Archive for Medicare

Summary of Telehealth Waivers as of April 1, 2020

Summary of Telehealth Waivers as of April 1, 2020

By: Jim Hoover, Burr & Forman, LLP

The changes made to the requirements for telehealth services since the start of the COVID-19 pandemic have been swift and substantial. For the first several weeks, it seems changes were made almost daily.  As time has passed, the changes to telehealth have stabilized enough that a summary of the current telehealth issues is possible. However, changes may still be forthcoming so the following is a summary of the significant topics related to providing telehealth services as of the date of this article. Physicians should continue to monitor announcements related to telehealth requirements as changes will surely continue to evolve. 

Medicare – On March 30, 2020, the Centers for Medicare & Medicaid Services (CMS) announced additional temporary expansion of telehealth services to Medicare beneficiaries. CMS’s announcement of this new reimbursement flexibility builds on its prior expansion of telehealth services to address the COVID-19 pandemic. Prior to the March 30, 2020 announcement, CMS announced the following: (1) the patient location requirement was being waived to allow the patient to be in their home or other location; (2) the audio-video link can be something as simple as Skype, FaceTime or Facebook Messenger video calls. However, the audio-video link has to be a real-time audio and a one-to-one video connection, and cannot be public-facing; (3) the patient cost share can be waived at the providers’ discretion; and (4) CMS stated it will not audit to verify that there is an established patient relationship.

CMS announced in its March 30, 2020 announcement that it is now also allowing Medicare beneficiaries to receive care via telehealth by: (1) adding more than 80 services to the list of services payable under the Medicare Physician Fee Schedule when furnished via telehealth, including emergency department visits, initial nursing facility and discharge visits, critical care services, home visits for new and established patients, and physical and operational therapy services; (2) allowing clinicians to provide Virtual Check-In services to new patients in the same manner as they previously could provide only to established patients; (3) allowing licensed clinical social workers, clinical psychologists, physical therapists, occupational therapists, and speech language pathologists to provide e-visits; (4) allowing clinicians to provide certain services by audio phone only to their patients; (5) allowing clinicians to provide Remote Patient Monitoring, for acute or chronic conditions, to both new and established patients; (6) removing certain frequency limitations on Medicare telehealth; (7) expanding the use of telehealth to certain home health and hospice services; and (8) expanding the definition of “homebound” so that when a physician determines that a Medicare beneficiary should not leave the home due to suspected or confirmed COVID-19, the patient can qualify for the Medicare Home Health benefit.

Medicare Miscellaneous Issues – Patient consent may be obtained annually and obtained by ancillary staff.  Direct Supervision of services, such as incident-to services, normally require that the supervising/billing physician be in the office suite and immediately available. However, for the duration of the PHE, direct supervision can be provided by real-time interactive audiovisual technology.

Billing

Medicare – As an initial matter, telephone calls are still not the same as telehealth for Medicare purposes. A full list of the Compliant List of Medicare Telehealth and the Medicare Telehealth Code List for 2019-2020 is located on CMS’ website at the following address https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Telehealth-Codes.

CMS is allowing payment for certain codes related to telehealth services because as an example, CMS recognizes that some problems can be handled over the phone without a face-to-face, but may require more than the 5-10 minutes. The codes for established patients for physician or other qualified professionals (nurse practitioners or physician assistants) include 99441 (requires 5-10 minutes of medical discussion), 99442 requires 11-20 minutes of medical discussion), 99443 (requires 21-30 minutes of medical discussion). Practitioners should report the E/M code that best describes the nature of the care they are providing. Previous guidance was to use POS 02 that will cause payment to be made at the lower facility rate. Alternatively, providers can choose to use the POS code that most accurately reflects where the service is performed and append modifier 95. This will cause payment to be made at the higher non-facility rate.

Alabama Medicaid – Medicaid normally requires separate credentialing for providers performing telehealth; however, that restriction has been waived for the time period for dates of service from 3/16/2020 – 4/16/2020. Medical providers may bill established patient evaluation and management codes 99211, 99212 and 99213 for telephone consultations. Psychologists and behavioral health professionals should bill 90832, 90834, 90837, 90846, 90847 and H2011. Verbal consent must be obtained and documented in the medical record. These visits will count against the patient’s office visit limit of 14 visits per year.

Blue Cross and Blue Shield of Alabama – is allowing providers to bill for telephone call treatment of existing patients under the established patient office visit codes for dates of service from 3/16/2020 – 4/16/2020. They are allowing codes up to 99213 with place of service code 02 for telehealth. No modifier is required. The physician should be the one speaking with the patient — not the office staff.

HIPAA – Over the past several weeks, the Office for Civil Rights (“OCR”) has issued several notices regarding HIPAA in light of the current COVID-19 pandemic. The OCR issued a Notification of Enforcement Discretion for Telehealth Remote Communications during the COVID-19 Nationwide Public Health Emergency. OCR stated that it would relax its enforcement actions with regard to compliance with certain aspects of HIPAA (and not enforce penalties) in order to allow providers to better treat their patients via telehealth. A health care provider that wants to use audio or video communication technology to provide telehealth to patients during the public health emergency can use any non-public facing remote audio or video communication product that is available to communicate with patients. Health care providers may use applications that allow for video chats, including Apple FaceTime, Facebook Messenger video chat, Google Hangouts video, or Skype, to provide telehealth without risk that OCR might seek to impose a penalty for noncompliance with the HIPAA Rules. However, communication applications that are public facing should not be used. OCR further stated that it would not impose penalties against health care providers for the lack of a Business Associate Agreement with video communication vendors. The above applies to telehealth provided for any reason, regardless of whether the telehealth service is related to the diagnosis and treatment of health conditions related to COVID-19. The OCR also issued additional guidance in the form of frequently asked questions (FAQs) which are available at https://www.hhs.gov/sites/default/files/telehealth-faqs-508.pdf.  

