2021 Payment Rules Affecting Pharmacy

2021 Payment Rules Affecting Pharmacy

As we move into the new outpatient/ambulatory payment year still in the midst of the COVID-19 pandemic, navigating payment rules across sites of care and ensuring that pharmacy is in sync with their organization’s overall strategies are essential. Themes finalized in the rule sets are: embrace patient centricity, continue to simplify (electronic health record requirements and reporting, regulations), cut costs and save money, and not lose focus on pharmacy’s efforts to combat the opioid crisis.

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2021 OPPS Effects

Our September issue (bit.ly/3rW3VQt) summarized the proposed Outpatient Prospective Payment System (OPPS) rules. The components of the rules most affecting pharmacy include:

1. Focus on site of care. Site-neutral payments remain in place.

2. Patient centricity. Continue to give beneficiaries more affordable choices on where to obtain care with the potential for lower out-of-pocket expenses, including those for surgeries. The inpatient-only list is phasing out within three years, beginning with 300 musculoskeletal-related services in 2021 and loosened restrictions for physician-owned hospitals. Criteria for adding surgical procedures to the ambulatory surgery center covered procedures list changed with 267 new ones.

3. Price transparency of hospital standard charges. Without changes from the proposed rules, transparency is required Jan. 1, 2021.

4. Prior authorization. Beginning July 1, 2021, the Centers for Medicare & Medicaid Services (CMS) is implementing a prior authorization process for cervical fusion with disk removal and implanted spinal neurostimulators in hospital outpatient departments. The current requirements for five categories of services, including the use of botulinum toxin injections, continues.

5. Payment rates for Medicare Part B drugs. For a summary, see Table 1.
Table 1. 2021 Payment for Drugs and Biologicals
New drugs not yet assigned unique HCPCS codesNew pass-through drugsNon pass-through separately payable drugs >$130/day based on ASPPolicy packaged or lower-cost packaged products costing =$130/day based on ASP
  SI G SI K SI N
  On the bill as separate line items On the bill as separate line items Not on the bill as separate line items, paid as part of the service bundle
95% of average wholesale price (AWP) Average sales price (ASP) + 6% Paid at ASP + 6% if not purchased under the 340B Program No change from CY2020
  46 products either keep pass-through status Payment based on wholesale acquisition cost (WAC) + 3% until enough ASP data gathered No separate reimbursement: drug costs are bundled into the procedure
  Pass-through status expired for 28 products during CY2020 Paid at ASP–22.5% if purchased under the 340B Program
    1. due to threshold price of $130/day
    2. or

  1. due to statute
  • Diagnostic radiopharmaceuticals
  • Contrast agents
  • Anesthesia drugs
  • Implantable biologicals
  • Drugs, biologicals, radiopharmaceuticals used as supplies in a diagnostic test or procedure
  • Drugs, biologicals used as supplies or implantable devices in surgical procedures
  26 additional products lose pass-through status during CY2021    
  All biosimilars eligible for pass-through, not just the 1st one for each reference product    

These OPPS changes apply only to Medicare patients treated in an OPPS setting and include continuing the current policy of paying hospitals average sales price (ASP) minus 22.5% for 340B-acquired drugs.

Most Favored Nation Rule

This approach to reduce drug costs is temporarily on hold. See the sidebar for more details.

2021 Physician Fee Schedule

The 2021 physician fee schedule (PFS) permanently expands telehealth services, alters physician payments and coding, and expands some clinicians’ scope of practice. Here are some key details:

Telehealth

Medicare added 60-plus services to its reimbursable list of 144 services covered via telehealth, as part of the COVID-19 public health emergency (PHE). According to CMS, “these additions allow beneficiaries in rural areas who are in a medical facility … to continue to have access to telehealth services such as certain types of emergency department visits, therapy services, and critical care services.” Category 1, covering services similar to office visits or psychiatry services and consultations, was expanded to add group psychotherapy, home visits and psychological testing. CMS also expanded category 3, including emergency department visits, therapy services and hospital discharge day management. It’s important to note that CMS doesn’t have statutory authority to permanently expand telehealth coverage beyond a rural benefit in Medicare; such an expansion requires an Act of Congress.

Additionally, CMS revised the “direct supervision” definition in its telehealth regulations to include the virtual presence of the supervising physician or practitioner using real-time video communications technology, including interactive audio and video. What is your health care organization’s virtual care strategy? Is pharmacy a part of this team? With hospital capacity a critical issue, has it invested in remote patient monitoring to enhance care in alternate sites? If so, how does this dovetail with Category 3 expansion, medication management or other clinical reimbursable services you could offer, such as the Medicare Diabetes Prevention Program?

