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Focus on Regulation

U.S. Department of Education Delays Implementation of Certain State Authorization Requirements until July 1, 2015

On June 24, the U.S. Department of Education further delayed the implementation date for certain state authorization regulations for colleges and universities that have been unable to meet the requirements of those regulations—so long as (1) the state in which the college or university is located is working to establish an acceptable authorization process that will take effect by July 1, 2015, and (2) the college or university can produce documentation of the state’s efforts.

The Department’s state authorization regulations, originally published in October 2010, include two basic requirements for an institution to be considered “legally authorized” by a state for purposes of participating in the Title IV student financial aid programs: (1) the state must authorize an institution by name to operate educational programs beyond secondary education, and (2) the state must have a process to review and appropriately act on complaints concerning the institution, including enforcement of applicable state laws related to fraud and false advertising. The deadline for compliance with these requirements has now been delayed twice: first, from the original deadline of July 1, 2013 to July 1, 2014; and now, from July 1, 2014 to July 1, 2015.

The Department is providing the second extension “to provide States with additional time to finalize processes for those institutions to be able to comply with the State authorization provisions in [34 C.F.R.] § 600.9(a) and (b).”  An institution must comply with those provisions with respect to each state in which the institution has a main campus or additional location offering at least 50 percent of an educational program.  In order for an institution that cannot meet those state authorization requirements to receive an extension until July 1, 2015, the institution must “obtain from the State an explanation, such as information on timeline and action steps to ensure compliance, of how an additional one-year extension will permit the State to finalize its procedures so that the institution is in compliance”, and that explanation must be provided to Department staff upon request.

National Health IT Week at the FCC

This week the Federal Communications Commission’s (FCC’s) CONNECT2HEALTHFCC Task Force, a group formed in March 2014 that is focused on using broadband deployment to accelerate the adoption of advanced healthcare technologies, is joining more than 400 other public and private organizations in recognizing National Health IT Week (NHIT week).  NHIT week is a series of events and activities aimed at increasing awareness of the ability of information technology (IT) to advance healthcare services.  For example, health IT, or electronic health records, can improve healthcare by increasing patient safety, decreasing medical errors, and facilitating better communication between patients and their healthcare providers.  The themes for this year’s NHIT week include patient engagement, advancing interoperability, and clinical quality and safety.

NHIT week began September 15 with the Annual Consumer Health IT Summit hosted by the Office of the National Coordinator for Health IT.  FCC Commissioner Mignon Clyburn delivered the keynote address at the Summit and will also present at the First Annual National Health IT Collaborative for the Underserved Conference on Tuesday, September 16.  The Conference will focus on strategies for using Health IT to eliminate disparities in healthcare and ensure that all patients have and use the tools available to maintain their health and well-being.  Additional NHIT week events include a webinar on new electronic health record certification criteria and a webinar on using health IT to improve the safety of healthcare.

The author wishes to thank Leigh Gusky, an Associate in our Washington, D.C. office, for her assistance in preparing this article.

Legislative Week of September 15, 2014-September 19th, 2014

Must Pass Legislation on Cue this Week:

Congress begins this week working on the must-pass continuing resolution (H J Res 124) to fund the government through mid-December.  Congress will then delay fiscal 2015 funding into the lame-duck session when they return after the November elections.  The House Rules Committee is expected to meet Monday evening to report a Rule for H.J. Res. 124.

Though there is broad support for President Obama’s military plans to aid Syrian Rebels, it is yet known whether Members will include the provision in the stop gap bill or find another legislative alternative.

Senate Legislative Activity

MONDAY, SEPTEMBER 15, 2014

The Senate will convene at 2:00 PM and will proceed to a period of Morning Business. At 5:30 PM, the Senate will proceed to vote on the Motion to Invoke Cloture on S. 2119 (Paycheck Fairness Act).  The Senate will then proceed to an Executive Session to vote on cloture on Executive Calendar #1003, Jeffrey Baran to be a Member of the Nuclear Regulatory Commission, and Executive Calendar #1004, Stephen Burns to be a Member of the Nuclear Regulatory Commission. If cloture is invoked on the above nominations, all post-cloture time will expire on Tuesday, September 16th at 2:15 PM, and the Senate will proceed to vote on confirmation.

