New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog has been updated to report on recent health policy developments, including the following:

  • Regulatory Developments. CMS has issued major final rules to update Medicare payment and other policies under the physician fee schedule (including proposed changes to Physician Payment Sunshine Act regulations), hospital outpatient prospective payment system, the ASC payment system, the home health PPS, and the ESRD PPS (including provisions impacting DMEPOS reimbursement and coverage). CMS also has announced a Medicare prior authorization program for certain ambulance transports. HRSA has withdrawn a pending 340B rule, NIH has released a proposed rule on clinical trial registration and results submission requirements, and HHS is soliciting suggestions for reducing the Medicare appeals backlog.
  • Other HHS Developments. CMS has released 2015 HCPCS files, announced 2015 outpatient therapy caps, expanded certain nursing home surveys, and announced a delay in enforcement of HIPAA health plan enumeration/Health Plan Identifier regulations. FDA has revised guidance on drug inspections, and the HHS Office for Civil Rights has issued a bulletin on privacy obligations under HIPAA in emergency situations.
  • OIG Developments. The HHS OIG has released its FY 2015 Work Plan and a compilation of top HHS management and performance challenges.
  • Health Industry Events. CMS is hosting calls on Medicare physician quality reporting programs, the improving dementia care in nursing homes, and certifying patients for Medicare home health benefits. CMS is holding meetings on inpatient hospital new technology add-on payment applications and hospital outpatient payments.
  • @ReedSmithHealth is on Twitter. For the latest health policy news, follow us at @ReedSmithHealth.

CMS Town Hall Meeting on FY 2016 New Technology Add-on Payments (Feb. 3)

On November 21, 2014, CMS is publishing a notice announcing that it will be holding a town hall meeting on February 3, 2015 to discuss fiscal year (FY) 2016 applications for add-on payments for new medical services and technologies under the Medicare hospital inpatient prospective payment system. Interested parties will have an opportunity to present comments and data regarding whether the FY 2016 new medical services and technologies applications meet the substantial clinical improvement criterion.

CMS Publishes Final 2015 Medicare Physician Fee Schedule Rule for 2015

On November 12, 2014, CMS published its final rule to update the Medicare physician fee schedule (MPFS) for CY 2015. Highlights of the sweeping rule include the following:

  • The Protecting Access to Medicare Act (PAMA) of 2014 provides for a 0% update to the conversion factor (CF) for MPFS services furnished between January 1, 2015 and March 31, 2015, with the CF adjusted afterwards according to the statutory Sustainable Growth Rate (SGR) formula. In the final rule, CMS determined that based on the zero percent update under PAMA and adjustments necessary to maintain budget neutrality, the CF for the first quarter of 2015 will be $35.8013 (compared to $35.8228 in 2014). CMS also announced that the CF for April 1, 2015 through December 31, 2015 will be $28.2239 – a 21.2% reduction -- unless Congress establishes an alternative CF or otherwise modifies the SGR formula. While there is an expectation that Congress eventually will override this payment cut, the form any such action might take is speculative at this point.
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CMS Finalizes CY 2015 Medicare OPPS/ASC Rates & Policies

On November 10, 2014, CMS published its final rule to update the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgical Center (ASC) Payment System rates and policies for calendar year (CY) 2015. The following are highlights of this major rulemaking:

  • The final OPPS fee schedule increase factor is 2.2%. This update reflects a hospital market basket increase of 2.9%, which is offset by two Affordable Care Act (ACA) provisions: a 0.2% reduction and a -0.5% “multi-factor productivity” (MFP) adjustment. The update for individual procedures can vary, and hospitals that do not meet Hospital Outpatient Quality Reporting (OQR) Program requirements are subject to a 2.0% reduction. CMS projects a 2.3% increase in total OPPS payments (about $900 million) for 2015, considering all policies in the rule.
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OIG Identifies Top HHS Management & Performance Challenges

The OIG has released its compilation of “2014 Top Management & Performance Challenges,” highlighting the following 10 most significant management and performance challenges now facing HHS:

  1. Implementing, Operating, and Overseeing the Health Insurance Marketplaces 
  2. Ensuring Appropriate Use of Prescription Drugs in Medicare and Medicaid 
  3. Protecting an Expanding Medicaid Program from Fraud, Waste, and Abuse 
  4. Fighting Waste and Fraud and Promoting Value in Medicare Parts A and B 
  5. Ensuring Quality in Nursing Home, Hospice, and Home- and Community-Based Care 
  6. The Meaningful and Secure Exchange and Use of Electronic Health Information 
  7. Effectively Operating Public Health and Human Services Programs to Best Serve Program Beneficiaries 
  8. Ensuring Effective Financial and Administrative Management 
  9. Protecting HHS Grants and Contract Funds from Fraud, Waste, and Abuse 
  10. Ensuring the Safety of Food, Drugs, and Medical Devices

CMS Adopts Major Changes to Medicare DMEPOS Payment/Coverage Policy Inside/Outside of Competitive Bidding Areas

This post was written by Elizabeth Carder-Thompson, Carol C. Loepere, and Debra A. McCurdy.

