However, because these codes can be furnished without the beneficiary’s face-to-face presence and using any number of non-face-to-face means of communication, CMS did not propose adding them to the list of Medicare telehealth services. CMS did propose covering these new RPM codes under the Physician Fee Schedule, albeit not as telehealth services.  These new codes are intended as a follow-up and expansion to CMS’ current coverage of CPT 99091 (Remote Patient Monitoring).

Note: CPT codes that contain an ‘X’ (e.g., 994X9) are placeholder codes that are intended, through the first three digits, to give readers an idea of the proposed placement in the code set of the potential code changes. These codes will not be used for claims reporting and will be removed and not retained when the final CPT Datafiles are distributed on August 31st of each year. To report the services for ‘X’ codes, be sure to refer to the actual codes as they appear in the CPT Datafiles publication distributed on or before August 31st of each year.

Interprofessional Internet Consultations

CMS similarly rejected requests to cover “Interprofessional Internet Consultation” codes (CPT 994X0, 994X6) as telehealth services, noting how these codes describe services that are inherently non face-to-face. Fortunately, CMS did propose covering these codes under the Physician Fee Schedule, just not as telehealth services.  That means these new codes are not subject to the same statutory restrictions of rural geography or qualified originating site as Medicare “telehealth services.”

Initial Hospital Care Services

Advocates asked CMS to add “Initial Hospital Care” CPT codes to the Medicare telehealth service list, something that has been requested (and rejected) in prior years.  The requested codes were:

  1. CPT 99221 (Initial hospital care, per day, for the evaluation and management of a patient, which requires 3 key components: A detailed or comprehensive history; A detailed or comprehensive examination; and Medical decision making that is straightforward or of low complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient’s and/or family needs. Usually the problem(s) requiring admission are of low severity.);
  2. CPT 99222 (for moderate complexity and moderate severity); and
  3. CPT 99223 (for high complexity and high severity).

CMS rejected adding these as covered telehealth services. The explanation was because CMS believes “it is critical that the initial hospital visit by the admitting practitioner be conducted in person to ensure that the practitioner with ongoing treatment responsibility comprehensively assesses the patient’s condition upon admission to the hospital through a thorough in-person examination.”

Hospitals, health systems, and telemedicine companies delivering inpatient hospital services should pay particular attention to this, as there is a material difference between these CPT codes and, for example, the telehealth consultation G-codes (which are covered by Medicare). With the cost-effectiveness, quality and access improvement, and high provider and patient satisfaction levels of telemedicine services, we have seen a continued expansion of this technology in the hospital setting (both emergency department and inpatient units).

Hospitals should take the time to understand when CMS allows telehealth services to be delivered to hospital inpatients, the billing and reimbursement implications, and how to build a compliant operational workflow (both under federal law, such as EMTALA and Medicare Conditions of Participation, but also state laws, such as scope of practice, supervision, and facility licensure).  This is particularly true as Medicare Administrative Contractors are expected to implement billing audits of telehealth services in the wake of the recent OIG report finding that 31% of telehealth claims did not meet the Medicare conditions for payment for telehealth services and should not have been paid. A companion OIG report auditing state Medicaid payments for telemedicine services remains in the works, and is expected to be released next year.

Frequency Limitations on Subsequent Hospital Care Services and Subsequent Nursing Facility Care Services

CMS also rejected requests to remove the frequency limitations on certain telehealth services already covered by Medicare.  They are:

  1. CPT codes 99231, 99232, and 99233 (Subsequent Hospital Care Services);
  2. CPT codes 99307, 99308, 99309, and 99310 (Subsequent Nursing Facility Care Services).

Unlike the initial hospital care services described above, Medicare does cover certain subsequent hospital care services delivered via telemedicine. However, there are frequency limits on these services (once every three days for hospital inpatient, and once every thirty days for skilled nursing facility resident). CMS rejected requests to remove the three day frequency limitation for Subsequent Hospital Care Services because CMS “continues to believe that admitting practitioners should continue to make appropriate in-person visits to all patients who need such care during their hospitalization.” Similarly, CMS refused to lift the thirty day frequency limitation for Subsequent Nursing Facility Care Services because CMS “continues to have concerns regarding the potential acuity and complexity of [skilled nursing facility] inpatients.”

Expanding the Use of Telehealth under the Bipartisan Budget Act of 2018

The Bipartisan Budget Act of 2018 made five important statutory changes to telehealth services under the Medicare program. CMS’ proposed rule addressed implementation of two of these changes as follows:

End-Stage Renal Disease Services: Patients at Home

The Act allows an individual determined to have end-stage renal disease receiving home dialysis to choose to receive certain monthly end-stage rental disease-related clinical assessments via telehealth.  CMS proposed including renal dialysis facilities and the home of a renal dialysis individual as Medicare telehealth originating sites for the purpose of meeting required conditions for Medicare Part B payment.  Should this change be adopted (and we anticipate it will), providers can deliver these services to patients in their homes and Medicare will reimburse for it.  However, there would be no originating site facility fee paid when the originating site is the patient’s home.

Telestroke Services: New Modifier and Mobile Stroke Units

The Act added special rules for telehealth services for purposes of diagnosis, evaluation, or treatment of symptoms of an acute stroke, including removing any restriction on the geographic locations and the types of originating sites where acute stroke telehealth services can be furnished.  This means telestroke will be covered by Medicare at hospitals in rural and urban areas, alike (which is a great improvement because patients living in cities also need stroke care).

In order to accommodate this change, CMS proposed creating a new modifier that would be used to identify acute stroke telehealth services.  The industry might be disappointed or frustrated to learn they need to (again) reprogram their EMR and billing software to create yet another telehealth modifier, particularly as CMS just last year eliminated the requirement to use the GT modifier and instead requires providers to bill using Place of Service Code 02.

In addition, CMS proposed adding “mobile stroke units” as a new originating site for acute stroke telehealth service.  The proposed rule defines mobile stroke unit defined as “a mobile unit that furnishes services to diagnose, evaluate, and/or treat symptoms of an acute stroke.”  In many regards, it appears that a telemedicine-augmented ambulance might meet the definition of a mobile stroke unit, and companies interested in exploring this new option may want to submit comments to CMS now and seek clarification or further details on how CMS expects billing to be conducted for telehealth services delivered while the patient is in a mobile stroke unit.

How to Submit Comments

Telemedicine industry advocates, entrepreneurs, and healthcare providers have the opportunity to comment on the proposed rule until 5 p.m. September 10, 2018.  Anyone may submit comments – anonymously or otherwise – via electronic submission at this link. Alternatively, commenters may submit comments by mail to:

  • Regular Mail: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1693-P, O. Box 8016, Baltimore, MD 21244-8016.
  • Express overnight mail: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1693-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

If submitting via mail, please be sure to allow time for comments to be received before the closing date.

For more information on telemedicine, telehealth, virtual care, and other health innovations, including the team, publications, and other materials, visit Foley’s Telemedicine and Digital Health Industry Team and read our 2017 Telemedicine and Digital Health Executive Survey.

Source link

read more
1 3 4 5 6 7
Page 5 of 7