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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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 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 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.

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.

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.

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.

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.

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. 

ONC Invites Applications for "Market R&D Pilot Challenge"

The Office of the National Coordinator for Health Information Technology (ONC) is launching the “Market R&D Pilot Challenge,” which will bring together health care organizations and innovative companies to test new health information technology products through pilot funding awards and facilitated matchmaking. Pilot proposals could be awarded in three domains: clinical environments (e.g., hospitals, ambulatory care, surgical centers); public health and community environments (e.g., public health departments, community health workers, mobile medical trucks, school- and jail-based clinics); and consumer health (e.g., self-insured employers, pharmacies, laboratories). Among other things, the program is intended to encourage early collaboration between entrepreneurs, medical and public health personnel, patients, and the research community in efforts to link health IT innovation to care delivery innovation. Up to 6 winning proposals will each receive a $50,000 award.

Reed Smith Client Alert: Analysis of HHS OIG Proposed Rule to Amend the Anti-Kickback Safe Harbors, CMP Rules on Beneficiary Inducements & Gainsharing Regulations

The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has published a major proposed rule that would amend the safe harbors to the Anti-Kickback Statute (AKS) and the Civil Monetary Penalty rules to protect certain payment practices and business arrangements from criminal prosecution or civil sanctions under the AKS. Reed Smith has prepared a Client Alert analyzing the proposed rule, highlighting areas where the OIG is seeking public comment. Overall, the OIG appears to recognize that new health care delivery mechanisms demand a more flexible approach to fraud and abuse enforcement than has been the case in the past, as discussed in our analysis.

The Client Alert is available here.

OIG and CMS Extend Fraud/Abuse Waivers for Medicare Shared Savings Program/ACOs; Invite Feedback on Waiver Policy

Today the OIG and CMS published a joint notice continuing the effectiveness of fraud and abuse law waivers granted in 2011 in connection with the Medicare Shared Savings Program, which is intended to encourage physicians, hospitals, and certain other types of providers and suppliers to form accountable care organizations (ACOs). 

By way of background, in a November 2, 2011 joint OIG-CMS interim final rule with comment period, the agencies established waivers of the application of the federal physician self-referral law, the federal anti-kickback statute, and certain civil monetary penalties law provisions to specified arrangements involving ACOs participating in the Shared Savings Program (the Waiver IFC).  In 2011 Reed Smith prepared an in-depth analysis of the Medicare Shared Savings Program, including an analysis of the Waiver IFC.  Because of a general 3-year deadline for publishing Medicare final rules after the publication of a proposed or interim final rule, the agencies are extending the timeline for publication of a final rule concerning Shared Savings Program waivers to avoid “creating legal uncertainty for ACOs participating in the Shared Savings Program and potentially disrupting ongoing business plans or operations of some ACOs.”  The notice also states that CMS is developing a proposed rule to make certain modifications to the Shared Savings Program regulations; in order to ensure that the final waiver regulations align with the Shared Savings Program rules, the agencies believe “the prudent course of action at this time is to extend the effectiveness of the Waiver IFC.”  Thus the Waiver IFC will remain in effect through November 2, 2015, unless a final waiver rule becomes effective on an earlier date.

 

In the notice, the agencies also suggest that they would benefit from additional stakeholder input to inform their understanding of:

  1. how and to what  extent ACOs are using the waivers;
  2. whether the existing waivers serve the needs of ACOs and the Medicare program;
  3. whether the  waivers adequately protect the Medicare program and beneficiaries from the types of harms associated with referral payments or payments to reduce or limit services; and
  4. whether there are new or changed  considerations that should inform the development of additional notice  and comment rulemaking.

No deadline is specified for providing feedback on these considerations. 

Proposed Revisions to Home Health Conditions of Participation

On October 9, 2014, CMS is publishing a proposed rule that would extensively revise the conditions of participation (CoPs) that home health agencies (HHAs) must meet to participate in the Medicare and Medicaid programs. The rule is intended to provide HHAs with enhanced flexibility while focusing provider efforts on the services delivered to the patient, the quality of care furnished by the HHA, and quality assessment and performance improvement efforts. According to CMS, the proposed CoPs “reflect a fundamental change in our regulatory approach -- a change that to a large extent establishes a shared commitment between CMS and HHA providers to achieve improvements in the quality of care furnished to HHA patients.” CMS expects its patient-centered, outcome-oriented approach to enhance the working relationship between state survey agencies and HHAs, and provide a basis for improved performance that will help ensure that quality care is provided to all patients.