House Legislative Activity

MONDAY, SEPTEMBER 15, 2014
On Monday, the House will meet at 12:00 p.m. for Morning Hour debate and 2:00 p.m. for legislative business, with votes postponed until 6:30 p.m.

Legislation Considered Under Suspension of the Rules:

1)      H.R. 4771 – Designer Anabolic Steroid Control Act of 2014, as amended (Rep. Pitts – Energy and Commerce)

2)      S. 2154 – Emergency Medical Services for Children Reauthorization Act of 2014 (Sen. Casey – Energy and Commerce)

3)      H.R. 83 – To require the Secretary of the Interior to assemble a team of technical, policy, and financial experts to address the energy needs of the insular areas of the United States and the Freely Associated States through the development of action plans aimed at reducing reliance on imported fossil fuels and increasing use of indigenous clean-energy resources, and for other purposes, as amended (Rep. Christensen – Energy and Commerce)

4)      H.R. 3044 – To approve the transfer of Yellow Creek Port properties in Iuka, Mississippi (Rep. Nunnelee – Transportation and Infrastructure)

5)      S. 1086 – Child Care and Development Block Grant Act of 2014, as amended (Sen. Mikulski – Education and Workforce)

6)      H.R. 5108 – To establish the Law School Clinic Certification Program of the United States Patent and Trademark Office, and for other purposes (Rep. Jeffries – Judiciary)

7)      H.R. 3006 – To authorize a land exchange involving the acquisition of private land adjacent to the Cibola National Wildlife Refuge in Arizona for inclusion in the refuge in exchange for certain Bureau of Land Management lands in Riverside County, California, and for other purposes (Rep. Calvert – Natural Resources)

8)      S. 476 – To amend the Chesapeake and Ohio Canal Development Act to extend to the Chesapeake and Ohio Canal National Historical Park Commission (Sen. Cardin – Natural Resources)

9)      S. 1603 – Gun Lake Trust Land Reaffirmation Act (Sen. Stabenow – Natural Resources)

10)   H.R. 5205 – Northern Nevada Land Conservation and Economic Development Act (Rep. Amodei – Natural Resources)

11)   H.R. 3222 – Flushing Remonstrance Study Act (Rep. Meng – Natural Resources)

12)   H.R. 2569 – Upper Missisquoi and Trout Wild and Scenic Rivers Act (Rep. Welch – Natural Resources)

13)   H.R. 4119 – West Hunter Street Baptist Church Study Act (Rep. Johnson (GA) – Natural Resources)

14)   H.R. 5405 – Promoting Job Creation and Reducing Small Business Burdens Act (Rep. Fitzpatrick – Financial Services)

15)   H.R. 3374 – American Savings Promotion Act, as amended (Rep. Kilmer – Financial Services)

16)   H.R. __ – Insurance Capital Standards Clarification Act of 2014 (Rep. Barr – Financial Services)

17)   H.R. 2866 – Boys Town Centennial Commemorative Coin Act, as amended (Rep. Terry – Financial Services)

18)   H.R. 2996 – Revitalize American Manufacturing and Innovation Act, as amended (Rep. Reed – Science, Space, and Technology)

TUESDAY, SEPTEMBER 16, 2014 AND THE BALANCE OF THE WEEK
On Tuesday and Wednesday, the House will meet at 10:00 a.m. for Morning Hour debate and 12:00 p.m. for legislative business.  On Thursday, the House will meet at 9:00 a.m. for legislative business and recess immediately.  The House will reconvene at approximately 9:45 a.m. for the purposes of receiving, in a Joint Meeting with the Senate, the Honorable Petro Poroshenko, President of Ukraine.  The House will meet at 12:00 p.m. for legislative business.  On Friday, the House will meet at 9:00 a.m. for legislative business, with last votes expected no later than 3:00 p.m.

