Articles Posted in Medicaid

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Beginning January 21, 2021, only COVID-19 diagnostic tests that are completed within two days will be paid at the current rate by Medicare. Since the outbreak of the COVID-19 pandemic, diagnostic testing has been an important part of strategies to combat the virus. In an early push to expand COVID-19 diagnostic testing capacity, on April 15, 2020, the Centers for Medicare & Medicaid Services (“CMS”) announced that Medicare would increase the payment to laboratories for high-throughput COVID-19 diagnostic tests from approximately $51 to $100 per test.

However, on October 15, 2020, CMS announced a change to this policy. Beginning January 1, 2021, COVID-19 diagnostic tests run on high-throughput technology will be paid at a base rate of $75 per test. A $25 per test add-on payment will then be paid to laboratories for a high throughput COVID-19 diagnostic test if the laboratory: (1) completes the test in two calendar days or less, and (2) completed the majority of all the previous months’ high-throughput COVID-19 diagnostic tests in two calendar days or less. The second requirement includes all of a laboratory’s high-throughput COVID-19 diagnostic tests in the precious month, not just those that are billed to Medicare. Thus, only tests that meet both these requirements will continue to be paid at $100 per test, while others will be paid at $75 per test. CMS indicates that this change is intended to support faster testing and also reflect the resource costs laboratories face to complete testing in a timely fashion.

In the event of an audit, CMS indicates that a laboratory that received the $25 per test add-on would be required to produce documentation of timeliness based on their performance in the month preceding the date of the test. These increased documentation requirements could effectively begin as early as December 2020. Because the new payment rates become effective January 1, 2021 but take into account tests completed in the previous month, laboratories will likely have to complete the majority of their tests run in December 2020 in two days or less to qualify for the add-on payment in January 2021.

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Medicare Administrative Contractor (“MAC”) CGS announced that beginning in October 2020, it would conduct post-payment reviews of hospice general inpatient (GIP) claims. Specifically, the reviews will be conducted if the claims were for 7 or more days of service, utilized revenue code 0656, and were submitted before March 1, 2020. These claims are particularly being targeted by CGS because GIP claims encompass a level of care intended for short term interventions, wherein symptoms can be controlled within 48 to 72 hours from the GIP setting. As such, if the claims were for 7 days or longer, CGS will flag the claim for review.

Common reasons for a denial following a hospice post payment review include: (1) Documentation does not indicate the patient had a terminal prognosis of 6 months or less; (2) Basic patient information is missing from the Notice of Election; (3) The physician narrative statement is not a true clinical narrative; (4) Failure to meet Face-to-Face requirements; and (5) The documentation did not support that the GIP level of care was reasonable or necessary.

An uptick in post-payment reviews leading to full-blown audits is to be expected for all provider types. As of August 3, the Centers for Medicare & Medicaid Services (“CMS”) announced that its suspension of Medicare claim audits would be lifted. Due to the 2019 Novel Coronavirus (“COVID-19”), CMS had suspended most audits on March 30, specifically pre- and post-payment reviews conducted by MACs. As such, providers should be vigilant about following their compliance plans. Not only are Medicare audits resuming, but private payors have also resumed audits. Specifically, laboratories are expected to see a large amount of private payor audits surrounding COVID-19 testing.

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Recently, the White House announced it will not postpone implementation of the hospital price transparency rule, set to take effect on January 1, 2021.  Based on President Trump’s Executive Order on Improving Price and Quality Transparency in Healthcare, issued on June 24, 2019, CMS released the “Ambulatory Surgical Center (ASC) Price Transparency Requirements for Hospitals to Make Standard Charges Public Final Rule.” The rule allows patients to access hospital pricing information easily so that they have an idea of potential charges prior to receiving a bill and thus can shop for lower cost services.

Under the rule, hospitals are required to publish negotiated rates, gross charges, and discounted cash prices in a public, online format. The data must be free, in an easily accessible format, include a description of each item or service, and be updated yearly. Furthermore, hospitals must create a minimum of 300 “shoppable” healthcare services and display them in a consumer-friendly manner. Shoppable services are services that are often offered by multiple providers, so patients can research ahead of time and compare these services among various providers and make informed decisions on quality and cost. The goal is that as consumers have more price transparency and are more able to shop for their healthcare services, competition among hospitals and insurance providers will potentially increase and reduce healthcare costs as a result.

Hospitals oppose the transparency rule, claiming that it violates hospitals’ First Amendment rights and that CMS does not have the power to require hospitals to disclose their negotiated prices. Hospitals also claim the rule will increase administrative work, requiring more compliance costs. Although the American Hospital Association filed suit over the rule, a federal judge upheld it in June, concluding that CMS can mandate that hospitals reveal their negotiated prices. The AHA appealed the decision and oral arguments are scheduled for October 15.

