This Week in Washington: The Senate waits to see if price range reconciliation settlement has sufficient votes to cross.
Upcoming Hearings
Congress
Home
- Home Passes Three Healthcare Payments
- Extra Than 100 Members Name for Extra Funding to Assist Well being Clinics’ Monkeypox Response
Senate
- Sen. Leahy Releases Appropriations Package deal
- Sens. Manchin and Schumer Attain Settlement on Price range Reconciliation
- 5 Senate Democrats Introduce Invoice to Enable U.S. Overseas Help for Abortion Care Overseas
- Sen. Hassan Requires No Surprises Act to be Prolonged to Extra Services
- Sen. Peters Calls on HHS and DHS to Make clear Steerage on the Importation of and Journey with Abortion Remedy
- Sens. Schumer, Wyden and Booker Introduce Invoice to Take away Hashish from the Federal Checklist of Managed Substances
- Sen. Klobuchar Calls on FTC to Examine Amazon’s Proposed Acquisition of One Medical
Administration
- HHS Secures 66 Million Doses of Moderna’s COVID-19 Booster Vaccine
- HHS Allocates Extra Monkeypox Vaccines
- HHS, Division of Labor and Treasury Concern Steerage on Start Management Protection
- HHS Releases Reality Sheet on Monkeypox Response
- CMS Pronounces the Launch of the Nursing House 5-Star High quality Score System
- CMS Approves Extension of Postpartum Protection in Connecticut, Massachusetts and Kansas
- CMS Releases Maternity Care Motion Plan
- CMS Releases HCBS High quality Measure Set
- CMS Pronounces $49 Million in Grants Awarded By way of the Connecting Children to Protection Nationwide Marketing campaign
- FDA to Maintain Public Workshop on Biosimilar Growth Applications
Proposed Guidelines
- HHS Pronounces Proposed Rule to Implement Part 1557 of the ACA
- FDA Releases Proposed Rule to Standardize the Nationwide Drug Code Format
- CMS Releases CY 2023 Doctor Price Schedule Proposed Rule
- CMS Publishes Proposed Rule on Rural Hospitals
- CMS Publishes Finish-Stage Renal Illness Potential Fee System Proposed Rule
- CMS Releases FY 2023 House Well being Potential Fee Methods Price Proposed Rule
Last Guidelines
- CMS Publishes Last Rule to Replace FY 2023 Hospice Fee Price
- CMS Publishes FY 2023 Inpatient Psychiatric Services Potential Fee System Last Rule
- CMS Points FY 2023 Inpatient Rehabilitation Facility Potential Fee System Last Rule
- CMS Publishes Last Rule Updating CLIA Proficiency Testing Rules for Analytes
- HHS Points Last Rule Withdrawing SUNSET Rule
- CMS Releases Discover of Profit and Parameters for 2023 Last Rule
- Last Rule to Change {Qualifications} for Merchandise to be Thought of “Made in America” Launched
Experiences
- FDA Releases Progress Report on the Generic Drug Cluster
- GAO Report on Sexual Harassment Insurance policies on the VA
- GAO Report on the Protection Well being Company’s Oversight of Pediatric Lead Publicity
- GAO Report on Federal Efforts to Promote Wholesome Consuming
- CBO Report Offers Extra Data on the INSULIN Act
- CBO Report on the Impression of Making the Enhanced Premium Tax Credit Everlasting
- Congressional Price range Workplace Value Estimates of Healthcare Payments
Upcoming Hearings
August 3
Senate Finance Committee Hearing: “A System in Want of Restore: Addressing Organizational Failures of the U.S.’s Organ Procurement and Transplantation Community”
2:30 p.m.
Congress
Home
Home Passes Three Healthcare Payments
On July 27, the Home of Representatives voted to cross three healthcare payments. Data on the payments and their content material might be discovered under.
Extra Than 100 Members Name for Extra Funding to Assist Well being Clinics’ Monkeypox Response
On July 25, Reps. Jerrold Nadler (D-NY) and David Cicilline (D-RI) led a bunch of greater than 100 members of Congress in a letter to President Biden, Well being and Human Providers (HHS) Secretary Xavier Becerra and Facilities for Illness Management and Prevention (CDC) Director Rochelle Walensky. Within the letter, the members counseled latest actions to enhance monkeypox vaccine distribution and increase testing capability, and requested that further funding be offered to assist well being clinics.
