HHS Releases HIPAA Security Risk Assessment Tool

HHS has developed a Security Risk Assessment (SRA) tool to help providers comply with a Health Insurance Portability and Accountability Act (HIPAA) requirement that covered entities conduct a risk assessment to ensure compliance with HIPAA’s administrative, physical, and technical safeguards and to determine where electronic protected health information could be at risk. The SRA tool is intended to help entities regulated under HIPAA better understand potential vulnerabilities and identify safeguards that they could institute.

Obama Administration Proposes FY 2015 Budget with Medicare, Medicaid Savings Provisions

On March 4, 2014, the Obama Administration released its proposed federal budget for fiscal year (FY) 2015. Virtually all types of health care providers, health plans, and drug manufacturers would be impacted by the budget provisions if adopted as proposed – an unlikely scenario given the Republican House leadership’s reaction to the document. Nevertheless, the Medicare and Medicaid savings proposals (many of which are carry-overs from prior budgets) could resurface as spending offsets in the pending negotiations on Medicare physician fee schedule reform legislation or in future budget negotiations. Highlights of the Administration’s Medicare and Medicaid legislative proposals include the following (all savings estimates are for the 10-year period of FYs 2015-2024):

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FDA Provides Direction on "Dear Doctor" Letters

This post was written by Jillian W. Riley.

On January 16, 2014, the Food and Drug Administration (FDA) issued a final guidance document for industry providing specific recommendations on the content and format of Dear Health Care Provider (DHCP or “Dear Doctor”) letters. DHCP letters are an important means of communicating new information to the health care provider community about a product that is already on the market. The guidance provides insight into (1) when to send a DHCP letter, (2) what information should be included, (3) how to organize the letter, and (4) how to format the letter. The recent guidance finalizes a draft guidance FDA published in November of 2010. 

The guidance stresses the importance of collaborating with FDA when crafting DHCP letters to ensure that a DHCP letter is appropriate under the circumstances, that the target audience has been identified, and that the message is clearly conveyed. Additionally, the guidance provides template examples to aid industry in drafting a clear and effective DHCP letter.

Medicare Appeals Backlog Prompts Hold on New Provider Appeals

Citing a “rapid and overwhelming increase in claim appeals,” the HHS Office of Medicare Hearings and Appeals (OMHA) has temporarily suspended the assignment of most new provider requests for an Administrative Law Judge (ALJ) hearing. In a memorandum to high-volume appellants dated December 24, 2013, Chief ALJ Nancy Griswold announced that the suspension, which was effective July 15, 2013, is expected to last at least 2 years, during which the OMHA will work through a backlog of appeals involving almost 357,000 Medicare claims and entitlements already assigned to the 65 ALJs. Note that notwithstanding the suspension, OMHA will continue to assign and process requests filed directly by Medicare beneficiaries. As previously reported, the OMHA is hosting a Medicare Appellant Forum on February 12, 2014 to provide additional information to appellants and providers on efforts to make the appeals process work more efficiently.

FDA Releases Final Guidance on Qualification Process for Drug Development Tools

This post was written by Jennifer Pike.

The Food and Drug Administration (FDA) has announced the availability of a final guidance document which describes the qualification process for drug development tools (DDTs) intended for use, over time, in multiple drug development programs. DDTs are methods, materials, or measures that aid drug development. Examples of DDTs include biomarkers and patient reported outcome instruments.

The purpose of the guidance document is to describe the formal process that FDA will use in working with sponsors of DDTs to guide them as they refine the tools and rigorously evaluate them for use in the regulatory process. The guidance also provides a framework for interactions between FDA and sponsors to support work towards qualification of DDTs, as well as explains the kinds of data that should be submitted to support qualification of a DDT and creates a mechanism for FDA’s formal review of the data to ultimately qualify the DDT. For purposes of the guidance, the submitter of a DDT is the person, group, organization (including the federal government), or consortium that takes responsibility for and initiates a DDT qualification proposal using the procedures described in the guidance.

