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Congress Considers Expanding Medicare Coverage for Prescription Weight Loss Medications

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Congress Considers Expanding Medicare Coverage for Prescription Weight Loss Medications

By: Jessie Bekker, Burr & Forman LLP

Some Congressional leaders voted to expand Medicare coverage for prescription medications to treat obesity.

The House of Representatives Ways and Means Committee voted in late June to pass the Treat and Reduce Obesity Act of 2023. If passed, the bill would approve Medicare Part D coverage for glucagon-like peptide-1 agonists, or GLP-1 agonists, including semaglutide, a diabetes medication. 

The medications, also approved by the Food and Drug Administration (FDA) for the treatment of cardiovascular disease, have gained popularity under name brands including Wegovy and Ozempic for their promotion of weight loss. 

The Treat and Reduce Obesity Act of 2023 would allow Medicare Part D to cover obesity treatment medications for those who also present with at least one comorbidity. The Act would also expand Medicare coverage for intensive behavioral therapy related to obesity when provided upon referral from primary care providers by other physician specialists and health care providers, including nurse practitioners, physician assistants, registered dietitians and clinical psychologists. (Medicare currently only provides coverage for obesity-related intensive behavioral therapy provided by primary care practitioners).

A version of the bill was introduced in the Senate in 2023 and referred to the Committee on Finance.

The bill has received bipartisan support, but it is not the first time Congress has considered the measure. In 2021, Congress considered a bill by the same name in both the House and Senate, but it gained little traction.

According to the Congressional Budget Office (CBO), which assesses the estimated economic impact of proposed legislation, “the evidence suggests that the amount of potential savings on cardiac care and other health care would be less than the current net federal cost of [anti-obesity medication],” basing its determination on the current costs of those medications against spending on treatment of common conditions associated with obesity, like cardiovascular disease. The CBO attributed the net economic loss to the high cost of anti-obesity medications and comparatively small decrease in health care spending by people who lost weight and experienced health benefits. The CBO further noted that it expected Medicare cost-sharing and premiums to increase in the event of coverage for anti-obesity medications.

Concurrently, Medicare Advantage providers are contemplating coverage for anti-obesity medications. In statements to Modern Healthcare, Kaiser Permanente’s Kaiser Health Plan and CVS Health’s Aetna reported that each would begin providing coverage for brand name Wegovy to their enrollees.

The CBO reported that U.S. net sales of Ozempic, Wegovy, and Rybelsus, an oral version of Ozempic versus its injectable counterpart, totaled $3.4 billion in the second quarter of 2023, while U.S. net sales of all glucagon-like peptide-1 agonists in that time period totaled $5.9 billion. Meanwhile, FDA reports show demand for semaglutide injections have driven shortages of the drugs.

Jessie Bekker is an attorney at Burr & Forman LLP practicing exclusively in the firm’s healthcare practice group. Jessie can be reached at jbekker@burr.com or (205) 458-5275.

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Medical Association Endorses Prior Authorization Bill Reintroduced in Congress

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Medical Association Endorses Prior Authorization Bill Reintroduced in Congress

On June 12, bipartisan lawmakers introduced an updated version of the Improving Seniors’ Timely Access to Care Act in both the House (H.R. 8702) and Senate (S. 4532). The Medical Association is supporting the latest version of this legislation that was introduced, once again, by Senators Roger Marshall, MD (R-KS), Krysten Sinema (I-AZ), John Thune (R-SD), and Sherrod Brown (D-OH), as well as Representatives Mike Kelly (R-PA), Suzan DelBene (D-WA), Ami Bera, MD (D-CA) and Larry Bucshon, MD (R-IN). 

In the 117th Congress (2021-2022), the Improving Seniors’ Timely Access to Care Act garnered more than 378 total bipartisan cosponsors in the House and Senate and also passed the full House of Representatives. In addition, the legislation secured endorsements from more than 500 outside organizations, including the Medical Association of the State of Alabama and numerous other national and state medical societies.  

Unfortunately, the version of this bill that passed the House in the 117th Congress was never considered in the Senate because it produced a score of $16 billion from the Congressional Budget Office (CBO), thus necessitating modifications to lessen the bill’s fiscal imprint. While electronic prior authorization rules that the Biden administration finalized in Jan. 2024 lowered the $16 billion score substantially, the recently introduced bill is amended to ensure it ultimately scores as close to $0 as possible.  