Senate
Sen. Leahy Releases Appropriations Package deal
On July 28, Sen. Pat Leahy (D-CT) launched 12 appropriations payments. The laws would supply $10.5 billion for the Facilities for Illness Management and Prevention and $1.4 billion for the Psychological Well being Block Grant. Sens. Leahy, Patty Murray (D-WA) and Chris Coons (D-DE) additionally launched a $21 billion emergency supplemental funding bill to deal with the continued COVID-19 pandemic. Extra info on the Labor, Well being and Human Providers, Schooling, and Associated Businesses part of the Appropriations bundle might be discovered under.
Sens. Manchin and Schumer Attain Settlement on Price range Reconciliation
On July 27, Senate Majority Chief Chuck Schumer (D-NY) announced that he had reached an settlement with Sen. Joe Manchin (D-WV) on the Fiscal Yr (FY) 2022 Price range Reconciliation Package deal. As a part of the settlement, the Inflation Discount Act of 2022 might be added to the FY 2022 Price range Reconciliation invoice. The settlement revives the reconciliation bundle, which was beforehand considered useless because it didn’t have sufficient votes. Votes might be held on the brand new reconciliation bundle subsequent week. Data on the Inflation Discount Act of 2022 might be discovered under.
5 Senate Democrats Introduce Invoice to Enable U.S. Overseas Help for Abortion Care Overseas
On July 27, Sens. Cory Booker (D-NJ), Tammy Duckworth (D-IL), Mazie Hirono (D-HI), Tina Smith (D-MN) and Richard Blumenthal (D-CT) launched the Abortion is Health Care Everywhere Act. The invoice would be certain that U.S. overseas help may very well be used to offer complete healthcare, together with abortion companies, by repealing the 1973 Helms Modification to Overseas Help Act.
Sen. Hassan Requires No Surprises Act to be Prolonged to Extra Services
On July 25, Sen. Maggie Hassan (D-NH) wrote a letter to the Well being and Human Providers Secretary Xavier Becerra, Labor Secretary Marty Walsh and Treasury Secretary Janet Yellen calling for extra shock medical billing protections. Sen. Hassan known as for the protections within the No Surprises Act to be prolonged to all related amenities, together with birthing facilities, clinics, hospice amenities, nursing houses, pressing care facilities and dependancy remedy facilities.
Sen. Peters Calls on HHS and DHS to Make clear Steerage on the Importation of and Journey with Abortion Remedy
On July 21, Sen. Gary Peters (D-MI) wrote to the Secretary of Well being and Human Providers (HHS) Xavier Becerra and Secretary of Homeland Safety (DHS) Alejandro Mayorkas, calling on them to extra proactively shield reproductive healthcare. In his letter, Sen. Peters requested for HHS and DHS to make clear steerage on the importation of abortion remedy and journey with abortion remedy.
Sens. Schumer, Wyden and Booker Introduce Invoice to Take away Hashish from the Federal Checklist of Managed Substances
On July 21, Sens. Chuck Schumer (D-NY), Ron Wyden (D-OR) and Cory Booker (D-NJ) launched the Cannabis Administration and Opportunity Act (CAOA), which might take away hashish from the federal checklist of managed substances. The invoice would additionally set up a Heart for Hashish Merchandise on the Meals and Drug Administration (FDA) to control the hashish business. A abstract of the invoice might be discovered here.
Sen. Klobuchar Calls on FTC to Examine Amazon’s Proposed Acquisition of One Medical
On July 21, Sen. Amy Klobuchar (D-MN) wrote to Federal Commerce Fee (FTC) Chair Lina Khan calling for an investigation into Amazon’s proposed acquisition of One Medical. Sen. Klobuchar expressed concern that the acquisition would hurt competitors and will have destructive implications for private well being information.
