By creator to www.jdsupra.com
This week in Washington: Congress passes persevering with decision, funding the federal government till Feb. 18.
Congress
Upcoming Hearings/Markups
Home
- Reps. McMorris Rodgers and Comer Request Data on Biden Administration Compliance With COVID-19 Vaccine Mandates
Senate
- Congress Passes Persevering with Decision to Fund Authorities Till Feb. 18
- Sens. Tuberville and Burr Request Data on Monoclonal Antibody Contracts
Administration
- President Biden Declares New Actions to Fight COVID-19 This Winter
- HHS Declares Second Spherical of Telehealth Grants for Title X Awardees
- HHS Launches a 405(d) Aligning Well being Care Trade Safety Approaches Program Web site
- HRSA Declares $1.5 Billion in Funding for the Healthcare Workforce in Rural and Underserved Areas
- CMS Places COVID-19 Vaccine Mandate on Maintain
- CMS Declares That 810,000 Enrolled Throughout Week Three of Open Enrollment
- CMS Points RFI Looking for Public and Stakeholder Enter on the Organ Transplantation System
- CMS Publishes Medicare Telemedicine Knowledge Snapshot
- CMS and CDC Situation New Process Codes for COVID-19 Therapeutics
- CDC Updates COVID-19 Booster Suggestions
- FDA Advisors Vote in Favor of Authorizing Merck’s COVID-19 Capsule
Proposed Guidelines
- FDA Points Draft Steering on Premarket Submissions for Gadget Software program Capabilities
- HHS Points Proposed Rule to Withdraw the SUNSET Rule
- FDA Points Draft Trade Steering on Actual-World Knowledge Requirements
- FDA Points Proposed Rule on Over-the-Counter Listening to Aids
- FDA Points Steering on Steady Manufacturing of Drug Substances and Merchandise
- FDA Points Steering Updating Distinctive Gadget Identification Coverage
Closing Guidelines
- FDA Points Closing Rule to Amend Laboratory Meals Testing Necessities
- CMS Points Closing Rule to Delay VBP Reporting and the Inclusion of U.S. Territories
- CMS Points Closing Rule Rescinding Medicare Protection of Modern Expertise and “Cheap and Needed” Closing Rule
- CMS Points Closing Rule for Finish-Stage Renal Illness Potential Fee System
- CMS Points CY 2022 Medicare Hospital Outpatient Potential and Ambulatory Surgical Heart Fee Programs Closing Rule
- CMS Points CY 2022 Medicare Doctor Payment Schedule Closing Rule
- CMS Points 2022 House Well being Potential Fee System Price Closing Rule
Courts
- Supreme Court docket Hears Arguments in Becerra v. Empire Well being
- PCMA Drops Lawsuit Relating to PBM Rebate Disclosure
- Missouri District Court docket Blocks CMS Vaccine Mandate in Ten States
- Kentucky District Court docket Blocks Federal Contractor Vaccine Mandate in Three States
Stories
- GAO Report on the Black Lung Advantages Program
- GAO Report on VA Property Administration
- HHS ASPE Report on Shock Billing
Upcoming Hearings/Markups
December 8
Home Agriculture Committee, Vitamin, Oversight, and Division Operations Subcommittee Listening to: “Evaluation of USDA Vitamin Distribution Applications”
10:00 a.m.
For extra info, click on here.
Home Vitality and Commerce Committee, Well being Subcommittee Listening to: “The Way forward for Biomedicine: Translating Biomedical Analysis into Personalised Well being Care”
10:30 a.m.
For extra info, click on here.
Senate Veterans’ Affairs Committee Listening to: “To Contemplate the Nomination of Kurt D. DelBene to be Assistant Secretary of Veterans Affairs for Data and Expertise”
3:00 p.m.
For extra info, click on here.
December 9
Home Oversight and Reform Committee Listening to: “Unsustainable Drug Costs: Findings from the Committee’s Drug Pricing Investigation and the Want for Structural Reforms”
10:30 a.m.
For extra info, click on here.