More specifically, the legislation requires the Office of National Coordinator for Health Information Technology (ONCHIT) and the Centers for Medicare & Medicaid Services (CMS) to submit a report to Congress on the use of prior authorization in Medicare Advantage and what constitutes “real-time decisions” for “routinely approved services.” The legislation also delegates explicit authority to CMS to implement this newly defined real-time prior authorization decision-making process for routinely approved services in Medicare Advantage. Finally, the legislation delegates explicit authority to the secretary of Health and Human Services to enforce the real-time prior authorization processes for routinely approved services and issue tighter timelines for health plans to make utilization management decisions, such as 24 hours for emergent services.  

Of note, the legislation is unchanged as it relates to: 

·         Mandating compliance with uniform electronic prior authorization technical standards 

·         Barring Medicare Advantage plans from utilizing faxes or proprietary payer portals 

·         Including robust transparency requirements (e.g., disclosure of policies and evidence utilized in formulating prior authorization, listing of all services subjected to prior authorization, how many services are denied and overturned on appeal, etc.) 

·         Permitting insurers to create gold-carding programs 

Click here for the Endorsement List.

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Inside the massive proposed 2023 Medicare physician pay schedule

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Inside the massive proposed 2023 Medicare physician pay schedule

The Medical Association of the State of Alabama is working with the AMA and national specialties to analyze CMS’s proposed physician fee schedule for 2023 to determine its impact on physician practices. The Medical Association in partnership with these other medical organizations will provide appropriate comments to CMS once the full impact of the proposal is determined.

The following is a brief summary from the AMA of what is in the proposal:

The 2023 Medicare Physician Payment Schedule (PFS) rule contains a mix of payment cuts, policy proposals and announcements regarding payment for telehealth and evaluation-and-management (E/M) services.

Slogging through the document’s 2,066 pages can be a daunting task. The AMA, however, has released a 12-page summary (PDF) that has crystalized some of the Proposed Rule’s highlights. The Centers for Medicare & Medicaid Services (CMS) has released a fact sheet that also gives the agency’s view of the highlights.

Conversion factor reduced

The first item on the payment schedule discussed in the summary is the proposed $33.0775 Medicare conversion factor (CF) for 2023, which represents a $1.53 reduction (4.42%) from the 2022 CF. The reduction is driven by the expiration of a one-time 3% CF increase Congress passed last December as part of an appropriation package that averted scheduled Medicare physician payment cuts totaling around 9.75%.

Additionally, about 1.5% of the CF reduction is attributable to a budget-neutrality statute requiring that, when there is projected growth of $20 million in spending on services included in the payment schedule, there must be corresponding cuts elsewhere.

The projected growth in spending stems from an upward adjustment for inpatient E/M services provided in hospitals, nursing homes, emergency departments and home health services.

More E/M changes proposed

CMS is building on the revisions it adopted for 2021 for E/M services provided in physician offices and other outpatient settings. The agency is proposing to generally adopt the Current Procedural Terminology (CPT®) codes and guidelines developed by the CPT Editorial Panel and the valuations recommended by the AMA RVS Update Committee (RUC) for inpatient and other settings, according to the summary.

“In total, the E/M code sets being revised for 2023 comprise approximately 20% of all allowed charges under the Medicare Physician Payment Schedule,” the summary says. “Therefore, these changes, along with other coding and valuations changes, are estimated to require a reduction of about 1.5% to the 2023 Medicare conversion factor due to statutory budget neutrality requirements.”

Along with the reduced CF, the payment schedule includes a 0% payment update that fails to account for significant inflation in practice costs.

Telehealth coverage extended

Early in the COVID-19 pandemic, CMS expanded the Medicare Telehealth List with the addition of some 150 services, including emergency department and telephone visits. Some of these services were listed as “interim” with coverage lasting until the end of the public health emergency (PHE), while others would have coverage extended for another five months after the PHE ends.

For 2023, CMS proposes extending coverage for all interim telehealth services for five months after the PHE ends. Meanwhile, the House of Representatives voted overwhelmingly for a bipartisan bill that extends Medicare telehealth payment and regulatory flexibilities through the end of 2024.

CMS also proposes to add a number of other services to the telehealth coverage list including therapy services, ophthalmology services, and patient education and training in self-measured blood pressure management.

Additionally, CMS proposes to raise payment rates for opioid treatment programs to better reflect the costs of the counseling services, while also proposing to pay for the initiation of buprenorphine to treat opioid-use disorder via telehealth, rather than just in person, to further improve access.

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The AMA, in collaboration with 120 other physician and health care organizations, is working to develop specific recommendations (PDF) to Congress and CMS that will put the nation’s health care system on solid and sustainable financial ground.

