CMS Publishes Update to DME Items Subject to Face-to-Face Encounter, Written Order Prior to Delivery Requirements

Today CMS published a notice updating the Healthcare Common Procedure Coding System (HCPCS) codes on the Durable Medical Equipment (DME) List of “Specified Covered Items” that require a face-to-face encounter and a written order prior to delivery (although CMS still is delaying enforcement of the face-to-face examination – but not the detailed written order – requirement). 

By way of background, in the 2013 Medicare physician fee schedule final rule, CMS established a list of Specified Covered Items that require a written order prior to delivery and a face-to-face encounter with a physician or other specified health care professional during the 6 months prior to the written order, and the conditions for compliance.  The initial items subject to this provision included:  items that require a written order prior to delivery under the Medicare Program Integrity Manual; items that cost more than $1,000; and items identified as particularly susceptible to fraud, waste, and abuse.  CMS announced its intention to update the list through rulemaking as necessary.  Today’s notice removes two codes from the original list because they represent items that are no longer payable by Medicare:  E0457 (Chest shell) and E0459 (Chest wrap).  The updated list is available here.

CMS Publishes Corrections to 2015 Medicare Physician Fee Schedule Final Rule

CMS has published corrections to its final 2015 Medicare physician fee schedule rule. Among other things, the rule reflects a previously-announced correction to the conversion factor for the first quarter of 2015 ($35.7547), revises the April 1 – December 31, 2015 conversion factor to $28.1872 (assuming that Congress does not take action to avert this pending cut), makes numerous code-specific relative value unit corrections, and revises quality measure details. CMS is also adding regulatory text that had been inadvertently omitted regarding general supervision of non-face-to-face aspects of transitional care management services. 

CMS Proposed Rules in the Pipeline

CMS recently sent several major proposed rules to the White House Office of Management and Budget for regulatory clearance – the last step before publication in the Federal Register. OMB is reviewing proposed rules to update the skilled nursing facility, inpatient rehabilitation facility, and inpatient psychiatric facility prospective payment systems (PPS) for fiscal year (FY) 2016, and the FY 2016 acute inpatient PPS proposed rule also should be joining them in the near future. Other CMS regulations pending at OMB include proposed rules updating the Medicare and Medicaid Electronic Health Record (EHR) Incentive Program meaningful use requirements for 2015 through 2017 and Medicaid managed care regulations.

Obama Administration Finalizes Health Insurance Wraparound Coverage Rule

The Departments of Labor, Health and Human Services, and Treasury published a final rule on March 18, 2015 that amends the definition of excepted benefits to allow group health plan sponsors, in limited circumstances, to offer wraparound coverage to individuals who are purchasing individual health insurance in the private market, including through the Affordable Care Act (ACA) Health Insurance Marketplace. The rule establishes the following pilot programs for wraparound coverage: a pilot allowing wraparound benefits only for Multi-State Plans in the Marketplace, and a pilot allowing wraparound benefits for part-time workers or retirees who enroll in an individual market plan (or Basic Health Plan coverage). There are several significant conditions and limitations to this type of coverage. The wraparound coverage must provide meaningful benefits beyond coverage of cost sharing (e.g., coverage of services considered to be out-of-network by the primary plan, reimbursement for the full cost of primary care or non-formulary prescription drugs), and may not consist of an account-based reimbursement arrangement. This type of wraparound coverage could be offered as excepted benefits to coverage that is first offered no earlier than January 1, 2016 and no later than December 31, 2018 (a year later than initially proposed), and that ends on the later of: (1) the date that is three years after the date wraparound coverage is first offered; or (2) the date on which the last collective bargaining agreement relating to the plan terminates after the date wraparound coverage is first offered.

CMS Finalizes SMART Act MSP Appeals Provisions

This post was written by Katie Hurley and Debra McCurdy.

The Centers for Medicare & Medicaid Services (CMS) has published a final rule that implements Medicare Secondary Payer (MSP) appeals provisions under the Strengthening Medicare and Repaying Taxpayers Act of 2012 (SMART Act). Specifically, the rule addresses the right of appeal and a new multilevel appeal process for liability insurance (including self-insurance), no-fault insurance, and workers’ compensation laws or plans when Medicare pursues an MSP recovery claim directly from the applicable plan. The regulations are effective on April 28, 2015; applicable plans are parties to initial determinations issued on or after April 28, 2015 where CMS pursues recovery directly from the plan. Throughout the final rule, CMS reiterates its authority to recover directly from an applicable plan regardless of any prior attempts to recover from the beneficiary or provider, underscoring the need to address MSP recovery in all personal injury settlements with Medicare beneficiaries.