Evaluation and Management (E/M) Coding and Payment

CMS has increased the relative value of several PFS payments to prioritize CMS’s investment in primary care and chronic disease management. The payments allow for nonphysician practitioners to provide the care they were trained and licensed to give, and encourage health care professionals to practice at the top of their license and spend more time with patients. In general, the payments support clinicians who manage the ongoing care of patients with a host of chronic diseases. But more specific care settings are also incentivized, including patient transitions between hospitals, nursing facilities and the home, including those with dementia.

For more information, check out the following resources:

COVID-19 Antibody Treatment

Medicare has announced it will cover and pay for casirivimab and imdevimab, two monoclonal antibody infusions developed by Regeneron, the same way it covers and pays for COVID-19 vaccines—when furnished consistent with the FDA’s emergency use authorization (EUA) for the infusions.

CMS identified specific code(s) for the monoclonal antibody products and specific administration code(s) for Medicare payment, effective Nov. 21, 2020 (Table 2). For more information, see the FDA’s fact sheet on the casirivimab and imdevimab EUA at bit.ly/3h8ixar.

Table 2. Antibody Infusion Codes
ProductHCPCSLong DescriptorShort Descriptor
Regeneron’s antibody casirivimab and imdevimab (REGN-COV2) Q0243 Injection, casirivimab and imdevimab, 2400 mg casirivimab and imdevimab
M0243 Intravenous infusion, casirivimab and imdevimab includes infusion and post-administration monitoring casirivi and imdevi infusion

Additionally, CMS finalized a new requirement for all hospitals to report their inventory of COVID-19 therapeutics to provide information needed to track and accurately allocate therapeutics to the hospitals that need additional inventory to care for patients and meet surge needs.

CMS Floats Most Favored Nation Model for Drug Payment

Skipping the normal rulemaking process, which requires weeks for public comment, the Centers for Medicare & Medicaid Services (CMS) issued what is known as an “interim final rule”—a move typically only reserved for rules that need to go into place quickly. The rule, which was slated to take effect Jan. 1, 2021, but is now on hold due to a temporary restraining order (TRO), creates a new mandatory payment model for separately payable Part B drugs that ties reimbursement to prices that other countries (i.e., Most Favored Nation [MFN]) pay for the same drugs. The rule only applies to traditional Medicare beneficiaries, not for people with private insurance. The administration is pushing the rule to lower traditional Medicare drug spending.

The Participants

  • Medicare-participating physicians
  • Nonphysician practitioners
  • Supplier groups (such as group practices)
  • Hospital outpatient departments including 340B covered entities
  • Ambulatory surgerycenters
  • Other providers and suppliers that receive separate Medicare Part B fee-for-service payment for the model’s included drugs
  • Excludes cancer hospitals, children’s hospitals, critical access hospitals, rural health centers, federally qualified health centers and Indian Health Service facilities, providers in the Maryland Total Cost of Care Model that have an annual global budget for health care spending; additionally, participants can request exemption based on financial hardship.

The Details

CMS will pay for the 50 costliest Medicare Part B drugs “at comparable amount to the lowest adjusted price paid by any country in the Organization for Economic Co-operation and Development that has a gross domestic product (GDP) per capita that is at least 60% of the U.S. GDP per capita,” according to the agency.

The model will introduce an MFN price for 50 drugs, 38 of which are oncology related. After a price is established, the model will phase it in with the applicable average sales price (ASP): by 25% per year for performance years 1 to 3, and reach 100% by performance years 4 to 7. The goal is to give providers “time to adjust to the model payment amounts and formulas.” Complicating this fluctuation is a 6% add-on payment that is replaced by a flat fee add-on, regardless of product cost, and which will be calculated based on 6.1% of the 2019 historical spending on all of the MFN drugs in total, adjusted every year based on inflation. CMS sets the fixed add-on payment for administering the drugs quarterly: The per-dose add-on for first quarter 2021 will be $148.73. If a drug becomes in short supply, the price will revert to ASP.

The manufacturer’s price remains the same and won’t be lowered to compensate for the MFN price. Involve your group purchasing organization to determine any anticipated decreases in contracted costs, effective Jan. 1, 2021, that parallel decreased reimbursement for MFN Model drugs for traditional Medicare beneficiaries. Providers may have to develop mechanisms such as rebates or discounts with the manufacturer. Success depends on providers negotiating drug prices down to meet reduced reimbursement levels, but it‘s unclear whether or by how much manufacturers would actually lower the prices they charge health care providers. If unsuccessful, providers have to choose whether to offer the drugs at a financial loss. Beneficiaries will pay lower coinsurance for these high-cost Part B drugs and will not pay coinsurance on the add-on payment.

As for the TRO placed on the MFN Model, it was issued on Dec. 23 to allow time for the issuing court to hear arguments on permanently blocking the rule.

For more information, see the CMS MFN fact sheet at go.cms.gov/34xKx2l.

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