RISE summarizes this week’s regulatory news from the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS), and Office of Inspector General (OIG).

HHS to CMS: Reassess recommendation for 2022 Medicare Part B premium

HHS Secretary Xavier Becerra instructed CMS on Monday to reassess its recommendation for the 2022 Medicare Part B premium due to the dramatic price change of the Alzheimer’s drug, Aduhelm.

“With the 50 percent price drop of Aduhelm on January 1, there is a compelling basis for CMS to reexamine the previous recommendation,” he said.

CMS set the monthly premium for Part B, which covers doctor visits and other outpatient services, at $170.19 in 2022, a $21.60 increase from 2021 and the largest dollar increase ever. One reason for the spike: The agency said in November it had to put aside money in case it decided to cover the new drug and similar drugs used to treat Alzheimer’s disease. Biogen, which manufactures Aduhelm, initially set the annual price for the drug at $56,000 – it recently cut the annual price to $28,200.

On Wednesday, CMS released a proposed National Coverage Determination (NCD) memorandum, which indicated it plans to cover Food and Drug Administration (FDA) approved monoclonal antibodies that target amyloid for treatment of Alzheimer’s disease through coverage with evidence development. This means FDA-approved drugs would be covered for Medicare beneficiaries only if they are enrolled in qualifying clinical trials.

Currently, Aduhelm is the only monoclonal antibody directed against amyloid beta approved by the FDA for the treatment of Alzheimer’s disease.

In the absence of a national coverage policy, Medicare Administrative Contractors decide whether the drug is covered for a Medicare patient on a claim-by-claim basis.

Comments on the proposed determinations will be open for 30 days. CMS plans to announce its final decision on the NCD by April 11.

White House requires private insurers to pay for at-home COVID-19 tests

The White House will require insurance companies and group health plans to cover the cost of FDA-approved over-the-counter, at home COVID-19 tests, so people with private health coverage can get them for free beginning Jan. 15. The new coverage requirements means that most consumers with private health coverage can go online to a pharmacy or store, buy a test, and either get it paid for up front by their health plan or get reimbursed for the cost by submitting a claim to their plan.

Insurance companies and health plans must cover eight free over-the-counter at-home tests per covered individual per month. That means a family of four, all on the same plan, would be able to get up to 32 of these tests covered by their health plan per month. These tests can be purchased without the need for a health care provider’s order or individualized clinical assessment, and without any cost-sharing requirements, such as deductibles, copayments or coinsurance, prior authorization, or other medical management requirements.

The move is meant to help reduce the spread of COVID-19 and quickly diagnose COVID-19 so that it can be effectively treated.

State Medicaid and Children’s Health Insurance Program programs are already required to cover FDA-authorized at-home COVID-19 tests without cost-sharing. Medicare pays for COVID-19 diagnostic tests performed by a laboratory, such as PCR and antigen tests, with no beneficiary cost sharing when the test is ordered by a physician, non-physician practitioner, pharmacist, or other authorized health care professional. Medicare Advantage plan members should check to see if their plan offers coverage and payment for at-home, over-the-counter COVID-19 tests.

HHS: Nearly 14M Americans enroll in ACA marketplace coverage ahead of Jan. 15 open enrollment deadline

More than 13.8 million consumers have signed up for 2022 health care coverage that started January 1 through the Affordable Care Act Health Insurance Marketplaces, on HealthCare.gov, and state-based marketplace. CMS announced that this year’s open enrollment period, which began Nov. 1, 2021 and ends on Jan. 15, 2022, continues to outpace previous year’s enrollment.

“Thanks to the American Rescue Plan, more Americans across the country are gaining affordable health coverage than ever before, especially when we most need it during this pandemic,” HHS Secretary Xavier Becerra, said in the announcement. “We will continue to reach out and get people covered until the very last minute of the January 15th final deadline.”

OIG releases MA compliance audit findings of Healthfirst Health Plan

A new Office of Inspector General compliance report reveals the findings of its audit of Healthfirst Health Plan Inc., which focused on seven groups of high-risk diagnosis codes. The audit was conducted to determine whether the selected diagnosis codes that the organization submitted to CMS for use in CMS’ risk adjustment program complied with federal requirements.

OIG said it sampled 240 unique enrollee-years with the high-risk diagnosis codes for which Healthfirst received higher payments for 2015-2016. The review was limited to the portions of payments associated with the high-risk diagnosis codes, which totaled close to $788,000.

The audit found that for 155 of the 240 enrollee-years, the diagnosis codes submitted to CMS were not supported in the medical records and resulted in net overpayments of $516,509. Based on the sample results, OIG estimated that Healthfirst received at least $5.2 million in net overpayments for the high-risk diagnoses codes in 2015 and 2016.

OIG recommended Healthfirst refund the $5.2 million of net overpayments and look for similar instances of noncompliance that occurred before or after the audit period and refund any additional overpayments to the federal government. It also recommended that the organization look at its existing compliance procedure to identify areas for improvement to ensure high-risk diagnosis codes are coded properly.

Although Healthfirst did not agree to all the recommendations, it didn’t object to any of the errors identified by OIG. Instead, the organization requested OIG limit our recommended recovery to the overpayments identified in the sample and not the extrapolated value of those overpayments. It also said that the OIG audit methodology didn’t account for “actuarial equivalence” and disagreed that it should perform audits of high-risk diagnoses or enhance its compliance program.

OIG stands behind its findings and recommendations. No statutory authority limits its use of extrapolation to estimate a recovery and OIG said it correctly applied federal requirements underlying the MA program.