Washington Healthcare Update

November 9, 2020

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This week in Washington: Washington’s focus has been on the presidential and Senate races.




Proposed Regulations/Guidance

Final Regulations/Guidance




Neal, Pallone Tell CMS to Not Ease Physician-Owned Hospital Restrictions

On Oct. 21, the House Ways and Means Chair Richard Neal (D-MA) and Energy and Commerce Chair Frank Pallone (D-NJ) sent a letter to the Centers for Medicare and Medicaid Services (CMS) to voice opposition to a provision in CMS’s proposed hospital outpatient pay rule that loosens restrictions on physician-owned hospitals. Neal and Pallone added that the proposal goes against a moratorium on the expansion of physician-owned hospitals that Congress put in place to counter concerns. They also were concerned about physician-owned hospitals’ picking patients selectively, self-referring, increasing costs and utilization, and hurting the quality of care.


CMS Announces Medicare A and B Deductibles and Part B Premium

On November 6, the Centers for Medicare and Medicaid Services announced Medicare Part A and B deductibles and premiums for 2021. The Medicare Part A inpatient deductible that beneficiaries will pay when admitted to the hospital is $1,484 in 2021, an increase of $76 from $1,408 in 2020. The majority of Medicare beneficiaries pay no Part A premium. The standard monthly premium for Medicare Part B enrollees will be $148.50 in 2021, an increase of $3.90 from $144.60 in 2020. The annual deductible for Medicare Part B beneficiaries is $203 in 2021, an increase of $5 from $198 in 2020.

Exchange Rule for Plan Year 2022 Under Review by OMB

On Nov. 5, the Office of Management and Budget (OMB) reviewed the proposed annual exchange rule for the 2022 plan year that outlines key marketplace policies, including network adequacy, actuarial value, the open enrollment window and the auto-enrollment process.

CMS, Treasury Approves Waiver Letting GA Exit Healthcare.gov in 2023

On Nov. 1, the Centers for Medicare and Medicaid Services (CMS) and the Department of Treasury approved Georgia’s request to exit healthcare.gov, take over eligibility determinations and rely on its own agents, brokers and insurance carriers for enrollment services starting 2023. The waiver, the Georgia Access Model, is the first approved under the Trump administration’s 1332 revised guidance and is expected to be challenged in court.

Proposed Regulations/Guidance

HHS Seeks Department Review of Every Rule, Every Decade

On Nov. 4, the Department of Health and Human Services (HHS) proposed a rule that would require HHS to review all its rules every 10 years to determine whether they are still necessary and eliminate those deemed burdensome and no longer necessary. HHS estimates approximately 2,480 rules would be revisited if the rule were implemented. Rules that are not reviewed in a timely manner would also be eliminated. A review of a rule will look at whether the rule has had a significant economic impact on a substantial number of small entities. The review will also look at the continued need for the rule; complaints about it; the rule’s complexity; the extent to which a rule duplicates or conflicts with other rules; and whether technological, economic and legal changes favor amending or rescinding the rule.

Find the proposed rule here. Public comments are due by Jan. 4, 2021.

CMS: Fourth COVID-19 Interim Final Rule with Comment Period

On Oct. 28, the Centers for Medicare and Medicaid Services (CMS) released another interim final rule in anticipation of the COVID-19 vaccine. The interim final rule announces that states must maintain enrollment only of validly enrolled beneficiaries in one of three tiers of coverage, with coverage maintained through the end of the month in which the COVID-19 public health emergency ends. The rule also allows that states seeking a 1332 waiver during the COVID-19 pandemic could request an expedited review of their application, and a shortened public comment period.

The Section 1332 waivers allow states to request exemptions from various Affordable Care Act (ACA) requirements and implement their own reforms. The interim final rule lays out CMS’s plan to provide free coverage of COVID-19 vaccines and therapeutics, and also lets the Department of Health and Human Services (HHS), the Department of Treasury and states modify the requirement to hold public comment periods to discuss the progress of a 1332 waiver. This rule is meant to prevent the spread of COVID-19 by limiting the need for the states to hold the public hearings required as part of the waiver application. The policy is effective immediately, although the Trump administration will be taking comments for 60 days.

Find the interim final rule here.

Medicare CY 2021 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Policy Issues and Healthcare Common Procedure Coding System (HCPCS) Level II Proposed Rule

On Oct. 27, the Centers for Medicare and Medicaid Services (CMS) proposed a durable medical equipment (DME) pay rule that would permanently increase pay for rural areas, expand coverage of continuous glucose monitors (CGMs), codify procedures for determining pay for new DME and expand coverage of external infusion pumps for certain drugs. The proposed rule asks for feedback on whether CMS should continue its current pay method for DME equipment that has essentially been removed from the bid program until that equipment goes back into bidding. If finalized, the rule would classify all CGMs as DME and establish payment amounts for the items and related supplies.

Find the proposed rule here. Public comments are due by Jan. 4, 2021.

Final Regulations/Guidance

CMS Finalizes Add-On Pay for Home Dialysis Equipment in 2021

On Nov. 2, the Centers for Medicare and Medicaid Services (CMS) finalized new Medicare add-on payments for innovative dialysis equipment that can be used in the home as part of its 2021 end-stage renal disease pay rule. Under the rule, CMS will pay 65 percent of a Medicare Administrative Contractor-determined pre-adjusted, per treatment amount reduced by an average per treatment offset amount of $9.32 for two years for home dialysis machines. CMS says after the two-year add-on period ends, the home dialysis machines would not become eligible outlier services and no change would be made to the ESRD pay system base rate. Overall, CMS projects the 2021 ESRD pay rule will raise ESRD facilities’ pay by 2 percent compared to 2020.

Find the final rule here.


Find a comprehensive look at “Courts and Healthcare Policy in 2020” here.

Federal Judge Vacates Public Charge Rule Nationwide

On Nov. 2, a federal judge vacated the Trump administration’s public charge rule, declaring it should immediately be stopped nationwide. Judge Gary Feinerman sided with Cook County, IL, and the Illinois Coalition for Immigrant and Refugee Rights that the Trump administration’s rule violates the Administrative Procedure Act. The Department of Homeland Security (DHS) asked the judge to limit any move to vacate the rule to Illinois, but Feinerman disagreed. In his rule, Feinerman also said litigation could proceed on the plaintiffs’ claim that the rule violates the equal protection component of the Fifth Amendment’s Due Process Clause.


GAO: Organ Transplants – Changes in Allocation Policies for Donated Livers and Lungs

On Nov. 4, the Government Accountability Office (GAO) released a report on organ transplantation of livers and lungs. The report explains new policy changes, where organs are typically offered first to the sickest patients who are a specified distance from the donor hospital—allowing sick patients to be eligible for organs that are donated across larger geographic areas.

Find a full report here.

If you have any questions, contact the following individuals atMcGuireWoods Consulting:

Stephanie Kennan, Senior Vice President
Mariam Eatedali, Research Associate

Founded in 1998,McGuireWoods Consulting LLC(MWC) is a full-service public affairs firm offering infrastructure andeconomic development, strategic communications & grassroots, and governmentrelations services. McGuireWoods Consulting is a subsidiary of theMcGuireWoods LLPlaw firm and has been named in The National Law Journal’s special annualreport, “The Influence 50,” for the past several years. In the most recentreport, McGuireWoods Consulting was ranked 15th of the 1,900 governmentrelations firms in Washington, D.C.

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