Congress
Home
Reps. McMorris Rodgers and Comer Request Data on Biden Administration Compliance With COVID-19 Vaccine Mandates
On Nov. 23, Reps. Cathy McMorris Rodgers (D-WA-5) and James Comer (R-KY-1) wrote to the Performing Director of the Workplace of Administration and Price range (OMB) Shalanda Younger requesting an replace on the Biden administration’s compliance with latest COVID-19 vaccination necessities for federal workers.
The total letter might be discovered here.
Senate
Congress Passes Persevering with Decision to Fund Authorities Till Feb. 18
On Dec. 2, the Home and Senate voted to go a unbroken decision (CR) that will fund the federal government till Feb. 18, averting a authorities shutdown within the brief time period. Congress might want to undertake one other measure to fund the federal government from Feb. 18 till the top of fiscal yr 2022. The CR doesn’t embody any measures to mitigate the Medicare sequester cuts which can be set to return on Jan. 1.
Sens. Tuberville and Burr Request Data on Monoclonal Antibody Contracts
On Nov. 23, Sens. Tommy Tuberville (R-AL) and Richard Burr (R-NC) wrote three letters requesting extra info relating to the Division of Well being and Human Providers’ (HHS) and Division of Protection’s (DOD) choice to grant a $142 million contract to KPMG to advertise monoclonal antibody (mAb) therapy. The letters have been addressed to the DOD’s Performing Undersecretary of Protection Gregory Kausner, KPMG’s S. Lawrence Kocot and HHS Secretary Xavier Becerra and raised considerations in regards to the administration’s cancelling present mAb contracts and KPMG’s public outreach marketing campaign.
The total letter might be discovered here.
Administration
President Biden Declares New Actions to Fight COVID-19 This Winter
On Dec. 2, President Biden introduced new actions to fight COVID-19 with the emergence of the brand new Omicron variant and with the winter months approaching. President Biden’s plan consists of increasing entry to free and insurer-funded at-home COVID-19 exams, securing antivirals and enacting extra necessities for individuals touring internationally. The White Home continues to emphasize the significance of COVID-19 vaccination for all People and booster doses for these eligible.
President Biden’s announcement might be discovered here.
HHS Declares Second Spherical of Telehealth Grants for Title X Awardees
On Nov. 23, the Division of Well being and Human Providers (HHS) introduced that Title X awardees might apply for $35 million in telehealth grants. That is the second spherical of Title X grants, as $256 million in grant funding was introduced on Oct. 27. The grants come after the Biden administration ended a Trump-era coverage on Oct. four that prevented Title X grantees from referring sufferers for abortions.
Telehealth grant purposes will open on Feb. 3, 2022 and grants will begin on Might 1, 2022.
HHS Launches a 405(d) Aligning Well being Care Trade Safety Approaches Program Web site
On Dec. 2, the Division of Well being and Human Providers (HHS) launched a web site for the 405(d) Aligning Well being Care Trade Safety Approaches Program. The brand new web site offers sources and merchandise to lift consciousness about cybersecurity practices within the sector in an effort to construct cybersecurity resiliency.
The web site might be discovered here.
HRSA Declares $1.5 Billion in Funding for the Healthcare Workforce in Rural and Underserved Areas
On Nov. 22, the Well being and Human Providers Division’s (HHS) Well being Assets and Providers Administration (HRSA) introduced $1.5 billion in well being workforce mortgage compensation and scholarship packages. The packages will present mortgage compensation help and scholarships to healthcare suppliers in rural and underserved areas and can permit for added monetary help for Nationwide Well being Service Corps and Nurse Corps members.
CMS Places COVID-19 Vaccine Mandate on Maintain
On Nov. 30, a Louisiana federal district court docket decide halted the mandate nationwide whereas lawsuits are thought of. On Dec. 2, the Facilities for Medicare and Medicaid Providers (CMS) introduced it could not implement or implement its healthcare employee vaccine mandate as a result of court docket injunctions. The vaccine rule would apply to healthcare employees in Medicare- and Medicaid-certified suppliers and suppliers. For extra info on the court docket injunctions, see the “Courts” part of this article.
The CMS memo describing the suspension of the rule might be discovered here.