State Licensure – Most states have greatly relaxed or streamlined their licensing requirements and application process to make it easier for physicians to provide telehealth services across state lines. However, the application process and requirements for each state differ so it is extremely important for physicians to check with each state. For example, the state of Tennessee requires the practitioner to complete and submit an application, which can be found at: https://www.tn.gov/content/dam/tn/health/documents/cedep/novel-coronavirus/Boards-Executive-Order-Form.pdf. The determination is made on a case by case basis. It appears most applications are being approved by the Tennessee Department of Health because as of the end of March 2020 the Department had received 61 applications and approved 59 applications, denied one, and one was under review. The State of Florida, for purposes of preparing for, responding to, and mitigating any effect of COVID-19, permits health care professionals not licensed in Florida to provide health care services to a patient located in Florida using telehealth, for a period not to exceed 30 days unless extended by order of the State Surgeon General. The exemption applies only to out of state health care professionals holding a valid, clear, and unrestricted license in another state or territory in the United States who are not currently under investigation or prosecution in any disciplinary proceeding in any of the states in which they hold a license.

While the telehealth waivers and notifications have slowed down in recent days, it is still very important for physicians to keep updated on the various requirements from state licensing authorities and payors.

Jim Hoover practices with Burr & Forman LLP and works exclusively within the firms Health Care Industry Group and primarily handles healthcare litigation and compliance matters.

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Families First Coronavirus Response Act (HR6201) Summary

Families First Coronavirus Response Act (HR6201) Summary

Last night President Trump signed what is being called the second coronavirus stimulus bill. It provides for free coronavirus screening, $1 billion in additional unemployment insurance funding to all states, a bump in Medicaid FMAP, $1 billion in food aid, and two provisions to provide paid sick leave to employees. 

 Emergency Paid Sick Leave

This provision gives 80 hours or 2 weeks of paid sick leave to individuals who work for employers with fewer than 500 employees. This applies to all employees, both full time and part-time with part-time receiving leave equal to the average number of hours worked. There is also no tenure of employment requirement. This leave is available to workers who are:

  1. In self-isolation because of a coronavirus diagnosis
  2. Obtaining a diagnosis or care due to coronavirus symptoms
  3. Complying with an order to self-isolate because of exposure to someone with coronavirus
  4. Caring for a family member with a diagnosis or symptoms
  5. Caring for a child without access to daycare or school because of closure.

If the employee falls under the first 3 categories, they are entitled to full pay, but if work is missed to care for a family member or a child without access to school or daycare only two-thirds of pay is due. An employer cannot force an employee to use existing, traditional sick leave first.

Emergency Family and Medical Leave Act (EFMLA)

If after the first 2 weeks, the employee needs additional days, the EFMLA will be triggered. The existing FMLA provides 12 weeks of unpaid leave, but this emergency measure would provide that up to 10 weeks of that emergency eave that would be paid. The first two weeks under EFMLA would remain unpaid and during the following 10 weeks employees would be entitled to two-thirds of their pay.

Like the emergency paid sick leave provision, EFMLA would be for those diagnosed with coronavirus, caring for a family member diagnosed, and caring for a child without access to daycare or school. Unlike the paid sick leave provision, employees must have worked for 30 days and there is a hardship exemption for small business with under 50 employees. Under the hardship exemption, the US Department of Labor is given the authority to develop regulations to exempt a small business if EFMLA threatens the viability of the business. 

The United States Secretary of Labor has the authority to issue regulations for good cause to (1) exclude certain health care providers and emergency responders from the definition of eligible employee; and to exempt small businesses with fewer than 50 employees when the imposition would jeopardize the viability of the business. 

Tax Credit for Employers 

Employers would be eligible for a refundable tax credit of 100 percent of qualified sick leave wages paid and family leave wages paid against their employer-side payroll tax liability. Employers can claim a quarterly tax credit against payroll taxes for payments associated with these 2 provisions up to the total payroll taxes in that quarter.

Medicaid

The bill temporarily increases the Medicaid FMAP in all states by 6.2% beginning in the calendar quarter of the emergency and ending the quarter it is declared over. Coronavirus testing must also be provided with no cost sharing. Those eligible will only lose coverage if they leave the state.

The bill also creates a new Medicaid eligibility category for the uninsured. Uninsured individuals would only be eligible to receive diagnostic testing for coronavirus, no treatment, but that testing would be done at no cost and reimbursed at 100% FMAP.

Unemployment Insurance

As states expand the criteria for unemployment to include coronavirus reasons, the US Labor Department reported 281,000 new claims for unemployment insurance last week, a 70,000 jump over the previous week. The bill gives states $1 billion for unemployment insurance nationwide that will provide relief to those who are facing coronavirus-related job loss.  The unemployment aid would be broken in two separate payment structures. The first 50% of the grant would be sent to states for State Unemployment Agency staffing, technology, and other administrative costs so long as the states comply with three provisions in the bill. (1) Require employers to provide notification to the potential UI eligibility to laid off workers; (2) ensure that workers can apply for benefits in person, by phone, or online; two of the three must be available; (3) the state must notify applicants when an application is received and being processed and if the application cannot be processed, what information is needed to successfully process the claim.  Currently, the State of Alabama would meet the current requirements to receive their portion of the first $500 million package. The other $500 million would be reserved for an emergency grant package for those states that may have seen at least a 10% increase in unemployment. There is also flexibility built into the unemployment provision with the goal of making it easier for workers to access unemployment benefits by waiving waiting weeks and work search requirements.

States could potentially be eligible for Extended Benefits (EB) for unemployment compensation programs when the unemployment rate surpasses certain thresholds to trigger EB programs.  The first extended benefits trigger could allow for an additional 13 weeks of unemployment benefits after a claimant exhausts current state benefits (14 weeks of state UI benefits).

Food Assistance

The bill adds $500 million to provide access to nutritious foods to low-income pregnant women or mothers with young children who lose their jobs or are laid off due to the COVID-19 emergency through the Special Supplemental Nutrition Program for Women Infants and Children (WIC). There is also $400 million to assist local food banks to meet increased demand for low-income Americans during the emergency. The work requirement for the supplemental nutrition assistance program (SNAP) is also suspended. There are also provisions to provide funding and flexibility in the free and reduced lunch program if a school is closed for 5 consecutive days and for at home delivery of meals to the elderly. 