Legislation Considered Under Suspension of the Rules:

1)      H.R. 3593 – VA Construction Assistance Act of 2014, as amended (Rep. Coffman – Veterans’ Affairs)

2)      H.R. 5404 – Department of Veterans Affairs Expiring Authorities Act of 2014 (Rep. Denham – Veterans’ Affairs)

3)      H.R. 4276 – Veterans Traumatic Brain Injury Care Improvement Act of 2014 (Rep. Cassidy – Veterans’ Affairs)

4)      S. 2258 – Veterans’ Compensation Cost-of-Living Adjustment Act of 2014 (Sen. Begich – Veterans’ Affairs)

5)      H.R. 24 – Federal Reserve Transparency Act  (Rep. Broun – Oversight and Government Reform)

6)      H.R. 5169 – Senior Executive Service Accountability Act, as amended (Rep. Walberg – Oversight and Government Reform)

7)      H.R. 5170 – Federal Records Accountability Act of 2014, as amended (Rep. Meadows – Oversight and Government Reform)

8)      H.R. 5418 – To prohibit officers and employees of the Internal Revenue Service from using personal email accounts to conduct official business (Rep. Boustany – Ways and Means)

9)      H.R. 5419 – To amend the Internal Revenue Code of 1986 to provide for a right to an administrative appeal relating to adverse determinations of tax-exempt status of certain organizations (Rep. Boustany – Ways and Means)

10)   H.R. 5420 – To amend the Internal Revenue Code of 1986 to permit the release of information regarding the status of certain investigations (Rep. Boustany – Ways and Means)

11)   H.R. 3043 – Tribal General Welfare Exclusion Act (Rep. Nunes – Ways and Means)

12)   H.R. 495 – Free File Program Act of 2014, as amended (Rep. Roskam – Ways and Means)

13)   H.R. 4137 – Preserving Welfare for Needs Not Weed Act (Rep. Reichert – Ways and Means)

14)   H.R. 4994 – Improving Medicare Post-Acute Care Transformation (IMPACT) Act of 2014 (Rep. Camp – Ways and Means)

15)   H.R. __ – To amend title 49, United States Code, to provide for limitations on the fees charged to passengers of air carriers (Rep. Hudson – Homeland Security)

The House will also possibly consider the following legislation:

H.J. Res. 124Continuing Appropriations Resolution, 2015 (Rep. Rogers (KY) – Appropriations) (Subject to a Rule)

H.R. __ – American Energy Solutions for Lower Costs and More American Jobs Act (Rep. Terry – Natural Resources/Energy and Commerce) (Subject to a Rule)

H.R. __ – Jobs for America Act (Rep. Camp – Ways and Means) (Subject to a Rule)

EUROPEAN COMMISSION RELEASES IMPLEMENTATION REPORT ON RARE DISEASES

On 5 September 2014, the European Commission released the Implementation report on the Commission Communication on Rare Diseases: Europe’s challenges (COM(2008) 679 final) and Council Recommendation of 8 June 2009 on an action in the field of rare diseases (2009/C 151/02) (the “Implementation Report”).

As part of the European Commission’s drive to take action concerning rare diseases, the Implementation Report analyses the extent to which the Commission’s measures on rare diseases have been established.

The Implementation Report provides an overview of the European Union (“EU”) rare diseases strategy to date, including the Commission Communication (COM(2008) 679 final) and Council Recommendation (2009/C 151/02). Continue Reading

Cabinet Office publishes consultation on draft regulations on the statutory register of lobbyists under the Lobbying Act

In a consultation published yesterday, the Cabinet Office is seeking views on draft regulations relating to the statutory register of lobbyists that was introduced by the recently enacted Transparency of Lobbying, Non-Party Campaigning and Trade Union Administration Act 2014 (the “Lobbying Act“). Although the draft regulations are substantially concerned with the detailed administration of the register, there are a couple of interesting points to note about the consultation.

Continue Reading

Reform to the bedroom tax: the Affordable Homes Bill

Since 1 April 2013, new rules introduced by the Welfare Reform Act 2012 in a bid to reduce growth in welfare spending mean that most social housing tenants judged to have too much living space have had their housing benefit cut.

The policy is referred to by the Government as the “under-occupation deduction” or the removal of the “spare room subsidy”, but is commonly known as the “bedroom tax”. The bedroom tax has proved to be highly controversial because of its impact on vulnerable tenants who are penalised for having adapted homes or because their landlord or local authority does not provide appropriately sized housing.