CMS Declares That 810,000 Enrolled Throughout Week Three of Open Enrollment
On Nov. 24, the Facilities for Medicare and Medicaid Providers (CMS) introduced that 810,000 individuals chosen plans from healthcare.gov through the third week of the Inexpensive Care Act’s (ACA) open enrollment interval. This brings the full to 2.43 million individuals signed up since Nov. 1.
CMS Points RFI Looking for Public and Stakeholder Enter on the Organ Transplantation System
On Dec. 1, the Facilities for Medicare and Medicaid Providers (CMS) issued a Request for Data (RFI) titled “Request for Data: Well being and Security Necessities for Transplant Applications, Organ Procurement Organizations, and Finish-Stage Renal Illness Services” to solicit public and stakeholder suggestions on the organ transplantation system. CMS is fascinated about feedback on methods to enhance organ donations, enhance the standard of dialysis care and entry to dialysis providers, and enhance fairness in organ donation and transplantation. The suggestions will inform future laws and rulemaking.
Feedback will probably be accepted till Feb. 1, 2022.
The RFI might be discovered here.
CMS Publishes Medicare Telemedicine Knowledge Snapshot
On Dec. 3, the Facilities for Medicare and Medicaid Providers (CMS) launched a Medicare Telemedicine Knowledge Snapshot, which offers info on Medicare beneficiaries who used telemedicine providers. The snapshot reveals that 28 million Medicare beneficiaries used telemedicine providers from March 1, 2020, to Feb. 28, 2021.
The Medicare Telemedicine Knowledge Snapshot might be considered here.
CMS and CDC Situation New Process Codes for COVID-19 Therapeutics
On Dec. 1, the Facilities for Medicare and Medicaid Providers (CMS) applied seven new process codes to explain the introduction or infusion of therapeutics for COVID-19 therapy into the Worldwide Classification of Ailments, Tenth Revision, Process Coding System (ICD-10-PCS). The brand new codes will go into impact on April 1, 2022. The Facilities for Illness Management and Prevention’s (CDC) Nationwide Heart for Well being Statistics (NCHS) can also be implementing three new analysis codes into the ICD-10 Medical Modification (CM) that will probably be efficient on April 1, 2022, as properly.
The code tables and index might be discovered here.
CDC Updates COVID-19 Booster Suggestions
On Nov. 29, the Facilities for Illness Management and Prevention (CDC) up to date its COVID-19 booster advice. The CDC now recommends that everybody 18 years outdated and above obtain a COVID-19 booster dose, both six months after their Pfizer or Moderna collection or two months after their Johnson & Johnson vaccine. The booster advice accompanies the latest emergence of the Omicron variant.
FDA Advisors Vote in Favor of Authorizing Merck’s COVID-19 Capsule
On Nov. 30, the Meals and Drug Administration’s (FDA) advisors voted 13-10 in favor of authorizing Merck’s COVID-19 capsule molnupiravir to deal with mild-to-moderate COVID-19 in adults. This places the capsule on observe for FDA approval.
Proposed Guidelines
FDA Points Draft Steering on Premarket Submissions for Gadget Software program Capabilities
On Nov. 3, the Meals and Drug Administration (FDA) printed new draft steering titled “Content material of Premarket Submissions for Gadget Software program Capabilities.” The steering offers info on documentation sponsors must submit for FDA’s analysis of the protection and effectiveness of machine software program capabilities. When closing, the steering will change prior steering issued in 2005.
Public feedback will probably be accepted till Feb. 2, 2022.
The draft steering might be discovered here.
HHS Points Proposed Rule to Withdraw the SUNSET Rule
On Oct. 29, the Division of Well being and Human Providers (HHS) issued a proposed rule that will withdraw the January 2021 closing rule titled “Securing Up to date and Needed Statutory Evaluations Well timed (SUNSET).” The SUNSET closing rule required HHS laws with a major financial impression to be reviewed each 10 years, with laws mechanically expiring in the event that they weren’t reviewed. This may have impacted greater than 17,000 HHS laws and required a overview course of significantly quicker than HHS ever performed.
The rule would have gone into impact in March 2021, however HHS issued a delay following a lawsuit.
Feedback will probably be accepted till Dec. 28, 2021.
The proposed rule might be discovered here.
