Articles Posted in Compliance

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A Medicare license revocation can drastically affect a provider or practice; for example, more than 90% of primary care providers accept Medicare, and Medicare beneficiaries account for at least 50% of primary care physicians’ patient population. A revocation can jeopardize providers’ livelihood and lead to other consequences, including loss of hospital staff privileges, bars on reenrollment, and harm to a provider’s reputation within the medical community. Despite these penalties, as Medicare revocation rules evolved, CMS broadened the language permitting the agency to revoke a license, without much guidance or specificity, leaving providers with little information on the exact behavior they must avoid to prevent a revocation.

Since 2008, CMS has significantly expanded the instances in which a provider’s Medicare license can be revoked. In 2008, CMS added a new reason for revocation, 42 C.F.R. § 424.535(a)(10), which allows CMS to revoke a provider’s Medicare license if the provider does not document or does not provide CMS access to certain documentation. In 2014, CMS added a new section to 424.535(a)(8), section (a)(8)(ii).

Under an (a)(8) revocation, CMS can revoke a provider’s enrollment in Medicare if the provider commits certain abuses related to billing. Prior to 2014, under the original rule, an (a)(8) revocation was limited to specific circumstances in which the provider submitted claims for services that could not have been provided to the individual on a the date of those services. These circumstances could include, the beneficiary is deceased, the physician or beneficiary is not in the location where the service were provided, or when the necessary equipment for the service were not in the location where the services occurred.

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On October 22, 2020, the Department of Health and Human Services (“HHS”) announced changes to the allowable uses of a Provider Relief Fund (“PRF”) payment and also expanded the categories of providers eligible to receive a payment in the Phase 3 General Distribution. The PRF is a $175 billion fund created by Congress in the CARES Act and administered by HHS to provide financial relief to healthcare providers during the COVID-19 pandemic.

Acceptance of a PRF payment is conditioned on the acceptance by the provider of certain restrictions on how the payment may be used and the filing of reports in which the provider demonstrates compliance with these restrictions. One such restriction is that the funds may be used for “lost revenue attributable to the coronavirus.” When HHS first released the reporting requirements for PRF payments, it indicates that such lost revenues would be demonstrated by a negative change in year-over-year net patient care revenue from 2019 to 2020. Many saw this as placing an arbitrary cap on the amount of financial relief that struggling providers could receive from the PRF. In response to feedback, HHS has amended this requirement. Regarding use of the PRF payment to cover lost revenue attributable to coronavirus, HHS now requires that, “after reimbursing healthcare related expenses attributable to coronavirus that were unreimbursed by other sources, providers may use remaining PRF funds to cover any lost revenue, measured as a negative change in year-over-year actual revenue from patient care related sources.” (emphasis added).

HHS also announced expansion of the categories of providers who are eligible to apply for payments as part of the Phase 3 General Distribution of the PRF. The PRF previously included $30 billion Phase 1 and $20 billion Phase 2 General Distributions to eligible providers, primarily those that bill Medicare or Medicaid. The $20 billion Phase 3 General Distribution, announced October 1, 2020, was intended to provide financial relief to for providers who were either excluded from the initial two phases, or who were eligible under the first two phases but require additional funding to cover ongoing financial losses accrued during the pandemic. On October 22, 2020, HHS announced it was expanding Phase 3 eligibility to include the following providers, regardless of whether they accept Medicare or 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 19, 2020, the Department of Health and Human Services (HHS) released the much-anticipated reporting requirements for providers who received payments under the Provider Relief Fund (PRF). The PRF is a $175 billion fund created Congress through the CARES Act and administered by HHS to provide financial relief to healthcare providers during the COVID-19 pandemic. HHS previously amended the reporting requirements to require that any provider who received more than $10,000 from the PRF must file a report by February 15, 2021 and indicated that further details on reporting would be released at a later date. The new reporting system opens to payment recipients on October 1, 2020.

HHS breaks down the new reporting requirements into four date groups of data elements. First, providers must report Demographic Information, such as the Reporting Entity (whether the entity is reporting for a PRF payment it received or is reporting for a payment its subsidiary received), TIN, NPI, fiscal year-end date, and federal tax classification.

Second providers must report “expenses attributable to coronavirus not reimbursed by other sources.” Expenses attributable to coronavirus may be incurred in treating confirmed or suspected cases of coronavirus, preparing for possible or actual coronavirus cases, maintaining healthcare delivery capacity, etc. Providers who received between $10,000 and $499,999 in aggravated PRF payments need only report their net expenses that are attributable to coronavirus and not reimbursed by another source. These expenses need only be reported in two aggregate categories: (1) General and Administrative expenses and (2) other healthcare related expenses.  However, providers who received $500,000 or more in aggregate PRF funds must report in significant detail on sub-categories of these expenses.

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On September 14, 2020, Wachler & Associates posted a blog detailing all of the speculation surrounding recoupment of the CARES Act Advanced and Accelerated Payments (“AAP”) Program. As of then, CMS had not yet made a statement on when CMS would begin AAP loan recoupments. Originally, providers were told to expect to see recoupments on these loans 120-days from issuance of the loan. Many providers, however, had surpassed their 120-day time limit but did not see any indication that payments were being recouped to repay the loan.

On Friday, September 18, 2020, CMS Administrator Seema Verma confirmed that CMS would not begin recouping AAP loans until Congress passes legislation on the matter. This timely statement comes just before the House passed H.R. 8337, FY 2021 Continuing Resolution, through December 11, 2020 (Appropriations), on September 22, 2020. This bill would give providers with AAP loans one year from issuance before CMS begins recoupment, instead of the original time limit of 120-days from issuance. This bill would also lower the recoupment rate and the interest rate. It is not yet known when there will be a vote in the Senate on the bill, but the bill is expected to pass the Senate.

For over 35 years, Wachler & Associates has represented healthcare providers and suppliers nationwide in a variety of health law matters, and our attorneys can assist providers and suppliers in understanding new developments in the CARES Act and when to expect accelerated payment recoupment to begin. If you or your healthcare entity has any questions pertaining to healthcare compliance, please contact an experienced healthcare attorney at 248-544-0888 or

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