However, this may be about to change after a private member’s bill, the Affordable Homes Bill (the “Bill“), was introduced by Liberal Democrat backbencher Mr Andrew George. Although the wording of the Bill is not entirely clear it appears to make two significant proposals that aim to help protect vulnerable tenants and soften the effect of the bedroom tax.

1.  The first proposal introduces three new exemptions to the bedroom tax.

a.  The first exemption will apply where an adaptation has been made to a home, in order to provide assistance for the disability needs of a claimant, a claimant’s partner or a close relative who lives at the dwelling. The claimant must be able to demonstrate to the relevant authority:

i.  that the adaptation is necessary for the disability;

ii.  it meets the needs of that disability; and

iii.  the cost of the adaptation is not less than a specified de minimis amount.

b.  The second exemption will apply to a claimant, a claimant’s partner or a close relative who lives at the dwelling and is in receipt of any component of Disability Living Allowance or Personal Independence Payment. If they can show that they cannot reasonably share a room due to their disability, the tenant will be allowed an additional room without a reduction of their housing benefit entitlement.

c.  The third exemption will exempt all claimants whose landlord or local authority has not made a “reasonable offer of alternative accommodation” where an extra room exists but is not needed.

2.  The second proposal aims to force the Government to secure a review of the availability of affordable and intermediate housing in England.

On 5 September 2014, MPs showed strong support for the Bill when they backed it at the second reading by 306 votes to 231.The Bill attracted significant media attention as a result of the Labour support for a Liberal Democrat Bill. Whether the Bill is robust enough to withstand a line by line analysis at the committee stage remains to be seen, but it does appear that there is hope for change.

FERC Largely Disclaims Jurisdiction Over Certain LNG Project Facilities; Incoming Chairman Bay Dissents in Part

On September 4, 2014, the Federal Energy Regulatory Commission (Commission or FERC) issued two orders declining to exercise jurisdiction over the siting and construction of two proposed liquefied natural gas (LNG) projects designed to liquefy domestic and imported natural gas and send it by truck, rail, or vessel to ultimate end-users of the LNG, while clarifying that it retains jurisdiction over certain sales of LNG in interstate commerce.

Read More: FERC Largely Disclaims Jurisdiction Over Certain LNG Project Facilities; Incoming Chairman Bay Dissents in Part

Legislative Week of September 8, 2014- September 12, 2014

Congress Returns After August Recess Break:

Congress returns for a short period until they break again for another recess to campaign for the November mid-term elections.  They are expected to return to their districts September 19th.  Priorities remaining on the congressional agenda include the future of Export-Import Bank and avoiding a government shutdown after September 3o.  Congress will most likely pass a short-term continuing resolution to keep the government funded most-likely through mid-December.   The measure has yet to be filed, but House lawmakers are expected to start work this week.  The Senate is expected to take up the CR later this month.  This will be leave Congress waiting until the lame-duck session to work on final appropriations.

Senate Legislative Activity

The Senate will convene at 2 p.m. and at 5:30 p.m.  The Senate will proceed to an Executive Session  to  vote on the nomination of a circuit court judge, as well as confirmation of three new members to the Social Security Advisory Board.  The chamber then votes on limiting debate on the motion to proceed to a joint resolution (S J Res 19) that would allow Congress to limit campaign contributions and expenditures:

  • Executive Calendar #848, Jill Pryor to be US Circuit Judge for the Eleventh Circuit.
  • Executive Calendar #910, Henry Aaron to be a Member of the Social Security Advisory Board.
  • Executive Calendar #911, Henry Aaron to be a Member of the Social Security Advisory Board (reappointment).
  • Executive Calendar #908, Alan Cohen to be a Member of the Social Security Advisory Board. (Expected voice vote).
  • Executive Calendar #909, Lanhee Chen to be a Member of the Social Security Advisory Board. (Expected voice vote).
  • The Senate will then proceed to a Legislative Session and vote on the Motion to Invoke Cloture on the Motion to Proceed to S.J. Res. 19 (Joint resolution proposing an amendment to the Constitution of the United States relating to contributions and expenditures intended to affect elections).

House Legislative Activity

MONDAY, SEPTEMBER 8, 2014
On Monday, the House will meet at 2:00 p.m. for legislative business, It is expected to consider 21 bills under suspension of the rules.  First votes are postponed until 6:30 p.m.