On November 6, 2014, CMS published a final rule that makes significant and highly technical changes to Medicare payment policies for durable medical equipment (DME), prosthetics, orthotics, and supplies (DMEPOS).  Notably, the rule finalizes a new methodology for adjusting Medicare DMEPOS fee schedule payment amounts across the country using information from the Medicare DMEPOS Competitive Bidding Program (CBP). CMS estimates that this methodology will cut Medicare DMEPOS reimbursement by more than $4.4 billion over fiscal years 2016 through 2020. The rule also finalizes a mechanism to test the use of bundled monthly payment amounts for certain DME under competitive bidding; modifies CBP change of ownership (CHOW) and termination of contract rules; and codifies Medicare hearing aid coverage policy. Note that CMS did not adopt its proposal to clarify practitioner qualifications for providing custom fitting services for orthotics. The following is a summary of the final rule, with particular emphasis on revisions to CMS’s July 11, 2014 proposed rule.

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CMS Finalizes 0.3% Cut in Medicare Home Health PPS Rates for CY 2015

On November 6, 2014, CMS published a final rule to update the Medicare home health prospective payment system (HH PPS) for CY 2015. CMS estimates that the final rule will cut Medicare payments to home health agencies (HHAs) by 0.30%, or $60 million, in 2015. Specifically, while the rule provides a 2.1% home health payment update percentage ($390 million increase), that update is more than offset by a reduction of 2.4% ($450 million) attributable to a rebasing adjustment (the second year of a four-year phase-in). Under the final rule, the national standardized 60-day episode payment for CY 2015 is $2,961.38.

The final rule also adopts a number of policy proposals. Notably, CMS is simplifying the home health face-to-face encounter documentation requirements, including eliminating the narrative as part of the certification of eligibility and providing more flexibility in procedures for obtaining documentation supporting patient eligibility. The final rule specifies that associated physician claims for certification/re-certification of eligibility will not be covered when a patient does not meet home health eligibility criteria. CMS also discusses comments it received on a potential HHA Value-Based Purchasing (VBP) model, under which CMS would test whether payment incentives would lead to higher quality of care for beneficiaries. CMS is considering testing such a model beginning in 2016; additional details will be provided in future rulemaking. The final rule also, among other things: recalibrates HH PPS case-mix weights; simplifies therapy reassessment timeframes; establishes a minimum OASIS assessment submission threshold; revises the speech-language pathology personnel conditions of participation; and places limitations on the reviewability of civil monetary penalties imposed for HHA noncompliance with federal participation requirements.

CMS Publishes Final 2015 ESRD PPS Rule

CMS published its final rule to update the Medicare end-stage renal disease (ESRD) PPS for CY 2015 on November 6, 2014. For CY 2015, the final ESRD PPS base rate is $239.43, which reflects a 0.0 percent update mandated by section 217(b)(2) of PAMA, and the application of a wage index budget-neutrality adjustment factor to the CY 2014 ESRD PPS base rate of $239.02. Nevertheless, CMS estimates that the rule will increase payments to ESRD facilities by approximately $30 million in 2015 due to updates to the outlier threshold amounts. The final rule also, among other things: rebases the ESRD bundled market basket using 2012 data; revises the market basket measures; updates the labor-related share value with a two-year transition; clarifies the eligibility criteria for the low volume payment adjustment; and implements a PAMA provision providing that payment for ESRD-related oral-only drugs will not be made under the ESRD PPS prior to January 1, 2024. CMS also adopted updates to the ESRD Quality Incentive Program (QIP) for payment years 2017 and 2018, including changes to the measure sets and establishment of a new scoring methodology beginning in 2018. Finally, the rule makes significant changes to Medicare reimbursement policy for DME, prosthetics, orthotics, and supplies (DMEPOS), as discussed in a separate post.

