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Despite a determination by the Department of Health and Human Services (“HHS”) that laboratory developed tests (“LDTs”) do not require premarket approval, the Food and Drug Administration (“FDA”) has asserted that the at-home collection kit portion of a COVID-19 LDT does require FDA pre-market approval.

Testing by clinical laboratories is regulated by the FDA and by the Clinical Laboratory Improvement Amendments (“CLIA”), as administered by the Centers for Medicare & Medicaid Services (“CMS”). The FDA regulates medical devices, including in vitro diagnostic products (“IVDs”). The FDA considers LDTs to be IVDs that are intended for clinical use and are designed, manufactured, and used within a single laboratory. CLIA, on the other hand, regulates the laboratory itself and classifies LDTs as “high complexity tests,” with corresponding standards imposed on the laboratory. Importantly, regarding the LDT itself, CLIA requires only analytical validation, which can occur after testing has already begun. LDTs may also be subject to more stringent state and private sector oversight.

Historically, the FDA had exercised enforcement discretion and not regulated LTDs, but this began to change in recent decades. However, in August 2020, HHS directed that, absent rule and commenting and at least during the COVID-19 public health emergency, the FDA would not require premarket review and approval of LDTs. This allowed clinical laboratories to develop and begin using LDTs to test for COVID-19 without delaying for an FDA Emergency Use Authorization (“EUA”) or other approval. Some of these LDTs included at-home collection kits wherein the patient collected the sample at home, sometimes under the telemedicine supervision of a health care professional, and shipped it to the laboratory for testing.

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On December 2, 2020, The Centers for Medicare & Medicaid Services (CMS) released the 2021 Outpatient Prospective System (OPPS) Final Rule. The main goals of the rule are to (1) provide patients more choice in where they can receive affordable, quality health care, and (2) reduce their out-of-pocket costs. The new rule furthers CMS’s recent goal to expand patient choice by increasing the locations that accept Medicare payment for newly added services.

The rule finalizes the proposal to eliminate the Inpatient Only List (IPO),—giving beneficiaries more choice in where they can receive care. The IPO designated specific surgical procedures that necessitate inpatient care due to the nature of the procedure. Therefore, the procedures on the IPO were not covered by Medicare through the OPPS. By phasing out the list, these procedures will now be eligible for Medicare reimbursement in an inpatient setting as well as a hospital outpatient environment, if appropriate, based on the determination of the provider. The phase out of the IPO will occur over three years, beginning with 300 musculoskeletal services, and complete removal of the list by CY 2024. The rule also finalizes other provisions to offer beneficiaries additional choice in their healthcare options, including adding 11 procedures to the Ambulatory Service Center (ASC) Covered Procedures List (CPL).

Furthermore, the rule continues the current 340B purchased drugs payment policy. Under Section 340B of the Public Health Service Act, participating hospitals and other providers can purchase specific outpatient covered drugs directly from the manufacturer at a lower price. The 2018 OPPS Final Rule adopted a policy that Medicare will pay an adjusted Average Sales Price (ASP) less 22.5 percent for separately payable drugs purchased through the 340B program. According to CMS, keeping this current policy will be necessary to maintain stable payment during the COVID-19 public health emergency. Rural community hospitals, children’s hospitals, and Prospective Payment System (PPS) cancer hospitals will remain exempt from the 340B payment policy. These hospitals will continue to report a modifier for drugs acquired through the 340B program and be paid the ASP plus 6 percent.

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On Tuesday, December 1, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released the final rule for the 2021 Medicare physician fee schedule. As part of the updated physician fee schedule, CMS changed quality reporting requirements to the Medicare Shared Savings Program—specifically with regards to telehealth services. In the wake of the 2019 Novel Coronavirus (“COVID-19”) pandemic, telehealth has become a central form of providing healthcare. Telehealth will now be permanently allowed for Medicare recipients who receive evaluation and management (“E/M”) services at home. Telehealth will also be temporarily permitted for emergency and other visits—CMS hopes to make these permanently available one day as well.