Administration
HHS Secures 66 Million Doses of Moderna’s COVID-19 Booster Vaccine
On July 29, the Division of Well being and Human Providers (HHS) announced that it will be buying 66 million doses of Moderna COVID-19 booster vaccine in preparation to be used within the fall and winter.
HHS Allocates Extra Monkeypox Vaccines
On July 28, the Division of Well being and Human Providers (HHS) announced it will allocate a further 786,000 doses of the JYNNEOS monkeypox vaccine to states and jurisdictions, bringing the overall quantity of vaccines to 1.1 million doses.
HHS, Division of Labor and Treasury Concern Steerage on Start Management Protection
On July 28, the Departments of Well being and Human Providers (HHS), Labor and Treasury issued guidance to make clear protections for contraception protection included within the Inexpensive Care Act (ACA). The steerage stresses that the ACA requires most non-public well being plans to offer contraception and household planning counseling for gratis.
HHS Releases Reality Sheet on Monkeypox Response
On July 21, the Division of Well being and Human Providers (HHS) launched a fact sheet on the company’s response to the monkeypox outbreak. The actual fact sheet consists of efforts taken to extend the distribution of vaccines, checks and coverings in addition to elevating consciousness.
CMS Pronounces the Launch of the Nursing House 5-Star High quality Score System
On July 27, the Facilities for Medicare and Medicaid Providers (CMS) announced the launch of its enhanced Nursing House 5-Star High quality Score System. The ranking system incorporates nursing residence information on weekend staffing charges and workers turnover, which has been revealed since January. The Nursing House 5-Star High quality Score System will incorporate further information on complete nurse staffing hours per resident, RN turnover, administrator turnover and complete nurse workers turnover. The ranking system presents the info in a extra consumer-friendly format and might be up to date quarterly. A truth sheet on the updates might be discovered here.
CMS Approves Extension of Postpartum Protection in Connecticut, Massachusetts and Kansas
On July 26, the Facilities for Medicare and Medicaid Providers (CMS) approved a Medicaid and Youngsters’s Well being Insurance coverage Program (CHIP) protection extension for 12 months postpartum within the states of Connecticut, Massachusetts and Kansas. It will prolong Medicaid and CHIP protection to a further 19,000 folks.
CMS Releases Maternity Care Motion Plan
On July 26, the Facilities for Medicare and Medicaid Providers (CMS) launched its Maternity Care Action Plan. The motion plan identifies 5 key gaps in maternity care: protection and entry to care, information, high quality of care, workforce and social helps. The motion plan explains the steps CMS is taking to deal with these gaps.
CMS Releases HCBS High quality Measure Set
On July 21, the Facilities for Medicare and Medicaid Providers (CMS) released a home- and community-based companies (HCBS) high quality measure set for the primary time. The measure set will present perception into the standard of HCBS applications and facilitate efforts to trace well being outcomes. Use of the standard measure is voluntary.
CMS Pronounces $49 Million in Grants Awarded By way of the Connecting Children to Protection Nationwide Marketing campaign
On July 19, the Facilities for Medicare and Medicaid Providers (CMS) announced that $49 million had been awarded via the brand new Connecting Children to Protection Marketing campaign to organizations working to scale back uninsured charges amongst youngsters and households. Data on the grantees might be discovered here.
FDA to Maintain Public Workshop on Biosimilar Growth Applications
On July 19, the Meals and Drug Administration (FDA) introduced that it will be holding a digital public workshop titled “Growing the Effectivity of Biosimilar Growth Applications” on Sept. 19 from 9 a.m. to 4 p.m. Registration info and extra particulars might be discovered here.
Proposed Guidelines
HHS Pronounces Proposed Rule to Implement Part 1557 of the ACA
On July 25, the Division of Well being and Human Providers (HHS) launched a proposed rule to implement Section 1557 of the Affordable Care Act (ACA) that bans discrimination primarily based on race, shade, nationwide origin, intercourse, age and incapacity in sure well being applications and actions. The proposed rule expands civil rights protections for sufferers in sure federally funded applications by clarifying the scope and utility of Part 1557. An HHS press launch on the proposed rule might be discovered here.