CMS to Expand Nursing Home MDS Focused Surveys

In mid-2014, state survey agencies and CMS piloted a short-term focused survey in five states to assess nursing home Minimum Data Set, Version 3.0 (MDS 3.0) coding practices and its relationship to resident care. According to a CMS memo to state survey agencies, these surveys enhanced surveyors’ ability to identify errors and deficiencies, such as inaccuracies related to staging and documentation of pressure ulcers, the classification of antipsychotic drugs, and coding regarding the use of restraints. CMS therefore announced that it plans to expand these surveys nationwide in 2015. The scope of some or all of the focused surveys also will be expanded to include an assessment of the staffing levels of nursing facilities. Specifically, the assessment is intended to verify the staffing data self-reported by the nursing home and identify changes in staffing levels throughout the year.

CMS Adopts Changes to Open Payments/Physician Payment Sunshine Act Regulations

This post was written by Elizabeth Carder-Thompson, Katie C. Pawlitz, Nancy E. Bonifant and Debra A. McCurdy.

As part of the final 2015 Medicare physician fee schedule rule, CMS is adopting – with certain refinements – its proposed changes to the regulations implementing the Physician Payment Sunshine Act. By way of background, the Sunshine Act requires pharmaceutical and medical device manufacturers and group purchasing organizations to submit to CMS certain information on payments and transfers of value to physicians and teaching hospitals, as well as physician ownership information. This data is being made publicly available on the CMS “Open Payments” website, http://go.cms.gov/openpayments.

Specifically, In the final rule, published on November 13, 2014, CMS adopted the following provisions pertaining to the Sunshine Act regulations:

  • CMS deleted the reporting exclusion for payments made to speakers at accredited continuing medical education events. Importantly, CMS points out that such payments may still be excluded from reporting, since “payments or other transfers of value, including payments made to physician covered recipients for purposes of attending or speaking at continuing education events, which do not meet the definition of an indirect payment, as defined at §403.902, are not reportable.” Under §403.902, indirect payments refer to payments or other transfers of value made by an applicable manufacturer to a covered recipient through a third party, where the applicable manufacturer requires, instructs, directs, or otherwise causes the third party to provide the payment or transfer of value, in whole or in part, to a covered recipient(s).
  • The Final Rule requires the reporting of the marketed name and therapeutic area or product category of the related covered drug, device, biological, or medical supply, unless the payment or other transfer of value is not related to a particular covered or non-covered drug, device, biological or medical supply. Previously, for devices or medical supplies manufacturers had the option of reporting the therapeutic area or product category instead of the marketed name. In the Final Rule, CMS also removed language allowing manufacturers the option to report “up to five” related covered products. It is not clear from the Final Rule whether such an option will still be available in practice, or if manufacturers will only be able to report a single, related covered product. Reporting marketed names for non-covered drugs, devices, biologicals, or medical supplies will continue to be optional. CMS also acknowledges that a payment or other transfer of value associated with a research payment regarding a device or medical supply may not have a marketed name. Therefore, CMS is specifying that manufacturers will continue to have an option to report either a device or medical supply marketed name, therapeutic area or product category when reporting research payments.
  • CMS is requiring applicable manufacturers to report stocks, stock options, or any other ownership interest as distinct categories.
  • CMS is deleting the definition of “covered device” as duplicative of the definition of “covered drug, device, biological or medical supply.”

CMS is implementing data collection requirements for these provisions beginning January 1, 2016, for reporting to CMS in 2017.

CMS Updates Outpatient Therapy Caps for 2015

CMS has announced that the CY 2015 Medicare outpatient therapy limit is $1,940 for physical therapy and speech-language pathology combined and $1,940 for occupational therapy. The therapy cap exceptions process was extended through March 31, 2015 by the Protecting Access to Medicare Act of 2014.

CMS Announces 3-State Medicare Prior Authorization Model for Repetitive Nonemergent Ambulance Transport

In light of government reports finding high utilization and potential improper Medicare payments associated with repetitive scheduled nonemergent ambulance transports, CMS will test a prior authorization model program for these services in New Jersey, Pennsylvania, and South Carolina. CMS defines repetitive ambulance service as medically necessary ambulance transportation that is furnished in 3 round trips or more times during a 10-day period, or at least once per week for at least 3 weeks. CMS notes that such repetitive ambulance services are often needed by beneficiaries receiving dialysis, wound care, or cancer treatment. The use of prior authorization will not create new clinical documentation requirements for suppliers; instead information that is already required to support Medicare payment will be furnished earlier in the process, prior to rendering services. The prior authorization program is scheduled to begin December 1, 2014 and last three years.