FDA,OHRP Considering Guidance on Use of Electronic Informed Consent In Clinical Investigations

As discussed on our sister blog, Life Sciences Legal Update, the FDA has published a notice soliciting comments on a draft guidance document on the use of electronic media and processes to obtain informed consent for FDA-regulated clinical investigations of medical products.  The HHS Office for Human Research Protections (OHRP) also is considering whether to adopt the policy for research regulated under HHS protection of human subjects regulations.

CMS Finalizes 2016 ACA Marketplace Plan Benefit & Payment Parameters

The Centers for Medicare & Medicaid Services (CMS) has finalized its Affordable Care Act (ACA) Marketplace health plan payment parameters and essential benefit standards for 2016. The rule addresses numerous policies, including: allocation of risk corridors collections for 2016; recalibration of risk adjustment factors; revisions to reinsurance and cost sharing parameters; user fees for federally-facilitated exchanges; standards for qualified health plans, including quality improvement strategy and provider directory requirements; Small Business Health Options Program requirements; conditions that trigger rate review; clarification that coverage satisfying the minimum value requirement must include substantial coverage of inpatient hospital and physician services; medical loss ratio program revisions; new policies and procedures for enrollee requests for prescription drugs not included on a plan’s formulary; and establishment of the 2016 annual open enrollment period as November 1, 2015 through January 31, 2016.  The final rule will be published on February 27, 2015. A related CMS fact sheet is available here.

Final Medicare Advantage/Part D Rule for Contract Year (CY) 2016

CMS has published a final rule revising Medicare Advantage (MA) and Part D prescription drug benefit regulations for CY 2016. Among other things, the final rule:

  • Implements a statutory provision requiring MA and Part D contracts to provide the right to “timely”’ inspection and audit and allowing CMS to require MA organizations or Part D prescription drug plan (PDP) sponsors to hire an independent auditor to validate correction of CMS audit findings.
  • Establishes U.S. citizenship and lawful presence as an eligibility requirement for enrollment in MA and Part D plans (effective June 1, 2015).
  • Makes several policy changes intended to promote efficient dispensing of drugs in long-term care (LTC) facilities, including prohibiting payment arrangements that penalize the adoption of more efficient LTC dispensing techniques by prorating dispensing fees based on days’ supply or quantity dispensed, and requiring that any difference in payment methodology among LTC pharmacies incentivizes more efficient dispensing techniques.
  • Requires MA Prescription Drug (MA-PD) plans to establish and maintain a process with network pharmacies to ensure timely and accurate point-of-sale transactions and coordinate Part A, Part B, and Part D drug benefits administered by the MA PD plan.
  • Requires a sponsor’s Pharmacy & Therapeutics committee to document its process for an objective party to determine whether disclosed financial interests are conflicts of interest and management of any recusals due to conflicts.

Other provisions of the rule address, among other things, business continuity for MA organizations and PDP sponsors; codification of recent quality improvement program policies; and notification requirements related to changes to Part D plans. CMS is not finalizing a number of proposals included in the January 2014 proposed rule, including provisions that would have: lifted the protected class designation on three drug classes; required Medicare Part D sponsors to include in preferred networks any pharmacy willing to accept the sponsor’s terms and conditions; reduced the number of Part D plans a sponsor may offer; and codified CMS interpretation of the Part D non-interference clause.

CMS Issues Final 2016 Funding Methodology for ACA Basic Health Program

On February 24, 2015, CMS published its final methodology and data sources 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 is using the same methodology in 2016 as was established in the final 2015 payment notice, with updated values for several factors.

CMS Corrects 2015 Medicare OPPS/ASC Final Rule, Impacts Rates

Today CMS published a notice correcting its November 10, 2014 final rule updating the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgical Center (ASC) Payment System rates and policies for calendar year 2015. In addition to fixing various technical errors (e.g., status indicator and addenda corrections for specific codes), the notice increases the OPPS conversion factor from $74.144 to $74.173, which will slightly increase payment rates for most ambulatory payment classifications. On the other hand, CMS is reducing the 2015 ASC conversion factor slightly, from $44.071 to $44.058. 