Posted in: Medicaid, Medicare, Members

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Telehealth in Alabama during COVID-19 Public Health Emergency (PHE)

Telehealth in Alabama during COVID-19 Public Health Emergency (PHE)

prepared by Kim Huey, MJ, CHC, CPC, CCS-P, PCS, CPCO, COC

March 19, 2020

The most important thing to remember is that payers have differing definitions of what they consider telehealth.  I recommend checking with the applicable insurer for the most up-to-date information affecting requirements for coding and billing of telehealth services.  A few things to ask about: 

  • What are the effective dates?  Most insurers are limiting this exemption to a specific period of time. 
  • What services are covered? 
  • How are those to be billed? 
  • Do we use telehealth codes or office visit codes? 
  • What place of service? 
  • What modifiers are necessary?
  • For fee-for-service, traditional Medicare

The information below pertains to the major payers in Alabama as of 3/18/2020 –

Blue Cross Blue Shield of Alabama is allowing providers to bill for phone call treatment of existing patients under the established patient office visit codes from 3/16/2020 – 4/16/2020.  They are allowing codes up to 99213 with place of service code 02 (zero two) for telehealth. No modifier is required.  Many providers are concerned about reaching that level of service when no examination can be performed.  Remember that established patient office visits require only two of the three key components – history, examination, medical decision-making.  If the physician documents an expanded problem-focused history and low complexity medical decision-making, 99213 will be supported.  This must be the physician speaking with the patient, not the office staff.

Alabama Medicaid normally requires separate credentialing for providers performing telehealth; however, that restriction has been waived 3/16/2020 – 4/16/2020 (dates of service).   Medical providers may bill established-patient evaluation and management codes 99211, 99212 and 99213 for telephone consultations.   Psychologists and behavioral health professionals should bill 90832, 90834, 90837, 90846, 90847 and H2011. A dental provider should bill D0140.  Place of service code 02 (zero two) for telehealth and modifier CR are required.  Verbal consent must be obtained and documented in the medical record.  These visits will count against the patient’s office visit limit of 14 visits per year.

United Health Care is waiving originating site restrictions for their commercial, Medicare Advantage, and Medicaid plans.  The patient may be at home or at another location.  All the other requirements for telehealth must be met – real-time audio and video communication system required. These include the place of service 02 and the GQ (asynchronous telecommunications system) or GT (interactive audio and video telecommunication system) modifier.  This waiver is only in effect until April 30, 2020.

Medicare

Fee-For-Service Medicare DOES NOT allow telephone calls to be billed as telehealth.  The PHE waiver provides three specific exceptions to the existing telehealth regulations:

  1. the patient can be in their home or other location – they do not have to be in a healthcare facility in a HPSA.
  2. the audio-video link can be something as simple as Skype or FaceTime or Facebook Messenger video calls – but it has to be a real-time audio AND video one-to-one connection, not something public-facing
  3. costshare can be waived – it is not automatically, but it can be waived at the providers’ discretion.

CMS also stated that they will not audit to verify that there is an established patient relationship.  Services are limited to the list of telehealth services at:  https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Telehealth-Codes

This does include office visits, consultations, Transitional Care Management, and Annual Wellness Visits.  Place of service is 02 (zero two) for telehealth.  No modifier is necessary unless you are billing from a CAH Method II hospital (GT) or you are treating the patient for an acute stroke (G0).  There is also a modifier for a telemedicine demonstration project in Alaska or Hawaii (GQ).

NOTE: Although CMS stated that no modifier is necessary, Palmetto GBA is requesting modifier CR be appended for tracking purposes.

For services that have a site of service differential, payment will be made at the facility rate.

CMS has not specified an end date for these exceptions, just that they will be allowed as long as the Public Health Emergency declaration is in effect.

If there is not a real-time audio-video connection, then you are limited to one of the following:

Virtual Check-In

  • G2012 – 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 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
  • G2010 – Remote evaluation of recorded video and/or images submitted by an established patient (e.g., store and forward), including interpretation with follow-up with the patient within 24 business hours, 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

Please note the following restrictions:

  • Established patients only (same definition as for other E&M services)
  • Verbal consent required and must be documented in the patient’s medical record
  • No service-specific documentation requirements but medical necessity must be documented.
  • May only be billed by those providers who can perform and bill E&M services

To clarify – G2012 has been in effect since 1/1/2019 – it is supposed to be for an established patient, but CMS has said they will not audit for that requirement during this time.  It does not require the video link, so it is really the only option for phone calls.  It cannot be related to an office visit within the past 7 days, as that would be considered part of the work of the already-billed office visit.  And if the doctor tells the patient to come in at the first available appointment, it can’t be billed as it would be considered the pre-work for the upcoming office visit.  As it specifies 5-10 minutes of medical discussion, time should be documented.

For email or portal communication, we also have these codes, new for 2020:

  • #99421 – Online digital evaluation and management service, for an established patient, for up to 7 days, cumulative time during the 7 days; 5-10 minutes
  • #99422 – …11-20 minutes
  • #99423 – … 21 or more minutes

Please note the following restrictions:

  • Patient-initiated digital communications requiring a clinical decision that would otherwise be made during an office visit
  • Physician/Qualified Healthcare Professional (QHP) time only
  • Not billable if patient seen in person or through telehealth within 7 day period

For All Payers –

There have been questions on how to perform a visit by phone or audio-video without being able to examine the patient.  First of all, established patient visits require two of the three key components:  history, examination, and medical decision-making.  A visit can be billed based on history and medical decision-making.  However, some examination can be done without laying hands on the patient.  Observation can be done through video, and sometimes just through audio.  A physician can observe skin tone, abnormal movements, respiratory effort and many other exam elements without being able to necessarily touch the patient.  A complete Psychiatric exam can be accomplished through talking with the patient.

For example, the patient calls in with complaint of dysuria. The physician documents the complaint (Duration, Timing) and further asks questions about fever, nausea and vomiting (Constitutional and Gastrointestinal Review of Systems).  He also reviews the patient’s Past Medical History and Allergies.   Based on her previous history, he suspects that the patient has a urinary tract infection and orders an antibiotic.