In addition to the changes in telehealth, CMS is also giving Medicare Accountable Care Organizations (“ACOs”) an extended period of time to increase their quality performance standards from the 30th percentile to the 40th. In fact, they now have two more years to reach this goal because the initial goal of January 2021 was not feasible in the wake of COVID-19. Although this deadline has been extended by two years, ACOs must begin reporting quality measures through new MIPS platforms within the next year. Lastly, CMS has begun tapering the form of quality measurement from reporting 10 measures to the CMS Web Interface or reporting 3 measures under MIPS in 2021 to reporting just 6 quality measures under MIPS in 2022. ACOs are concerned with these changes being implemented during a pandemic, but CMS expects positive outcomes to result from the changes, nonetheless.

Most pertinently for physicians, is that CMS has lowered the fee schedule’s conversion factor by 10.2%. This means that instead of the conversion factor being $36.09, it is now $32.41. That change paired with many changes to E/M services and codes could lead to physicians seeing a change in their revenue. The changes in these E/M codes reflect the recent shift to prioritize value-based care. These updated E/M codes will now prioritize time spent evaluating and managing patient care, rather than quantity of interventions or procedures.

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On November 20, 2020, the Centers for Medicare & Medicaid Services (CMS) released the final rules amending the Stark Law and Anti-Kickback Statutes (AKS).  Efforts to clarify these outdated laws began in 2018, with the goal to reduce regulatory obstacles for care coordination, following a general move toward value-based care. The Stark Law and AKS were initially created for a fee-for-service healthcare system, where there are financial incentives to provide more services to patients. However, the current U.S. healthcare system is shifting towards rewarding providers for keeping patients healthy and providing quality care, focusing on the value a payment has to a patient rather than the amount of services billed. The final rules offer increased flexibility to providers, reduce administrative burdens, and emphasize the interests of the patient.

The Physician Self-Referral Law, or the Stark Law, was initially enacted to prohibit physicians from making referrals to entities in which the physician has a financial relationship. The ambiguous language in the Stark Law created uncertainty as to whether certain relationships might violate the law and discouraged potential innovative relationships. As such, the final rule creates exceptions to the self-referral prohibitions for specific value-based payment arrangements among various providers and suppliers, and offers new guidance for providers with a financial relationship governed by the Stark Law. Under the rule, a value-based arrangement is one that provides at least one value-based activity to a patient between the value-based enterprise and at least one of its participants, or the participants in the same value-based enterprise. A value-based activity can mean the provision of a service, an action, or refraining from taking an action, so long as the activity is reasonably curated to achieve a value-based purpose. The exceptions apply to all patients, not just Medicare beneficiaries. The final rule creates three new exceptions to the Stark Law:

  1. Value-based arrangements for participants in a value-based enterprise that is financially responsible for, and assumes the entire prospective financial risk, for the cost of all related patient care items and services for every patient;
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On November 16, 2020, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a special fraud alert targeting remuneration associated with speaking arrangements paid for by pharmaceutical and medical device companies. The alert addressed both honoraria paid to the speaking physician and benefits provided to attendees, such as meals or alcohol.

OIG has taken the position that the fees paid to speakers and the benefits provided to attendees may constitute unlawful “remuneration” under the Anti-Kickback Statute (AKS) meant to induce or reward referrals. Pursuant to the AKS, it is unlawful to knowingly and willfully solicit, receive, offer, or pay any remuneration to induce or reward, among other things, referrals for, or orders of, items or services reimbursable by a Federal health care program. According to OIG, pharmaceutical and medical device companies paid nearly $2 billion to physicians and health care professionals for speaker-related services in 2017, 2018, and 2019 combined.

OIG clarified that not every physician speaking arrangement violates the AKS and that it does not intend to discourage meaningful training or education. However, OIG outlined several factors that, in OIG’s view, increase the risk that an arrangement could violate the AKS. These factors include:

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On October 22, 2020, Michigan Governor Gretchen Whitmer signed legislation reducing the liability of businesses and governmental agencies as it relates to COVID-19 exposure. There were three Acts passed that dealt with responding to COVID-19 risks and liabilities, all three of which retroactively apply beginning March 1, 2020.