CMS Needs More Time to Finalize ACA Rule on Return of Medicare Overpayments

CMS warns requirement to report/return overpayments is in effect even without regulations

The Centers for Medicare & Medicaid Services (CMS) needs more time to finalize its February 16, 2012 proposed rule on reporting and returning of Medicare overpayments, according to a CMS notice to be published on February 17, 2015. The 2012 rule would provide details on implementation of an Affordable Care Act (ACA) provision requiring enrolled providers and suppliers (and certain other enrollees) receiving Medicare funds to report and return Medicare overpayments by the later of 60 days after the date on which the overpayment was identified or, if applicable, the date any corresponding cost report is due. Although the requirement to refund an overpayment already exists in federal law, the proposed rule would clarify what constitutes “identification” of an overpayment, the mechanics of when and how an overpayment must be returned, and the period of time subject to repayment. CMS had received a large number of comments from providers and suppliers and their industry associations that the proposed rule’s refund reporting policies and procedures would impose significant administrative burdens.

The Social Security Act requires public notice if an agency will take more than three years to finalize a proposed rule. CMS states that “the complexity of the rule and scope of comments warrants the extension of the timeline for publication” for an additional year (until February 16, 2016). Specifically, CMS has “determined that there are significant policy and operational issues that need to be resolved in order to address all of the issues raised by comments to the proposed rule and to ensure appropriate coordination with other government agencies.” The agency warns stakeholders, however, that “even without a final regulation they are subject to the statutory requirements found in section 1128J(d) of the Act and could face potential False Claims Act liability, Civil Monetary Penalties Law liability, and exclusion from Federal health care programs for failure to report and return an overpayment.”

Obama Administration Releases FY 2016 Budget Proposal with Medicare/Medicaid Provisions

On February 2, 2015, the Obama Administration released its proposed federal budget for fiscal year (FY) 2016. The budget would impact all types of health care providers, health plans, and drug manufacturers if adopted as proposed – which is unlikely given Republican control of the House and Senate. Nevertheless, Congress can be expected to consider the Medicare and Medicaid savings proposals (many of which are carry-overs from prior budgets) during expected debate in the coming months on Medicare physician fee schedule (MPFS) reform legislation or during future budget negotiations.

The following is a summary of the major Medicare, Medicaid, and related policy proposals contained in the FY 2016 budget proposal.

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CMS Plans Spring Rulemaking to Modify Meaningful Use Requirements

CMS has announced that it plans to issue regulations this spring to address provider concerns about the burden associated with compliance with Medicare and Medicaid Electronic Health Record (EHR) Incentive Program meaningful use requirements. Specifically, in a January 29, 2015 blog post by Patrick Conway, MD, Deputy Administrator for Innovation and Quality and CMS Chief Medical Officer, CMS announced that upcoming regulations would:

  • Realign hospital EHR reporting periods to the calendar year facilitate hospitals incorporation of 2014 Edition software into their workflows and better align with other CMS quality programs;
  • Modify other aspects of the program to reduce complexity and lessen providers’ reporting burdens; and
  • Reduce the EHR reporting period in 2015 to 90 days to accommodate these changes.

These changes are separate from another rulemaking expected to be released next month that would address the Stage 3 meaningful use criteria for 2017 and subsequent years.

CMS Announces New 6-Month Extension of Moratoria on Enrollment of HHAs, Ambulance Suppliers in Designated Areas

CMS is extending -- for another 6 months -- its current enrollment moratoria for new ground ambulance suppliers and home health agencies (HHAs) in designated metropolitan areas. The moratoria, which affect enrollment in Medicare, Medicaid, and the Children’s Health Insurance Program, apply to new ground ambulances in the Houston and Philadelphia metropolitan areas and new HHAs in the metropolitan areas of Fort Lauderdale, Miami, Chicago, Detroit, Dallas, and Houston. CMS discusses its rationale for extending the enrollment moratoria, including the factors suggesting a high risk of fraud, waste, or abuse, in a notice to be published on February 2, 2015. The extension is effective January 29, 2015. CMS may lift the moratoria before the end of the 6-month period or announce additional extensions.

Stage 3 EHR Incentive Program, Health IT Certification Rules at OMB

HHS has sent to the White House Office of Management and Budget (OMB) for final regulatory clearance a proposed rule on Stage 3 meaningful use criteria for the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs. The Stage 3 rule will focus on advanced use of EHR technology to promote improved outcomes for patients, and it propose changes to the reporting period, timelines, and structure of the program, including providing a single definition of meaningful use. Likewise, HHS is seeking review of proposed rule that would, among other things, establish a new 2015 Edition Base EHR definition and modify the ONC Health Information Technology (IT) Certification Program to make it more broadly applicable to other types of health IT health care settings and programs. The rules are not available yet, but could be approved for publication in the Federal Register at any time.

