This Week in Washington: Home and Senate not in session, U.S. reaches debt-ceiling restrict
Congress
Home
- Rep. Frank Pallone Questions FDA and NIH Over Federally Funded Scientific Trial Reporting Compliance
Administration
- FDA Looking for Public Feedback on the Use of FDA System Person Charges
- FDA Grants 510(okay) Clearance to SeluxDX in vitro Antimicrobial Resistance (AMR) Take a look at
- FDA Rejects Eli Lilly Accelerated Approval Request for Alzheimer’s Drug Donanemab
- FDA Releases Replace Relating to COVID-19 Take a look at Expiration Dates
- FDA Publicizes Panel Assembly Date to Focus on iPLEDGE REMS Program for Isotretinoin Merchandise
- FDA Updates Two COVID-19 Testing Tips
- FDA Indicators U.S.-Switzerland Mutual Pharmaceutical Manufacturing Recognition Settlement
- CMS Publicizes New Steps to Strengthen Nursing House Security and Transparency
- HHS Releases 2023 Discover Relating to Annual Replace of HHS Poverty Tips
Proposed Guidelines
- HHS Proposes Rule to Make clear Beneficiary Spiritual Protections
- HHS Workplace for Civil Rights Releases Proposed Rule Looking for to Make clear Well being Care Supplier Conscience Safety Rights
- SAMHSA Looking for Public Feedback Relating to Opioid Use Dysfunction Remedy Remedy Requirement Reforms
- SAMHSA Introduces Proposed Rule to Higher Align SUD Affected person Privateness with HIPAA
- CMS Releases Proposed Profit and Fee Parameters for 2024
- CMS Releases Proposed Adjustments to Contract Yr 2024 Medicare Program Plans
- CMS Proposes MA Plan Advertising, Half D Low-income Entry, Prior Authorization and Behavioral Well being Reforms
- CMS Proposes Healthcare Plan Alternate Rule for 2024
- CMS Requests Info on Important Well being Advantages Proposed Rule
- HHS Proposes Adopting Healthcare Attachments Requirements
- FDA Proposed Rule Would Substitute Investigational New Drug Annual Report
- FDA Proposes Exempting Sure Standard Meals, Dietary Dietary supplements and Cosmetics From Investigational New Drug Necessities
- HRSA Proposed Rule Adjustments Regarding 340B Disputes
Closing Guidelines
- CMS Closing Rule Provides Objects to DMEPOS Order Listing and Updates Healthcare Widespread Process Coding System (HCPCS)
- FDA Delays Tobacco Product Required Warning Closing Rule Efficient Date
- CMS Points Correction on Scientific Laboratory Enchancment Amendments (CLIA) Closing Rule
Reviews
- HHS OIG Reveals Excessive Charge of COVID-19 Infections in Nursing Properties
- GAO Releases Report on HHS Oversight Over Enhanced Potential Pandemic Pathogens Analysis
- CMS Releases Preliminary Report on Federal Unbiased Dispute Decision (IDR) Course of
- CBO Releases Value Estimate Exhibiting Anticipated 2023 Consolidated Appropriations Act Budgetary Results
Congress
Home
Rep. Frank Pallone Questions FDA and NIH Over Federally Funded Scientific Trial Reporting Compliance
On Jan. 19, Rep. Frank Pallone (D-NJ) despatched a letter to the Meals and Drug Administration (FDA) and the Nationwide Institutes of Well being (NIH), elevating issues over whether or not medical product sponsors are submitting federally funded medical trial outcomes to the ClinicalTrials.gov database. Medical merchandise sponsors are required to submit medical trial outcomes to the federal database, with a view to present healthcare suppliers and researchers with security and efficacy info. A latest examine revealed that as much as 31 % of medical trials are going unreported.
Senate not in session
Administration
FDA Looking for Public Feedback on the Use of FDA System Person Charges
On Jan. 19, the Meals and Drug Administration (FDA) introduced that it’s requesting public feedback concerning the usage of FDA machine consumer charges. A portion of charges is at the moment getting used to help the Nationwide Analysis System for Well being Know-how (NEST) premarket Actual-World Proof (RWE) actions. The FDA is asking stakeholders to recommend different methods the company might distribute the consumer payment funds. Public feedback are due by March 20, 2023.
