This week in Medicare updates—3/31/2021
Acute Hospital Care At Home Approved List
On March 19, CMS updated a List of approved hospitals participating in the Acute Care Hospital at Home program as of March 19, 2021. The program expanded to include a total of 111 hospitals across 48 systems in 29 states.
Administrative Delay of Effective Date and Correction: Securing Updated and Necessary Statutory Evaluations Timely (SUNSET)
On March 23, HHS published a Delay of Effective Date and Correction for a final rule in the Federal Register regarding the “Securing Updated and Necessary Statutory Evaluations Timely” (SUNSET) final rule, which was published in the Federal Register on January 19, 2021. HHS is delaying the effective date pending judicial review and is correcting typos in headings which referred to incorrect section numbers in 42 CFR. The final rule would allow HHS regulations to expire if they weren’t assessed and reviewed within 10 years of each rule’s promulgation. A lawsuit was filed on March 9, 2021, seeking to overturn the final rule.
Dates: The effective date of the final rule is delayed for one year until March 22, 2022. The correction is effective as of March 22, 2022, and amendatory instruction #10 in FR 2021-00597 (86 FR 5694), published January 19, 2021, is corrected.
Claims Processing Instructions for NCD 20.4 Implantable Cardiac Defibrillators (ICD)
On March 23, CMS published Medicare Claims Processing Transmittal 10635 regarding claims processing system changes for ICDs with dates of service on or after February 15, 2018. CMS will cover ICDs effective as of that date for six different patient indications. Some of those indications will require an encounter for formal shared decision-making using an evidence-based decision tool on ICDs prior to implantation. Details on billing, coding, and coverage information are available in the transmittal.
CMS published MLN Matters 12104 on the same date.
Effective date: February 15, 2018
Implementation date: July 6, 2021
Changes to the Laboratory NCD Edit Software for July 2021
On March 23, CMS published Medicare Claims Processing Transmittal 10658 regarding the July 2021 quarterly release of the edit module for clinical diagnostic laboratory services. The release contains changes to the laboratory NCD code lists for July 2021 which need to be updated in the lab edit module.
CMS published MLN Matters 12171 on the same date.
Effective date: July 1, 2021 - unless noted differently in requirements
Implementation date: July 6, 2021
Extensive Revision of Medicare Secondary Payer (MSP) Manual, Chapter 7: MSP Recovery
On March 23, CMS published Medicare Secondary Payer Transmittal 10629 regarding directions to the MACs to review changes to Chapter 7 of the manual, which had been undergoing revisions for years and now has certain references removed and information condensed.
Effective date: April 19, 2021
Implementation date: April 19, 2021
Medicare Updates Data on COVID-19 Impacts on Medicare Beneficiaries
On March 24, CMS updated a Data Snapshot regarding Medicare beneficiaries and COVID-19. The data provides information on Medicare beneficiaries based on encounters from January 1 to December 26, 2020. The previous snapshot had been issued based on data through November 21, 2020, meaning this edition of the snapshot reflects the change in COVID-19 data over the course of one month. Some of the findings from this most recent release include:
- There are over 2.7 million total COVID-19 cases among Medicare beneficiaries and nearly 700,000 hospitalizations. The number of COVID-19 cases among Medicare beneficiaries increased by over 790,000 in one month, as there were slightly less than 2 million total COVID-19 cases through November 21.
- The average Medicare payment per fee-for-service Medicare COVID-19 hospitalization was $22,995, a slight decrease from the previous snapshot’s average of $23,558. Medicare fee-for-service payments totaled $10.3 billion for COVID-19 hospitalizations December 26, up from $7.4 billion through November 21.
- The rate of COVID-19 cases in rural areas exceeded the rate of cases in urban areas for the first time since Medicare started releasing COVID-19 data snapshots.
- According to discharge data, 18% of Medicare patients hospitalized with COVID-19 died, a decrease from deaths in 19% of Medicare patients hospitalized as of the previous month’s data.
CMS published a Press Release on the data snapshot on the same date.
New Provider Enrollment Administrative Action Authorities
On March 24, CMS published Special Edition MLN Matters 21003 regarding a final rule issued September 10, 2019, which intends to create new authorities to prevent problematic providers and suppliers from being able to enroll in federal health insurance programs and to stop fraud, waste, and abuse before it happens. The article includes information about the new authorities created from that rule and provides information about affiliation disclosures, expansions to re-enrollment bars, and the creation of a re-application bar.