FDA Points Draft Trade Steering on Actual-World Knowledge Requirements
On Oct. 22, the Meals and Drug Administration (FDA) introduced business draft steering titled “Knowledge Requirements for Drug and Organic Product Submissions Containing Actual-World Knowledge.” The steering consists of suggestions to assist sponsors adjust to the Federal Meals, Drug and Beauty Act when submitting research knowledge from real-world knowledge sources.
Public feedback will probably be accepted till Dec. 21, 2021.
The draft steering might be discovered here.
FDA Points Proposed Rule on Over-the-Counter Listening to Aids
On Oct. 20, the Meals and Drug Administration (FDA) issued a proposed rule titled “Medical Units: Ear, Nostril, and Throat Units; Establishing Over-the-Counter Listening to Aids.” The proposed rule would set up a brand new class of over-the-counter (OTC) listening to aids that might be offered to customers instantly with no medical examination or audiologic listening to. The proposed rule comes after President Biden’s July Govt Order aimed toward selling competitors within the financial system directed the FDA to extend entry to OTC listening to aids.
Public feedback will probably be accepted till Jan. 18, 2022.
The proposed rule might be discovered here.
FDA Points Steering on Steady Manufacturing of Drug Substances and Merchandise
On Oct. 12, the Meals and Drug Administration issued a draft steering doc titled “Q13 Steady Manufacturing of Drug Substances and Drug Merchandise,” which was ready with the help of the Worldwide Council for Harmonisation (ICH). The draft steering offers clarification on the event and operation of steady manufacturing and builds on prior tips Q7-Q10.
Feedback will probably be accepted till Dec. 13, 2021.
The steering might be discovered here.
FDA Points Steering Updating Distinctive Gadget Identification Coverage
On Oct. 14, the Meals and Drug Administration (FDA) issued a draft steering titled “Choose Updates for Distinctive Gadget Identification: Coverage Relating to World Distinctive Gadget Identification Database Necessities for Sure Units.” The steering revises the 2020 Distinctive Gadget Identification Steering. The up to date steering explains there are particular class I gadgets for which the FDA won’t implement the World Distinctive Gadget Identification Database (GUDID) submission necessities, and in addition states how a category I machine labeler can decide if the machine is within the scope of compliance coverage.
Feedback will probably be accepted till Dec. 13, 2021.
The steering might be discovered here.
Closing Guidelines
FDA Points Closing Rule to Amend Laboratory Meals Testing Necessities
On Dec. 1, the Meals and Drug Administration (FDA) issued a closing rule titled “Laboratory Accreditation for Analyses of Meals.” The rule amends FDA laws to determine a program for accredited laboratories to check meals beneath sure circumstances.
The ultimate rule will go into impact on Feb. 1, 2022.
The ultimate rule might be discovered here.
CMS Points Closing Rule to Delay VBP Reporting and the Inclusion of U.S. Territories
On Nov. 17, the Facilities for Medicare and Medicaid Providers (CMS) launched a closing rule titled “Medicaid Program; Delay of Efficient Date for Provision Referring to Producer Reporting of A number of Greatest Costs Related to a Worth Based mostly Buying (VBP) Association; Delay of Inclusion of Territories in Definition of States and United States.” The ultimate rule delays the perfect worth provisions and reporting associated to VBP preparations as a part of the Medicaid Drug Rebate Program (MDRP) from Jan. 1, 2022, to July 1, 2022. As well as, the rule additionally delays the inclusion of 5 U.S. territories within the MDRP’s regulatory definition of “states” from April 1, 2022, to Jan. 1, 2023.
The laws will probably be efficient on Dec. 20, 2021.
The ultimate rule might be discovered here.
CMS Points Closing Rule Rescinding Medicare Protection of Modern Expertise and “Cheap and Needed” Closing Rule
On Nov. 12, the Facilities for Medicare and Medicaid Providers (CMS) launched a closing rule to rescind the Trump administration’s “Medicare Protection of Modern Expertise (MCIT) and Definition of ‘Cheap and Needed’” (MCIT/R&N) Closing Rule. The ultimate rule was printed on Jan. 14, 2021, and would have gone into impact on Dec. 15, 2021. The rule would have granted as much as 4 years of expedited Medicare protection for sure designated “breakthrough” gadgets that obtain market authorization. CMS states that the rule did contemplate the variations in gadgets and the potential security impression on Medicare sufferers.
