For more information about this blog post, please contact Khaled J. Klele, Ryan M. Magee, Labinot Alexander Berlajolli, or Connor Breza.

CMS Releases Proposed Payment Rules

86 FR 35874: Under the 2022 Home Health Prospective Payment System proposed rule, Centers for Medicare & Medicaid Services (“CMS”) would increase payments to home health agencies by 1.8 percent, which CMS estimates to be $330 million.  However, CMS noted that home health agencies may see an aggregate 0.1 percent, or $20 million, decrease in payments due to the reductions made in the rural add­‑on payment.  CMS also proposed a nationwide expansion of the Home Health Value‑Based Purchasing model, which was originally implemented in nine states on January 1, 2016.

The proposed rule also would make permanent some of the home health conditions of participation implemented during the COVID‑19 pandemic, including the 14‑day on‑site supervisory requirement when a patient is receiving skilled nursing services.  Comments are due by August 27, 2021.

86 FR 36322: Under the 2022 End‑Stage Renal Disease (“ESRD”) Prospective Payment System proposed rule, CMS would increase the current base rate for ESRD by $2.42 to $255.55 for 2022.  CMS also proposed lifting the payment rate for renal dialysis services for individuals with acute kidney injury to $255.55.  The new rule would update the outlier services’ fixed‑dollar loss amounts for 2022 using 2020 data, such that for pediatric beneficiaries, the fixed‑dollar loss amount would decrease from $44.78 to $30.38, and the Medicare allowable payment amount would decrease from $30.88 to $28.73; for adult beneficiaries, the fixed‑dollar loss amount would decrease from $122.49 to $111.18, and the Medicare allowable payment would decrease from $50.92 to $47.87.

Due to the significant impact of COVID‑19, CMS proposed to modify scoring and payment methodologies to ensure that no facility will receive a payment reduction in 2022.  Additionally, the rule would extend the remaining deadlines for ESRD providers and facilities to submit September through December 2020 ESRD quality incentive program data until September 1, 2021.  Comments are due by August 31, 2021.

86 FR 39104: Under the 2022 Physician Fee Schedule proposed rule, the conversion factor for 2022 is $33.58, decreased from $34.89 in 2021.  CMS also suggested defining a “physician‑owned distributor” as a medical device manufacturer or applicable group purchasing organization, where physicians or a physician’s immediate family members have at least 5 percent ownership or receive compensation in the form of a commission, return on investment, profit‑sharing, profit distribution, or other remuneration directly or indirectly based on sale or distribution of devices.  The new definition would only be for open payments reporting, and it would not apply to the Anti‑Kickback Statute or its safe harbors.  Comments are due by September 13, 2021.

CMS Finalizes 5 Payment Rules

CMS has released final payment rules for inpatient facilities, skilled nursing facilities, hospices, inpatient psychiatric facilities, and inpatient rehabilitation facilities.  The final rules are effective October 1, 2021.

Inpatient Facilities

86 FR 44774: Under the Inpatient Prospective Payment System (“IPPS”) final rule, CMS estimates that, overall, hospitals that report quality data and are meaningful users of electronic health records (“EHRs”) will see a 2.5 percent increase in Medicare rates for 2022.  CMS expects that hospital payments will increase by an aggregate $2.3 billion.  An add‑on payment for COVID‑19 treatment through the end of the fiscal year in which the public health emergency ends also was finalized under the rule.

Additionally, CMS has added five new measures to the Inpatient Quality Reporting Program, including COVID‑19 vaccination rates among healthcare personnel and a maternal morbidity structural measure.  CMS also finalized changes to the interoperability program to reduce the burden on eligible hospitals and critical access hospitals, including an increase to the minimum required score for the objectives and measures from 50 to 60 points (out of 100 points) to be considered a meaningful EHR user.

Skilled Nursing Facilities

86 FR 42424: The final rule increases payments to skilled nursing facilities (“SNFs”) by 1.2 percent in 2022.  CMS estimates that the overall economic impact will be a $410 million increase in Medicare Part A payments to SNFs in 2022.  Additionally, the final rule requires SNFs to report the COVID‑19 vaccination status of their employees to the Centers for Disease Control and Prevention’s National healthcare Safety Network on a weekly basis.

Hospices

86 FR 42528: Under the final rule, hospices will see a 2 percent increase in payments for 2022, which CMS estimates to be $480 million, as well as an increase to the cap that limits the amount of payments a hospice receives per patient annually to $31,297.61.  CMS also will implement a new measure for the Hospice Quality Reporting Program called the Hospice Care Index, which has 10 indicators of quality that are calculated from the claims data.  Moreover, the final rule makes permanent several waivers issued during the COVID‑19 pandemic, including a waiver that allowed the use of pseudo‑patients for hospice aide competency testing.

Inpatient Psychiatric Facilities

86 FR 42608: The final rule increases the payment rate for inpatient psychiatric facilities (“IPFs”) by 2 percent in 2022.  CMS estimates that the overall economic impact will be an $80 million increase in payments to IPFs.  Moreover, CMS finalized a policy to ensure that medical residents will not be displaced if their teaching hospital or program closes, preventing them from getting board‑certified.  IPFs will also be required to report the COVID‑19 vaccination status of their employees to the CDC NHSN.

Inpatient Rehabilitation Facilities

86 FR 42362: Under the final rule, there will be a net increase to the payment rate for inpatient rehabilitation facilities (“IRFs”) of 1.5 percent in 2022.  The net increase includes the IRF market basket increase factor of 1.9 percent, less a 0.4 percent decrease in estimated IRF outlier payments.  CMS estimates that the overall payments to IRFs will increase by $130 million in 2022.  Like SNFs and IPFs, IRFs are also required to report the COVID‑19 vaccination status of their employees.