The creation of the DDT qualification process is one of multiple initiatives FDA has undertaken, as a result of its 2004 FDA’s Critical Path Initiative, to support the development of new DDTs. DDTs can help streamline the drug development process, improve the chances for clinical trial success, and yield more information about a treatment or disease. Comments to the guidance may be submitted at any time at www.regulations.gov.

HHS Allows Grandfathering of Certain Insurance Policies Cancelled under ACA Rules

President Obama announced on November 14, 2013 that HHS has adopted an administrative policy to allow insurers to continue to offer certain health insurance policies scheduled to be cancelled effective January 1, 2014 because of more stringent coverage requirements under the ACA. In short, under the“transitional” policy outlined in a letter to state insurance commissioners, health insurance issuers may choose to continue coverage that would otherwise be terminated or cancelled, and affected individuals and small businesses may choose to re-enroll in such coverage if the coverage was in effect on October 1, 2013 and the insurer meets certain conditions, including notification to the affected insureds regarding: (1) any changes in the options that are available to them; (2) which of the specified market reforms would not be reflected in any coverage that continues; (3) their potential right to enroll in a qualified health plan offered through a Health Insurance Marketplace and possibly qualify for financial assistance; (4) how to access such coverage through a Marketplace; and (5) their right to enroll in health insurance coverage outside of a Marketplace that complies with the specified market reforms.  State agencies responsible for enforcing the specific market reforms are “encouraged to adopt the same transitional policy.” The letter notes the risk corridor program should help ameliorate unanticipated changes in premium revenue for health insurers, although the Administration will consider additional regulatory changes to provide additional assistance. The policy applies to health insurance coverage that is renewed for a policy year starting between January 1, 2014, and October 1, 2014, but the Administration has left open the possibility of extending the transition policy. Despite this announcement, House Speaker John Boehner has indicated that the House will proceed with its scheduled vote tomorrow on H.R. 3350, the “Keep Your Health Plan Act.” 

Obama Administration Releases Initial Health Insurance Marketplace Enrollment Numbers

On November 13, 2013, HHS issued its first report on ACA Health Insurance Marketplace/Exchange enrollment statistics. According to the Administration, 106,185 individuals have selected health plans during the first 33 days of the open enrollment period (October 1 through November 2, 2013), although this figure also includes individuals who have not yet purchased a policy and who are technically not yet enrolled in a plan. Note that the majority of the individuals who have selected a plan – almost 75% -- have gone through a state-based marketplace, with fewer than 27,000 individuals selecting a plan through the federally-facilitated marketplace (where HHS is running the marketplace alone or in partnership with the state). State numbers vary significantly, with 35,364 individuals in California selecting a plan through the state-run marketplace (about a third of all insurance selections nationwide for the period), compared to only 42 North Dakota residents selecting a plan through the federal marketplace. An additional 396,261 individuals nationwide have been assessed to be eligible for Medicaid or CHIP, representing 26% of the total applicants for coverage through the marketplaces. HHS also reports high volumes of traffic on marketplace websites and call centers, with almost 25 million unique visitors on marketplace websites and more than 3.1 million calls to state and federal marketplace call centers.

CMS Announces Medicare DMEPOS Bidding Round 1 Recompete Contract Suppliers

CMS has announced the names of 282 suppliers that have been awarded 3-year contracts under the Medicare DME, prosthetics, orthotics, and supplies (DMEPOS) competitive bidding program “Round 1 Recompete.” As discussed in our previous reports, this phase of bidding applies to nine geographic areas where competitive bidding contracts have been in effect since 2011, but it includes a broader array of products than currently covered. The contract period for the Round 1 Recompete is January 1, 2014 through December 31, 2016.