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On October 6, 2020, the Centers for Medicare & Medicaid Services (CMS) released guidance giving hospitals until December 9, 2020 to comply with COVID-19 reporting requirements or risk termination from the Medicare and Medicaid Programs. CMS also released reporting requirements for influenza data, which are currently optional but which CMS plans to make mandatory in the coming weeks.

The COVID-19 reporting requirements were initially published in guidance by the Department of Health and Human Services (HHS) on July 29, 2020 and were incorporated into a Final Rule on September 2, 2020. Hospitals are required to report, on a daily basis, several data elements relating to their COVID-19 response. These data points include inpatient bed and ICU bed capacity and occupancy, total number of ventilator and total number of ventilators in use, total suspected or confirmed positive COVID-19 patients, numbers of COVID-19 patients receiving certain treatments, emergency department overflow, and the previous day’s COVID-19 deaths. CMS indicates this information is used to coordinate the federal response to the virus.

Beginning October 7, 2020, hospitals that are not in compliance with the reporting requirements or that are not reporting currently began receiving notifications from CMS. These letters gave hospitals three weeks to bring their reporting into compliance. Hospitals that do not come into compliance will continue to receive a series of enforcement letters. On December 9, 2020, hospitals that have been out of compliance with the reporting requirements for 14 weeks (beginning September 2, 2020, the release of the Final Rule) will be sent by CMS a letter terminating them from the Medicare and Medicaid programs. The termination will be effective within 30 days of the date of the notification of termination. Any terminated hospital will have the right to appeal, the ability come into compliance to avoid termination, and the opportunity to avail themselves of a 30-day reasonable assurance period under 42 CFR § 489.57. CMS indicates that the 14-week compliance window only applies to current enforcement. Future enforcement actions related to these reporting requirements will be subject to a shorter process.

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Payment for the Medicare home health benefit depends on a series of complex criteria that must be supported by documentation in the medical record, including a face-to-face encounter, homebound status, and need for skilled services. The requirements for home health documentation change frequently and give rise to some of the common pitfalls in home health audits.

First, the face-to-face encounter requirement requires that a qualified provider, usually the certifying physician, have an encounter with the beneficiary within a certain timeframe, for reasons related to the reason that the beneficiary requires home health, and properly document the beneficiary’s need for home health. Until 2015, the qualified provider was required to include a “brief narrative” supporting the need for home health. This requirement has since been dropped in favor of a more holistic review of the medical record, and the signature and organizational requirements have changed as well in recent years.

Second, the documentation must support that the beneficiary is homebound. Homebound status turns on a complex test. To qualify for homebound status, the beneficiary must: (1) because of illness or injury, need the aid of supportive devices, special transportation, or another person in order to leave their residence or have a condition such that leaving home is medically contraindicated; and (2) exhibit a normal inability to leave home and leaving home must require a considerable and taxing effort. Over time, CMS has adjusted language to tighten these requirements. Certain infrequent absences from the home, such as for religious services or doctor’s appointments, will not disqualify a beneficiary.

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On Wednesday, September 30, 2020, the Senate passed the bipartisan government funding bill that will relax Medicare loan repayments in the wake of the 2019 Novel Coronavirus (“COVID-19”) pandemic. The House passed this bill the week prior to the Senate vote, and the President signed the bill into law the very same day that the Senate approved the bill.

Providers who initially received a loan through the CARES Act Advanced and Accelerated Payment Program (“AAP”) will now have one year from when the loan was issued before recoupment will begin. This gives providers much more time to repay these loans, as opposed to the initial 120-day recoupment period that was previously intact. Furthermore, the extension speaks to the AAP’s intent—AAP loans were meant to keep Medicare-reimbursed providers financially stable during the nationwide pandemic, which is still ongoing.

In addition to the recoupment period being extended, the recoupment rate will also be lowered. Initially, it would have been 100% recoupment until the loan was repaid. Moving forward, after the one year passes and recoupment begins, the Centers for Medicare and Medicaid Services (“CMS”) will recoup 25% for the first 11 months and then 50% for the following 6 months. Lastly, the interest rate on the AAP loans has been lowered from 9.6% to 4%.

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On September 25th 2020, and in response to the 2019 Novel Coronavirus (“COVID-19”) pandemic, the Centers for Medicare & Medicaid Services (“CMS”) announced a new Quick Start Guide and expedited review process to make it easier for laboratories pursuing Clinical Laboratory Improvement Amendments (“CLIA”) certification to offer COVID testing. These tools will reduce delays in and aid laboratories in understanding the certification process to help address the COVID-19 crisis.

CMS regulates all human laboratory tests through the CLIA program. The intent of the CLIA program is to provide safe, quality testing and ensure that results are accurate regardless of where the test was conducted. In addition to meeting quality assurance and performance standards to show that they can offer reliable and accurate testing, laboratories must also pay CLIA administration fees prior to certification. CLIA fees are calculated depending on the type of certificate requested by the laboratory and the amount and type of tests being performed.