FDA Grants 510(okay) Clearance to SeluxDX in vitro Antimicrobial Resistance (AMR) Take a look at
On Jan. 19, the Meals and Drug Administration (FDA) granted 510(okay) clearance to an in vitro antimicrobial resistance check developed by Selux Diagnostics. The check makes use of Selux Diagnostics’ Subsequent Era Phenotyping (NGP) System, which the corporate claims can ship focused outcomes quicker than different antimicrobial resistance exams available on the market.
FDA Rejects Eli Lilly Accelerated Approval Request for Alzheimer’s Drug Donanemab
On Jan. 19, the Meals and Drug Administration (FDA) rejected Eli Lilly’s request to grant accelerated approval to its Alzheimer’s drug donanemab. The FDA cited that it didn’t obtain satisfactory security information to grant the accelerated approval. The FDA is requesting that Eli Lilly submit information on at the very least 100 medical trial sufferers who’ve been receiving the drug for no less than 12 months.
FDA Releases Replace Relating to COVID-19 Take a look at Expiration Dates
On Jan. 19, the Meals and Drug Administration (FDA) Middle for Units and Radiological Well being introduced that the shelf life for 3 COVID-19 exams is longer than beforehand thought. The expiration dates of the Abbott Diagnostics Scarborough BinaxNOW COVID-19 Antigen Self-Take a look at, the MaximBio ClearDetect COVID-19 Antigen House Take a look at and the iHealth Labs iHealth COVID-19 Antigen Speedy Take a look at have now been prolonged. The extensions come after FDA reviewed new information offered by the producers listed above, which confirmed the exams having related ranges of accuracy previous their unique expiration dates.
FDA Publicizes Panel Assembly Date to Focus on iPLEDGE REMS Program for Isotretinoin Merchandise
On Jan. 14, the Meals and Drug Administration (FDA) introduced that the FDA Drug Security and Threat Administration Advisory and the Ophthalmic Medicine Advisory Committees would meet in March to debate the iPLEDGE Threat Analysis and Mitigation Technique (REMS) Program for isotretinoin merchandise. The iPLEDGE REMS Program was not too long ago modified by the FDA and went into impact final month. Sufferers, suppliers and pharmacies have been experiencing issues and interruptions utilizing the modified program.
For extra info, click on right here.
FDA Updates Two COVID-19 Testing Tips
On Jan. 13, the Meals and Drug Administration (FDA) up to date the COVID-19 Coverage for Coronavirus Illness-2019 Exams (Revised): Steerage for Builders and Meals and Drug Administration Employees and the Coverage for Evaluating Influence of Viral Mutations on COVID-19 Exams: Steerage for Take a look at Builders and Meals and Drug Administration Employees testing tips. The updates define details about new COVID-19 variants and element particular actions the FDA has taken in response to them. The FDA additionally clarified that the testing tips will stay in impact so long as Part 564 of the Federal Meals, Drug, and Beauty Act recommends the emergency use of in vitro diagnostic exams for the detection of COVID-19.
FDA Indicators U.S.-Switzerland Mutual Pharmaceutical Manufacturing Recognition Settlement
On Jan. 12, the Meals and Drug Administration (FDA) signed off on the Settlement on Mutual Recognition of Pharmaceutical Good Manufacturing Follow agreed upon by america and Switzerland. The mutual recognition will simplify the great manufacturing follow inspection course of between the FDA and the Swiss Company for Therapeutic Merchandise (Swissmedic). The FDA and Swissmedic should each be certain that their respective good manufacturing practices meet U.S and Swiss necessities, earlier than the mutual recognition settlement is allowed to enter impact.
For extra info, click on right here.
CMS Publicizes New Steps to Strengthen Nursing House Security and Transparency
On Jan. 18, the Facilities for Medicare and Medicaid Providers (CMS) introduced that it will take new motion to strengthen nursing house security and transparency. CMS plans to start focused, off-site audits to judge whether or not nursing houses are correctly diagnosing residents with schizophrenia. CMS is anxious about nursing houses incorrectly diagnosing residents and prescribing them antipsychotics, which might have harmful unwanted side effects. CMS additionally plans to start publicly displaying survey citations that nursing house services are disputing, to extend transparency of services and assist inform customers who’re on the lookout for a nursing house.