By way of background, under DMEPOS competitive bidding, only suppliers that are winning bidders, meet licensing and other standards, and enter into a contract with CMS may furnish selected categories of DMEPOS to Medicare beneficiaries in competitive bidding areas (CBAs), with very limited exceptions. Contract suppliers are paid based on the median of the winning suppliers’ bids in the CBA, rather than the DMEPOS fee schedule amount. CMS reported earlier this year that Medicare reimbursement will be cut by an average of 37% compared to fee schedule amounts under the Round 1 Recompete contracts, which include the following six product categories: (1) Respiratory Equipment and Related Supplies and Accessories (includes oxygen, oxygen equipment, and supplies; continuous positive airway pressure devices and respiratory assist devices, and related supplies and accessories; and standard nebulizers); (2) Standard Mobility Equipment and Related Accessories (includes walkers, standard power and manual wheelchairs, scooters, and related accessories); (3) General Home Equipment and Related Supplies and Accessories (includes hospital beds and related accessories, group 1 and 2 support surfaces, transcutaneous electrical nerve stimulation devices (TENS), commode chairs, patient lifts, and seat lifts); (4) Enteral Nutrients, Equipment and Supplies; (5) Negative Pressure Wound Therapy Pumps and Related Supplies and Accessories; and (6) External Infusion Pumps and Supplies.

CMS reports that Round 1 Recompete contract suppliers have 620 locations to serve Medicare beneficiaries in the CBAs, and about 58% of these suppliers are “small suppliers” with gross revenues of $3.5 million or less. CMS will now accelerate educational efforts aimed at suppliers, referral agents, and beneficiaries in preparation for the new contracts.

CMS Guidance on Medicare Inpatient Hospital Admissions Two-Midnight Policy

CMS continues to release subregulatory guidance on the inpatient hospital admission/medical review criteria that were adopted in the final FY 2014 Medicare inpatient prospective payment system/long-term care hospital final rule. In short, under this new policy, if the ordering practitioner expects a beneficiary’s surgical procedure, diagnostic test, or other treatment to require a stay in the hospital lasting at least two midnights, and admits the beneficiary as an inpatient based on that expectation, it is generally appropriate that the hospital receive Medicare Part A payment. The order must also be documented in the medical record in accordance with the regulations, and a physician must certify the medical necessity of hospital inpatient services. CMS recently posted updated subregulatory instructions related to prepayment and post-payment review schedules and parameters, along with answers to frequently-asked implementation questions.

CMS Launches Virtual Research Data Center

On November 12, 2013, CMS announced the launch of its Virtual Research Data Center (VRDC), which is intended to provide researchers with more convenient, timely, and cost-effective access to secure CMS health care data without needing to request that the agency ship encrypted data files. According to CMS, traditional physical delivery of a large sample of Medicare Parts A, B, and D data can cost more than $100,000 for a single year of data, while a researcher’s use of the VRDC for a single project over the course of the year would cost approximately $40,000. CMS notes that individually-identifiable beneficiary information remains in the CMS data environment under the VRDC model, which helps safeguard against breaches or unauthorized uses of the data.

Applications for 2015 HCPCS Codes Due Jan. 3, 2014

The deadline for applications for new Healthcare Common Procedure Coding System (HCPCS) codes to be considered for the 2015 update is January 3, 2014. A copy of the application and other details about the process are available here

OIG Examines Inappropriate Medicare Payments on Behalf of Deceased or Unlawfully-Present Beneficiaries

According to the HHS Office of Inspector General (OIG), the Medicare program continues to make inappropriate payments on behalf deceased beneficiaries and beneficiaries who are unlawfully-present in the country. First, despite safeguards intended to prevent and recover Medicare payments made on behalf of deceased beneficiaries, Medicare inappropriately paid $23 million in 2011 for claims with service dates after beneficiaries' deaths. The majority of the improper payments were made under Medicare Part C. The OIG recommended a series of steps to improve payment safeguards in this area and to address providers and suppliers identified by the OIG with high numbers of claims with service dates after beneficiaries' deaths.

In a separate report, the OIG found that CMS did not adequately prevent Medicare Part D payment for unlawfully-present beneficiaries for calendar years 2009 through 2011. As a result, CMS inappropriately accepted 279,056 prescription drug event records submitted by Part D sponsors with unallowable gross drug costs totaling $29.0 million on behalf of 4,139 unlawfully-present beneficiaries. CMS used those records to make final payment determinations to sponsors. The OIG recommended that CMS resolve improper Part D payments made for drugs provided to unlawfully-present beneficiaries and take steps to develop and implement controls to prevent inappropriate payments in the future.