Electronic Distribution of Prescribing Information for Prescription Drugs & Biologicals

The FDA published a proposed rule on December 18, 2014 that would require electronic distribution of the prescribing information intended for health care professionals, which is currently distributed in paper form on or within the prescription drug or biological product packaging. FDA also is proposing that prescribing information intended for health care professionals will no longer be permitted to be distributed in paper form with the package from which a prescription drug or biological product is dispensed, except as provided by this regulation. According to the FDA, its proposal is intended to facilitate the distribution of updated prescribing information as new information becomes available or prescribing information changes are made, and to ensure that “the most current prescribing information for distributed prescription drugs will be available and readily accessible to health care professionals at the time of clinical decisionmaking and dispensing.” Comments on the proposed rule will be accepted until March 18, 2015.

CMS Publishes Medicare QIO Criteria

CMS has published notices setting forth the criteria it will use to evaluate the effectiveness and efficiency of Quality Innovation Network (QIN) and Beneficiary and Family Centered Care (BFCC) Quality Improvement Organizations (QIOs) that entered into contracts with CMS in 2014.

IRS Issues Additional ACA Requirements for Tax-Exempt Hospitals

On December 31, 2014, the IRS published final regulations providing guidance on the community health needs assessment and financial assistance policy requirements for charitable hospitals under the ACA. The regulations address the entities that must meet these requirements, related reporting obligations, and the consequences for failing to satisfy these ACA requirements. The regulations apply to taxable years beginning one year after December 29, 2014.

FDA One Step Closer to New Direct-To-Consumer Television Ad Requirements

This post was written by Jennifer Pike.

Last February, the Food and Drug Administration (FDA) asked for public feedback on a proposed research study related to prescription drug television advertisements. In a notice published in the Federal Register on January 13, 2015, FDA announced its intention to continue to move forward with the proposed study. Specifically, the notice announced that the Agency had submitted a proposed collection of information to the Office of Management and Budget (OMB) for review and approval. The notice describes the general framework for the study, entitled “Disclosure Regarding Additional Risks in Direct-to-Consumer (DTC) Prescription Drug Television (TV) Advertisements (Ads),” and it provides FDA’s response to the 55 comments it received regarding its February 2014 notice.

Current FDA regulations (21 CFR § 202.1) require that TV and radio ads present a product’s major risks in audio, or audio and visual parts of the ads (“major statements”). FDA is concerned that these major statements are too long, resulting in reduced consumer comprehension, minimization of important risk information, and, potentially, therapeutic noncompliance due to fear of side effects. At the same time, and in conflict with the above, FDA is concerned that DTC TV ads do not include adequate risk information. FDA believes that providing limited risk information in ads will promote improved consumer perception and understanding of serious and actionable drug risks.

OMB is accepting comments on the collection of information until February 12, 2015.

Administration Issues Proposed Rules on ACA Summary of Benefits and Coverage, Excepted Benefits/Wraparound Coverage

On December 30, 2014, the Internal Revenue Service (IRS), the Employee Benefits Security Administration (EBSA), and the Centers for Medicare & Medicaid Services (CMS) published a proposed rule that would revise Affordable Care Act (ACA) summary of benefits and coverage (SBC) and uniform glossary requirements for group health plans and health insurance coverage. The changes, which would modify a February 14, 2012 rulemaking, are intended to help plans and individuals better understand their health coverage options and compare plans. For instance, the proposed rule would add another coverage example to the SBC to illustrate costs for consumers, streamline the SBC, and revise the uniform glossary that helps consumers understand insurance terms. If finalized, the new requirements would be implemented for plan years beginning on or after September 1, 2015. Comments on the proposed changes are due by March 2, 2015.  The Departments also issued revised draft SBC template, instructions, and supplemental materials.

Separately, the agencies published a proposed rule on December 23, 2014 that would amend the definition of excepted benefits to allow group health plan sponsors, in limited circumstances, to offer wraparound coverage to individuals who are purchasing individual health insurance in the private market, including through the ACA Health Insurance Marketplace. The rule proposes the following pilot programs for wraparound coverage: a pilot allowing wraparound benefits only for Multi-State Plans in the Marketplace, and a pilot allowing wraparound benefits for part-time workers or retirees who enroll in an individual market plan. There are several significant conditions and limitations to this type of coverage. This type of wraparound coverage could be offered as excepted benefits to coverage that is first offered no later than December 31, 2017 and that ends on the later of: (1) the date that is three years after the date wraparound coverage is first offered; or (2) the date on which the last collective bargaining agreement relating to the plan terminates after the date wraparound coverage is first offered.  Comments will be accepted until January 22, 2015.