A patient with asthma calls in with an exacerbation – the physician can actually hear the patient wheezing over the telephone – that would be documented as a problem-focused examination.

The key point is that the physician himself must have the conversation with the patient on the phone or through the audio-video link.  This may be something that a nurse may have handled previously, but now it must be performed by the physician to be billable. 

Posted in: Blue Cross Blue Shield of Alabama, CMS, Medicaid, Medicare, Members, Technology

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Appropriate Use Criteria for Advanced Diagnostic Imaging

Appropriate Use Criteria for Advanced Diagnostic Imaging

Contributed by: Gregg Everett, Gilpin Givhan

The Protecting Access to Medicare Act (PAMA) was passed in 2014.  PAMA required the Centers for Medicare and Medicaid Services (CMS) to establish a program that promotes “Appropriate Use Criteria” (AUC) for advanced diagnostic imaging. AUC’s are evidence-based criteria that assist professionals who order and furnish certain imaging services to make the most appropriate treatment decisions for specific clinical conditions. Once the AUC program is fully implemented (2021), payment will only be made for an advanced diagnostic imaging service if the Medicare claim indicates that the ordering professional consulted with a qualified Clinical Decision Support Mechanism (CDSM) about whether the ordered service meets an applicable AUC.  A CDSM is an interactive electronic tool for use by clinicians that communicates AUC information and assists in making appropriate treatment decisions during a patient’s workup.  An ordering professional is a physician or other licensed professional who orders an imaging service.  The settings covered include hospital outpatient departments (which includes the hospital’s ER), ambulatory surgery centers, physicians’ offices and IDTF’s.  

Advanced diagnostic imaging services include MRI’s, CT scans, PET scans and nuclear medicine. The CDSM must be reported on claims for payment using G-codes, modifiers and, eventually, the ordering physician’s NPI. For the period July 1, 2019, through December 31, 2019, only voluntary reporting was required.  Beginning January 1, 2020, an educational and operations testing period will be implemented, which is expected to run through December 31, 2020. For now, CMS will still pay a claim, whether or not the claim correctly includes AUC information. Eventually, CMS must develop outlier criteria (which will require some ordering professionals to obtain prior authorizations) and will not pay those claims that do not have AUC information, unless a specific exception is met. The exceptions include emergency services provided to individuals with emergency medical conditions (EMTALA definition), inpatient care where payment is made under Part A Medicare, or significant hardships, which includes insufficient internet access and EHR or CDSM vendor issues.  

Qualified CDSM’s (only national professional medical specialty societies or other organizations of providers who predominantly provide direct patient care may develop CDSM’s) must be approved by CMS and must meet other criteria, such as providing a certification or other documentation at the time of the order that a qualified CDSM was consulted, and whether or not the service ordered met the requirements of the specific referenced AUC. The regulations also list certain “priority clinical areas” that will be monitored to identify outlier ordering professionals as follows:  coronary artery disease (suspected or diagnosed), suspected pulmonary embolisms, headache (traumatic and non-traumatic), hip pain, low back pain, shoulder pain (including suspected rotator cuff injury), cancer of the lung (primary or metastasis, and suspected or diagnosed), and cervical and back pain. Ordering physicians and settings for these imaging services should begin the process of including AUC’s on Medicare claims in January 2020.

For more information see:

  1. “Protecting Access to Medicare Act of 2014,” Section 216, (Public Law 113-93), 42 U.S.C. Section 1395m(p) and (q).
  2. 42 CFR Section 414.94 – “Appropriate Use Criteria for Advanced Imaging Services.
  3. “Appropriate Use Criteria (AUC) for Advanced Diagnostic Imaging – Educational and Operations Testing Period—Claims Processing Requirements”; MLN Matters Number MM11268 Revised December 6, 2019.

Posted in: CMS, Legal Watch, Medicare, Members

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CMS Releases Physician Fee Schedule Final Rule

CMS Releases Physician Fee Schedule Final Rule

The Centers for Medicare and Medicaid Services (CMS) released its final rule for the CY 2020 Physician Fee Schedule. The Medical Association and the AMA will continue to review the rule and analyze these policies in the coming weeks. Attached is a summary of some of the policies CMS finalized in the rule.

Some of the highlights of the final rule are:

  1. E/M Coding: Finalizes new E/M coding policy effective January 1, 2021. E/M codes for new patients will be 4 levels (CPT codes 99202-205) and for established patients, there will be 5 levels (CPT Codes 99211-99215)
  2. Conversion factor: $36.09 resulting in a .14% increase in fees
  3. Scope of Practice-Physician Supervision Requirements for Physician Assistants (PAs). CMS finalized its revisions to regulations on physician supervision for physician assistant services. The current policy requires general physician supervision for PA services, however, CMS’ revisions provide that the statutory physician supervision requirement for PA services is met when a PA furnishes their services in accordance with state law and state scope of practice rules for PAs in the state in which the services are furnished.
  4. Physician Enrollment CMS finalized new authority to deny or revoke a physician’s enrollment if he or she has been subject to prior action from a state oversight board, federal or state health care program, Independent Review Organization (IRO) determination(s), or any other equivalent governmental body or program that oversees, regulates, or administers the provision of health care with underlying facts reflecting improper physician or other eligible professional conduct that led to patient harm

For a full summary of the physician payment rule, click here.

Posted in: CMS, Medicaid, Medicare

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Changes Coming to AKS, Stark and CMP Laws

Changes Coming to AKS, Stark and CMP Laws

On October 9, 2019, the Office of Inspector General (“OIG”) and the Centers for Medicare and Medicaid Services (“CMS”) published proposed rules to revise the Stark Law, Anti-Kickback Statute and Civil Monetary Penalty Statute.  These statutes create criminal and civil penalties for certain financial arrangements involving providers. According to OIG and CMS, the goal of the proposed rules is to address barriers created by the rules that interfere with care coordination.  The additional safe harbors were necessary to allow for coordination of patient care among providers because of the increased focus on value-based care. Value-based programs reward healthcare providers with incentive payments for quality of care. Examples of these programs include Hospital Value-Based Purchasing, Hospital Readmission Reduction Program and Hospital Acquired Conditions Reduction Program.