Update to Pulmonary Rehabilitation (PR), Cardiac Rehabilitation (CR) and Intensive Cardiac Rehabilitation (ICR) Program Manual Sections
On March 24, CMS published Medicare Benefit Policy Transmittal 10573 and Medicare Claims Processing Transmittal 10573 regarding updates to both manuals to align the manual language on coverage provisions for PR, CR, and ICR with the conditions for coverage of these services as codified in regulatory text in 42 CFR §410.47 and §410.49.
Effective date: January 1, 2010
Implementation date: April 26, 2021
FAQs: Application of OIG’s Administrative Enforcement Authorities to Arrangements Directly Connected to the COVID-19 Public Health Emergency
On March 24, the OIG updated an FAQ regarding changes to enforcement for certain arrangements which are directly connected to COVID-19. The new FAQ addresses whether a federally qualified health center in a rural area can provide free space to a retail pharmacy administering COVID-19 vaccines to FQHC patients and the general public.
Hospitals Reported That the COVID-19 Pandemic Has Significantly Strained Health Care Delivery
On March 24, the OIG published a Report based on a survey of hospital administrators about the issues hospitals faced in confronting the COVID-19 PHE as of February 2021. The OIG categorized responses into direct challenges hospitals faced, what types of help hospitals feel they’d need in addressing those challenges, and what types of long-term opportunities for improvement could help prevent or reduce these challenges in the future.
OIG Advisory Opinion No. 21-01
On March 24, the OIG published an Advisory Opinion regarding whether the OIG would impose sanctions under the anti-kickback statute and beneficiary inducements civil monetary penalties should the requestor of the opinion provide a free drug to certain patients who are prescribed the drug. The requestor is a pharmaceutical manufacturer whose drug is approved by the FDA. The drug is a personalized medication created from the patient’s own cells and is intended to be a one-time, potentially curative treatment. Due to certain patient safety risks, the drug may only be administered at facilities certified by the requestor and can only be prescribed by certain physicians. The requestor provides the drug for free under an arrangement for patients who don’t have insurance coverage, cannot afford the drug, and meet certain eligibility requirements. While the drug isn’t anticipated for use among the Medicare population, it may be used for beneficiaries of other federal healthcare programs.
The OIG determined that the requestor’s arrangement would not constitute grounds for the imposition of sanctions under the beneficiary inducements civil monetary penalty, but it may generate prohibited remuneration under the federal anti-kickback statute. However, the OIG said it would not impose sanctions in this case because the arrangement is available for FDA-approved drug indications, the requestor provides the drug for free to all eligible patients regardless of care setting, and has other factors which distinguish it from other potentially problematic arrangements.
Home Health Payment Corrections
On March 25, CMS published a Note in MLN Connects regarding payment corrections MACs will be making automatically over the next few weeks affecting home health payments. Errors include claims spanning January 1 applying CY 2020 rates in error, late RAP penalties not applying to outlier amounts, and late RAP penalties applied after the value-based purchasing adjustment when the VBP should be the last calculation.
Resuming Hospital Survey Activities Following 30-Day Restrictions
On March 26, CMS published a Memorandum to state survey agency directors regarding the resumption of hospital surveys. CMS had limited hospital surveys for a 30-day period effective January 20, 2021, to enable hospitals to focus on caring for COVID-19 patients during hospitalization surges. That period was extended for an additional 30 days effective February 18. CMS is now lifting the limitations on survey activity effective March 23. The memorandum published on March 26 dictates when surveys postponed during January and February must be investigated by and included deadlines for hospitals to submit plans of correction or demonstrate compliance with any outstanding non-immediate jeopardy deficiencies.
Effective date: Immediately. This policy should be communicated with all survey and certification staff, their managers, and the State/CMS locations training coordinators within 30 days of this memorandum.
Updated Guidance for Emergency Preparedness-Appendix Z of the State Operations Manual
On March 26, CMS published a Memorandum to state survey agency directors regarding updates to Appendix Z of the manual to account for revised requirements for providers and suppliers to account for changes introduced by the Burden Reduction final rule, effective November 29, 2019. The updates also build on experiences during the COVID-19 PHE to include additional guidance on best practices, lessons learned, and planning considerations for emerging infectious diseases. CMS is working on updates to the Emergency Preparedness Basic Surveyor Training Course to reflect these changes and will provide notification at a later date when the updated course is available.
Effective date: Immediately. This policy should be communicated with all survey and certification staff, their managers, and the state/CMS location training coordinators within 30 days of this memorandum.