OCR Releases Ebola Bulletin

The recent Ebola outbreak has prompted the HHS Office for Civil Rights (OCR) to release a new bulletin for covered entities and business associates regarding their privacy obligations under HIPAA in emergency situations. The bulletin, “HIPAA Privacy In Emergency Situations,” provides an overview of the limited ways in which covered entities and business associates may use and disclose protected health information in emergencies, such as the Ebola outbreak.

NIH Releases Proposed Rule on FDAAA Requirements for ClinicalTrials.Gov Registration and Results Submission

NIH has just released a proposed rule that would clarify and expand requirements for the submission of clinical trial registration and results information, including adverse event information, to the ClinicalTrials.gov database in conformance with the Food and Drug Administration Amendments Act of 2007 (FDAAA). The rule would implement the statutory requirement for the submission of summary results information for trials involving drugs, biological products, and devices that are approved, licensed, or cleared by FDA, and it proposes to extend such requirements to clinical trials of drugs, biological products, and devices that are not approved, licensed, or cleared by FDA. Among other things, the proposed rule would require the responsible party (i.e., the trial sponsor or principal investigator) to register an applicable clinical trial no later than 21 days after enrolling the first participant, and results generally would be required to be submitted no later than 1 year after the completion date of the clinical trial (the date of final data collection for the primary outcome measure studied). Results submission could be delayed for up to two additional years with certification that either an unapproved, unlicensed, or uncleared product studied in the trial is still under development by the manufacturer or that approval will be sought for a new use of an approved, licensed, or cleared product that is being studied in the trial. Extension requests also could be submitted for “good cause.” With regard to adverse events reporting, the proposed rule would require the responsible party to submit information summarizing the number and frequency of adverse events experienced by participants enrolled in a clinical trial, by arm and organ system, and it specifies the form of that reporting. The proposed rule would require submitted information to be updated at least annually if there are changes to report, with provisions for more rapid updating in certain circumstances. The proposed rule does not impose requirements on the design or conduct of clinical trials or on the data that must be collected during clinical trials. The proposed rule is scheduled to be published on November 21, 2014, and comments will be accepted for 90 days after publication.

CMS Call on Changes to Physician Quality Reporting Programs for 2015 (Dec. 2)

On December 2, 2014, CMS is hosting a provider call to discuss changes to the Medicare physician quality reporting programs in the 2015 Medicare Physician Fee Schedule final rule. Among other things, the call will cover changes impacting the Physician Quality Reporting System (PQRS), Value-based Payment Modifier, Physician Compare, Electronic Health Record (EHR) Incentive Program, Comprehensive Primary Care Initiative (CPC), and Medicare Shared Savings Program.

CMS Call: Certifying Patients for the Medicare Home Health Benefit (Dec. 16)

CMS is hosting a call on December 16, 2014 to discuss a provision of the CY 2015 Home Health Prospective Payment System final rule that established a new patient certification requirement for home health agencies beginning January 1, 2015.  Registration information is available here.  

CMS Delaying Enforcement of HIPAA Health Plan Enumeration/Health Plan Identifier Regulations

CMS has announced that it is delaying until further notice enforcement of its regulations pertaining to health plan enumeration and use of the Health Plan Identifier (HPID) in HIPAA transactions, which were adopted in a September 5, 2012 final rule. This enforcement delay, which is effective October 31, 2014, applies to all HIPAA covered entities, including healthcare providers, health plans, and healthcare clearinghouses. This enforcement discretion period will allow HHS to consider recent recommendations by the National Committee on Vital and Health Statistics (NCVHS) that covered entities not use the HPID in the HIPAA transactions.

HRSA Withdraws Pending 340B Rule, Plans New 2015 Rulemaking

The Health Resources and Services Administration (HRSA) has officially withdrawn from Office of Management and Budget review a long-awaited proposed rule to establish comprehensive requirements for entities and manufacturers participating in the 340B Drug Pricing Program. HRSA notes in a web posting that it intends to issue proposed guidance for notice and comment in 2015 addressing “key policy issues raised by various stakeholders committed to the integrity of the 340B program.”  The agency also plans to release proposed rules on manufacturer civil monetary penalties, calculation of the 340B ceiling price, and administrative dispute resolution.

CMS Call: National Partnership to Improve Dementia Care in Nursing Homes (Dec. 9).