Anti-Kickback 

The proposed changes in the published rule include three new safe harbors for certain remuneration exchanged between or among participants in a value-based arrangement intended to foster better coordinated patient care.  These include:

  1. Care Coordination Arrangements to Improve Quality Health Outcomes and Efficiency,
  2. Value-Based Arrangements with Substantial Downside Financial Risk, and
  3. Value-Based Arrangements with Full Financial Risk.

The proposed rule also offers a new safe harbor for certain tools and support furnished to patients to improve health quality outcomes and efficiency, such as health-related technology or patient health-related monitoring tools.  Additionally, a new safe harbor is proposed for remuneration provided in connection with a CMS sponsored innovation model, which is intended to reduce the need for separate and distinct fraud and abuse waivers.

There is a proposed safe harbor for donations of cybersecurity technology and services as well as modifications to the existing safe harbor for electronic health records and services to add protections for certain related cybersecurity technology, to update provisions regarding intra-operability, and to remove the sunset date that previously existed.

The rule proposes a positive change to the Personal Services and Management Contracts safe harbor, by eliminating the requirement that periodic or part-time services be on a specific schedule or interval. Additionally, the safe harbor adds a provision for “outcome-based payments.”  Outcome-based payments are those payments that reward the provider for improving patient or population health by achieving one or more outcome measures or that reduce payor costs while improving or maintaining the improved quality of care for patients.

Another existing provision related to warranties is updated to revise the definition of warranty and provide protection for bundled warranties for one or more items of related services.  Local transportation is covered by an existing safe harbor, but the proposed change expands and modifies mileage limits for rural areas and for transportation for patients discharged from inpatient facilities.

Lastly, the Accountable Care Organization Incentive Program is added to the exception of the definition of “remuneration.”

Stark Law

The physician self-referral law, known as the Stark Law, has not been significantly updated since its enactment in 1989.  The proposed changes seek to reduce the burden on physicians and allow for coordination of care.

Like the new safe harbors under the AKS, the proposed changes to the Stark Law include value-based arrangements.  A value-based arrangement is defined as an arrangement for the provision of at least one value-based activity for a target patient population between or among the value-based enterprise (“VBE”) and one or more VBE participants or VBE participants in the same value-based activity.

Another update to the Stark Law includes a proposed change clarifying the existing provision that allows a physician in a group practice to be paid a share of the overall profits of the group that is indirectly related to the volume or value of the physician’s referrals.  Additionally, there are changes to how the law treats productivity bonuses for physicians.

According to CMS, the intent of the proposed changes is to alleviate the fear physicians may have in entering into legitimate relationships to coordinate and improve care of patients.

CMP

There is only one proposed change for the Civil Monetary Penalty statute, and it adds a new statutory exception to the prohibition on beneficiary inducements for telehealth technologies furnished to certain in-home dialysis patients.

For all the proposed rules, OIG and CMS are seeking public comments, which are due December 31, 2019.  For more information on the proposed rules visit https://oig.hhs.gov/compliance/safe-harbor-regulations/index.asp and https://www.cms.gov/newsroom/fact-sheets/modernizing-and-clarifying-physician-self-referral-regulations-proposed-rule.


Article contributed by Angie C. Smith, Esq. with Burr Forman.

Posted in: Legal Watch, Medicaid, Medicare

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Medical Association Opposes Scope of Practice Expansion Executive Order

Medical Association Opposes Scope of Practice Expansion Executive Order

President Trump issued an executive order on October 3, 2019 as an alternative to “Medicare for All”. Initially, the order was titled “Protecting Medicare From Socialist Destruction” but was changed to “Protecting and Improving Medicare for Our Nation’s Seniors.”

The executive order does include some items that the Medical Association of the State of Alabama supports; however, there are concerns that the language within the order appears to expand the scope of practice of non-physician providers.

President Trump directed the Secretary of Health and Human Services, Alex Azar, to propose a new regulation within the next year that would “eliminate burdensome regulatory billing requirements, conditions of participation, supervision requirements, benefit definitions, and all other licensure requirements […] that are more stringent than applicable federal or state laws require and that limit professionals from practicing at the top of their profession.”

Possibly the most alarming language found within the order is that President Trump gave Azar only one year to propose regulations that would “ensure that items and services provided by clinicians, including physicians, physician assistants, and nurse practitioners are appropriately reimbursed in accordance with work performed rather than the clinician’s occupation.”

Mark Jackson, the Executive Director of the Medical Association, believes the language within the order should raise serious concerns for physicians in Alabama. “We believe that medical school matters and physicians should always be the head of the healthcare team,” Jackson says. ”Our mission is to promote the highest quality of healthcare for the people of Alabama. Therefore, we fully support physician-led team-based care and will be co-signing a letter with the American Medical Association as well as working closely with our Congressional Delegation to address our concerns.”

View the letter here.

Posted in: Advocacy, Medicare, Members

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CMS Is Expanding Its Enforcement Ability

CMS Is Expanding Its Enforcement Ability

Pursuant to a new rule, entitled Program Integrity Enhancements to the Provider Enrollment Process, the Centers for Medicare & Medicaid Services (“CMS”) is expanding its ability to combat fraud and abuse within the healthcare industry.

Under the new rule, CMS will be able to identify individuals and entities that pose a fraud and abuse risk solely based on “affiliations” with other entities that have been sanctioned by CMS. CMS can then take steps to prevent such identified individuals and entities from participating in the Medicare program. At the request of CMS, enrolling providers will disclose
any current or previous “affiliation” with an organization that has uncollected debt (regardless of amount and regardless of appeal status), experienced a payment suspension, been excluded, or had its billing privileges denied or rescinded (regardless of the basis). As used within the new rule, “affiliation” would include, among other things, an individual with 5% or greater indirect or direct ownership interest, officer, director, individual with operational or managerial control, or any reassignment relationship.

The provider community has expressed a number of concerns with this new rule, as the new rule gives a large amount of discretion to CMS without comparable notice or remedy to the provider. Consequently, in light of this new rule, Medicare providers and suppliers need to carefully and thoroughly examine any individual with whom it has an “affiliation” relationship to
avoid negative consequences.