CMS has implemented various measures to address the need to expand laboratory capacity during the COVID-19 public health emergency. CMS now allows pathologists to review laboratory data and results remotely to increase capacity while minimizing exposure risks to healthcare providers. CMS also stated that it will not enforce the requirement to have a separate certificate for laboratories participating at temporary COVID testing sites, as long as the primary location of the laboratory does possess a certificate. Furthermore, laboratories in hospital or university campuses in adjoining buildings and under the same director only need one certificate if located at the same physical location or address. This reduces the number of CLIA certificates labs must apply for, allowing them to begin COVID testing more rapidly.

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The Centers for Medicare & Medicaid Services (CMS) announced on September 22, 2020 that the Medicare Prior Authorization Model for Repetitive, Scheduled Non-Emergent Ambulance Transport (RSNAT) will be expanded nationwide. Under this system, Medicare pays ambulances for the transport of patients to their scheduled, non-emergency healthcare appointments.

The prior authorization model was launched in 2014 by CMS in select states that displayed a higher utilization of RSNAT services. RSNAT services are essential medical services that have been previously scheduled and require non-emergency ambulance transportation for at least three round trips within ten days, or a minimum of once a week for at least three weeks. These types of ambulance services are covered under Medicare Part B, provided that the services are deemed medically necessary. Under the payment model, the ambulance transportation company must submit a prior authorization request to their Medicare administrative contractor (MAC) on behalf of the beneficiary and include a physician certification statement noting the medical necessity of the service. Once the physician certification statement has been reviewed, the MAC will issue a determination as to whether the beneficiary qualifies for RSNAT.

The purpose of the prior authorization model is to decrease Medicare spending through the reduction of ambulance transportation services that are not covered by Medicare and do not meet coverage standards, without negatively impacting access to care for beneficiaries. The prior authorization model began in 2014 with New Jersey, Pennsylvania, and South Carolina participating, and in 2016 expanded to Delaware, the District of Columbia, Maryland, North Carolina, Virginia, and West Virginia. The model will now be expanded nationwide as a result of the success in those nine states.

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Due to the 2019 Novel Coronavirus (“COVID-19”) pandemic, many Michigan residents have found themselves without any health insurance coverage. On September 15, 2020, the Michigan Department of Insurance and Financial Services (“DIFS”) released a press statement informing Michigan residents that extended health insurance enrollment periods are available for qualified residents through the Health Insurance Marketplace.

Special Enrollment Periods (“SEPs”) allow individuals who missed the yearly open enrollment period but have experienced a specific life event to sign up for health insurance. Generally, individuals have 60 days before and 60 days after a qualifying life event to enroll in an insurance plan through the Health Insurance Marketplace. Life events that qualify individuals to enroll in an SEP include: household changes, such as marriage, divorce, or the birth of a child; changes in residence; and a loss of health insurance. Typically, if an individual misses an SEP enrollment window, he or she must wait until the next open enrollment period to apply.

Individuals who have lost healthcare coverage due to job loss during the COVID-19 pandemic may still be eligible for coverage through various healthcare outlets. Those who have lost health insurance as a result of job loss may become eligible for Medicaid if they live in a state with expanded Medicaid under the Affordable Care Act (“ACA”) and meet certain income limits. Michigan is one such state that has expanded Medicaid coverage under the ACA. Additionally, ACA Marketplace coverage is available to those who do not have employer sponsored health insurance and do not qualify for Medicaid. Furthermore, subsidies may be available to individuals with a family income between 100% and 400% of the poverty line. COBRA is another option for those who lost job-based health insurance. COBRA will allow employer-based coverage to continue after employment ends, however, this is often a costly option because the individual must pay the entire premium as well as an additional 2%.

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On September 13, 2020, President Trump issued an executive order targeting prescription drug process paid by Medicare under Part B and Part D. The order, titled “Executive Order on Lowering Drug Prices by Putting Americans First,” outlines a new policy that Medicare should not pay more for Part B or Part D prescription drugs than the “most-favored-nation price.”

The order defines the “most-favored-nation price” as the lowest price, after adjusting for volume and differences in GDP, for a drug that the manufacturer sells to an Organization for Economic Co-operation and Development (“OECD”) member country with a comparable GDP per capita. For reference, Norway, Austria, and the Netherlands are all OECD member countries with a GDP per capita comparable to the United States.

The order has no immediate effect on prescription drug prices. Change will only occur once regulations have been promulgated, and this process has not yet begun. However, the order directs the Department of Health and Human Services (“HHS”) to “immediately” implement a test payment model. The test model would apply the new policy to certain high-cost prescription drugs and biological products covered by Part B to determine whether paying the “most-favored-nation price” leads to better clinical outcomes and/or cost-saving. The order also directs HHS to develop and implement a similar test payment model for Part D prescription drugs but does not impose a timeline on HHS to do so.

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