More specifically, CMS proposes to establish the following four CoPs (in addition to retaining current requirements related to comprehensive assessment of patients):

  • “Patient rights” would emphasize the HHA's responsibility to respect and promote the rights of each home health patient.
  • “Care planning, coordination of services, and quality of care” would incorporate the interdisciplinary team approach to provide home health services focusing on the care planning, coordination of services, and quality of care processes.
  • “Quality assessment and performance improvement” (QAPI) would require each HHA to conduct ongoing quality assessment, incorporate data-driven goals, and maintain an evidence-based performance improvement program of its own design to affect continuing improvement in the quality of patient care.
  • “Infection prevention and control” would require HHAs to follow accepted standards of practice to prevent and control the transmission of infectious diseases and to educate staff, patients, and family members or other caregivers on these accepted standards.

CMS proposes to remove many process details from the current CoPs where they do not achieve the goal of ensuring desired outcomes. CMS is not proposing to incorporate by reference any specific clinical practice guidelines or professional standards of practice; HHAs would be responsible for identifying their own performance problems through their QAPI programs, addressing them, and continuously striving to improve the quality of care, patient outcomes and satisfaction, and efficiency/economy. The proposed CoPs also are designed to enable surveyors to look at outcomes of care and “how effectively the provider was pursuing a continuous quality improvement agenda.”  CMS will accept comments for 60 days after publication (December 8, 2014).

Older Entries

October 6, 2014 — CMS Corrects Final FY 2015 Medicare IPPS/LTCH Rule

October 6, 2014 — CMS Releases CY 2015 Amount in Controversy Thresholds for Medicare Appeals

October 6, 2014 — ONC Final Rule on EHR Certification Criteria

October 3, 2014 — DEA Issues Final Rule on Safe, Secure Disposal of Controlled Substances

October 2, 2014 — OIG Releases Proposed Revisions to Anti-Kickback Safe Harbors, CMP Rules on Beneficiary Inducements & Gainsharing

September 24, 2014 — HHS OIG Paints with Broad Brush in Criticizing Drug Manufacturer Coupon Programs

September 8, 2014 — OMB Clears OIG Proposed Rule on Anti-Kickback Safe Harbors, CMPs for Beneficiary Inducements & Gainsharing

September 8, 2014 — CMS Final Rule Revises EHR Meaningful Use Timeline

September 4, 2014 — CMS Finalizes ACA Marketplace Eligibility Redetermination/Renewal Process for 2015

September 4, 2014 — HHS Revises ACA Contraception Coverage Requirements

August 26, 2014 — FDA Seeks Comments to Updated Guidance on Informed Consent in Clinical Trials

August 20, 2014 — CMS Finalizes Medicare Hospice Payment Policies for FY 2015

August 19, 2014 — CMS Issues FY 2015 Medicare SNF PPS Final Rule

August 18, 2014 — CMS Finalizes Medicare IPPS/LTCH PPS Update for FY 2015

August 18, 2014 — CMS Publishes Final FY 2015 Update to Medicare IRF PPS

August 16, 2014 — IRS issues ACA Branded Prescription Drug Fee Regulations

August 12, 2014 — CMS Issues Final Medicare Inpatient Psychiatric Facility PPS Rule for FY 2015

August 12, 2014 — HHS Officially Sets October 1, 2015 Date for ICD-10 Implementation

August 12, 2014 — CMS Again Extends Moratoria on Enrollment of HHAs, Ambulance Suppliers in Designated Areas

July 25, 2014 — CMS Issues Proposed CY 2015 Medicare OPPS/ASC Rule

July 25, 2014 — CMS Publishes Proposed MPFS Rule for 2015

July 25, 2014 — CMS Proposes ESRD PPS Update for CY 2015

July 25, 2014 — Proposed ACA Eligibility Redetermination/Renewal Process for 2015