HHS Releases 2023 Discover Relating to Annual Replace of HHS Poverty Tips
On Jan. 12, the Division of Well being and Human Providers (HHS) launched a discover concerning the replace of HHS poverty tips used to find out eligibility standards for Medicaid and different federal applications. HHS is required to replace the poverty tips yearly, to account for value adjustments pushed by inflation. The replace in poverty tips matches the annual enhance in costs as measured by the Shopper Value Index (CPI). The rules on this discover replicate the 8.0 % enhance in costs that occurred between 2021 and 2022.
For extra info, click on right here.
Proposed Guidelines
HHS Proposes Rule to Make clear Beneficiary Spiritual Protections
On Jan. 13, 9 federal businesses, together with the Division of Well being and Human Providers (HHS), launched a proposed rule that seeks to make clear and restore spiritual liberty protections for people who obtain federally funded social companies. The proposed rule would require federal grantees who administer social service applications to inform people that they might not be discriminated in opposition to based mostly on their faith. The rule would additionally advise federal businesses on how they’ll help people with discovering suppliers which are extra reflective of their beliefs.
Along with HHS, the Departments of Agriculture, Schooling, Homeland Safety, Housing and City Improvement, Justice, Labor and Veterans Affairs and the U.S. Company for Worldwide Improvement are proposing the rule.
Public feedback will probably be accepted till March 14, 2023. For extra info, click on right here.
HHS Workplace for Civil Rights Releases Proposed Rule Looking for to Make clear Healthcare Supplier Conscience Safety Rights
On Jan. 5, the Division of Well being and Human Providers (HHS) Workplace for Civil Rights (OCR) launched a proposed rule that seeks to partially rescind a 2019 last rule titled “Defending Statutory Conscience Rights in Well being Care; Delegations of Authority.” The proposed rule would maintain a framework in place created by a 2011 last rule titled “Regulation for the Enforcement of Federal Well being Care Supplier Conscience Safety Legal guidelines.” Sure provisions of the 2019 last rule associated to federal conscience protections could be retained, however these which are redundant and complicated could be eradicated.
Public feedback will probably be accepted till March 6, 2023. For extra info, click on right here.
SAMHSA Looking for Public Feedback Relating to Opioid Use Dysfunction Remedy Remedy Requirement Reforms
On Dec. 16, the Substance Abuse and Psychological Well being Providers Administration (SAMHSA) issued a discover of proposed rulemaking, requesting public feedback on its proposal to change rules for opioid use dysfunction remedy medicines. The proposed rule seeks to make remedy in Opioid Remedy Applications (OTP) extra accessible to sufferers, and simpler to ship to suppliers. The proposed rule additionally seeks to extend the uptake of evidence-based remedies for substance use issues and is in keeping with the Division of Well being and Human Providers’ (HHS) Overdose Prevention Technique.
Public feedback will probably be accepted till Feb. 14, 2023. For extra info, click on right here.
SAMHSA Introduces Proposed Rule to Higher Align SUD Affected person Privateness with HIPAA
On Nov. 28, the Substance Abuse and Psychological Well being Providers Administration (SAMHSA) launched a proposed rule that might align sure insurance policies within the Confidentiality of Substance Use Dysfunction Affected person Data with the Well being Insurance coverage Portability and Accountability Act (HIPAA), per Congress’ instruction within the CARES Act.
The proposed rule would enable suppliers to reveal Half 2 data after sufferers give consent as soon as, and that consent would apply to all future makes use of. They might additionally be capable to redisclose these data as permitted by the HIPAA privateness rule. Moreover, the rule would give sufferers the flexibility to acquire a listing of disclosure conditions and the suitable to request restrictions on sure disclosures. It might additionally give the Division of Well being and Human Providers (HHS) new enforcement powers, like civil cash penalties for people who violate Half 2 protections.
Public feedback will probably be accepted till Jan. 31, 2023. For extra info, click on right here.
CMS Releases Proposed Profit and Fee Parameters for 2024
On Dec. 21, the Facilities for Medicare and Medicaid Providers (CMS) launched a proposed rule that outlines proposed funds and provisions for danger adjustment and danger adjustment information validation applications, operated by the Division of Well being and Human Providers (HHS). The proposed rule additionally outlines proposed 2024 consumer payment charges for issuers providing certified well being plans (QHPs) by means of federally-facilitated exchanges (FFEs), and state-based exchanges on the federal platform (SBE-FPs).