FDA Releases Proposed Rule to Standardize the Nationwide Drug Code Format
On July 25, the Meals and Drug Administration (FDA) issued a proposed rule titled “Revising the National Drug Code Format and Drug Label Barcode Requirements.” The proposed rule would amend the Nationwide Drug Code (NDC) to require one standardized format for all NDCs.
Public feedback might be accepted till Nov. 22, 2022.
CMS Releases CY 2023 Doctor Price Schedule Proposed Rule
On July 7, the Facilities for Medicare and Medicaid Providers (CMS) revealed a proposed rule titled “Medicare and Medicaid Programs: Calendar Year (CY) 2023 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies, Medicare Shared Savings Program Requirements, etc.” The proposed rule would make adjustments to the doctor payment schedule (PFS) and Medicare Half B cost insurance policies to higher replicate the worth of companies. The proposed rule additionally would:
- Enable licensed skilled counselors, counselors and therapists to offer behavioral well being companies beneath common supervision,
- Take into account medical psychologists and medical social staff as a part of a affected person’s major care workforce for cost functions,
- Incorporate advance shared financial savings funds to sure new Medicare Shared Financial savings Program Accountable Care Organizations (ACOs),
- Enhance entry to colon most cancers screening,
- Enable CMS to pay for dental companies which can be integral to coated medical companies,
- Replace the Medicare Financial Index (MEI) price share weights,
- Solicit public suggestions on methods to enhance world surgical bundle valuation,
- Undertake adjustments to the Analysis and Administration (E/M) go to coding and documentation,
- Prolong some companies quickly accessible through telehealth via CY 2023,
- Add new Healthcare Widespread Process Coding System (HCPCS) codes and valuation for continual ache administration,
- Present Medicare protection for opioid use dysfunction companies offered by opioid remedy applications,
- Enable beneficiaries to entry audiology companies with out a doctor referral,
- Make clear Medicare fee-for-service cost insurance policies for dental companies,
- Change the coding, billing and cost guidelines for pores and skin substitutes,
- Refine the cost quantity for preventive vaccine administration beneath the Medicare Half B vaccine profit and
- Replace rules on Medicare Floor Ambulance information assortment.
Extra sources on the proposed rule might be discovered under:
Public feedback might be accepted till Sept. 6, 2022.
CMS Publishes Proposed Rule on Rural Hospitals
On July 7, the Facilities for Medicare and Medicaid Providers (CMS) revealed a proposed rule titled “Medicare and Medicaid Programs; Conditions of Participation (CoPs) for Rural Emergency Hospitals (REH) and Critical Access Hospital CoP Updates.” The proposed rule establishes the CoPs that REHs want to fulfill as a way to take part in Medicare and Medicaid, with the target of making certain that REHs present a top quality of care. As well as, the proposed rule would additionally change the Important Entry Hospital necessities for participation in Medicare and Medicaid.
Public feedback might be accepted till Aug. 29, 2022.
CMS Publishes Finish-Stage Renal Illness Potential Fee System Proposed Rule
On June 28, the Facilities for Medicare and Medicaid Providers (CMS) revealed a proposed rule titled “Medicare Program: End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, etc.” The proposed rule would replace the Finish-Stage Renal Illness (ESRD) Potential Fee System and the cost fee for renal dialysis service offered by an ESRD facility for folks with acute kidney harm for calendar 12 months 2023. As well as, the rule consists of requests for info on potential cost changes for brand spanking new renal dialysis medicine and merchandise and well being fairness points.
Public feedback might be accepted till Aug. 22, 2022.
CMS Releases FY 2023 House Well being Potential Fee Methods Price Proposed Rule
On June 17, the Facilities for Medicare and Medicaid Providers (CMS) launched a proposed rule titled “Calendar Year 2023 Home Health Prospective Payment System Rate Update.” The proposed rule would replace Medicare cost insurance policies and charges for residence well being companies (HHAs). A CMS fact sheet says the rule would replace residence well being cost and residential infusion remedy charges for Fiscal Yr 2023. As well as, the rule would finish the suspension of non-Medicare and non-Medicaid information for HHA sufferers and increase the baseline years within the Expanded House Well being Worth-Based mostly Buying (HHVBP) Mannequin.