July 23, 2014 — OIG Seeks Input on Potential Revisions to its Permissive Exclusion Criteria

July 23, 2014 — Proposed ACA Eligibility Redetermination/Renewal Process for 2015

July 7, 2014 — CMS Proposes Major Changes to Medicare DMEPOS Payment/Coverage Policy Inside/Outside of Competitive Bidding Areas

July 3, 2014 — CMS Proposes Changes to Sunshine Act "Open Payments" Regulations in 2015 Medicare Physician Fee Schedule Rule

July 1, 2014 — CMS Proposes 0.3% Cut in Medicare Home Health PPS Rates for CY 2015

June 27, 2014 — CMS Planning Changes to Medicare Shared Savings Program/Accountable Care Organization (ACO) Rules

June 24, 2014 — Medicare Payment Adjustments for Low-Volume Hospitals and Medicare-Dependent Hospitals

June 24, 2014 — HHS Issues Spring 2014 Semiannual Regulatory Agenda

June 24, 2014 — Obama Administration Finalizes Employment Orientation Limit Applicable to ACA Health Coverage Waiting Period

June 2, 2014 — CMS Finalizes Updates to Medicare Advantage/Part D Policies for 2015

June 2, 2014 — CMS Finalizes ACA Exchange, Insurance Market Standards for 2015 and Beyond

May 30, 2014 — CMS Formally Proposes Modified Electronic Health Record (EHR) Meaningful Use Timeline

May 22, 2014 — CMS Proposes Medicare Prior Authorization Process for DMEPOS Subject to "Unnecessary Utilization"

May 20, 2014 — OIG Proposed Rule Would Expand Civil Monetary Penalty Authority

May 16, 2014 — HHS OIG Proposes Expansion of Exclusion Authorities

May 16, 2014 — Another OIG Fraud Rule in the Pipeline: Anti-kickback Safe Harbors, CMPs for Beneficiary Inducements, Gainsharing

May 15, 2014 — CMS Adopts Final Rule to Reduce Provider Regulatory Burdens

May 15, 2014 — CMS Proposes Medicare Hospice Payment Policies for FY 2015

May 15, 2014 — CMS Proposes FY 2015 Update to Inpatient Psychiatric Facility PPS

May 15, 2014 — CMS Adopts PPS for Federally Qualified Health Centers (FQHCs), Amends CLIA Rules

May 15, 2014 — IRS Issues Final Rules on Affordable Insurance Exchange Reporting Requirements

May 14, 2014 — CMS Proposes FY 2015 Update to Medicare IRF PPS

May 14, 2014 — OIG Proposes Rules to Expand Exclusion, CMP Authorities

May 13, 2014 — CMS Invites Comments on Sunshine Act "Open Payments" Dispute Resolution/Corrections Process

May 13, 2014 — CMS Issues FY 2015 Medicare SNF PPS Proposed Rule

May 8, 2014 — Hundreds of Drugs and Biologics Face Labeling Changes under New FDA Plan

May 8, 2014 — CMS Streamlines Medicare Requirements for Imaging Services Performed in ASCs and Hospital Radiopharmaceutical Preparation

May 1, 2014 — CMS Releases Proposed Medicare Inpatient PPS/LTCH Update for FY 2015

April 28, 2014 — Proposed FY 2015 Medicare Payment Rules in the Pipeline

April 28, 2014 — CMS Proposes Updated Life Safety Code for Health Care Facilities

April 25, 2014 — Busy Week for FDA's Center for Devices and Radiological Health

April 8, 2014 — RACs Correct $2.4 Billion in Medicare Claims in FY 2012

April 8, 2014 — CMS Announces System to Collect Hospice Care Data Beginning July 1, 2014

April 2, 2014 — FDA Proposal Amends Medical Device Classification Rules

March 24, 2014 — Obama Administration Continues to Update ACA Insurance Exchange and Health Plan Regulations

March 20, 2014 — CMS Rule Increases FY 2014 Medicare Payments for Low-Volume Hospitals

March 19, 2014 — CMS Rule Requires Qualified Health Plans to Accept Certain Third-Party Premium Payments