The proposed rule would additionally introduce necessities associated to:
- Updating standardized plan choices
- Lowering plan alternative overload
- Re-enrollment hierarchy
- Plan and plan variation advertising and marketing identify necessities for QHPs
- Important group supplier (ECP) and community adequacy
- Failure to file and reconcile
- Particular enrollment durations (SEPs)
- Annual family earnings verification
- Deadline for QHP issuers to report enrollment and fee inaccuracies
- State Alternate improper fee measurement program
- Necessities for brokers, brokers and web-brokers aiding FFE and SBE-FP customers
Public feedback will probably be accepted till Jan. 30, 2023. For extra info, click on right here.
CMS Releases Proposed Adjustments to Contract Yr 2024 Medicare Program Plans
On Dec. 27, the Facilities for Medicare and Medicaid Providers (CMS) launched a proposed rule that might revise rules for Medicare Benefit, Prescription Drug Profit, Value Plan and Applications of All-Inclusive Take care of the Aged (PACE) plans. The proposed rule would implement adjustments associated to:
- Star Rankings
- Remedy remedy administration
- Advertising and communications
- Well being fairness
- Supplier directories
- Protection standards
- Prior authorization
- Passive enrollment
- Community adequacy
- Identification of overpayments
- Formulary adjustments
Public feedback will probably be accepted till Feb. 13, 2023. For extra info, click on right here.
CMS Proposes MA Plan Advertising, Half D Low-income Entry, Prior Authorization and Behavioral Well being Reforms
On Dec. 14, the Facilities for Medicare and Medicaid Providers (CMS) launched a proposed rule that seeks to overtake advertising and marketing practices for Medicare Benefit (MA) plans. The proposed rule comes after CMS instructed MA plan issuers that it was involved with the style through which MA plans had been marketed, significantly on tv and by third-party advertising and marketing group advertisements.
Among the proposed rule adjustments embrace:
- Prohibiting tv commercials that don’t specify a plan identify.
- Prohibiting commercials that use phrases and imagery that will mislead or confuse MA plan beneficiaries.
- Prohibiting the usage of Medicare language or logos in commercials.
- Prohibiting MA plan entrepreneurs from utilizing the phrases “finest” and “most” to explain their plans, until they’ve documentation to help such statements.
- Banning gross sales shows that instantly observe an academic occasion.
- Banning agent distribution and assortment of Scope of Appointment and Enterprise Reply Playing cards at instructional occasions.
- Banning brokers from conducting gross sales or enrollment conferences with beneficiaries inside 48 hours after acquiring their consent.
Moreover, the proposed rule seeks to develop entry to low-income Half D subsidies and biosimilars. CMS wish to grant Half D low-income subsidies to people who at the moment qualify for partial low-income subsidies. The company needs to make sure that people who qualify for full low-income subsidies should not have to face deductibles, premiums or mounted copay necessities for sure medicine. CMS can be proposing that Half D plan sponsors be capable to substitute model medicine with lower-cost choices.
The proposed rule additionally comprises language concerning the prior authorization course of and behavioral well being reforms. CMS is incorporating a number of suggestions from a report on prior authorization request denials, issued by the Workplace of the Inspector Basic (OIG). The proposed rule additionally consists of provisions that search to grant MA enrollees entry to behavioral well being service suppliers. The proposed rule would require MA organizations to incorporate behavioral well being companies in care coordination applications.
Public feedback will probably be accepted till Feb. 13, 2023. For extra info, click on right here.
CMS Proposes Healthcare Plan Alternate Rule for 2024
On Dec. 12, the Facilities for Medicare and Medicaid Providers (CMS) launched the 2024 proposed rule for plans within the alternate. The proposed rule consists of key adjustments to community adequacy requirements and can barely decrease consumer charges for 2024. As well as, the rule:
- Proposes to restrict to 2 the nonstandardized plan choices for every product community sort and steel tier degree, with an exception for catastrophic plans. This requirement solely applies to HealthCare.gov, which residents in 38 states use to purchase ACA plans. It doesn’t apply to state-run marketplaces.