Public Act 236 of 2020, or rather, “COVID-19 Response and Reopening Liability Assurance Act,” protects persons and entities from liability as long as they have complied with all federal, state, and local laws, as well as any regulations, executive orders, or agency orders. The protection is against any “COVID-19” claim, which is “a tort claim . . . for damages, losses, indemnification, contribution, or other relief arising out of, based on, or in any way related to exposure or potential exposure to COVID-19.” The Act grants employers the ability to claim immunity from COVID-19 claims where there was an isolated deviation from strict compliance with COVID-19 laws that was unrelated to the plaintiff’s claims. The Act is does not create a private cause of action.

Public Act 237 of 2020 is specific to employees and amends the Michigan Occupational Safety and Health Act. Much like Public Act 236, this Act grants liability protection to employers for employee exposure to COVID-19 so long as the employer followed all relevant rules and regulations.

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On November 16, 2020, the Centers for Medicare & Medicaid Services (CMS) released its 2020 Estimated Improper Payment Rates. Under the 2019 Payment Integrity Act, CMS is required to review Medicare Fee-For-Service (FFS), Medicare Part C, Medicare Part D, Medicaid, and the Children’s Health Insurance Program (CHIP) and estimate the amount of improper payments made under each program.

The reported improper payment data for CMS FY 2020 represents claims submitted July 1, 2018 through June 30, 2019. Due the COVID-19 pandemic, CMS temporarily halted all data requests to providers and state agencies regarding incorrect payments from March to August 2020. To compile the report, CMS adjusted calculation methods for reporting improper payment rates for the 2020 Agency Financial Report (AFR), using data already available at the time of the COVID-19 pandemic or data voluntarily provided. The calculated rates still meet national precision requirements.

The FY 2020 improper payment rate for Medicare FFS, which includes Part A and Part B, was estimated to be 6.27% or $25.74 billion. This represents a notable decrease from FY 2019, for which the improper payment rate was estimated as 7.25%, or $28.91 billion. The result of this decrease is likely due to reductions in the improper payment estimates for home health and skilled nursing facilities, which saw a $5.90 billion and $1 billion decrease, respectively. These decreases are likely due to several policy clarifications by CMS.

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A change in the White House means changes to healthcare policy and changes to healthcare regulatory actions taken by the Department of Health and Human Services (“HHS”) and other federal agencies. Although a changing healthcare landscape, COVID-19 pandemic, and political wrangling are likely to alter the goals and actions of the incoming administration, here are some of the healthcare policy priorities currently articulated by President-Elect Biden that providers may see.

Health Insurance Public Option

While foregoing the “Medicare-for-all” approach and leaving the commercial health insurance industry intact, a health insurance public option could increase competition for commercial insurers and exert downward pressure on rates. A new health insurance public option would also seek to use its bargaining power to negotiate lower prices. The increased public option would also provide Medicaid-like coverage for low income individuals who live in states that have not expanded Medicaid, but who would otherwise be eligible for Medicaid.

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On November 9, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released the 2020 Medicaid and Children’s Health Insurance Program (“CHIP”) managed care final rule. The previous rule was released in 2016 and was extremely strict with its requirements, causing some states to struggle to comply. Since 2016, CMS’s goal has been to reduce the financial and administrative burden of the program, as well as reducing any federal regulatory barriers.

When the 2016 rule was released, many commenters wished for greater state-to-state flexibility to establish Medicaid and CHIP payments because every state had different needs for its enrollees. The 2020 final rule took note of that concern and now allows states much greater flexibility to set up payment schedules. CMS expects that the final rule will increase state flexibility in administering the program without having to cut off anyone’s access to the program—This would not have been possible based on the 2016 final rule.

Specifically, the final rule significantly revised eight areas of the regulatory framework:

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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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