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American Rescue Plan Offers $940 Million for Medicaid Expansion and Other Benefits for Healthcare

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American Rescue Plan Offers $940 Million for Medicaid Expansion and Other Benefits for Healthcare

The American Rescue Plan Act of 2021, signed by President Biden on Thursday, includes a number of key provisions that strengthen both public and private health insurance coverage. Among its Medicaid and the Children’s Health Insurance Program (CHIP) provisions, the American Rescue Plan encourages states to finally take up the Medicaid expansion by offering even more favorable financial incentives than those already in place and allows states to provide longer postpartum health coverage for new mothers.

Right now, some 300,000 Alabamians living in the health coverage gap. They earn too much to qualify for Medicaid under the state’s stringent income limit but too little to qualify for subsidized ACA marketplace plans. If Alabama were to expand Medicaid and provide much-needed healthcare coverage for these individuals, the state would receive an estimated $940 million over two-years for doing so. 

A complete analysis of the Act and its potential impact is below. 

HEALTHCARE PROVISIONS

Additional Federal Funding to States that Newly Adopt the Medicaid Expansion

  • Newly expanding states would receive a 5-percentage-point increase in their FMAP for all non-expansion enrollees, who account for most of a state’s Medicaid enrollees and costs. The increase would begin the first day of the quarter that expansion begins and last for two years. Not only that, this increase is on top of the 6.2-percentage-point FMAP increase that all states will receive for the duration of the public health emergency under last year’s Families First Act, which will provide $86 billion in additional federal Medicaid dollars in 2020 and 2021. 
  • According to the Center for Budget and Policy Priorities (CBPP), Alabama would receive an estimated $940 million in federal funds for expanding. 

New Medicaid and CHIP Option for States to Extend Postpartum Coverage for 12 Months

  • The American Rescue Plan offers states a new “state plan” option to provide pregnancy-related Medicaid and CHIP coverage for one year after the end of pregnancy, extending coverage well beyond the current cutoff of 60 days. States can take up this option starting in the first calendar year quarter one year after enactment, which is April 1, 2022. The option, however, is temporary and will be available to states for five years unless Congress acts to extend it at a later time.
  • The Congressional Budget Office (CBO), for example, estimates that about 45 percent of women covered by Medicaid on the basis of pregnancy now become uninsured after the end of the 60-day postpartum coverage period. Alabama is no different, and this new option would directly help address our current maternal mortality statistics. 

Expansion of the State Medicaid Option for Coverage of COVID-19 Testing for the Uninsured to Include Coverage for COVID-19 Vaccines and Treatment

  • The Families First legislation included a Medicaid option for states to cover COVID-19 testing for the uninsured through the duration of the public health emergency. The federal government picks up 100 percent of the cost. The American Rescue Plan expands this fully federally-funded option to cover COVID-19 vaccines and their administration, and treatment, including prescription drugs, and treatment for conditions that complicate COVID-19 treatment.

Policies to Improve the Affordability and Access of Private Insurance Coverage

  • COBRA Coverage: Premiums for COBRA coverage for individuals who are laid off or leave their jobs because of the pandemic will be subsidized at 100% through September 30, 2021. The employer or health plan could claim a refundable tax credit against its Medicare payroll tax liability for the cost of the premiums.
  • Affordable Care Act (ACA) Marketplace Subsidies: Refundable credits for households with income between 100% to 400% of the federal poverty level (FPL). For 2021 and 2022, premiums for individuals with income at 150% of the FPL will be eliminated, while premiums for all other households will be capped at 8.5% of their income.
  • Health Insurance Marketplace: $20 million in grants to states to modernize and update health insurance marketplace systems, programs, or technology.

Public Health Provisions

  • $7.66 billion to expand the public health workforce, including grants to state, local, and territorial health departments that increase the number of contact tracers, social support specialists, community health workers, public health nurses, epidemiologists, lab personnel, disease intervention specialists and communications personnel.
  • $7.6 billion for testing and vaccinations at community health centers (CHCs).
  • $3 billion for block grant programs under the Substance Abuse and Mental Health Services Administration (SAMHSA) to provide community mental health services and prevention and treatment of substance abuse.
  • $800 million for the National Health Service Corps, as well as $100 million reserved for state student loan repayment programs, $200 million for the Nurse Corps Loan Repayment program, and $330 million for teaching health centers that operate graduate medical education.
  • $250 million for states to establish “strike teams” that could be deployed at skilled nursing facilities (SNFs) with high rates of COVID-19.
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Summary of Telehealth Waivers as of April 1, 2020

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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

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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. 

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

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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. 

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Appropriate Use Criteria for Advanced Diagnostic Imaging

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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.
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CMS Releases Physician Fee Schedule Final Rule

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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.

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Changes Coming to AKS, Stark and CMP Laws

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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.

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