ACA Health Insurance Marketplace Opens for Business to Mixed Reviews

On October 1, 2013, the Affordable Care Act’s (ACA) long-awaited Health Insurance Marketplace was launched at www.healthcare.gov. As has been widely reported, many consumers experienced technical problems using the federal site to enroll in qualified health plans, which the Administration has largely chalked up to greater-than-expected demand and site capacity issues that are being addressed on an ongoing basis. On the other hand, critics including Republican lawmakers have argued that the Marketplace site’s glitches indicate the deeper problems with the enrollment system that should have been anticipated (and which they contend lend support to continued efforts to delay or repeal the ACA). The White House has confirmed that individuals are signing up through federal exchanges, but the Administration is not releasing enrollment statistics at this time, choosing instead to release enrollment data on a regular monthly basis starting in November. The Administration also has stressed that consumers have until December 15, 2013 to apply for coverage that starts January 1, 2014, and enrollment in the Marketplace is open until March 31, 2014. In a related development, the Centers for Medicare & Medicaid Services (CMS) has announced that while small businesses may view available plans being offered through the federally-facilitated Small Business Health Option Program (SHOP) Marketplace as of October 1, 2013, all functions (including enrollment) will not be available until November.  Enrollment experiences at state Marketplaces reportedly vary, with some states such as California and New York announcing success in enrolling thousands of consumers, while other states reportedly are encountering technical problems that have hindered enrollment.

CMS Limits Compliance Reviews under New "2 Midnight" Inpatient Admissions Policy

As discussed in previous reports, the final FY 2014 IPPS rule established new criteria for determining the appropriateness of inpatient admissions. In brief, under this policy, CMS generally will presume that surgical procedures, diagnostic tests, and other treatments are appropriate for Medicare Part A inpatient hospital payment when the physician admits a patient based on the expectation that the patient will require a stay of at least two midnights. On September 26, 2013, CMS issued FAQs on the new policy, in which it announces it is directing MACs and Recovery Audit Contractors (RACs) to limit review of hospital compliance with this policy. Specifically, MACs and RACs will be instructed not to review claims spanning more than two midnights after admission for a determination of whether the inpatient hospital admission and patient status was appropriate, and CMS will not permit RACs to review inpatient admissions of one midnight or less that begin on or after October 1, 2013 through the end of the year. On the other hand, CMS will instruct the MACs to conduct limited “probe” prepayment reviews of inpatient hospital claims spanning less than two midnights after admission to determine for medical necessity of the patient status in accordance with the two midnight benchmark to assess compliance and provide feedback to CMS for purposes of developing further education and guidance. Since the probe reviews will be conducted on a prepayment basis, hospitals can rebill denied inpatient hospital admissions in accordance with the IPPS rule. CMS notes that while medical review will not be focused this issue, “physicians should make inpatient admission decisions in accordance with the 2 midnight provisions in the final rule.” Moreover, CMS warns that “evidence of systematic gaming, abuse or delays in the provision of care in an attempt to surpass the 2-midnight presumption could warrant medical review.”

CMS Posts Revised Gapfill Payments for New Molecular Pathology Codes; Reconsideration Requests Due Oct. 30, 2013

CMS has posted revised Medicare gapfill prices, including the 2014 National Limit Amount (NLA), for new molecular pathology codes under the Medicare Clinical Laboratory Fee Schedule (CLFS). CMS will accept reconsideration requests until October 30, 2013. If CMS revises any NLA under the reconsideration process, the revised NLA will be the upper payment limit effective January 1, 2014. Once the reconsideration process is completed, the determination will be final and not be subject to further reconsideration.