The ultimate rule might be discovered here. A CMS press launch on the ultimate rule might be discovered here.
CMS Points Closing Rule for Finish-Stage Renal Illness Potential Fee System
On Oct. 29, the Facilities for Medicare and Medicaid Providers (CMS) printed a closing rule titled “Finish-Stage Renal Illness Potential Fee System, Fee for Renal Dialysis Providers Furnished to People with Acute Kidney Harm, Finish-Stage Renal Illness High quality Incentive Program, and Finish-Stage Renal Illness Therapy Decisions Mannequin.” The ultimate rule updates fee charges beneath the Finish-Stage Renal Illness (ESRD) Potential Fee System (PPS) for renal dialysis providers beginning Jan. 1, 2022. The rule additionally updates the acute kidney harm (AKI) dialysis fee charge for renal dialysis providers and the ESRD Therapy Decisions (ETC) Mannequin.
The ultimate rule will go into impact on Jan. 1, 2022.
The ultimate rule might be discovered here. The CMS reality sheet on the ultimate rule might be discovered here.
CMS Points CY 2022 Medicare Hospital Outpatient Potential and Ambulatory Surgical Heart Fee Programs Closing Rule
On Nov. 2, the Facilities for Medicare and Medicaid Providers (CMS) launched a Closing Rule titled “Calendar Yr (CY) Medicare Program: Hospital Outpatient Potential Fee and Ambulatory Surgical Heart (ASC) Fee Programs and High quality Reporting Applications; Worth Transparency of Hospital Normal Expenses; Radiation Oncology Mannequin.” CMS is required by the January 2021 Hospital Worth Transparency Closing Rule to replace Medicare fee insurance policies for Outpatient Potential Fee System (OPPS) hospitals and ASCs on an annual foundation. The adjustments within the closing rule goal to strengthen enforcement of hospital worth transparency necessities and can cease the phased elimination of the Inpatient Solely (IPO) listing for surgical procedures. CMS will enhance the penalty for hospitals that don’t adjust to the Hospital Worth Transparency Rule beginning on Jan. 1, 2022. The ultimate rule additionally halts the elimination of the IPO listing. As well as, the rule updates the OPPS fee charges for hospitals that meet high quality reporting necessities by 2.zero %. The ultimate rule additionally particulars the Radiation Oncology Mannequin, which is about to start on Jan. 1, 2022, and final for 5 years.
The ultimate rule will go into impact on Jan. 1, 2022.
The ultimate rule might be discovered here. The CMS reality sheet on the ultimate rule might be discovered here.
CMS Points CY 2022 Medicare Doctor Payment Schedule Closing Rule
On Nov. 2, the Facilities for Medicare and Medicaid Providers (CMS) issued a closing rule titled “Calendar Yr (CY) 2022 Fee Insurance policies beneath the Doctor Payment Schedule and Different Modifications to Half B Fee Insurance policies; Medicare Shared Financial savings Program Necessities; Supplier Enrollment Regulation Updates; and Supplier and Provider Prepayment and Put up-payment Medical Evaluation Necessities.” The rule consists of coverage adjustments for Medicare funds beneath the Doctor Payment Schedule (PFS) and would proceed the protection of Medicare telehealth providers and finalize adjustments to the Medicare Diabetes Prevention Program (MDPP) expanded mannequin, amongst different issues. The CY 2022 PFS conversion issue is $33.59, a lower from the CY 2021 issue of $34.89.
The ultimate rule will go into impact on Jan. 1, 2022.
The ultimate rule might be discovered here. The CMS reality sheet on the ultimate rule might be discovered here.
CMS Points 2022 House Well being Potential Fee System Price Closing Rule
On Nov. 2, the Facilities for Medicare and Medicaid Providers (CMS) printed a proposed rule titled “Calendar Yr (CY) 2022 House Well being Potential Fee System Price Closing Rule.” The rule will develop the House Well being Worth-Based mostly Buying (HHVBP) Mannequin. As well as, the rule updates the Medicare House Well being Potential Fee System (HH PPS) and the house infusion remedy providers fee charges for CY 2022. As well as, the proposed rule makes everlasting adjustments to the house well being Circumstances of Participation (CoP) applied through the COVID-19 public well being emergency.