- Seeks so as to add to the standardized plan possibility necessities together with a proposal to not embrace a regular possibility for the nonexpanded bronze plan tier.
Public feedback will probably be accepted till March 13, 2023. For extra info, click on right here.
CMS Requests Info on Important Well being Advantages Proposed Rule
On Dec. 2, the Facilities for Medicare and Medicaid Providers (CMS) issued a request for info on a proposed rule that pertains to the important well being advantages (EHBs) included within the Affected person Safety and Inexpensive Care Act (ACA). CMS is requesting feedback to realize a greater understanding of the protection of EHBs in well being plans, and to judge whether or not EHBs must be modified or up to date to account for adjustments in medical proof and scientific developments.
Public feedback will probably be accepted till Jan. 31, 2023. For extra info, click on right here.
HHS Proposes Adopting Healthcare Attachments Requirements
On Dec. 15, the Workplace of the Secretary of the Division of Well being and Human Providers (HHS) launched a proposed rule that might implement requirements for “well being care attachments” transactions, to help healthcare claims and prior authorization transactions. The proposed guidelines would additionally implement a regular for digital signatures and modify the usual for referral certification and authorization transactions.
Public feedback will probably be accepted till March 21, 2023. For extra info, click on right here.
FDA Proposed Rule Would Substitute Investigational New Drug Annual Report
On Dec. 9, the Meals and Drug Administration (FDA) launched a proposed rule that might change the investigational new drug (IND) annual reporting requirement. The proposed rule would substitute the IND annual report with a brand new report titled the Meals and Drug Administration Improvement Security Replace Report (FDA DSUR). The FDA intends to make the brand new report in step with the format and content material of the event security replace report that’s supported by the Worldwide Council for Harmonization of Technical Necessities for Prescribed drugs for Human Use (ICH).
Public feedback will probably be accepted till March 9, 2023. For extra info, click on right here.
FDA Proposes Exempting Sure Standard Meals, Dietary Dietary supplements and Cosmetics From Investigational New Drug Necessities
On Dec. 9, the Meals and Drug Administration (FDA) launched a proposed rule that seeks to exempt sure medical investigations of lawfully marketed standard meals, dietary dietary supplements and cosmetics from the investigational new drug utility (IND) requirement, when the medical investigations are carried out for the needs of finding out the merchandise’ potential use as a drug. Though these merchandise could be exempt from IND necessities, they might nonetheless be topic to different investigations to make sure the rights and security of people. The FDA believes the proposed rule will cut back regulatory burden on the company.
Public feedback will probably be accepted till March 9, 2023. For extra info, click on right here.
HRSA Proposed Rule Adjustments Regarding 340B Disputes
On Nov. 29, the Well being Sources and Providers Administration (HRSA) launched a proposed rule that outlines adjustments to how the executive dispute decision (ADR) course of must be dealt with, for diversions, duplicate reductions and overcharges underneath the 340B program. HRSA goals to make the method much less formal and extra expeditious. The proposed adjustments embrace:
- Establishing a extra accessible and well timed ADR course of, whereas structuring the method to be much less formal and inflexible.
- Eliminating the $25,000 minimal dispute threshold for drug makers and 340B suppliers to make use of the method.
- Restructuring the ADR panel to be composed of subject-matter specialists from HRSA’s Workplace of Pharmacy Affairs.
- Requiring that lined entities and drug corporations try to resolve disputes in good religion on their very own earlier than the ADR course of is initiated.
- Permitting for a reconsideration course of when both lined entities or drug corporations are dissatisfied with the ADR panel’s choice.
Public feedback will probably be accepted till Jan. 30, 2023. For extra info, click on right here.
Closing Guidelines
CMS Closing Rule Provides Objects to DMEPOS Order Listing and Updates Healthcare Widespread Process Coding System (HCPCS)
On Jan. 17, the Facilities for Medicare and Medicaid Providers (CMS) launched a last rule that can replace the Healthcare Widespread Process Coding System (HCPCS) codes for required Face-to-Face Encounter and Written Order Previous to Supply (F2F/WOPD) necessities relevant to Sturdy Medical Gear, Prosthetics, Orthotics and Provides (DMEPOS) orders. The replace follows CMS’ choice so as to add new non-statutorily required DMEPOS objects to the F2F/WOPD record. CMS believes the addition of this stuff will defend Medicare enrollees and additional cut back Medicare fraud, waste and abuse.