Older Entries

December 30, 2014 — Annual OIG Solicitation of Anti-Kickback Safe Harbor, Fraud-Alert Topic Proposals

December 30, 2014 — Happy New Year! FDA Helps Industry Ring in New Year with Generous DSCSA Compliance Policy

December 17, 2014 — CMS Proposes Changes to Medicare Shared Savings Program/ACO Payment Regulations

December 16, 2014 — CMS Proposes Updating Certain Medicare/Medicaid Policies to Recognize Same-Sex Marriages

December 16, 2014 — CMS Proposes 2016 ACA Marketplace Plan Benefit & Payment Parameters

December 13, 2014 — HHS Posts Fall 2014 Regulatory Agenda

December 13, 2014 — FY 2016 Federal Financial Participation Matching Amounts Released

December 8, 2014 — CMS Finalizes Rule to Strengthen Medicare Provider Enrollment Regulations and Permit Revocations for Patterns/Practices of Improper Claims Submissions; Defers Expanded Awards for Medicare Fraud Tipsters

December 8, 2014 — CMS Delaying Enforcement of Medicare Part D Drug Prescriber Enrollment Requirements

December 5, 2014 — CMS Announces 2015 Provider Enrollment Application Fee Amount

December 5, 2014 — Presidential Bioethics Commission Seeks Comments on Ethical Implications of Public Health Response to Ebola Outbreak & Other Emergencies

December 5, 2014 — CMS Adopts Changes to Medicaid DSH Rules

December 5, 2014 — CMS Publishes Corrections to Home Health PPS, DMEPOS Surety Bond Rules

December 5, 2014 — CMS to Conduct Hyperbaric Oxygen Prior Authorization Pilot Program

December 2, 2014 — FDA Public Meeting on Regulatory Oversight of Laboratory Developed Tests (Jan 8-9)

December 1, 2014 — CMS Extends Comment Period on Home Health COP Proposed Rule

November 20, 2014 — CMS Publishes Final 2015 Medicare Physician Fee Schedule Rule for 2015

November 20, 2014 — CMS Finalizes CY 2015 Medicare OPPS/ASC Rates & Policies

November 20, 2014 — CMS Adopts Major Changes to Medicare DMEPOS Payment/Coverage Policy Inside/Outside of Competitive Bidding Areas

November 20, 2014 — CMS Finalizes 0.3% Cut in Medicare Home Health PPS Rates for CY 2015

November 20, 2014 — CMS Publishes Final 2015 ESRD PPS Rule

November 19, 2014 — CMS Adopts Changes to Open Payments/Physician Payment Sunshine Act Regulations

November 19, 2014 — CMS Announces 3-State Medicare Prior Authorization Model for Repetitive Nonemergent Ambulance Transport

November 19, 2014 — NIH Releases Proposed Rule on FDAAA Requirements for ClinicalTrials.Gov Registration and Results Submission

November 18, 2014 — HRSA Withdraws Pending 340B Rule, Plans New 2015 Rulemaking

November 5, 2014 — HHS OMHA Soliciting Suggestions for Reducing Medicare Appeals Backlog

October 29, 2014 — OIG Extends Comment Deadline on Permissive Exclusion Criteria

October 28, 2014 — Final CY 2015 Medicare Payment Rules in the Pipeline

October 28, 2014 — CMS Seeking Nominations for New Advisory Panel on Clinical Diagnostic Lab Tests

October 28, 2014 — CMS Proposes 2016 Funding Methodology for ACA Basic Health Program

October 28, 2014 — CMS Announces Medicare Deductible, Coinsurance Amounts for 2015

October 28, 2014 — Draft HHS Guidance on Disclosing Risks in Standards of Care Research

October 28, 2014 — ONC Invites Applications for "Market R&D Pilot Challenge"

October 21, 2014 — Reed Smith Client Alert: Analysis of HHS OIG Proposed Rule to Amend the Anti-Kickback Safe Harbors, CMP Rules on Beneficiary Inducements & Gainsharing Regulations

October 17, 2014 — OIG and CMS Extend Fraud/Abuse Waivers for Medicare Shared Savings Program/ACOs; Invite Feedback on Waiver Policy

October 8, 2014 — Proposed Revisions to Home Health Conditions of Participation

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