Legislation Considered Under Suspension of the Rules:

1)    S. 231 – Multinational Species Conservation Funds Semipostal Stamp Reauthorization (Sen. Portman – Oversight and Government Reform)

2)    H.R. 4939 – Designating the facility of the United States Postal Service located at 2551 Galena Avenue in Simi Valley, California, as the “Neil Havens Post Office” (Rep. McKeon – Oversight and Government Reform)

3)    H.R. 4651 – Designating the facility of the United States Postal Service located at 601 West Baker Road in Baytown, Texas as the “Specialist Keith Erin Grace Jr. Memorial Post Office” (Rep. Stockman – Oversight and Government Reform)

4)    H.R. 2819 – Designating the facility of the United States Postal Service located at 275 Front Street in Marietta, Ohio, as the “Veterans Memorial Post Office Building” (Rep. Johnson (OH) – Oversight and Government Reform)

5)    H.R. 5089 – Designating the facility of the United States Postal Service located at 2000 Mulford Road in Mulberry, Florida, as the “Sergeant First Class Daniel M. Ferguson Post Office” (Rep. Ross – Oversight and Government Reform)

6)    H.R. 2678 – Designating the facility of the United States Postal Service located at 10360 Southwest 186th Street in Miami, Florida, as the “Larcenia J. Bullard Post Office Building” (Rep. Garcia – Oversight and Government Reform)

7)    H.R. 5019 – Designating the facility of the United States Postal Service located at 1335 Jefferson Road in Rochester, New York, as the “Specialist Theodore Matthew Glende Post Office” (Rep. Slaughter – Oversight and Government Reform)

8)    H.R. 4443 – Designating the facility of the United States Postal Service located at 90 Vermilyea Avenue, in New York, New York, as the “Corporal Juan Mariel Alcantara Post Office Building” (Rep. Rangel – Oversight and Government Reform)

9)    H.R. 3957 – Designating the facility of the United States Postal Service located at 218–10 Merrick Boulevard in Springfield Gardens, New York, as the “Cynthia Jenkins Post Office Building” (Rep. Meeks – Oversight and Government Reform)

10) H.R. 78 – Designating the facility of the United States Postal Service located at 4110 Almeda Road in Houston, Texas, as the “George Thomas ‘Mickey’ Leland Post Office Building” (Rep. Jackson–Lee – Oversight and Government Reform)

11) H.R. 4189 – Designating the facility of the United States Postal Service located at 4000 Leap Road in Hilliard, Ohio, as the “Master Sergeant Shawn T. Hannon and Master Sergeant Jeffrey J. Rieck and Veterans Memorial Post Office Building”, as amended (Rep. Stivers – Oversight and Government Reform)

12) H.R. 5030 – Designating the facility of the United States Postal Service located at 13500 SW 250 Street in Princeton, Florida, as the “Corporal Christian A. Guzman Rivera Post Office Building” (Rep. Ros–Lehtinen – Oversight and Government Reform)

13) H.R. 5106 – Designating the facility of the United States Postal Service located at 100 Admiral Callaghan Lane in Vallejo, California, as the “Philmore Graham Post Office Building” (Rep. Thompson (CA) – Oversight and Government Reform)

14) H.R. 2495 – American Super Computing Leadership Act, as amended (Rep. Hultgren – Science, Space, and Technology)

15) H.R. 5309 – Tsunami Warning, Education, and Research Act of 2014 (Rep. Bonamici – Science, Space, and Technology)

16) H.R. 744 – Stopping Tax Offenders and Prosecuting Identity Theft Act of 2014 (Rep. Wasserman Schultz – Judiciary)

17) H.R. 3109 – To amend the Migratory Bird Treaty Act to exempt certain Alaskan Native articles from prohibitions against sale of items containing nonedible migratory bird parts (Rep. Young (AK) – Natural Resources)

18) H.R. 4283 – To amend the Wild and Scenic Rivers Act to authorize the Secretary of the Interior to maintain or replace certain facilities and structures for commercial recreation services at Smith Gulch in Idaho (Rep. Simpson – Natural Resources)