Government Shutdown Update: Medicare Claims Processing Continues, but Other Key Functions on Hold

The ongoing partial federal government shutdown that began on October 1, 2013 due to the government funding impasse is having a varied impact on health care provider operations. CMS has ordered Medicare Administrative Contractors (MACs) to continue to perform all Medicare claims processing and payment functions during the government shutdown. Some providers may experience the impact of the shutdown, however, in the form of curtailed survey and certification activities. In short, CMS is directing state survey agencies to continue to investigate and enforce only complaints involving immediate jeopardy or harm to individuals and revisit surveys necessary to prevent provider termination. Many other survey activities are being suspended during the federal government shutdown, including Medicare recertification surveys, revisits that are not required to prevent termination of Medicare participation, Medicare initial surveys, validation surveys, complaint investigations that do not allege immediate jeopardy or actual harm, Patient Safety Initiative Pilot Surveys, MDS or OASIS activities, informal dispute resolutions, or new improvement projects funded by collected civil monetary penalty funds. The shutdown also has hampered federal rulemaking activities; a lengthy shutdown could throw a wrench into CMS efforts to finalize annual Medicare payment rules for systems updated on calendar year basis (including the Medicare physician fee schedule, the hospital outpatient prospective payment system, and the ambulatory surgical center payment system), increasing uncertainty about major proposed policy changes. The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) is continuing Medicare and Medicaid oversight and enforcement activities, including maintaining its fraud and abuse hotline, while most other OIG activities will be suspended during this period. In other areas, the HHS shutdown contingency plan estimates that the shutdown will result in 52% of HHS employees being furloughed, with the Administration for Children and Families, the Substance Abuse and Mental Health Services Administration, the Administration for Community Living, and the Agency for Healthcare Research and Quality having the vast majority of their staff on furlough. A wide range of HHS activities are also being curtailed, including payments under the Children’s Hospital GME Program and Vaccine Injury Compensation Claims, most new National Institutes of Health admissions and grant awards, the Centers for Disease Control and Prevention annual seasonal influenza program, and routine Food and Drug Administration activities not funded through user fees, among many other programs. There is no clear sign of when a deal on a funding bill will be reached.

CMS Sets 1% Payment Update for Medicare Ambulance Rates in 2014

The Medicare ambulance fee schedule will be increased by a 1.0% inflation adjustment for 2014, CMS announced in a recent transmittal.  This update reflects a 1.8% increase in the consumer price index for all urban consumers (CPI-U), which is partially offset by a -0.8% multi-factor productivity adjustment mandated by the ACA. The 2014 ambulance fee schedule file is expected to be posted next month.

HHS OCR Releases HIPAA Privacy Rule Guidance Documents

As reported on our sister blog, http://www.lifescienceslegalupdate.com/, the HHS Office for Civil Rights (OCR) has made a number of recent announcements regarding HIPAA Privacy Rule implementation. First, OCR has issued guidance on how the changes to the HIPAA Privacy Rule’s marketing provisions under the Health Information Technology for Economic and Clinical Health (HITECH) Act and the January 25, 2013 “Omnibus Rule” apply to refill reminders and other communications about current prescriptions for drugs or biologics.  Second, OCR has delayed until further notice enforcement of the requirement that certain HIPAA-covered laboratories revise their notices of privacy practices to comply with the Omnibus Rule. Third, OCR has released resources to assist law enforcement and emergency planners when addressing information-sharing that may be subject to the HIPAA Privacy Rule.  Finally, OCR has released model Notices of Privacy Practices that health care providers and health plans may use to communicate with their patients and plan members about their privacy practices and their patients’ privacy rights with respect to their personal health information.

Medicare Rates to Fall by Average of 37% under DMEPOS Competitive Bidding "Round 1 Recompete" Contracts

CMS has announced the contract prices for items included in the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive bidding “Round 1 Recompete.”  As discussed in our previous reports, this phase of bidding applies to nine geographic areas where competitive bidding has been in effect since 2011, but it includes a broader array of products. The contract period for the Round 1 Recompete is January 1, 2014 through December 31, 2016.