Public feedback might be accepted till Aug. 16, 2022.
Last Guidelines
CMS Publishes Last Rule to Replace FY 2023 Hospice Fee Price
On July 27, the Facilities for Medicare and Medicaid Providers (CMS) revealed a last rule titled “Medicare Program; FY 2023 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements.” The ultimate rule makes updates to Medicare hospice funds and the mixture cap quantity for Fiscal Yr (FY) 2023. The FY 2023 hospice cost replace might be elevated to three.8% and a everlasting budget-neutral 5% cap might be established on any lower to an space’s wage index. The ultimate rule additionally discusses the Hospice Outcomes and Affected person Analysis instrument and gives an replace on FY 2023 High quality Measures, the Client Evaluation of Healthcare Suppliers and Methods, and Hospice Survey Mode Experiment. A press launch on the ultimate rule with further info might be discovered here.
The ultimate rule will go into impact on Oct. 1, 2022.
CMS Publishes FY 2023 Inpatient Psychiatric Services Potential Fee System Last Rule
On July 27, the Facilities for Medicare and Medicaid Providers revealed a last rule titled “Medicare Program: FY 2023 Inpatient Psychiatric Facilities Prospective Payment System; Rate Update and Quality Reporting; Request for Information.” The ultimate rule will replace Medicare cost charges for the Inpatient Psychiatric Facility Potential Fee System (IPF PPS) for Fiscal Yr (FY) 2023 and units a everlasting 5% cap. The rule doesn’t make any adjustments to the IPF High quality Reporting Program. A press launch with further info might be discovered here.
The ultimate rule will go into impact on Oct. 1, 2022.
CMS Points FY 2023 Inpatient Rehabilitation Facility Potential Fee System Last Rule
On July 27, the Facilities for Medicare and Medicaid Providers (CMS) issued a last rule titled “Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2023 and Updates to the IRF Quality Reporting Program.” The ultimate rule updates cost insurance policies beneath the Inpatient Rehabilitation Facility (IRF) Potential Fee System (PPS) and the IRF High quality Reporting Program. The ultimate rule features a everlasting cap on year-to-year wage index decreases and can increase the IRF high quality information reporting necessities. A truth sheet in regards to the last rule might be discovered here.
The ultimate rule will go into impact for Oct. 1, 2022.
CMS Publishes Last Rule Updating CLIA Proficiency Testing Rules for Analytes
On July 11, the Facilities for Medicare and Medicaid Providers (CMS) revealed a last rule titled “Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance.” The ultimate rule makes adjustments to the proficiency testing (PT) rules beneath the Scientific Laboratory Enchancment Amendments (CLIA) of 1988. The updates will deal with present analytes and new applied sciences. As well as, the ultimate rule will make adjustments to the PT referral rules to verify they’re aligned with the CLIA statute. The ultimate rule will go into impact on Aug. 10, 2022, however amendments to Sec. Sec. 493.2 and 493.801 via 493.959 (amendatory directions 2 and 5 via 21) might be efficient on July 11, 2024.
HHS Points Last Rule Withdrawing SUNSET Rule
On Could 27, the Division of Well being and Human Providers (HHS) revealed a final rule to withdraw the “Securing Up to date and Needed Statutory Evaluations Well timed (SUNSET)” Last Rule of 2021. The SUNSET rule was initially set to enter impact on March 22, 2021, however was delayed till Sept. 22, 2022, following a lawsuit. The SUNSET rule would have required HHS to evaluate each rule to find out if it was nonetheless relevant after 10 years, and any guidelines not reviewed inside that timeframe could be routinely eradicated. In its withdrawal of the SUNSET rule, HHS acknowledged that the rule confronted important opposition from stakeholders and wouldn’t expedite rulemaking.
The rule is efficient instantly.