19) H.J.Res. 120 – Approving the location of a memorial to commemorate the more than 5,000 slaves and free Black persons who fought for independence in the American Revolution (Rep. Butterfield – Natural Resources)

20) H.R. 4527 – To remove a use restriction on land formerly a part of Acadia National Park that was transferred to the town of Tremont, Maine (Rep. Michaud – Natural Resources)

21) H.R. 4751 – To make technical corrections to Public Law 110‐229 to reflect the renaming of the Bainbridge Island Japanese American Exclusion Memorial (Rep. Kilmer – Natural Resources)

TUESDAY, SEPTEMBER 9, 2014 AND THE BALANCE OF THE WEEK
On Tuesday and Wednesday, the House will meet at 10:00 a.m. for Morning Hour debate and 12:00 p.m. for legislative business.

On Thursday, the House will meet at 9:00 a.m. for legislative business. Last votes are expected no later than 3:00 p.m.

On Friday, the House will not be in session.

Legislation Considered Under Suspension of the Rules:

1)    H.R. 5057 – EPS Service Parts Act of 2014, as amended (Rep. Gardner – Energy and Commerce)

2)    S. 276 – A bill to reinstate and extend the deadline for commencement of construction of a hydroelectric project involving the American Falls Reservoir (Sen. Risch – Energy and Commerce)

3)    H.R. 5161 – E–LABEL Act (Rep. Latta – Energy and Commerce)

4)    H.R. 4067 – To provide for the extension of the enforcement instruction on supervision requirements for outpatient therapeutic services in critical access and small rural hospitals through 2014 (Rep. Jenkins – Energy and Commerce)

5)    H.R. 4701 – Vector–Borne Disease Research Accountability and Transparency Act of 2014, as amended (Rep. Gibson – Energy and Commerce)

6)    H.R. 4290 – Wakefield Act of 2014 (Rep. Matheson – Energy and Commerce)

7)    H.R. 3670 – Anti–Spoofing Act (Rep. Meng – Energy and Commerce)

8)    H.R. 669 – Sudden Unexpected Death Data Enhancement and Awareness Act (Rep. Pallone – Energy and Commerce)

H.R. 5078 – Waters of the United States Regulatory Overreach Protection Act of 2014 (Rep. Southerland – Transportation and Infrastructure) (Subject to a Rule)

H.Res. 644 – Condemning and disapproving of the Obama administration’s failure to comply with the lawful statutory requirement to notify Congress before releasing the Taliban 5 (Rep. Rigell – Armed Services) (Subject to a Rule)

H.R. 3522 – Employee Health Care Protection Act (Rep. Cassidy – Energy and Commerce/Ways and Means) (Subject to a Rule)

Possible Consideration of a Continuing Resolution to Fund Government Operations for Fiscal Year 2015

Federal Circuit Revives Certain Sham Petitioning Antitrust Counterclaims in Tyco-Mutual ANDA Litigation

In a split decision, the U.S. Court of Appeals for the Federal Circuit affirmed summary judgment on two antitrust counterclaims brought by Mutual Pharmaceutical Co. (“Mutual”) against Tyco Healthcare Group (“Tyco”), while vacating summary judgment on two others.  Although the ruling is just the latest in a long line of cases analyzing sham petitioning issues related to the pharmaceutical space, the approach taken by the court could result in many more of these cases advancing far into litigation, and in some cases to a full trial if adopted by other courts. Continue Reading

FDA Issues Two Proposed Guidance Documents For Laboratory Developed Tests

On July 31, 2014, FDA provided Congress advance copies of two proposed guidance documents regarding Laboratory Developed Tests (LDTs), which the Agency had planned to issue 60 days later.  The first is titled FDA Notification and Medical Device Reporting for Laboratory Developed Tests; the second is Framework for Regulatory Oversight of Laboratory Developed Tests.  (A copy of the two proposed guidance documents can be found at the following link.)

FDA was required to provide advance notice to Congress for these guidance documents under Section 1143 of the Food and Drug Administration Safety and Innovation Act of 2012.  Both documents generally reiterate the risk-based approach to regulation of LDTs that FDA articulated in previous communications.  However, the Agency has now provided specific compliance deadlines for this class of products. Continue Reading