Contract prices under the Round 1 Recompete will average 37% below Medicare's fee schedule rates for the six product categories, according to files posted by the Competitive Bidding Implementation Contractor (CBIC) on October 1, 2013. The weighted average savings by product category are as follows:

Enteral Nutrients, Equipment & Supplies

External Infusion Pumps & Supplies

General Home Equipment and Related Supplies & Accessories

NPWT Pumps and Related Supplies & Accessories

Respiratory Equipment and Related Supplies & Accessories

Standard Mobility Equipment & Related Accessories

Overall Average








These savings compare to a 45% average cut for suppliers participating in Round 2 of the competitive bidding program and a 72% reduction under the national mail order competition for diabetic testing supplies; contracts for both of these programs went into effect July 1, 2013.

The CBIC also posted statistics on the number of Round 1 Recompete contract offers extended for each competitive bidding area (CBA) and product category and the number of supplier locations represented in those offers.  The contracting process for the Round 1 Recompete is now underway. Bidders who were not “winners” will be notified of the reasons they were not offered contracts. CMS plans to announce the names of contract suppliers this fall.

New Draft Guidances from FDA Address Expedited Review, Safety Labeling and More

This post was written by Jennifer Pike

The FDA has recently issued a number of new draft guidance documents that provide insight on a range of issues, including expedited drug review programs, medical device reporting, importation of unapproved drugs for market launch, and safety labeling changes. A brief summary and link to each draft guidance document is provided below:

  • Expedited Programs for Serious Conditions: Drugs and Biologics – This draft guidance provides a single resource for information on policies and procedures related to FDA’s expedited drug development and review programs: fast track designation, breakthrough therapy designation, accelerated approval, and priority review. The draft guidance is intended to help industry better understand each program, including when the programs can be used and the features of each.
  • Medical Device Reporting for Manufacturers – This draft guidance describes and explains the current FDA regulation that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for certain device-related adverse events. The document provides answers to frequently asked questions and includes a section on common reporting errors.
  • Pre-launch Activities Importation Request – This draft guidance describes FDA’s policy regarding requests for the importation of unapproved finished dosage form drug products by an applicant preparing the product for market launch, based on anticipated approval of a pending application (e.g., NDA, ANDA, BLA). It also describes the procedures for making such requests and the factors that FDA will consider in granting such requests.
  • Safety Labeling Changes: Implementation of Section 505(o)(4) of the FD&C Act– Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act, which was added by section 901 of the Food and Drug Administration Amendments Act of 2007, authorizes FDA to require certain drug and biological product application holders to make safety-related labeling changes based on new safety information that becomes available after approval of the drug or biological product. This draft guidance explains how FDA intends to implement section 505(o)(4), including a description of the types of safety labeling changes that ordinarily might be required under this section, how FDA plans to determine what constitutes new safety information, the procedures involved in requiring safety labeling changes, and enforcement of the requirements for safety labeling changes.

Older Entries

July 29, 2013 — OIG Self-Disclosure Protocol Submissions

June 28, 2013 — CMS Delays DME Face-to-Face Requirement until Oct. 1, 2013

June 11, 2013 — Medicare Trustees Forecast Longer Medicare Solvency

May 13, 2013 — HHS Releases Enhanced National Standards for Culturally and Linguistically Appropriate Services (CLAS) in Health Care, Highlights Compliance Efforts

May 13, 2013 — HHS Update on HIT Activities

April 15, 2013 — FDA Draft Guidance on Biosimilar Product Development Now Available

March 13, 2013 — CMS Issues First Guidance on Sequestration Impact on Medicare

March 13, 2013 — HHS Suspends Enrollment in Pre-Existing Condition Insurance Plan (PCIP)

March 13, 2013 — CMS Offers Tips and Timelines for ICD-10 Implementation

March 12, 2013 — 2013 Medicare Participation Enrollment Period for DMEPOS Suppliers Extended until April 15, 2013

March 12, 2013 — April 2013 Update to Medicare ASP Files

March 12, 2013 — FDA Issues New Guidance Documents

January 29, 2013 — CMS Issues Revised CMS-855S, 855O Medicare Enrollment Applications

January 29, 2013 — CMS Previews Medicaid Core Set of Health Home Quality Measures