The rule takes effect on November 4, 2019.

Kelli Fleming is a Partner at Burr & Forman LLP practicing exclusively in the firm’s healthcare industry group.

Posted in: Legal Watch, Medicaid, Medicare, Members

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Sign-on Letter: Improving Seniors’ Timely Access to Care Act

Sign-on Letter: Improving Seniors’ Timely Access to Care Act

September 9, 2019

Dear Members of Congress:

The undersigned patient, physician, health care professional, and other health care stakeholder
organizations strongly support the Improving Seniors’ Timely Access to Care Act of 2019 (H.R.
3107) recently introduced by Reps. Suzan DelBene (D-WA), Mike Kelly (R-PA), Roger
Marshall, MD (R-KS), and Ami Bera, MD (D-CA). This bipartisan legislation would help
protect patients from unnecessary delays in care by streamlining and standardizing prior
authorization under the Medicare Advantage program, providing much-needed oversight and
transparency of health insurance for America’s seniors. We urge you to join your colleagues in
supporting this important legislation.

Based on a consensus statement on prior authorization reform adopted by leading national
organizations representing physicians, medical groups, hospitals, pharmacists, and health plans,
the legislation would facilitate electronic prior authorization, improve transparency for
beneficiaries and providers alike, and increase Centers for Medicare & Medicaid Services (CMS)
oversight on how Medicare Advantage plans use prior authorization. Specifically, the bill
would:

  • Create an electronic prior authorization program including the electronic transmission of
    prior authorization requests and responses and a real-time process for items and services
    that are routinely approved;
  • Improve transparency by requiring plans to report to CMS on the extent of their use of
    prior authorization and the rate of approvals or denials;
  • Require plans to adopt transparent prior authorization programs that are reviewed
    annually, adhere to evidence-based medical guidelines, and include continuity of care for
    individuals transitioning between coverage policies to minimize any disruption in care;
  • Hold plans accountable for making timely prior authorization determinations and to
    provide rationales for denials; and
  • Prohibit additional prior authorization for medically-necessary services performed during
    a surgical or invasive procedure that already received, or did not initially require, prior
    authorization.

The demand and need for such reforms is growing — particularly as more seniors choose
Medicare Advantage for their health insurance needs. According to a recently released Kaiser
Family Foundation report, “A Dozen Facts About Medicare Advantage in 2019,” Medicare
Advantage enrollment has nearly doubled in a decade. One-third (34%) of all Medicare
beneficiaries — 22 million people — are enrolled in Medicare Advantage plans, and nearly four
out of five enrollees (79%) are in plans that require prior authorization for some services. The
Congressional Budget Office (CBO) projects that beneficiaries enrolled in Medicare Advantage
plans will rise to nearly half of all Medicare beneficiaries (about 47%) by 2029. Recognizing the
need to protect a growing number of Medicare beneficiaries, more than 100 members of
Congress called for such reforms in a letter last year to the CMS.

For our seniors — and as representatives of organizations seeking to protect patients from delays
in care and relieve unnecessary administrative burdens that impede delivery of timely care—we
are committed to advancing this legislation in Congress and ask that you join Representatives
DelBene, Kelly, Marshall, and Bera in co-sponsoring H.R. 3107 and securing its enactment.
Thank you.

