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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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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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On September 17, 2020, technology company Glow, Inc. (“Glow”) settled with the California attorney general in response to a data breach on Glow’s fertility-tracking app. This app was created so that women could compile their personal medical information as it relates to cycle and ovulation tracking. Between the years of 2013 and 2016, this app was subject to numerous allegations regarding its security.

According to the California attorney general, the app failed to require authorization from any user who would share their information with another user. This led to data sharing without proper consent. It also did not require a user to enter its old password before creating a new one, so any user could be locked out of their own account by someone attempting to steal data. The California attorney general alleged that these, among other privacy issues, violated California’s consumer protection and privacy laws. The settlement will require Glow to pay $250,000 and increase the privacy and security on the app. The settlement also requires Glow to obtain affirmative consent from all users before sharing any personal medical information.

Although this state case focused on issues from 2013-2016, this settlement is very timely and accurately reflects issues currently facing healthcare providers. During the 2019 Novel Coronavirus (“COVID-19”) pandemic, the Office of Civil Rights (“OCR”) has decided to temporarily stop giving penalties for noncompliance with HIPAA. The purpose of this is so that providers can continue to care for their patients while maintaining social distance protocol and implement telehealth in place of in-person office visits.

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On September 15, 2020, the Centers for Medicare & Medicaid Services (CMS) announced $75,000,000 in grants for rural providers. Grant recipients would participate in a seven-year payment test model designed to improve healthcare in rural communities. Applications are due February 16, 2021.

The grants are part of the Community Health Access and Rural Transformation (CHART) Model. The CHART Model is part of CMS’s Rethinking Rural Health initiative, which aims to ensure individuals in rural America have access to high quality, affordable health care by offering new and creative payment models.  According to CMS, the CHART Model “will test whether aligned financial incentives, increased operational flexibility, and robust technical support promote rural health care providers’ capacity to implement effective health care delivery system redesign on a broad scale.” The impact of the model will be evaluated by the Center for Medicare & Medicare Innovation (CMMI). The CHART Model contains two tracks: the Community Transformation Track and the Accountable Care Organization (ACO) Transformation Track. The newly announced grants are for the Community Transformation Track only.

Under the Community Transformation Track, CMS anticipates awarding 15 grants in the amount of $5,000,000 each, for a total of $75,000,000. Eligible applicants must serve a county or set of counties that are rural, as defined by the Federal Office of Rural Health Policy, and that includes at least 10,000 Medicare fee-for-service beneficiaries whose primary residence is within the county or set of counties. CMMI encourages applicants to submit letters of intent prior to submitting an application. Letters of intent are due January 18, 2021 and final applications are due February 16, 2021.

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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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In March 2020, Congress passed the CARES Act to provide relief for Americans during the 2019 Novel Coronavirus (“COVID-19”) pandemic. Part of the CARES Act included an expansion of the Advanced and Accelerated Payments Programs. The Department of Health and Human Services (“HHS”) stated that this expansion would go on for no more than four months, and that the Centers for Medicare and Medicaid Services (“CMS”) would seek recoupment of these accelerated payments after 120-days from issuance of the accelerated payment has passed.

Despite the timeline given by HHS, many hospitals and other healthcare providers have reported that after the 120-day timeline given by HHS had passed, CMS had not yet begun recoupment. Speculation supports the idea that the 120-day deadline is still intact, but that hospitals still have not seen recoupment because of a 30-day turnaround time. However, CMS released guidance that indicated recoupment would be automatic and begin immediately after the 120-day period, heightening confusion among hospitals.

Hospitals and other healthcare providers have been lobbying Congress to forgive these loans, but Congress has yet to come to a resolution. It is possible that CMS is hesitant to begin recoupment while these negotiations are occurring, because if Congress ultimately decides to offer loan forgiveness after CMS has begun recoupment, then CMS would be responsible for repaying the withheld monies.

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On September 2, 2020, the Centers for Medicare & Medicaid Services (CMS) finalized fiscal year (FY) 2021 policies in the Inpatient Prospective Payment System (IPPS) for acute care and long-term care hospitals. The rule safeguards access to critical diagnostic technology and medical treatments through increasing technological innovation in the medical industry, easing industry competition, and updating hospital payment policies. IPPS is the Medicare payment system for acute care hospitals. Payments are issued per inpatient or per patient discharge.  Discharge cases are categorized into diagnosis related groups (DRGs) based on similar diagnoses and services provided during the inpatient process. CMS updates the IPPS regulations each year, which allows inpatient hospitals to address quality improvement efforts and maximize cost effectiveness. The updated IPPS final rule takes effect on October 1, 2020 with two very noteworthy changes.

The first important change to the final rule is the switch to a market-based method for weight data collection for calculating Medicare Severity Diagnosis Related Groups (MS-DRGs). Currently, payments for cases under IPPS are calculated by multiplying a hospital’s standardized cost per case, adjusted by geographic location, by the relative weight for the MS-DRG assigned to the case. This cost-based methodology mainly uses hospital charges based on claims and hospital report data. However, recently CMS has acted to reduce Medicare’s use of hospital charge data, due to the thought that gross rates are an inaccurate representation of market costs. In the final rule, MS-DRG weights will instead be based on median payer specific negotiated charges for Medicare Advantage (MA) organizations, collected through Medicare cost reports. This new methodology will be fully implemented by FY 2024. CMS predicts that since hospitals are already obligated to publicly report payer-specific negotiated charges, that calculating and reporting the MA negotiated charge by MS-DRG will be less taxing on hospitals compared to the current method of weight data collection.

The second important change to the final rule is that it encourages the development of medical technology through the creation of several new alternative pathways and payment groups. Under this rule, 13 new technologies that applied for new FY 2021 add-on payments were approved. CMS will continue new technology add-on payments for a portion of the technologies that currently receive the add on payment. Thus, 24 technologies in total will be eligible to receive add-on payments for FY 2021. In addition, this payment expansion includes a new MS-DRG for Chimeric Antigen Receptor (CAR) T-cell Therapy, which will allow for more predictable compensation as well as accurate and efficient billing for hospitals paid through the IPPS when offering these immunotherapy procedures.

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On September 1, 2020, the Department of Health and Human Services (“HHS”) announced that Assisted Living Facilities (“ALFs”) are now eligible to apply for payments under the Provider Relief Fund (“PRF”). ALFs have until September 13, 2020 to begin the application process.

The PRF is a multi-billion-dollar fund created by Congress through the CARES Act to provide financial relief to healthcare providers during the COVID-19 pandemic. The PRF is administered by HHS and the Health Resource Services Administration (“HRSA”). HHS has subdivided the PRF into various allocations and distributions. Expanded eligibility for ALFs falls under the Phase 2 General Distribution, which is meant to cover providers who did not receive payments under the initial Phase 1 General Distribution.

Some ALFs who bill Medicare or Medicaid were eligible for payments under prior PRF distributions. ALFs who do not bill Medicare or Medicaid are now eligible to apply for a payment if: 1) they filed a federal tax return for fiscal years 2017, 2018, or 2019 (or are exempt from filing a return), 2) provided patient care after January 31, 2020, 3) have not permanently ceased providing patient care,  4) are not otherwise excluded from federal health care programs, and 5) agrees to the terms and conditions of the payment.

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