March 4, 2014 — ONC Proposes Updated Electronic Health Record (EHR) Certification Criteria for 2015

March 4, 2014 — Preliminary FY 2014 DSH Allotments Announced

March 3, 2014 — CMS Takes First Steps to Cut Medicare DMEPOS Fees Based on Competitive Bidding Prices

March 3, 2014 — Obama Administration Issues ACA Health Coverage Waiting Period Regulations

February 27, 2014 — There are HOW many calories in that? FDA Seeks Comments on Proposal to Update Nutrition Facts Food Label

February 24, 2014 — FDA to Overhaul an OTC System That "Isn't Working"

February 24, 2014 — Coming to a TV Near You? FDA Seeks Public Input on Limiting Risks Presented in Direct-to-Consumer Television Ads

February 18, 2014 — CMS Extends and Expands Moratoria on Enrollment of Home Health Agency, Ambulance Suppliers in Designated Areas

February 17, 2014 — CMS Seeks New Participants for Bundled Payments for Care Improvement Initiative

February 17, 2014 — IRS Issues ACA Employer "Shared Responsibility" Guidance; Delays Compliance Deadlines for Certain Employers

February 17, 2014 — Final HIPAA Rule Gives Patients Right to Access Test Results Directly from Labs

February 11, 2014 — CMS Invites Proposals for Frontier Community Health Integration Demonstration

January 30, 2014 — CMS Finalizes Rule to Strengthen Home- and Community-Based Services (HCBS) Options

January 30, 2014 — HHS Publishes FY 2015 FMAP Amounts

January 29, 2014 — Reed Smith Client Alert: CMS/OIG Extend Protections for Electronic Health Record Donations

January 20, 2014 — FDA Seeks Comments on Drug Company Social Media Guidance

January 8, 2014 — CMS Proposes Updates to Medicare Advantage/Part D Policies for 2015

January 7, 2014 — CMS Proposes Emergency Preparedness Requirements for Medicare/Medicaid Providers

January 7, 2014 — CMS, FDA Extend Pilot Program for Parallel Review of Medical Products

January 7, 2014 — OIG Seeks Anti-Kickback Safe Harbor, Fraud-Alert Topic Proposals

January 7, 2014 — HHS Proposes HIPAA Amendments Addressing Gun Background Checks

January 7, 2014 — CMS Proposes 2015 Funding Methodology for ACA Basic Health Program

January 7, 2014 — CMS Issues Formally Updates 2014 Health Exchange Enrollment Deadlines

January 7, 2014 — FDA Releases Final Guidance on Qualification Process for Drug Development Tools

January 6, 2014 — HHS Proposed Rule on Health Plan Certification of Compliance Requirements

January 6, 2014 — CMS Seeks Comments on MSP CMP Policies, Appeals Process

December 27, 2013 — Final Rules Issued Extending Protections of Electronic Health Record Donations

December 10, 2013 — CMS Issues Final Medicare OPPS, ASC Policies for 2014

December 10, 2013 — CMS Updates Medicare Physician Fee Schedule, Other Part B Policies for CY 2014

December 10, 2013 — CMS Finalizes 2014 ESRD PPS Rates; Phases in ESRD Drug Utilization Cut

December 10, 2013 — CMS Proposed Rule on ACA Benefit and Payment Parameters for 2015

December 10, 2013 — CMS Boosts Provider Enrollment Fee for 2014

December 3, 2013 — CMS Adopts Changes to Medicare Payment, Coverage Rules for DMEPOS

November 25, 2013 — Medicare Home Health PPS Rates Cut 1.05% Under Final 2014 Rule

November 25, 2013 — CMS Seeks Input on Quality Ratings for ACA Exchange Plans

November 14, 2013 — CMS Invites Nominees for Members of Advisory Panel on Hospital Outpatient Payment

November 14, 2013 — HHS Corrects March 2013 ACA Benefit, Payment Parameter Rules

November 13, 2013 — Obama Administration Publishes Final Mental Health/Substance Abuse Parity Rule

October 30, 2013 — CMS Finalizes ACA Exchange Program Integrity & Financial Oversight Standards

October 30, 2013 — CMS Releases Medicare Deductible, Coinsurance Amounts for 2014