Sincerely,

ACCSES
Aimed Alliance
Alliance for Aging Research
Alliance for Balanced Pain Management
Alliance for Patient Access
Alliance of Specialty Medicine
Alzheimer’s Association
Alzheimer’s Impact Movement
AMDA – The Society for Post-Acute and Long-Term Care Medicine
American Academy of Allergy, Asthma & Immunology
American Academy of Dermatology Association
American Academy of Facial Plastic and Reconstructive Surgery
American Academy of Family Physicians
American Academy of Hospice and Palliative Medicine
American Academy of Neurology
American Academy of Ophthalmology
American Academy of Otolaryngology – Head and Neck Surgery
American Academy of PAs
American Academy of Physical Medicine & Rehabilitation
American Academy of Sleep Medicine
American Alliance of Orthopaedic Executives
American Association of Clinical Endocrinologists
American Association of Clinical Urologists
American Association of Hip and Knee Surgeons
American Association of Neurological Surgeons
American Association of Nurse Practitioners
American Association of Orthopaedic Surgeons
American Association of Pediatric Ophthalmology and Strabismus
American Association on Health and Disability
American Autoimmune Related Diseases Association
American Brain Coalition
American Cancer Society Cancer Action Network
American Clinical Laboratory Association
American Clinical Neurophysiology Society
American College of Allergy, Asthma and Immunology
American College of Cardiology
American College of Emergency Physicians
American College of Gastroenterology
American College of Mohs Surgery
American College of Obstetricians and Gynecologists
American College of Osteopathic Surgeons
American College of Physicians
American College of Radiation Oncology
American College of Radiology
American College of Rheumatology
American College of Surgeons
American Congress of Rehabilitation Medicine
American Dance Therapy Association
American Gastroenterological Association
American Geriatrics Society
American Glaucoma Society
American Group Psychotherapy Association
American Liver Foundation
American Medical Association
American Medical Rehabilitation Providers Association
American Medical Women’s Association
American Music Therapy Association
American Nurses Association
American Occupational Therapy Association
American Osteopathic Association
American Osteopathic Colleges of Ophthalmology and Otolaryngology
American Physical Therapy Association
American Psychiatric Association
American Psychoanalytic Association
American Society for Clinical Pathology
American Society for Gastrointestinal Endoscopy
American Society for Radiation Oncology
American Society for Radiology and Oncology
American Society for Surgery of the Hand
American Society of Anesthesiologists
American Society of Cataract & Refractive Surgery
American Society of Clinical Oncology
American Society of Echocardiography
American Society of Hematology
American Society of Interventional Pain Physicians
American Society of Nephrology
American Society of Neuroimaging
American Society of Neuroradiology
American Society of Nuclear Cardiology
American Society of Ophthalmic Plastic and Reconstructive Surgery
American Society of Plastic Surgeons
American Society of Retina Specialists
American Society of Transplant Surgeons
American Spinal Injury Association
American Urological Association
American Uveitis Society
American Vein & Lymphatic Society
American-European Congress of Ophthalmic Surgery
America’s Physician Groups
Arthritis Foundation
Association for Molecular Pathology
Association of Academic Physiatrists
Association of American Medical Colleges
Association of Black Cardiologists
Association of Rehabilitation Nurses
Association of University Professors of Ophthalmology
Beyond Type 1
Brain Injury Association of America
Bridge the Gap – SYNGAP Education and Research Foundation
Cancer Support Community
CancerCare
Caregiver Action Network
Child Neurology Foundation
Children with Diabetes
Christopher & Dana Reeve Foundation
Clinician Task Force
CMSC- Consortium of Multiple Sclerosis Centers
Coalition For Headache And Migraine Patients
College Diabetes Network
College of American Pathologists
Community Oncology Alliance
Congress of Neurological Surgeons
Cornea Society
Crohn’s & Colitis Foundation
Delaware Academy of Ophthalmology
Depression and Bipolar Support Alliance
Derma Care Access Network
Diabetes Patient Advocacy Coalition
DiabetesSisters
Digestive Disease National Coalition
Disability Rights Education and Defense Fund
Dystonia Advocacy Network
Dystonia Medical Research Foundation
Epilepsy Foundation
Eye and Contact Lens Association
Eye Bank Association of America
Federation of American Hospitals
Free2Care
GBS|CIDP Foundation International
Global Alliance for Behavioral Health and Social Justice
Global Healthy Living Foundation
Global Liver Institute
Healthcare Information and Management Systems Society
Hematology/Oncology Pharmacy Association
IFAA – International Foundation for Autoimmune & Autoinflammatory Arthritis
International Essential Tremor Foundation
International Foundation for Gastrointestinal Disorders
International Society for the Advancement of Spine Surgery
Interstitial Cystitis Association
Lupus and Allied Diseases Association, Inc.
Medical Group Management Association
METAvivor
Movement Disorders Policy Coalition
Multiple Sclerosis Association of America
National Alopecia Areata Foundation
National Association for the Advancement of Orthotics & Prosthetics
National Association of Rural Health Clinics
National Association of Social Workers
National Association of Spine Specialists
National Association of State Head Injury Administrators
National Association of State Mental Health Program Directors
National Comprehensive Cancer Network
National Diabetes Volunteer Leadership Council
National Health Council
National Infusion Center Association
National Lipid Association
National Medical Association, Ophthalmology Section
National Multiple Sclerosis Society
National Osteoporosis Foundation
National Pancreas Foundation
National Patient Advocate Foundation
NephCure Kidney International
North American Neuro-Ophthalmology Society
Ocular Microbiology and Immunology Group
Outpatient Endovascular and Interventional Society
Partnership to Advance Cardiovascular Health
Partnership to Fight Chronic Disease
Partnership to Improve Patient Care
Prevent Blindness
Pulmonary Hypertension Association
Remote Cardiac Services Provider Group
Renal Physicians Association
Restless Legs Syndrome Foundation
RetireSafe
Sjogren’s Syndrome Foundation
Society for Cardiovascular Angiography and Interventions
Society for Vascular Surgery
Society of Critical Care Medicine
Society of Gynecologic Oncology
Society of Hospital Medicine
Spine Intervention Society
The Headache and Migraine Policy Forum
The Leukemia & Lymphoma Society
The Marfan Foundation
The Michael J. Fox Foundation for Parkinson’s Research
The Retina Society
The Society of Thoracic Surgeons
Tourette Association of America
Treatment Communities of America
Uniform Data System for Medical Rehabilitation
United Spinal Association
US Hereditary Angioedema Association
Alabama Academy of Ophthalmology
Alabama Society for the Rheumatic Diseases
Lakeshore Foundation
Medical Association of the State of Alabama
Neurosurgical Society of Alabama
Alaska Rheumatology Alliance
Alaska Society of Eye Physicians and Surgeons
Denali Oncology Group Alaska Chapter ASCO
Arizona Medical Association
Arizona Neurosurgical Society
Arizona United Rheumatology Alliance
The Arizona Clinical Oncology Society
Arkansas Medical Society
Arkansas Ophthalmological Society
Arkansas Rheumatology Association
Association of Northern California Oncologists
California Academy of Eye Physicians and Surgeons
California Association of Neurological Surgeons
California Medical Association
California Rheumatology Alliance
Medical Oncology Association of Southern California, Inc.
Cedars/Aspens, non-profit society of ophthalmic surgeon educators
Colorado Medical Society
Colorado Neurosurgical Society
Colorado Rheumatology Association
Colorado Society of Eye Physicians and Surgeons
Connecticut Rheumatology Association
Connecticut Society of Eye Physicians
Connecticut State Medical Society
Delaware Society for Clinical Oncology
Delaware State Neurosurgical Society
Medical Society of Delaware
Medical Society of the District of Columbia
Florida Medical Association
Florida Neurosurgical Society
Florida Society of Clinical Oncology
Florida Society of Ophthalmology
Florida Society of Rheumatology
Georgia Society of Clinical Oncology
Georgia Society of Rheumatology
Medical Association of Georgia
Hawaii Medical Association
Hawaii Society of Clinical Oncology
Association of Idaho Rheumatologists
Idaho Medical Association
Idaho Society of Ophthalmology
Illinois Medical Oncology Society
Illinois Society of Eye Physicians & Surgeons
Illinois State Medical Society
Illinois State Neurosurgical Society
Indiana Academy of Ophthalmology
Indiana Chapter, American College of Cardiology
Indiana Oncology Society
Iowa Medical Society
Iowa Oncology Society
Midwest Neurosurgical Society
Kansas Chapter, American College of Cardiology
Kansas Hospital Association
Kansas Medical Society
LeadingAge Kansas
Midwest Rheumatology Association
Kentucky Academy of Eye Physicians and Surgeons
Kentucky Association of Medical Oncology
Kentucky Chapter, American College of Cardiology
Kentucky Medical Association
Louisiana Academy of Eye Physicians and Surgeons
Louisiana Chapter, American College of Cardiology
Louisiana Neurosurgical Society
Louisiana State Medical Society
Rheumatology Alliance of Louisiana
Maine Medical Association
Maine Society of Eye Physicians and Surgeons
Maryland Chapter, American College of Cardiology
Maryland DC Society of Clinical Oncology
Maryland Society for the Rheumatic Diseases
Maryland Society of Eye Physicians and Surgeons
MedChi, The Maryland State Medical Society
Massachusetts Society of Clinical Oncologists
Massachusetts Medical Society
Michigan Society of Eye Physicians and Surgeons
Michigan Society of Hematology & Oncology
Michigan State Medical Society
Minnesota Medical Association
Minnesota Neurosurgical Society
Mississippi Arthritis and Rheumatism Society
Mississippi Oncology Society
Mississippi State Medical Association
Missouri Oncology Society
Missouri Society of Eye Physicians & Surgeons
Missouri State Medical Association
Montana Medical Association
Montana Neurosurgical Society
Montana State Oncology Society
Nebraska Chapter, American College of Cardiology
Nebraska Medical Association
Nebraska Rheumatology Society
Nevada State Medical Association
Northern New England Clinical Oncology Society
New Hampshire Medical Society
Medical Oncology Society of New Jersey
Medical Society of New Jersey
New Jersey Academy of Ophthalmology
New Jersey Neurosurgical Society
New Mexico Medical Society
Empire State Hematology & Oncology Society
Medical Society of the State of New York
New York State Neurosurgical Society
New York State Ophthalmological Society
New York State Rheumatology Society
North Carolina Medical Society
North Carolina Rheumatology Association
North Carolina Society of Eye Physicians & Surgeons
North Dakota Medical Association
North Dakota Society of Eye Physicians and Surgeons
Ohio Association of Rheumatology
Ohio Chapter, American College of Cardiology
Ohio Hematology Oncology Society
Ohio Ophthalmological Society
Ohio State Medical Association
Ohio State Neurosurgical Society
Oklahoma Academy of Ophthalmology
Oklahoma Chapter, American College of Cardiology
Oklahoma Neurosurgical Society
Oklahoma State Medical Association
Oregon Academy of Ophthalmology
Oregon Medical Association
Oregon Rheumatology Alliance
Oregon Society of Medical Oncology
Pennsylvania Academy of Ophthalmology
Pennsylvania Medical Society
Pennsylvania Neurosurgical Association
Pennsylvania Rheumatology Society
Philadelphia Rheumatism Society
Pittsburgh Ophthalmology Society
Pennsylvania Society of Oncology & Hematology
The Hospital and Healthsystem Association of Pennsylvania
Puerto Rico’s Hematology and Medical Oncology Association
Rhode Island Chapter, American College of Cardiology
Rhode Island Medical Society
Rhode Island Neurosurgical Society
Rhode Island Society of Eye Physicians and Surgeons
South Carolina Medical Association
South Carolina Oncology Society
South Carolina Rheumatism Society
South Carolina Society of Ophthalmology
South Dakota Academy of Ophthalmology
South Dakota State Medical Association
Tennessee Chapter, American College of Cardiology
Tennessee Medical Association
Tennessee Rheumatology Society
State of Texas Association of Rheumatologists
Texas Medical Association
Texas Ophthalmological Association
Society of Utah Medical Oncologists
Utah Medical Association
Utah Ophthalmology Society
Vermont Medical Society
Medical Society of Virginia
Virginia Association of Hematologist & Oncologist
Virginia Chapter, American College of Cardiology
Virginia Society of Eye Physicians and Surgeons
Neurosurgical Society of the Virginias