January 29, 2013 — PCORI Seeking Nominations for Advisory Panels

January 29, 2013 — New FDA Draft Guidance Addresses Combination Product Postapproval Modification Submissions

January 14, 2013 — CMS Announces 90-Day Enforcement Discretion Period for HIPAA Eligibility & Claim Status Operating Rules

January 14, 2013 — ONC Seeks Comments on Health IT Patient Safety Action and Surveillance Plan

January 11, 2013 — CMS Releases Updated Draft Medicaid FUL Files

January 9, 2013 — OCR Announces First HIPAA Breach Settlement Involving Less than 500 Individuals

December 3, 2012 — OCR Issues Guidance on De-identifying Protected Health Information

November 12, 2012 — CMS Releases 2013 HCPCS Update

September 28, 2012 — Hospitals Return Fire After Administration Warns Hospitals Against Gaming Payments through Electronic Health Records

September 27, 2012 — CMS Invites Comments on Preliminary Supervision Level Decisions for Selected Hospital Outpatient Services

September 27, 2012 — CMS Releases October 2012 Update to Medicare Part B Drug ASP Files

September 27, 2012 — CMS Releases Medicare Beneficiary Ombudsman Report

September 27, 2012 — HHS Report Details Savings from ACA Insurance Premium Standards

September 5, 2012 — Preliminary 2013 Medicare Clinical Laboratory Fee Schedule Determinations

September 5, 2012 — FDA Guidance on FY 2013 Medical Device User Fee Small Business Qualification and Certification

September 5, 2012 — FDA Issues Guidance for Comment on Refuse to Accept Policy for 510(k)s

August 8, 2012 — Putting Contractors on Notice: The New Public-Private Partnership Joins DOJ, HHS, and Private Sector Partners to Combat Health Care Fraud

July 31, 2012 — Obama Administration Public-Private Partnership Targets Health Care Fraud Prevention

July 31, 2012 — HHS Announces Funding Opportunity for State Innovation Models Initiative

July 31, 2012 — FDA Issues Draft Guidance Regarding Acceptance & Filing Review for PMA Applications

July 31, 2012 — Updated Draft Medicaid Drug Payment FUL Files Released

July 19, 2012 — HIPAA Electronic Funds Transfer, Remittance Advance Standards

July 19, 2012 — CMS Nursing Home Action Plan

July 19, 2012 — CMS Guidance on Medicaid Integrated Care Models

July 19, 2012 — CMS Answers Questions on 3-Day Payment Window Impact on Physician Offices

June 27, 2012 — Health IT Pilot Targets Prescription Drug Abuse

June 27, 2012 — CMS Outlines Conditions for Provider Use of Repackaged Medications

June 27, 2012 — Insurers to Provide $1.1 Billion in Rebates Under ACA Medical Loss Ratio (MLR) Standard

June 18, 2012 — National Prevention Council Action Plan Released

June 8, 2012 — CMS Accepting Comments on Draft Methodology for Calculating National Average Drug Acquisition Cost (NADAC)

June 8, 2012 — CMS Updates Supervision Levels for Selected HOPPS Services

June 8, 2012 — HHS Resources on Patient Access to Health Data

May 31, 2012 — HHS Corrects ACA Affordable Insurance Exchanges Rule, Issues Guidance for States.

May 14, 2012 — HHS Risk Adjustment Bulletin

May 10, 2012 — New ONC Health IT Resources

April 23, 2012 — HHS Issues its Open Government Plan Version 2.0

April 23, 2012 — HHS Establishes Administration for Community Living

April 23, 2012 — HHS seeks Comments on Revised Healthcare-Associated Infections (HAI) Action Plan

March 14, 2012 — CMS Releases Redesigned Medicare Benefit Statements

March 14, 2012 — Medicare Claims Must Use Version 5010 Format By April 1, 2012

March 14, 2012 — CMS Launches Medicare Advantage (MA) Audit Initiative

March 14, 2012 — 340B Enforcement Activities.