CMS Releases Discover of Profit and Parameters for 2023 Last Rule
On April 28, the Facilities for Medicare and Medicaid Providers (CMS) introduced the 2023 Notice of Benefit and Payment Parameters Final Rule, which goals to strengthen plan protection supplied on the federal Market. The ultimate rule would require healthcare.gov plans to supply a standardized model of every product an issuer sells in every metallic tier for plan 12 months 2023. The ultimate rule additionally finalizes trade person charges, updates high quality enchancment requirements associated to well being fairness and reduces the variety of verification necessities for particular enrollment intervals. The rules went into impact on July 1, 2022.
A CMS truth sheet on the ultimate rule might be discovered here.
Last Rule to Change {Qualifications} for Merchandise to be Thought of “Made in America” Launched
On March 4, the Division of Protection, the Basic Providers Administration and the Aeronautics and House Administration introduced a final rule that will enhance manufacturing of important provides within the U.S. as a part of President Biden’s “Made in America” coverage. The ultimate rule would require pharmaceutical corporations that need their merchandise to qualify as being “Made in America” for federal procurement functions to extend the share of drug components made within the U.S. from 55 % to 75 % within the subsequent seven years. Particularly, the ultimate rule would enhance the edge to 60 % in 2022, 65 % in 2024 and 75 % in 2029. As well as, the rule will permit the federal government to use worth preferences to pick drug merchandise and elements that may assist the growth of the home provide chain. The ultimate rule will go into impact on Oct. 25, 2022.
The White Home Reality Sheet on the ultimate rule might be discovered here.
Experiences
FDA Releases Progress Report on the Generic Drug Cluster
On July 28, the Meals and Drug Administration (FDA) launched a progress report on the World Generic Drug Affairs’ Generic Drug Cluster. The Generic Drug Cluster was created to advance generic drug improvement internationally. Since its creation, the discussion board has held plenty of occasions and conferences to facilitate collaboration on regulatory subjects.
GAO Report on Sexual Harassment Insurance policies on the VA
On July 28, the Authorities Accountability Workplace (GAO) revealed a report titled “Sexual Harassment: Opportunities Remain for VA to Improve Program Structure, Policies, and Data Collection.” The report notes that the Division of Veterans’ Affairs (VA) carried out two of the seven GAO suggestions from the June 2020 report, and important points stay. The GAO states that with out further motion, the VA will proceed to have excessive charges of sexual harassment reported by staff.
GAO Report on the Protection Well being Company’s Oversight of Pediatric Lead Publicity
On July 26, the Authorities Accountability Workplace (GAO) launched a report titled “Defense Health Agency: Oversight Needed to Better Ensure That Children Are Screened, Tested, and Treated for Lead Exposure.” The report notes that whereas the Protection Well being Company (DHA) has pediatric lead screening, testing and remedy pointers for army medical amenities, the DHA doesn’t be certain that the rules are being adhered to. The GAO recommends that the DHA develop an oversight plan and implement it at its amenities.
GAO Report on Federal Efforts to Promote Wholesome Consuming
On July 19, the Authorities Accountability Workplace (GAO) revealed a report titled “Healthy Eating: Government-wide solutions for promoting healthy diets, food safety, and food security.” The report summarizes work federal companies have performed on weight-reduction plan, meals security and meals safety. The GAO recommends that federal companies higher coordinate these efforts, as there have been duplicative efforts and different issues.
CBO Report Offers Extra Data on the INSULIN Act
On July 22, the Congressional Price range Workplace (CBO) launched a report titled “Additional Information about the INSULIN Act.” The report accommodates info on how the INSULIN Act would affect insulin costs and the federal price range in response to a request from Sens. Susan Collins (R-ME) and Jeanne Shaheen (D-NH).
CBO Report on the Impression of Making the Enhanced Premium Tax Credit Everlasting
On July 21, the Congressional Price range Workplace (CBO) launched a report titled “Health Insurance Policies.” Within the report, CBO explains how making the American Rescue Plan’s enhanced premium tax credit everlasting may affect the affordability of employment-based protection. The report was written in response to a request from Sens. Richard Burr (R-NC), Mike Crapo (R-ID) and Lindsey Graham (R-SC).
Congressional Price range Workplace Value Estimates of Healthcare Payments
The Congressional Price range Workplace (CBO) revealed price estimates of the next payments:
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