Washington Academy of Eye Physicians and Surgeons
Washington Rheumatology Alliance
Washington State Medical Association
Washington State Medical Oncology Society
West Virginia Academy of Eye Physicians & Surgeons
West Virginia State Medical Association
West Virginia State Rheumatology Society
Wisconsin Academy of Ophthalmology
Wisconsin Association of Hematology & Oncology
Wisconsin Medical Society
Wisconsin Rheumatology Association
Wisconsin State Neurosurgical Society
Wyoming County Community Health System
Wyoming Medical Society
Wyoming Ophthalmological Society

Posted in: Medicare, Uncategorized

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Navigate the New Medicare ID Transition in Nine Steps

Navigate the New Medicare ID Transition in Nine Steps

Due to a legislative mandate in MACRA passed in 2015, Medicare will no longer use Social Security numbers to identify individuals. Instead, a new randomly generated Medicare Beneficiary Identifier (MBI) will be assigned to all 58 million Medicare recipients. New Medicare ID cards containing the MBI are currently being sent to recipients.

The MBI replaces the Health Insurance Claim Number (HICN) used for Medicare transactions like billing, eligibility status, and claim status. Whereas the HICN started with the 10-digit Social Security number and ended with a letter or two designating a policy type, the 11-digit MBI will contain both letters and numbers throughout.

The transition to these new cards is a big step for patients as well as providers, and all stakeholders must be ready to accept, receive and transmit the new MBI.

Make the Transition in Nine Easy Steps

  • Educate practice staff about the rollout of the new Medicare cards with the new MBIs.
  • Contact practice-management system vendors about what system changes need to be made to accommodate the MBIs.
  • Alert your Medicare patients that they will be receiving new Medicare cards with their new MBIs.
  • Remind Medicare patients to confirm the Social Security Administration has their correct address on file to ensure they receive their new Medicare cards.
  • Tell Medicare patients to bring their new Medicare cards to their next appointment after they receive it.
  • Begin using the new MBI in Medicare transactions as soon as it is available for the patient.
  • Monitor eligibility responses for messages that indicate the patient was mailed a new Medicare card.
  • Starting Oct. 1, 2018, monitor remittance advices for messages that provide the patient’s MBI.
  • Sign up for the MBI look-up tool via your regional MAC portal.

For more information, log on to www.cms.gov and click the Medicare tab.

Posted in: Medicare

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