February 28, 2012 — HHS Announces Intent to Delay ICD-10 Compliance Date

February 28, 2012 — CMS Seeks Comments on Approach to ACA Actuarial Value and Cost-Sharing Reductions

February 28, 2012 — CMS Selects Initial ACA Insurance CO-Ops

February 28, 2012 — Status Report on ACA Pre-Existing Condition Insurance Plan (PCIP) Program

February 28, 2012 — HHS Frequently Asked Questions (FAQs) on ACA Essential Health Benefits

February 28, 2012 — CMS Proposes Medical Loss Ratio (MLR) Consumer Notices

February 28, 2012 — CMS Upgrades to PECOS Enrollment System

February 28, 2012 — OIG Examines MA Organizations' Identification of Potential Fraud & Abuse

February 28, 2012 — FY 2011 Health Care Fraud and Abuse Control Program Report

February 28, 2012 — CMS Updates Data on DMEPOS Competitive Bidding Program Health Outcomes

February 25, 2012 — CMS Releases 2013 Medicare Advantage/Part D Combined Advance Notice and Draft Call Letter

February 24, 2012 — CMS Posts Draft FUL Files for November 2011

February 13, 2012 — HHS Health IT Challenge Targets Post-Discharge Care

February 13, 2012 — FDA Issues Guidance on New Informed Consent Requirements

January 25, 2012 — CMS Finalizes Rules on Payments to Retiree Prescription Drug Plan Sponsors

January 25, 2012 — CMS Proposes Changes to Medicaid DSH Rules

January 25, 2012 — HHS Revises Rules Regarding Coverage of Contraceptive Services for Certain Religious Groups Offering Insurance

January 25, 2012 — CMS Establishes Procedures for Claims Against DMEPOS Surety Bonds

January 25, 2012 — CMS Releases Additional Draft ACA Medicaid Drug Pricing/FUL Files

January 25, 2012 — FDA Completes Work on Three Drug User Fee Programs

January 25, 2012 — FDA Guidance on Product Name Placement in Advertising and Promotional Labeling

January 25, 2012 — CMS Seeks Comments on Part D Reporting Requirements, & Issues Other Part D Updates

January 25, 2012 — National Health Care Spending Slowing, CMS Finds

January 5, 2012 — CMS Seeks Comments on ACA "Essential Health Benefits Bulletin"

December 13, 2011 — HHS Announces New Deadlines for Meaningful Use Compliance/EHR Incentives

December 13, 2011 — Summary of Benefits and Coverage Requirement Effective Date Delayed

December 13, 2011 — CMS Announces FY 2011 RAC Recovery Amounts

December 13, 2011 — CMS Posts First quarter 2012 Part B Drug ASP Files

December 13, 2011 — CMS Addresses Denials of HHA Claims Related to Face-to-Face Documentation Issues

December 13, 2011 — CMS Seeks Early Input on Future Quality & Efficiency Measures

December 13, 2011 — CMS Posts 2012 ICD-10-CM Code Update

December 13, 2011 — FDA Draft Guidance on Artificial Pancreas Device Systems, Hepatitis B Screening of Blood/Blood Components

November 30, 2011 — New CMS Demonstration Programs Target Medicare Improper Payments

November 30, 2011 — CMS Launches $1 Billion "Health Care Innovation Challenge"

November 30, 2011 — CMS Names First ACA Community-Based Care Transition Program Sites

November 30, 2011 — HHS Expands Health Insurance Information Website

November 30, 2011 — Early Retiree Reinsurance Program (ERRP) Payments

November 29, 2011 — Marilyn Tavenner to Replace CMS Administrator Donald Berwick

November 29, 2011 — CMS Announces "Enforcement Discretion Period" for HIPAA Transaction Standards

November 29, 2011 — CMS Posts Third Draft Federal Upper Limit (FUL) Files Under ACA

November 14, 2011 — CMS Announces Changes to Medicare Overpayment Notification Process

November 14, 2011 — CMS Resources on Transitions to HIPAA 5010 Transaction Standards/ICD-10

November 14, 2011 — CMS Solicits Comments on Coverage with Evidence Development Framework

November 14, 2011 — CMS Transmittal on 2012 Update to DMEPOS Fee Schedule