For more information about this blog post, please contact Khaled J. Klele, Ryan M. Magee, or Labinot Alexander Berlajolli.

86 FR 43618: This proposed rule rescinds the Most Favored Nation (“MFN”) Model – a drug pricing model that matches payments for Medicare Part B drugs and biologicals to the lowest price paid by other comparable countries. The MFN was intended as an innovative way to lower prescription drug costs, reduce Medicare reimbursement rates to healthcare facilities, and open negotiations to discounts with drug manufacturers.

Instead, however, as we covered in previous blog posts, several federal district courts intervened to temporarily prevent the Centers for Medicare and Medicaid Services (“CMS”) from implementing the MFN, originally scheduled to begin January 1, 2021. On December 23, 2020, the U.S. District Court for the District of Maryland issued a nationwide temporary restraining order, enjoining CMS’s implementation of the rule. In a related case, just days later on December 28, 2020, the U.S. District Court for the Northern District of California followed suit. Two more days later, on December 30, 2020, the U.S. District Court for the Southern District of New York also issued its own injunction, enjoining implementation of the rule specifically as it pertains to EYLEA®.  The underlying lawsuits allege, among other things, that CMS violated the dictates of the APA rulemaking process, the MFN exceeds statutory authority, and the MFN raises issues of constitutionality.

CMS is supposedly exploring new opportunities to address the high cost of Medicare Part B drugs and Medicare reimbursement spending. Comments to this proposed rule are due by October 12, 2021.

86 FR 35615: This final rule finalizes the methodology and data sources necessary to determine federal payment amounts to be made for program year 2022 to states that elect to establish a Basic Health Program (“BHP”) under the Patient Protection and Affordable Care Act. A BHP is another option for states to provide affordable health benefits to lower income individuals who satisfy certain income criteria. In states that elect to operate a BHP, the BHP will make affordable health benefits coverage available for individuals under age 65 with household incomes between 133 percent and 200 percent of the federal poverty level (“FPL”) who are not otherwise eligible for Medicaid, the Children's Health Insurance Program (“CHIP”), or affordable employer-sponsored coverage, or for individuals whose income is below these levels but are lawfully present non-citizens ineligible for Medicaid.

86 FR 41803: This proposed rule would reinterpret the scope of the general requirement that State payments for Medicaid services under a State plan must be made directly to the individual practitioner providing services, in the case of a class of practitioners for which the Medicaid program is the primary source of revenue. Specifically, this proposal, if finalized, would explicitly authorize states to make payments to third parties to benefit individual practitioners by ensuring health and welfare benefits, training, and other benefits customary for employees, if the practitioner consents to such payments to third parties on the practitioner's behalf. Comments are due by September 28, 2021.

For more information about this blog post, please contact Khaled J. Klele, Ryan M. Magee, or Labinot Alexander Berlajolli.

Adopted Telemedicine Rules

The below rules were adopted to establish the standards for providing services through telemedicine and telehealth for the following licensees:

• 53 N.J.R. 1283(a): licensees of the State Board of Marriage and Family Therapy Examiners
• 53 N.J.R. 1285(a): licensees of the Professional Counselor Committee of the State Board of Marriage and Family Therapy Examiners
• 53 N.J.R. 1288(a): physician assistants licensed by the State Board of Medical Examiners (the “BME”)
• 53 N.J.R. 1290(a): electrologists licensed by the Electrologists Advisory Committee and the BME

The New Jersey Nurse Licensure Compact

53 N.J.R. 936(b): In 2019, New Jersey entered the Nurse Licensure Compact. The Compact is an agreement between states in which nurses licensed in one member state ("home state") may work in another member state ("remote state") without obtaining a license in the remote state. To effectuate the Compact, the Board of Nursing adopted new rules to establish the procedures for applying for licenses with multistate privileges.

Hospices and Unused Medications

53 N.J.R. 700(b): This adopted rule establishes standards to which a hospice must adhere to in the event it elects to accept and dispose of surrendered prescription medications of its patients.  For example, the hospice must establish detailed written procedures that identifyies and limits which licensed professional may accept the surrendered prescription medications.

American Society for Radiation Oncology

53 N.J.R. 703(a): This adopted rule adds the American Society for Radiation Oncology (“ASTRO”) as a recognized accrediting body from which ambulatory care facilities and hospitals can obtain the mandatory accreditation of their radiation oncology programs and services.

Pharmacology and APNs

53 N.J.R. 937(a): This adopted rule requires an applicant for certification as an advanced practice nurse to complete six hours in pharmacology related to controlled dangerous substances, including education in pharmacologic therapy, addiction prevention and management, and issues concerning opioid drugs.

Reimbursement Codes for Podiatry

53 N.J.R. 1001(b): This adopted rule updates the reimbursement code information for podiatry services, such that the healthcare Common Procedure Coding System (“HCPCS”) procedure codes reflect the current codes authorized by the Centers for Medicare and Medicaid Services (“CMS”) and the reimbursement amounts provided by the Medicaid/NJ FamilyCare fee‑for‑service program.

Changes to Standards for Developmental Disabilities

53 N.J.R. 1145(b): This adopted rule sets forth the family maintenance standard, medical cost standard, tuition deduction standard, and the cost of care and maintenance rates that shall be used in the determination of eligibility and the contribution to care and maintenance of individuals residentially placed by the Division of Developmental Disabilities and their legally responsible relatives for the period beginning January 1, 2021.