The rule is ready to enter impact on April 17, 2023. For extra info, click on right here.
FDA Delays Tobacco Product Required Warning Closing Rule Efficient Date
On Nov. 25, the Meals and Drug Administration (FDA), in compliance with an order issued by the U.S. District Court docket for the Japanese District of Texas, delayed the efficient date of a last rule revealed on March 18, 2020, titled “Tobacco Merchandise; Required Warnings for Cigarette Packages and Commercials.” The rule, which was initially supposed to enter impact on June 18, 2021, establishes new cigarette well being warnings for cigarette packages and commercials.
The rule is now set to enter impact on Nov. 6, 2023. For extra info, click on right here.
CMS Points Correction on Scientific Laboratory Enchancment Amendments (CLIA) Closing Rule
On Nov. 17, the Facilities for Medicare and Medicaid Providers (CMS) corrected a technical error that was present in a last rule revealed within the Federal Register on July 11, 2022. The ultimate rule updates proficiency testing (PT) rules underneath the Scientific Laboratory Enchancment Amendments of 1988 (CLIA), to handle analytes and newer applied sciences.
The rule goes into impact July 11, 2024. For extra info, click on right here.
Reviews
HHS OIG Reveals Excessive Charge of COVID-19 Infections in Nursing Properties
On Jan. 20, the Division of Well being and Human Providers (HHS) Workplace of the Inspector Basic (OIG) launched an in depth report analyzing the excessive charge of COVID-19 infections in nursing houses in the course of the spring and fall of 2020. HHS discovered that greater than 1,300 nursing houses had COVID-19 an infection charges of 75 % or extra in the course of the spring and fall 2020 surges. Nursing houses that skilled extraordinarily excessive an infection charges additionally suffered excessive common mortality charges of roughly 20 %. HHS carried out this examine to find out whether or not these nursing houses complied with minimal Medicare nursing hour necessities, and whether or not they had been cited with any an infection management violations.
For extra info, click on right here.
GAO Releases Report on HHS Oversight Over Enhanced Potential Pandemic Pathogens Analysis
On Jan. 18, the Authorities Accountability Workplace (GAO) launched a report that analyzed the Division of Well being and Human Providers’ (HHS) oversight over analysis involving enhanced potential pandemic pathogens. GAO reviewed HHS oversight insurance policies and applications and analyzed HHS’ documentation of potential pandemic pathogens analysis grants. GAO discovered that HHS lacks a sturdy and efficient oversight mechanism for this sort of analysis, as a result of the HHS Framework, which asks federal businesses to refer “moderately anticipated” proposed analysis that will or will contain the usage of potential pandemic pathogens, lacks a transparent commonplace to find out what classifies as “moderately anticipated” analysis. GAO is recommending that HHS undertake a regular for “moderately anticipated” and assess the chance of statutory limitations.
For extra info, click on right here.
CMS Releases Preliminary Report on Federal Unbiased Dispute Decision (IDR) Course of
On Jan. 18, the Facilities for Medicare and Medicaid Providers (CMS) launched an preliminary report that analyzed how nicely the Unbiased Dispute Decision (IDR) Course of functioned between April 15 and Sept. 30, 2022. The federal IDR portal, which is utilized by healthcare suppliers and issuers to resolve fee disputes that fall underneath shock billing protections outlined within the No Surprises Act (NSA), first got here on-line on April 15, 2020. Since then, extra disputes have been submitted than initially anticipated. 90,078 disputes had been initiated by events throughout the timeframe specified above. These disputes had been primarily for out-of-network (OON) emergency and non-emergency objects and companies and air ambulance companies.
For extra info, click on right here.
CBO Releases Value Estimate Exhibiting Anticipated 2023 Consolidated Appropriations Act Budgetary Results
On Jan. 12, the Congressional Price range Workplace (CBO) launched a value estimate exhibiting the estimated budgetary results 2023 Consolidated Appropriations Act Divisions O by means of MM may have on well being applications and different federal coverage priorities. CBO estimates that the divisions will cut back the federal funds by $3.9 billion between 2023 and 2032.
For extra info, click on right here.