The ultimate rule will go into impact on Jan. 1, 2022.
The ultimate rule might be discovered here. The CMS reality sheet on the ultimate rule might be discovered here.
Courts
Supreme Court docket Hears Arguments in Becerra v. Empire Well being
On Nov. 29, the U.S. Supreme Court docket heard arguments within the case of Becerra v. Empire Well being Basis. The case discusses whether or not or not the Facilities for Medicare and Medicaid Providers (CMS) can exclude sufferers who’ve exhausted their Medicare Half A advantages when calculating hospitals’ disproportionate share funds (DSH).
PCMA Drops Lawsuit Relating to PBM Rebate Disclosure
On. Dec. 1, the Pharmaceutical Care Administration Affiliation (PCMA) dropped its lawsuit over a Trump administration rule that will have required pharmacy profit managers (PBMs) to reveal publicly the costs they negotiate with pharmaceutical firms. The Division of Well being and Human Providers (HHS) delayed enforcement of the rule indefinitely in August 2021.
Missouri District Court docket Blocks CMS Vaccine Mandate in Ten States
On Nov. 30, a federal district court docket in Missouri issued a preliminary injunction to dam the implementation and enforcement of the Facilities for Medicare and Medicaid Providers’ (CMS) vaccine mandate for healthcare staff in ten states. The court docket discovered that CMS acted with out authority and bypassed the discover and remark interval. The ten states impacted by the injunction and that wouldn’t have to adjust to the mandate (except the state of affairs adjustments) are: Alaska, Arkansas, Iowa, Kansas, Missouri, Nebraska, New Hampshire, North Dakota, South Dakota and Wyoming.
Kentucky District Court docket Blocks Federal Contractor Vaccine Mandate in Three States
On Nov. 30, the U.S. District Court docket for the Jap District of Kentucky blocked President Biden’s federal contractor vaccine mandate from being enforced in Kentucky, Ohio and Tennessee. Choose Gregory Van Tatenhove acknowledged {that a} president can not use their authority to handle the federal procurement of products and providers to impose vaccine mandates on the staff of federal contractors and subcontractors. The vaccine mandate requires firms doing enterprise with the federal authorities to make sure that their staff are absolutely vaccinated and gives no possibility for weekly testing.
Stories
GAO Report on the Black Lung Advantages Program
On Dec. 2, the Authorities Accountability Workplace (GAO) printed a report titled “Black Lung Advantages Program: Continued Inaction on Coal Operator Self-Insurance coverage Will increase Monetary Danger to Belief Fund.” The Division of Labor (DOL) oversees the Black Lung Incapacity Belief Fund. The report notes that the DOL took some steps to enhance its oversight of self-insured coal mine operators, however these efforts have been sophisticated by the COVID-19 pandemic. The GAO states that the DOL has not taken needed motion to forestall extra profit liabilities from being transferred to the belief fund and really useful that the DOL act on suggestions made in 2020.
The total report might be discovered here.
GAO Report on VA Property Administration
On Nov. 29, the Authorities Accountability Workplace (GAO) printed a report titled “VA Actual Property: Enhanced Communication and Efficiency Measurement Might Enhance Capital Asset Administration.” The report states that the Division of Veterans Affairs (VA) faces challenges in assembly its capital asset administration framework. The GAO recommends that the VA specify how development and discipline places of work ought to talk throughout mission improvement, outline the function of the knowledge know-how workplace and develop efficiency objectives for the VA’s capital asset administration.
The total report might be discovered here.
HHS ASPE Report on Shock Billing
On Nov. 22, the Well being and Human Providers (HHS) Division’s Workplace of the Assistant Secretary for Planning and Analysis (ASPE) printed a report on shock medical billing. The report discovered that shock medical payments are comparatively widespread for People with personal insurance coverage, with a median invoice of $1,200 for anesthesiologist providers, $2,600 for surgical help and $750 for care associated to childbirth. The report offers a background on shock billing and particulars the patron protections within the No Surprises Act that may go into impact on Jan. 1, 2022.
The total report might be discovered here.
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