On December 9, 2014, CMS is hosting a call to provide an update on the CMS National Partnership to Improve Dementia Care in Nursing Homes. The partnership focuses on continuing to reduce the use of unnecessary antipsychotic medications and other potentially-harmful medications in nursing homes and eventually other care settings.

CMS Releases 2015 HCPCS Files

CMS has posted the 2015 update to the alphanumeric HCPCS files.  The files include the Level II alphanumeric HCPCS procedure and modifier codes, their long and short descriptions, and information on Medicare coverage and pricing.

FDA Revises Guidance Defining Delays, Denials, Limits and Refusals of a Drug Inspection

This post was written by Vicki Morris.

The Food and Drug Administration (FDA) recently issued a notice announcing the Agency’s revised guidance for industry defining the types of action, inaction, and circumstances that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of making a drug adulterated. The revised guidance, entitled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection,” follows the enactment of the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA), which added a provision (and teeth) to the Food, Drug, and Cosmetic Act (the FD&C Act) concerning inspections that render a drug “adulterated” – a new term used by the FDA in this context. Specifically, a drug adulterated under FDASIA “has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.” FDA issued the revised guidance in response to comments on the Agency’s draft guidance for industry of the same title issued in July 2013.

The revised guidance clarifies FDA’s expectations regarding the types of action, inaction, and circumstances that make a drug adulterated under FDASIA and the FD&C Act. FDA also provides examples that constitute reasonable explanations for actions, inactions, or circumstances that could otherwise be considered delaying, denying or limiting inspection, or refusing to permit entry or inspection, as discussed below.

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HHS OMHA Soliciting Suggestions for Reducing Medicare Appeals Backlog

The HHS Office of Medicare Hearings and Appeals (OMHA) is seeking public comments on ways to address the substantial growth in the number of hearing requests being filed with OMHA and the backlog of pending cases. In particular, OMHA is seeking suggestions related to current OMHA initiatives or other recommendations for addressing the increased workload and/or backlog of appeals at the Administrative Law Judge (ALJ) level that comply with current statutory authorities and requirements. OMHA also seeks comments on whether there are any current regulations that apply to the ALJ level of the Medicare claim and entitlement appeals process that could be revised to streamline the adjudication process while ensuring that parties to the appeals are afforded opportunities to participate in the process and are kept apprised of their appeals.  Comments will be accepted until December 5, 2014.

HHS OIG Releases FY 2015 Work Plan

The HHS OIG has posted its FY 2015 Work Plan, which summaries the audit, evaluation, and other legal and investigative initiatives that the OIG intends to conduct in the coming year. The OIG plans numerous reviews of CMS, FDA, and other HHS agency programs, with a particular focus on Medicare and Medicaid reimbursement and program integrity policies. The OIG also forecasts areas that may be the subject of review in future years, including emerging Affordable Care Act marketplace issues, Medicaid expansion, and new Medicare payment and delivery models, among others. The OIG also plans to expand its work on Medicare and Medicaid reimbursement (including Medicaid managed care) and quality of care. The OIG notes that other areas under consideration for new reviews include the integrity of the drug and medical device supply chains; the security of electronic data; the use and exchange of health information technology; and emergency preparedness and response efforts.

OIG Extends Comment Deadline on Permissive Exclusion Criteria

The OIG published a notice today announcing that it is extending the public comment period on its July 11, 2014 notice soliciting recommendations for revising OIG's non-binding criteria for implementing its permissive exclusion authority under Section 1128(b)(7) of the Social Security Act.  The OIG notes that due to a technical problem, the public may have been unable to submit comments during the original comment period. The new comment deadline is December 29, 2014.

New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog has been updated to report on recent health policy developments, including the following:

  • Regulatory Developments. The OIG and CMS have extended fraud and abuse waivers in connection with the Medicare Shared Savings Program. CMS also published a rule on the ACA Basic Health Program, and CMS is expected to publish several major final 2015 Medicare payment rules in the coming days. Recent CMS notices have addressed clinical diagnostic lab tests and Medicare deductible and coinsurance amounts for 2015. The HHS Office for Human Research Protections issued guidance on disclosing risks in standards of care research, and the Office of the National Coordinator for Health Information Technology is inviting applications for a “Market R&D Pilot Challenge. Reed Smith has released a client alert on the “OIG Proposed Rule to Amend the Anti-Kickback Safe Harbors, CMP Rules on Beneficiary Inducements & Gainsharing Regulations.”
  • Other HHS Developments. CMS has posted preliminary determinations for new 2015 clinical laboratory fee schedule codes. CMS also has announced new innovation initiatives, including the Transforming Clinical Practice Initiative and the Accountable Care Organization Investment Model. CMS has released Medicare Advantage/Part D drug plan quality data, and it is requesting suggestions for future physician quality measures. CMS also has issued updates regarding the Sunshine Act “Open Payments” system and its Medicare appeals administrative agreement opportunity.  CDC has released several guidance documents on management of Ebola patients. The OIG has issued a report on Medicare beneficiary copayment costs for outpatient services provided at critical access hospitals.
  • Health Industry Events. CMS is hosting calls on inpatient rehabilitation facility quality reporting and transitioning to ICD-10. The HHS Office of Medicare Hearings and Appeals is holding a second Medicare Appellant Forum. Congressional panels are reviewing the government response to the Ebola outbreak.
  • @ReedSmithHealth is on Twitter. For the latest health policy news, follow us at @ReedSmithHealth.

Final CY 2015 Medicare Payment Rules in the Pipeline

CMS is expected to publish several major final Medicare payment rules for 2015 in the coming days. The agency has already submitted to the White House Office of Management and Budget (OMB) for regulatory clearance the final 2015 rules updating Medicare payments for outpatient hospitals, ambulatory surgical centers, home health agencies, and end-stage renal disease facilities, along with reimbursement policy updates impacting suppliers of durable medical equipment, prosthetics, orthotics, and supplies. The final Medicare physician fee schedule rule is not yet at OMB, but it should be following shortly. While the text of the regulations are not yet available, we expect that the rules will be put on display at the Federal Register in the near future. We will be providing summaries of the final rules in future updates.

CMS Seeking Nominations for New Advisory Panel on Clinical Diagnostic Lab Tests

On October 27, 2014, CMS published a notice announcing that it is establishing an Advisory Panel on Clinical Diagnostic Laboratory Tests, as authorized by the Protecting Access to Medicare Act of 2014 (PAMA). The Panel will provide recommendations to CMS on the following issues:

  • Calculation of weighted median for laboratory services using private payor rates.
  • Phase-in of reductions from private payor rate implementation.
  • Application of market rates.
  • Evaluation and designation of tests as advanced diagnostic laboratory tests.
  • Whether to use crosswalking or gapfilling to determine payment for a specific new test.
  • The factors used in determining coverage or payment processes for new clinical diagnostic laboratory tests.

CMS is requesting nominations for individuals to serve on the panel, which will consist of up to 15 individuals with expertise in issues related to clinical diagnostic laboratory tests, which may include representatives of clinical laboratories, molecular pathologists, clinical laboratory researchers, and experts in clinical laboratory science or the economics of clinical laboratory services. The deadline for submitting nominations is on November 26, 2014.

CMS Proposes 2016 Funding Methodology for ACA Basic Health Program

On October 23, 2014, CMS published the proposed methodology for determining federal payment amounts for states that elect to use the Basic Health Program to offer health benefits to low-income individuals otherwise eligible to purchase coverage through an Affordable Insurance Exchange/Marketplace for 2016. CMS proposes to use the same methodology in 2016 as was established in the final 2015 payment notice, with updated values. Comments will be accepted through November 24, 2014.

CMS Announces Medicare Deductible, Coinsurance Amounts for 2015

CMS has released the Medicare Part A inpatient hospital deductible and hospital and extended care services coinsurance amounts for 2015. Specifically, the 2015 Part A deductible for hospital inpatient admissions for the first 60 days of care will be $1,260, followed by $315 per day for days 61-90 and $630 per day for stays beyond the 90th day in a benefit period. The daily skilled nursing facility coinsurance for days 21 through 100 in a benefit period will be $157.50 in 2015. CMS also published the 2015 Medicare Part A premium amounts for the uninsured aged and disabled individuals who have exhausted other entitlement. Finally, CMS has announced that Medicare Part B premiums and deductibles will be unchanged in 2015, for the second consecutive year. Specifically, the 2015 premium varies by income from $104.90 to $335.70 per month, and the Part B deductible is $147.00 for all Part B beneficiaries.

Draft HHS Guidance on Disclosing Risks in Standards of Care Research

On October 24, 2014, the HHS Office for Human Research Protections published a notice announcing that it is seeking comments on draft guidance for the research community entitled “Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care.” The guidance addresses risks to subjects that are presented by research evaluating risks associated with standards of care, and which of these risks are reasonably foreseeable and should be disclosed to prospective research subjects as part of their informed consent. Comments on the guidance will be accepted until December 23, 2014.